Crucell corporate brochure (PDF)

Bringing innovation to global health 

Crucell 2010 

www.crucell.com

Contents 

Research and development – see page 12 

Technologies – see page 20 

Products – see page 26 

Our mission 

Crucell’s mission is to protect human lives 

from infectious diseases by bringing meaningful 

innovation to global health. 

Crucell is a global biopharmaceutical company focusing on the research 

and development, production and marketing of vaccines and antibodies 

against infectious disease worldwide. Currently we are combating 

twelve major infectious diseases with our range of marketed vaccines 

in the paediatric, travel and endemic, and respiratory fields. 

In this report you can read all about our mission, vision, strategic pillars 

and our commitment to the principles of Corporate Social Responsibility. 

For inquiries, please contact Corporate Communications. 

Email: communications@crucell.com. 

Overview 

Crucell at a glance 02 

Crucell: A global perspective 06 

Message from our CEO 08 

Our business 

Research and development, technologies and products 10 

Research and development 12 

Technologies 20 

Products 26 

Crucell’s commitment to the world 

Taking responsibility 32 

CSR highlights in 2010 35 

Our CSR policy 36 

Our CSR achievements, ambitions and targets 40

2010 key highlights 

Revenues and other operating income 

2010 Revenues and other operating income 

(€ million) 105+ 

2010 Product sales 

(€290.6 million) 

61% 

25% 

7% 

7% 

Product sales 290.6 

License revenues 32.7 

Service fees 6.5 

Other operating income, 

e.g. grants 35.6 

Total 365.4 

Paediatric 

Travel and endemic 

Respiratory 

Other 

mln 

Vaccine doses distributed in 2010 

In more than 100 countries around the world. 

€100.0 mln 

Research and development investment in 2010 

Compared to €70.2 mln in 2009. 

€290.6 mln 

Product sales in 2010 

€365.4 mln 

Total revenues and other operating income in 2010 

Compared to €358.0 mln in 2009. 

01

02 

Overview 

Crucell at a glance 

www.crucell.com

Overview – Crucell at a glance 

Crucell is a global biopharmaceutical company 

dedicated to bringing meaningful innovation to 

global health. We do this by discovering, developing, 

manufacturing and marketing products that 

combat major threats to the health of people 

worldwide. Our specialty is fighting infectious 

diseases—a growing healthcare challenge. 

03

04 


Our Company 

Innovation is the driving force behind our strong research and development 

(R&D) pipeline, with promising products in pre-clinical and clinical 

development. In 2010 alone, Crucell distributed more than 105 million 1 

vaccine doses in more than 100 countries around the world, and 

invested €100.0 million in R&D. 

Crucell is deeply committed to being a good corporate citizen: 

a company that creates significant value for society. Our mission is 

to make a truly meaningful contribution to global health by directing 

our proven talent for innovation towards the fight against infectious 

diseases. An entrepreneurial mind-set and social responsibility go 

hand-in-hand at Crucell. 

In 2010, 1,400 dedicated and skilled Crucell employees worldwide 

worked to bring significant benefit to the lives of people worldwide. We 

are fully committed to the principles of corporate social responsibility 

(CSR) and place great value on doing more to benefit society than we 

strictly ‘must’ do. Our mission underlies everything we do, from our core 

business activities to the sharing of scientific knowledge and community 

outreach programs in countries where help is needed the most. 

The combination of our innovative technologies, our core values and 

creative minds drives Crucell’s success, which we measure in human 

and business terms. 

Crucell is headquartered in Leiden, the Netherlands, with offices in 

China, Indonesia, Italy, Korea, Malaysia, Spain, Sweden, Switzerland, 

UK, the USA and Vietnam. 

Our strategy 

Infectious diseases are a major cause of illness and death throughout 

the world. The number of infectious outbreaks is increasing for many 

reasons: higher population density raises exposure to infectious agents, 

an aging population is more susceptible to infection, and a rise in 

1 Figure based on Crucell’s top five vaccines in terms of sales volumes: 

Quinvaxem®, Hepavax-Gene®, Epaxal®, Vivotif® and Inflexal® V. 

www.crucell.com 

global travel boosts the potential for spreading diseases across 

borders. In addition, natural disasters can have a devastating impact 

on sanitation, hygiene, infrastructure and healthcare facilities. 

At Crucell, we are dedicated to saving lives and preventing illness around 

the world. We focus strongly on unmet medical needs in developing 

countries, where infectious diseases exert their greatest toll. At the 

same time, we work to protect travelers and vulnerable groups living 

in industrialized countries. 

We target major health threats that demand innovative solutions, 

striving to lead rather than follow. We focus on infectious diseases 

because these pose an increasingly serious threat to the health of people 

worldwide—and we have the expertise to make a real difference in 

this disease area. 

The combination of our scientific know-how, innovative technologies 

and quality products positions Crucell to become a major player in the 

biopharmaceutical arena. 

Our strategy is based on three business drivers: 

1. A strong R&D pipeline with promising products in a range 

of major disease areas. 

2. Cutting-edge technologies that enable the discovery, 

development and production of biopharmaceutical products. 

These proprietary technologies drive in-house innovation and 

generate licensing revenue. 

3. A broad range of marketed vaccine products that together 

combat 12 major infectious diseases. 

1. Our strong research and development pipeline 

Innovation is the driving force behind our strong and broad R&D 

pipeline, with promising products in pre-clinical and clinical development. 

Product candidates include flu-mAb, an antibody effective against a


broad range of influenza virus strains, tuberculosis and malaria vaccines, 

and a rabies monoclonal antibody combination – all produced on our 

unique PER.C6® human cell-line technology. Read more on page 12. 

2. Our cutting-edge technologies 

Crucell’s proprietary technologies offer unique advantages for 

biopharmaceutical innovation. This competitive edge is exemplified 

by our PER.C6® technology, which is ideally suited to the manufacture 

of vaccines and therapeutic proteins, such as antibodies. Compared to 

traditional production platforms, PER.C6® human cell-line technology 

provides higher yields at lower cost, as well as safety advantages. 

Crucell licenses its PER.C6® technology and other technologies to the 

biopharmaceutical industry. Important partners and licensees include, 

among others, Johnson & Johnson, DSM Biologics, Merck & Co., 

Novartis, sanofi pasteur and Pfizer/Wyeth. Read more on page 20. 

3. Our broad range of innovative products 

Vaccines play a vital role in protecting against diseases and have 

contributed significantly to the improvement of global health. Currently 

we are combating twelve major infectious diseases with our range of 

marketed vaccines in the paediatric, travel and endemic, and respiratory 

fields. We are one of the major suppliers of vaccines to supranational 

organizations in the developing world, and the first manufacturer 

to launch a fully liquid pentavalent vaccine, called Quinvaxem®. 

This innovative combination vaccine protects against five important 

childhood diseases. Over 200 million doses have been sold since its 

launch in 2006 in more than 50 GAVI (the Global Alliance for Vaccines 

and Immunisation) countries. With this innovation, Crucell has become 

a major partner in protecting children in developing countries. Other 

products in Crucell’s core portfolio include Hepavax-Gene®, a vaccine 

against hepatitis B; Epaxal®, the only aluminum-free hepatitis A vaccine 

on the market; Vivotif® and Dukoral®, oral vaccines against typhoid 

and cholera, respectively; and Inflexal® V, a virosomal adjuvanted 

vaccine against influenza. Read more on page 26. 

Partners and licensees 

In addition to our own R&D activities, we have strategic partnerships 

with several leading healthcare companies, such as Johnson & Johnson, 

DSM Biologics, Merck, Novartis and sanofi pasteur. Through these 

agreements, our technologies play a vital role in the development 

of a vast number of vaccines and antibody products. 

05

06 

Overview 

Crucell: A global perspective 


9 

1. China 

Marketing and sales. 

2. Italy 


3. Korea 

Marketing and sales 

+ Manufacturing. 

5 

8 4 

7 

2 

6 

4. Netherlands (Headquarters) 


5. Spain 



6. Sweden 



1 

7. Switzerland 



8. UK 


9. USA 


3

Overview – Crucell: A global perspective 

Research and development 

Vaccines in development: 

Flavimun® yellow fever vaccine. 

Influenza Seasonal cell-based seasonal vaccine. 

Universal Influenza cell-based 

universal vaccine. 

Tuberculosis recombinant AdVac®based 

vaccine. 

Malaria recombinant AdVac®based 

vaccine. 

Ebola and Marburg recombinant AdVac®based 

vaccine. 

Technologies 

PER.C6® human cell line for development 

and manufacturing. 

AdVac® used with PER.C6® to develop 

recombinant vaccines. 

MAbstract® to discover novel drug targets 

and identify human monoclonal antibodies. 

Products 

Paediatric: 

Quinvaxem® fully liquid vaccine to protect 

against five important childhood diseases. 

Hepavax-Gene® recombinant hepatitis B 

vaccine. 

Epaxal® Junior low dosage, aluminum-free 

hepatitis A vaccine. 

MoRu-Viraten® vaccine for protection 

against measles and rubella. 

HIV recombinant AdVac®-based vaccine. 

HPV recombinant AdVac®-based vaccine. 

RSV recombinant AdVac®-based vaccine. 

Human monoclonal antibodies 

in development: 

Rabies antibody combination. 

Influenza antibodies. 

Hepatitis C antibody combination. 

Details on page 12 

STAR® to enhance yields of recombinant 

human antibodies and proteins. 

Virosome a vehicle enabling the use of 

virus antigens in the making of vaccines. 


Travel and endemic: 

Epaxal® aluminum-free hepatitis A vaccine. 

Vivotif® oral typhoid vaccine. 

Dukoral® only internationally licensed 

oral vaccine against cholera (and ETEC). 

Respiratory: 

Inflexal® V virosomal adjuvanted 

influenza vaccine. 


07

08 

Overview 

Message from our CEO 

Crucell’s mission to bring meaningful 

innovation to global health reflects a deep 

commitment to improving the lives of people 

worldwide. This underpins everything we do 

as a global organization and as individuals 

united by a common purpose. 

1 Figure based on Crucell’s top five vaccines in terms of sales volumes: Quinvaxem®, 

Hepavax-Gene®, Epaxal®, Vivotif® and Inflexal® V. 

2 Figures based on Crucell’s top 5 vaccines Quinvaxem®, Hepavax-Gene®, Epaxal®, Vivotif® 

and Inflexal® V. Total 101,666,000 doses minus 2% waste (2,033,320 doses) = 99,632,680 

doses sold in 2010 / 525600 minutes in 2010 = 189.5598 doses administered per minute. 


I am therefore delighted that talks held with Johnson & Johnson 

during 2010 have resulted in Crucell becoming the center of excellence 

for vaccines within the world’s largest and possibly most respected 

healthcare company. As a member of the Johnson & Johnson Family 

of Companies, we can do so much more to make the world we live in 

a healthier place. The combination of our two companies will enable 

Crucell to further accelerate growth, and our shared expertise and 

talent will help to make an even bigger difference in the lives of people 

worldwide. We are delighted by the prospect of pursuing our mission 

with the support of Johnson & Johnson that shares our passion for 

healthcare innovation, our values and our commitment to care for people. 

Protecting and contributing to society in the fullest possible sense 

and to the best of our ability is our core business, our passion 

and the essence of our company. Our commitment to the principles 

of corporate social responsibility is a logical extension of our mission 

to bring innovation to global health, focusing especially on the 

prevention of infectious diseases. 

During 2010, we distributed over 105 million 1 doses of vaccines 

to people around the world, with the majority going to infants in 

developing countries. The range of vaccines we have on the market 

prevents twelve major infectious diseases: childhood infections, travel 

and endemic illnesses, and respiratory disease. We estimate that a 

Crucell vaccine was given to 190 individuals 2 every minute during 2010, 

a thought that makes us very proud. 

However, I believe that the best measure of our impact on global health 

is not the number of doses we supply, but the number of deaths and 

cases of disease we prevent each year. In 2010, Crucell’s ‘top-five’ 

vaccines prevented more than 3.6 million cases of infectious disease 

and 809,823 deaths. 1 

Crucell’s core business is the discovery, development and delivery 

of innovative solutions for major health threats. Our specialty is the 

creation of much-needed immunization products: vaccines that safely

Overview – Message from our CEO 

and effectively mobilize the body’s own immune defenses against 

infections, and antibodies that provide ‘ready-made’ immune protection 

against invading microbes. After clean water, immunization is believed 

to be the most cost-effective health intervention and its key role in 

promoting the socioeconomic development of countries is becoming 

increasingly clear. 

The world population is predicted to reach 7 billion in 2011 and 

protecting these billions of individuals from infectious diseases is more 

important and challenging than ever. Trends such as climate change, 

globalization, urbanization, wider travel and population aging are 

presenting new opportunities for infectious pathogens to thrive 

and spread. Doing our utmost to tackle this problem is our primary 

responsibility and our privilege. It lies at the heart of Crucell. More 

importantly, I see that we are expanding the boundaries of that reality, 

day by day. Innovation is the foundation on which Crucell was built, 

and the fuel driving us forward. 

“ Crucell’s core business is the discovery, 

development and delivery of innovative 

solutions for major health threats.” 

Our achievements so far are thanks to the tireless efforts and 

dedication of our loyal employees, Crucell’s most important asset. 

In 2010 hundreds of talented people were recruited in order to further 

boost our capacity to bring innovation to global health going forward. 

Ronald H.P. Brus 

President and Chief Executive Officer 

Leiden, the Netherlands, April 18, 2011 

Improving healthcare access 

The cover photograph of this 

booklet shows an Expanded 

Program on Immunization (EPI) 

session set up by the nongovernmental 

organization 

Friendship in collaboration with 

local governmental agents in 

Bangladesh. The mothers holding 

young babies are waiting in line 

for their infants to receive Crucell’s 

Quinvaxem® vaccine. With support from Crucell, Friendship has 

set up the cold chain to enable children in these remote char areas 

to be immunized. This initiative is one of many described in our 

corporate social responsibility (CSR) report in this booklet. 

The EPI was established by the World Health Organization (WHO) 

in 1974 with the aim of ensuring that all children in all countries 

benefit from life-saving vaccines. The first diseases targeted by the 

EPI were diphtheria, pertussis (whooping cough), tetanus, measles, 

poliomyelitis and tuberculosis. In 1977, the WHO established global 

policies for immunization and set the goal of universal immunization 

for all children by 1990, as an essential element of the WHO 

strategy to achieve health for all. 

In 2009, an estimated 82% of children globally had received 

at least three doses of diphtheria–tetanus—pertussis vaccine 

(DTP3) by one year of age, which has traditionally been used as an 

indicator of EPI coverage. Additional vaccines have progressively 

been added to the original six recommended by the WHO in 1974. 

The EPI remains committed to the goal of universal access to all 

relevant vaccines for all at risk. 

Information on the EPI was sourced from the WHO website. 

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10 

Our business 

Research and development, technologies and products 

At Crucell we bring meaningful innovation to global 

health. We do this by discovering, developing, 

manufacturing and marketing products that combat 

major threats to the health of people worldwide. Our 

specialty is fighting infectious diseases—a growing 

healthcare challenge. In the following pages 

we highlight Crucell’s key innovations in the field 

of research and development, our cutting-edge 

technologies and robust product portfolio. 

€100.0 mln 

Invested in research and development in 2010. 

105+ mln 

Doses distributed in 2010. 

100 countries 

Crucell vaccines were distributed in more than 100 countries in 2010. 



Technologies 

Products

Our business – Research and development, technologies and products 

Development stage Discovery/ 

Pre-clinical 

Phase I Phase II Phase III Marketed Description 

Marketed products: 

Quinvaxem® Fully liquid vaccine for protection against five childhood diseases. 

Hepavax-Gene® Recombinant hepatitis B vaccine. 

Epaxal® Junior Low-dosage, aluminum-free hepatitis A vaccine (0.25ml). 

MoRu-Viraten® Vaccine for protection against measles and rubella. 

Epaxal® Aluminum-free hepatitis A vaccine. 

Vivotif® Oral typhoid vaccine. 

Dukoral® Only internationally licensed oral vaccine against cholera. 

Inflexal® V 

Vaccines in development: 

Virosomal adjuvanted influenza vaccine. 

Flavimun® Yellow fever vaccine. 

Tuberculosis Recombinant AdVac®-based tuberculosis vaccine. 1 

Malaria Recombinant AdVac®-based malaria vaccine. 2 

Ebola and Marburg Recombinant AdVac®-based Ebola and Marburg vaccine. 2 

HIV Recombinant AdVac®-based HIV vaccine. 3 

Cell-based Influenza Seasonal influenza vaccine produced on PER.C6.® 

Universal influenza Universal influenza vaccine produced on PER.C6.® 

HPV Recombinant AdVac®-based HPV vaccine. 4 

RSV Recombinant AdVac®-based RSV vaccine. 5 

Human monoclonal antibodies in development: 

Rabies antibody combination 

Mix of two monoclonal antibodies for post-exposure 

treatment of rabies. 6 

Influenza antibodies 

Hepatitis C antibody 

combination 

1 Partnered with Aeras. 

2 Partnered with NIH/NIAID, GSK. 

3 Partnered with Harvard. 

4 Human papilloma virus (HPV), partnered with Johnson & Johnson. 

5 Respiratory syncytial virus (RSV), partnered with Johnson & Johnson. 

6 Partnered with sanofi pasteur. 

Antibodies neutralizing a wide range of influenza subtypes, 

including H5 and H1. 

Neutralizing monoclonal antibody combination across all 

genotypes tested. 

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12 

Our business 


www.crucell.com

Our business – Research and development 

Crucell’s research efforts focus on developing 

vaccines and antibodies that address infectious 

disease and unmet medical needs. In this section 

you can read more about the discovery and 

development of next-generation medical products 

facilitated by our range of innovative technologies. 

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Our strong research and development pipeline 

Innovation is the driving force behind Crucell’s future growth supported 

by a strong R&D pipeline. Our scientists focus on the discovery and 

development of much-needed solutions for major threats to human 

health—particularly vaccines and antibodies for the prevention and 

treatment of infectious diseases. This has resulted in a broad pipeline 

of investigational products with the potential to revolutionize the fight 

against diseases such as influenza, rabies, malaria and tuberculosis. 

Vaccine development: based on AdVac® technology 

AdVac® technology involves the use of novel adenoviral vectors, such 

as Ad35 and Ad26, in vaccines for diseases caused by viruses, bacteria 

or parasites. These vectors are harmless adenoviruses that have been 

disabled so that they cannot replicate. A vector functions as an efficient 

‘gene taxi’, delivering into the human body a fragment of DNA that 

carries the code for a protein of a specific pathogen. Once inside the 

body, the vectors express (produce) these proteins and present them 

to the person’s immune system, which mounts its protective response. 

Using this versatile vaccine vector platform in combination with our 

PER.C6® manufacturing technology, we are working with our partners 

to develop vaccines against major threats to human health, including 

tuberculosis, malaria, Ebola and Marburg, HIV, human papilloma virus 

(HPV) and respiratory syncytial virus (RSV). See page 17. 

Tuberculosis (Phase II) 

Crucell joined forces with the nongovernmental organization (NGO) 

Aeras Global TB Vaccine Foundation in 2004 to develop a safe, effective 

and affordable vaccine against tuberculosis (TB). The traditional TB 

vaccine developed more than 85 years ago, Bacille Calmette Guérin 

(BCG), does not reliably prevent pulmonary disease—the most common 

form of TB—so there is a great need for a better alternative. 

Together with Aeras, we are developing the novel TB vaccine candidate 

AERAS-402/Crucell Ad35. The vaccine is based on Crucell’s innovative 

AdVac® technology, which uses novel harmless adenoviruses as vaccine 

vectors (vehicles). We are using the adenovirus 35 (Ad35) vector for this 

particular vaccine. 


AERAS-402/Crucell Ad35 is being designed as a ‘booster’ vaccine that 

will be given to people who have previously been vaccinated with 

the traditional TB vaccine or an improved, recombinant version of the 

BCG vaccine that is being developed by Aeras. The BCG vaccine will prime 

(prepare) the immune system to fight off TB infection and the AERAS-402/ 

Crucell Ad35 will be given later to boost this initial immune response. 

Data from AERAS-402/Crucell Ad35 clinical trials (Phase I and II) support the 

immunogenicity and acceptable safety profile of the candidate TB vaccine. 

In 2009, an estimated 1.7 million people 

died of tuberculosis. 

Source: WHO, Global TB Control 2010 report. 

Tuberculosis 

Estimated new TB cases (all forms) per 100,000 population in 2009. 

0–24 

25–49 

50–99 

100–299 

>300 

No estimate


Malaria 

Countries or areas at risk of transmission in 2009. 

Transmission occurs 

Limited risk of transmission 

No report 

Source: WHO, World Malaria Report 2010. 

Malaria (Phase I) 

Malaria is one of the most prevalent infections in tropical and subtropical 

regions. Children and pregnant women are most severely affected. 

According to the World Health Organization (WHO), half of the world’s 

population is at risk of malaria, and an estimated 225 million cases led 

to 781,000 deaths in 2009. There is currently no licensed vaccine to 

protect people against malaria, a disease caused by infection with the 

Plasmodium parasite and transmitted by mosquitoes. Therapies are 

available for malaria patients, but the worsening problem of drug 

resistance in many parts of the world is making adequate treatment and 

control of malaria increasingly difficult. In addition, many insecticides 

are no longer useful against the mosquitoes that transmit the disease. 

Crucell is working in collaboration with a number of research groups 

to develop a safe, effective and affordable vaccine against Plasmodium 

falciparum, the most lethal of the four species of malaria parasite that 

infect humans. Crucell’s approach is based on our innovative AdVac® 

technology, which uses novel, harmless adenoviruses as vaccine 

delivery vehicles (vectors). 

In April, 2010, Crucell entered into an agreement with GlaxoSmithKline 

Biologicals (GSK) to collaborate on developing a second-generation 

malaria vaccine candidate. Crucell is contributing the recombinant 

malaria vaccine candidate Ad35-CS, based on Crucell’s PER.C6® and 

AdVac® technologies, while GSK is contributing its late-stage malaria 

vaccine candidate RTS,S/AS. The collaborative partners aim to advance 

this new vaccine candidate into human clinical studies with the support 

of the PATH Malaria Vaccine Initiative (MVI). Clinical efficacy challenge 

trials sponsored by the MVI will be initiated in 2011 at the US Walter 

Reed Army Institute of Research, providing all agreements are finalized. 

Pending the results of these Phase I/IIa trials, Crucell and GSK expect 

to advance the prime boost candidate in further clinical studies with 

the support of public or non-profit partners who are interested in 

accelerating the development of a malaria vaccine. 

In May 2010, Crucell announced the start of a new Phase I clinical study 

in Burkina Faso, West Africa. Crucell is developing its malaria vaccine 

vector, Ad35-CS, in collaboration with National Institute of Allergy 

and Infectious Diseases (NIAID)/ National Institutes of Health (NIH), 

the Centre National de Recherche et de Formation sur le Paludisme 

(CNRFP) in Burkina Faso, and the Noguchi Memorial Institute for Medical 

Research at the University of Ghana. Enrolment has been completed 

and boost vaccinations are ongoing. This is the first study evaluating 

the safety and immunogenicity of this AdVac®-based malaria vaccine 

vector candidate in a population living in a malaria endemic area. 

Ebola and Marburg (Phase I) 

Ebola and Marburg are among the world’s most lethal viral diseases. 

Both Ebola and Marburg are among the few viruses causing hemorrhagic 

fever, a severe, often fatal disease in humans. There are currently no 

vaccines or antiviral therapies available for either disease. 

Crucell is developing a multivalent filovirus vaccine against Ebola 

and Marburg in collaboration with the Vaccine Research Center of the 

US National Institute of Allergy and Infectious Diseases (NIAID), 

part of the National Institutes of Health (NIH). 

The candidate vaccine is based on Crucell’s proprietary adenoviral 

vector technology and is produced using Crucell’s PER.C6® technology. 

15

16 


HIV (Phase I) 

Human immunodeficiency virus (HIV) is a retrovirus that causes acquired 

immune deficiency syndrome (AIDS), a condition in which the immune 

system progressively fails, leading to life-threatening infections. Over the 

past 25 years, HIV infection resulting in AIDS has claimed millions of lives, 

devastated communities, and enormously frustrated efforts to fight 

poverty, improve global health and promote economic development. 

According to the 2010 Progress Report (a joint report by UNAIDS, 

Unicef and WHO), the HIV epidemic remains a major global public health 

challenge, with a total of 33.4 million people living with HIV worldwide. 

In 2008 alone, 2.7 million people were newly infected with HIV. 

1 Source: WHO, factsheet on rabies. 


In August 2010, Crucell announced its participation in an international 

Phase I clinical trial in the United States and Africa of a combination 

of two AdVac®-based AIDS vaccine candidates, Ad26.ENVA.01 and 

Ad35-ENV, in healthy adults who are not infected with HIV. The clinical 

trial, which will be led by the International AIDS Vaccine Initiative (IAVI), 

represents a collaboration between IAVI, Crucell, the Ragon Institute, 

and Beth Israel Deaconess Medical Center (BIDMC), a major teaching 

hospital of Harvard Medical School. 

In 2008, an estimated 2.7 million people 

were newly infected with HIV. 

Source: WHO. 

Every 17,5 seconds one person dies of AIDS. 

Source: Stop Aids Now! 

The Ad26.ENVA.01 vaccine candidate used in this study is developed 

and manufactured by Crucell, while the Ad35-ENV vaccine is developed 

by IAVI. Both vaccines candidates are based on Crucell’s proprietary 

AdVac® technology. The planned Phase 1 trial of the vaccine combination 

represents a key step towards proof of concept studies to evaluate the 

efficacy of the vaccine combination in humans. 

HPV (Discovery/Pre-clinical) 

Genital infection with human papilloma virus (HPV) is very common in 

both men and women and usually spontaneously clears within one year 

after infection. In about 1% of individuals, however, HPV persists and 

ultimately results in genital neoplastic lesions.


In November 2010, Crucell announced the start of a discovery program 

leading to the development and commercialization of a therapeutic 

HPV vaccine. The discovery program is part of a strategic collaboration, 

signed in September 2009 with Johnson & Johnson, through its 

subsidiary Ortho-McNeil-Janssen Pharmaceuticals, Inc., to develop 

innovative products, including antibodies for influenza prevention 

and treatment. 

RSV (Discovery/Pre-clinical) 

Respiratory syncytial virus (RSV) is the most important cause of viral 

lower respiratory tract illness in infants and children. RSV-induced disease 

is the last of the major paediatric diseases for which no preventive 

vaccine is available. Current prevention in developed countries is based 

on the administration of a costly RSV-neutralizing antibody, which is 

given to high-risk infants, in particular premature newborns. RSV also 

induces severe disease in immunocompromized adults and elderly 

people with weak immune systems, for whom the RSV antibody is 

not available. 

In June 2010, Crucell announced the start of a discovery program 

leading to the development and commercialization of a universal RSV 

vaccine. The vaccine will be designed to prevent severe infections with 

the most common RSV strains in infants and the elderly. This discovery 

program is part of a strategic collaboration with Johnson & Johnson, 

signed in September 2009. 

As an encouragement towards the RSV research community, Crucell 

sponsored the VII Respiratory Syncytial Virus Symposium held in 

December 2010 and established the Innovation Award for RSV Research. 

This support highlights Crucell’s long-standing commitment to improve 

the health of people worldwide by advancing the fight against 

infectious diseases. 

Antibody development 

Antibodies are proteins made naturally by cells of the body’s immune 

system. They function as one of the body’s principal defense mechanisms 

against pathogens—disease-causing agents such as parasites, viruses 

or bacteria. As antibodies recognize and bind to invading pathogens, 

ultimately eliminating them, they play a crucial role in protecting 

humans against disease. 

Rabies antibody combination (Phase II) 

Rabies is a viral disease of mammals and is most often transmitted 

through the bite of a rabid animal. The virus infects the central nervous 

system, causing encephalitis (inflammation of the brain) and ultimately 

death if appropriate medical intervention is not given promptly. Every 

year, more than 15 million people worldwide receive a post-exposure 

preventive regimen to avert the disease. This is estimated to prevent 

327,000 rabies deaths annually. 1 

Nevertheless, an estimated 55,000 individuals exposed to rabies 

virus—mostly children—die each year. Most of those who die receive 

a rabies vaccine only, rather than the proper post-exposure treatment 

consisting of anti-rabies antibodies as well as a vaccine. Concerns 

about the availability and safety of the current, blood-derived 

antibody treatment have prompted the search for a safe, effective 

and affordable alternative. 

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18 


An estimated 55,000 individuals exposed to 

rabies virus—mostly children—die each year. 

Source: WHO. 

Crucell scientists in collaboration with scientists from Thomas Jefferson 

University (TJU) in Philadelphia and the US Centers for Disease Control 

and Prevention in Atlanta, USA to discover a combination of human 

monoclonal antibodies (mAbs) for the post-exposure treatment of 

rabies. Crucell’s innovative MAbstract® and PER.C6® technologies played 

a crucial role in the discovery and development of this promising therapy. 

The candidate mAb product is designed to be used together with rabies 

vaccine. Preclinical studies conducted during 2004 indicated that the 

mAb combination could neutralize (inactivate) rabies virus at least 

as effectively as blood-derived human rabies immune globulin (HRIG), 

the current gold standard for providing immediate protection against 

rabies virus. Since then, the rabies mAb combination has successfully 

progressed through phase I clinical trials in the USA and India (in 2006–7) 

and phase II trials in the USA and the Philippines. 

1 Source: US National Library of Medicine, National Institute of Health. 


Since January 2008, the route toward global availability of this 

next-generation, life-saving rabies biological has been facilitated by 

a strategic partnership between Crucell and sanofi pasteur, a world 

leader in rabies immunization. Under the terms of this agreement, 

Crucell will be responsible for manufacturing the commercial product 

and has retained exclusive distribution rights in Europe, co-exclusive 

distribution rights in China and the rights to sell to supranational 

organizations, while sanofi pasteur will have exclusive distribution 

rights for all other territories and co-exclusive distribution rights 

in China. 

A planned Phase II trial in India is expected to start in the first half 

of 2011. This study is designed to collect data on the safety and 

neutralizing activity of the rabies antibody combination plus vaccine 

in a simulated rabies post-exposure prophylaxis setting. 

The US Food and Drug Administration (FDA) has granted the rabies mAb 

combination Fast Track status, paving the way for priority handling 

of the regulatory dossier. 

Human monoclonal antibodies against a broad range of influenza 

strains (Pre-clinical) 

Imagine a single product that could solve all the problems currently 

limiting influenza control. It would have to reliably protect all subgroups 

of the population—especially the elderly—against serious illness 

and death, regardless of the causal viral strain. Ideally, it would both 

prevent and cure influenza. 

In December 2008, Crucell announced the discovery of a new class of 

mAbs with this extraordinary potential. Crucell also reported the results 

of preclinical studies involving a representative of this new mAb class, 

CR6261. The antibody was shown to neutralize a broad range of 

influenza viruses, including the currently circulating H1N1 seasonal 

flu strains (genetic descendants of the virus responsible for 40 million 

deaths during the pandemic of 1918–1919) and the highly pathogenic 

H5N1 (‘bird flu’) virus. More recent tests have shown that CR6261 

also combats the novel H1N1 virus that caused the 2009 pandemic.


In a pre-clinical study comparing CR6261 with the leading antiviral 

drug, oseltamivir, Crucell’s mAb strongly outperformed oseltamivir for 

influenza prevention and treatment. The study showed that CR6261 

provides immediate protection against influenza viruses, suggesting 

that it will be able to prevent disease spread and therefore ward off 

a threatening pandemic. In contrast, oseltamivir was less effective 

and in some cases, not effective at all. 

In September 2009, Johnson & Johnson, through its subsidiary 

Ortho-McNeil-Janssen Pharmaceuticals, Inc., entered into a strategic 

collaboration with Crucell for the development and commercialization 

of a universal mAb product (flu-mAb) for the treatment and prevention 

of influenza. An important recent step in the development of this 

flu-mAb has been the first production of this antibody product in a 

mobile and fully disposable FlexFactory®. 

Universal influenza vaccine (Discovery/Pre-clinical) 

The exciting flu-mAb research and development has laid the basis for 

the discovery and development of a vaccine that could protect against 

all subtypes of influenza virus. 

Hepatitis C antibody combination (Pre-clinical) 

Hepatitis C is a disease of the liver, caused by the hepatitis C virus (HCV). 

The virus can be transmitted by direct blood contact, for instance by 

sharing contaminated needles among drug users or by needle stick 

injuries in healthcare settings. 

Hepatitis C is a major global public health problem. A significant 

proportion of people (20–50%) develop progressive liver disease leading 

ultimately to liver cirrhosis, liver failure and hepatocellular carcinoma 

(HCC). 1 Most people who have been infected develop chronic disease. 

Symptomatic chronic HCV patients can be treated with antiviral agents 

(usually a combination of pegylated interferon and ribavirin), but with 

limited success. The only treatment option for end-stage liver disease 

is transplantation. HCV-induced cirrhosis is the leading cause for liver 

transplantation. It is estimated that up to 170 million people worldwide 

(3% of the world’s population) are infected with HCV. There is no 

available vaccine against HCV. 

In August 2009, Crucell obtained an exclusive license from Stanford 

University (Palo Alto, California) for the development of an antibody 

combination against HCV. A large panel of fully human mAbs against 

HCV is being evaluated by Crucell in a proof of concept phase. The mAbs 

have been found to neutralize the virus across all genotypes tested and 

each recognizes a different part of the HCV surface protein. 

19

20 

Our business 

Technologies 

www.crucell.com

Our business – Technologies 

Crucell’s strong research and development (R&D) 

pipeline is supported by a range of patented 

technologies. Our technologies open up new areas 

of research, speed our development programs 

and optimize production processes. In this section 

you can read about our technologies and the way 

Crucell continues to extend their applications. 

21

22 


Our cutting-edge technologies 

Crucell’s strong product portfolio is supported by a range of patented 

technologies. Our cutting-edge technology platforms enable the 

cost-effective discovery, development and production of a range 

of biopharmaceutical products, including innovative vaccines, 

therapeutic proteins and gene therapies. In therapeutic areas where 

Crucell does not plan to develop its own products, these proprietary 

technologies may be licensed out to other biopharmaceutical 

manufacturers or research groups. 

5 core platforms 


Core proprietary technology platforms 

Crucell has five core proprietary technology platforms, and two 

support technologies developed by Crucell to facilitate 

biopharmaceutical innovation: 

1. PER.C6® technology: a comprehensive package of technology and 

know-how based on our PER.C6® human cell line. It provides a safe 

and cost-effective manufacturing system for high-yield, large-scale 

production of vaccines, recombinant proteins including monoclonal 

antibodies, and gene therapy products. 

2. AdVac® technology: a technology based on the development and 

production of novel adenovirus vectors. It can be used together 

with PER.C6® technology to develop recombinant vaccines against 

life-threatening diseases or to develop gene therapy products. 

3. MAbstract® technology: a human-based antibody phage display 

technology that facilitates the discovery of novel drug targets 

and the identification of human monoclonal antibodies against 

those targets. 

4. STAR® technology: a gene expression technology that enhances 

yields of recombinant human antibodies and therapeutic proteins 

on mammalian cells lines. 

5. Virosome technology: a virosome is a virus-like particle that 

acts as a vaccine adjuvant and carrier system. Vaccines based 

on virosome technology combine high efficacy with high purity, 

and therefore low potential for causing side effects. 

Support technologies 

A. Recombinant Paramyxovirus technology: a novel vaccine design 

technology based on recombinant measles vectors. These vaccine 

vectors can be manufactured economically in large quantities, 

and induce strong and sustained immune responses against the 

antigens they carry. 

B. Hansenula polymorpha technology: an innovative yeast-based 

production platform widely used for the manufacture of industrial 

proteins, food and feed additives, and highly immunogenic vaccines— 

such as Crucell’s Hepavax-Gene® vaccine against hepatitis B.


PER.C6® technology: an innovative package 

The PER.C6® human cell line is the cornerstone on which Crucell was 

built. It was originally developed for making antibodies against cancer 

and for gene therapy, but around 2002 researchers in the company 

discovered that a wide range of viruses also grow very well on 

PER.C6®. This meant that PER.C6® could be developed as a platform 

for producing the new viral vaccines the world needs—classical as 

well as adenovirus-based vaccines. 

PER.C6® technology offers major advantages over other platforms used 

for manufacturing biological products and is uniquely positioned 

to meet the key challenges in the industry. These include the need to 

produce larger volumes of product more quickly and cost-effectively, 

while meeting increasingly stringent safety requirements. 

The heart of PER.C6® technology is the PER.C6® human cell line. 

This is a continuously dividing set of cells derived from a single 

human cell, immortalized using recombinant DNA technology. Like 

other continuous cell lines, PER.C6® cells can replicate indefinitely— 

but that is where the comparison ends. 

One of the great advantages of PER.C6® cells is that they grow to much 

higher density than other continuous cell lines. This is due to inherent 

characteristics of the PER.C6® cells themselves, which are further 

enhanced by the intensified manufacturing process and special growth 

media developed as part of the PER.C6® technology package. 

The ability of PER.C6® cells to grow to exceptionally high densities 

means that much more biological product can be harvested from 

much smaller bioreactors. For example, PER.C6® cells infected with 

virus for manufacturing purposes produce at least 10 times more virus 

per milliliter than any other cell line does. The same yield can therefore 

be obtained from a 500-liter bioreactor using PER.C6® as a 5000-liter 

or larger bioreactor using another cell line. This translates into 

significant savings in capital expenditure and production costs, as well 

as shorter production times. PER.C6® technology is an ideal companion 

for other innovative Crucell technologies, such as the virosome 

(a vaccine design technology combining high efficacy with low side 

effects) and AdVac® technology (which focuses on the development 

of novel adenovirus vectors and is used with PER.C6® to develop 

recombinant vaccines). 

27 g/L 

Record-level titer achieved at harvest for an antibody 

product using PER.C6® human cell line technology. 

10 times 

More virus per millimeter are produced by 

PER.C6® infected cells. 

23

24 


The PERCIVIA PER.C6® Development Center 

is designed to further develop the PER.C6® 

cell line and to provide turnkey solutions for 

licensees utilizing the PER.C6® human cell 

line to produce pharmaceutical proteins. 

PERCIVIA PER.C6® Development Center 

In September 2010, Crucell and Royal DSM announced the expansion 

of activities in their existing joint venture, the PERCIVIA PER.C6® 

Development Center (Cambridge, Massachusetts, US), to transform 

the company from a development center into a full biopharmaceutical 

company for the development of PER.C6®-based biobetter proteins 

and monoclonal antibodies as well as global licensing of the PER.C6® 

human cell line for production of third party monoclonal antibodies 

and other proteins. The joint venture, in which DSM and Crucell each 

hold an equal equity share, will be known as PERCIVIA LLC. The joint 

venture will broaden its scope and will focus on proprietary development 

of PER.C6®-based biobetter proteins and monoclonal antibodies, 

initially to early clinical stages. 

AdVac® technology 

AdVac® technology involves the development and manufacture 

of novel vectors (gene transport vehicles) made from adenoviruses 

(harmless cold viruses) that very rarely infect humans, such as Ad35. 

Genetic material encoding for viruses, parasites or bacteria can be 

inserted into these vectors to make novel vaccines against a broad 

range of human pathogens, or the vectors can be used to make 

gene therapy products. 


AdVac® technology is a powerful vector system, especially when 

coupled with Crucell’s PER.C6® technology, which unlike any other 

cell line does not allow replication-competent adenoviruses to form 

during the production of replication-deficient vectors. 

AdVac® technology is based on adenoviruses that very rarely infect 

humans, whereas other adenovirus vectors are based on viruses that are 

widespread in human populations—and therefore much more likely to 

encounter pre-existing immunity. By circumventing pre-existing immune 

responses against the adenovirus vector, AdVac®-based vaccines allow 

accurate dose control and are potentially more effective than other 

adenoviral vector vaccines. 

AdVac®-based vectors share the advantages of the widely used 

adenovirus vectors, such as scalable production, high yields and the 

ability to mediate a strong T-cell immune response.


MAbstract® technology 

MAbstract® technology is a human antibody-based phage display 

system, which facilitates the discovery of novel drug targets and the 

identification of human monoclonal antibody against those targets. 

A phage (or ‘bacteriophage’) is a virus that can infect and multiply in 

bacteria. In phage display technology, phages are genetically engineered 

to expresses the pathogen-binding part of a human antibody on their 

surfaces. In the application of MAbstract® technology, a library of 

phages exposing a wide variety of human antibody fragments on their 

surfaces is brought into contact with disease-causing microorganisms 

(pathogens) or parts of pathogens in order to identify human antibodies 

that selectively bind to targets of interest. 

MAbstract® technology is an efficient method for the discovery of 

human antibodies to be applied for the prevention, diagnosis and 

therapy of diseases. 

STAR® technology 

STAR® technology is a gene expression technology. Acquired by Crucell 

in 2004, it has proved extremely valuable for increasing production 

of recombinant antibodies and therapeutic proteins on mammalian 

cell lines. STAR® technology uses well-established mammalian cell banks 

for protein and antibody production, thereby eliminating the need 

for specially engineered mammalian cells. It allows for very rapid, 

stable mammalian cell clone generation and typically generates stable 

mammalian cell clones that produce 5 to 10 times more antibody or other 

therapeutic protein than cell clones generated without STAR® technology. 

Virosome technology 

Virosome technology is a tool for developing novel vaccines against 

infectious and chronic diseases. A virosome is a virus-like particle that 

acts as a vaccine carrier and adjuvant (immunity enhancing) system. 

Vaccines based on virosome technology combine high efficacy with 

high purity, which means they are effective and safe to use even 

in infants and individuals with a weakened immune system. 

25

26 

Our business 

Products 

www.crucell.com

Our business – Products 

Crucell focuses on developing and marketing 

vaccines and antibodies against a range of 

infectious diseases in the paediatric, travel and 

endemic, and respiratory fields. We currently have 

a product portfolio of vaccines against twelve 

major infectious diseases, such as influenza, 

hepatitis A, hepatitis B and typhoid fever. 

27

28 


Our broad range of innovative products 

Vaccines play a vital role in protecting against disease and have 

contributed significantly to the improvement of global public health. 

Smallpox was eradicated through the use of vaccines. Significant 

advances include the introduction of combination vaccines and 

the development of new vaccine technologies. 

In 2010, a Crucell vaccine was given to 190 people every minute. 1 Over 

the full year, more than 105 million doses of vaccines were distributed 

in more than 100 countries, thereby preventing more than 3.6 million 

cases of infectious diseases and over 809, 000 deaths that would 

otherwise have occurred. 





In this section, you will find information about Crucell’s marketed 

products and comprehensive information about the diseases each 

of these vaccines is designed to prevent. 

Quinvaxem® 

Quinvaxem® fully liquid pentavalent (five-in-one) vaccine protects 

infants against five deadly childhood infections: diphtheria (D), 

tetanus (T), pertussis (P, whooping cough), hepatitis B (HepB), and 

Haemophilus influenzae type b (Hib). 

Combination vaccines help to simplify and harmonize vaccination 

schedules, leading to increased vaccine coverage and greater costeffectiveness. 

As the first fully liquid pentavalent DTwP–HepB–Hib 

vaccine brought to the market, Quinvaxem® further simplified vaccine 

delivery because it is ready to use as soon as the vial is opened. 

This makes it an ideal choice for protecting babies in developing 

countries with infrastructure and hygiene problems. Quinvaxem® 

remains the only fully liquid pentavalent vaccine that offers these 

advantages in a preservative-free formulation. 

Since the launch of Quinvaxem® in 2006, over 200 million doses of 

this life-saving vaccine have been delivered to developing countries, 

including 50 GAVI-supported countries. Most were low-income 

countries supplied through Unicef and the Pan American Health 

Organization (PAHO). With this innovation, Crucell has become 

a major partner in protecting children in under-resourced countries.


Cases of disease prevented by Quinvaxem® 

< 5,000 

5,000–10,000 

10,000–100,000 

> 100,000 

No report 

Hepavax-Gene® 

Hepavax-Gene® is a recombinant vaccine against hepatitis B virus 

infection, providing long-term protection. With a track record of more 

than 800 million doses administered worldwide since the launch 

of this vaccine in 1997, it is also one of the established WHO 

pre-qualified vaccines. 

190 people 

Were given a Crucell vaccine every minute during 2010. 

105+ mln 

Doses of vaccines were distributed in more than 

100 countries in 2010. 

3.6 mln 

Cases of infectious diseases were prevented in 2010. 

29

30 


MoRu-Viraten® 

MoRu-Viraten® is a safe, well-tolerated and effective vaccine for 

protection against measles and rubella in children, adolescents 

and adults. As MoRu-Viraten® is free of egg proteins and antibiotics, 

it can be safely used in children with allergies to these substances. 

The vaccine has been marketed since 1986 and is on the WHO list 

of vaccines for purchase by UN agencies. 

Epaxal® and Epaxal® Junior 

Virosomal adjuvanted Epaxal®is the only aluminum-free hepatitis A 

vaccine on the international market. The absence of aluminum reduces 

the pain associated with injection, making this vaccine especially 

suitable for children. A virosome is a biodegradable adjuvant system 

and provides a more natural presentation of the antigens than 

traditional adjuvants. Epaxal® induces protective antibody levels 

within 10 days after the initial injection. A second dose prolongs 

effective protection for an estimated 30 years or more. The booster 

dose is preferably injected 6–12 months after the first dose but 

may be given up to 10 years later. 


Epaxal® is approved for use in adults and children from 1 year of age. 

The vaccine is currently licensed in more than 35 countries under the 

brand names Epaxal®, HAVpur®and VIROHEP-A. 

Vivotif® 

Vivotif® is a live attenuated oral vaccine for immunization of children and 

adults against typhoid fever. It is available as gastro-resistant capsules for 

oral administration. It is the only oral vaccine approved for protection 

against typhoid fever. The most common cause of this bacterial disease 

is Salmonella serotype Typhi (S. Typhi). The protective action starts 

about 10 days after the last dose is taken. Vivotif® is remarkably well 

tolerated, with post-marketing experience over more than 20 years 

confirming that adverse events are rare. Vivotif® typhoid fever vaccine is 

currently licensed in more than 30 countries, including the United States. 

Dukoral® 

Dukoral® oral inactivated cholera vaccine provides safe, effective 

and convenient protection against cholera for people living in at-risk


areas as well as visitors to these regions. Outbreaks of severe disease 

in regions where cholera is endemic put local populations at risk 

of serious illness and death. Travelers’ diarrhea caused by cholera is 

generally not life-threatening but is distressing and debilitating, spoiling 

many holidays and business trips. This preventable diarrheal infection 

is now the most common travel illness but remains an under-recognized 

problem. Dukoral® was first licensed in 1992 and is now registered in 

65 countries for the prevention of cholera, with additional indications 

(ETEC, travelers’ diarrhea) in some of these countries. It is an oral 

inactivated vaccine approved for use in adults and children from 

two years of age. Dukoral® drinkable vaccine is easy to use and offers 

84–86% protection against cholera, as demonstrated in field clinical 

trials on various continents. Dukoral® also has a reassuringly favorable 

safety profile, with an adverse event rate comparable to placebo 

reported in clinical trials. The vaccine’s safety and tolerability has 

been confirmed over many years of use around the world. 

Inflexal® V 

Inflexal® V virosomal adjuvanted vaccine offers protection against 

influenza thanks to its virosome technology—one of Crucell’s patented 

innovations. Virosomes are reconstituted influenza virus envelopes, 

constructed without the genetic information of the virus so that they 

are unable to replicate or cause infections. In the context of vaccines, 

virosomes serve as both a carrier system and an adjuvant. 

Inflexal® V is the only adjuvanted influenza vaccine licensed for all 

age groups (from 6 months upwards). 

Since its launch in 1997, Inflexal® V has been licensed in 38 countries 

with over 60 million doses distributed. Extensive experience in 

the market has confirmed its efficacy and favorable safety profile. 

The vaccine’s unique design and manufacturing process eliminate the 

need for thiomersal (a vaccine preservative) or formaldehyde (commonly 

used to inactivate influenza viruses) and minimize residual traces of 

antibiotics, detergent and hen’s egg protein compared with other 

influenza vaccines. 

The vaccine’s antigen composition changes in accordance with annual 

recommendations issued by the World Health Organization (WHO) 

on the basis of data on the circulating influenza virus strains. 

Other products 

We also distribute a variety of other products, such as Gardasil® 

(Merck) and Prolastin® (Talecris). 

31

32 

Crucell’s commitment to the world 

Taking responsibility 

www.crucell.com

Crucell’s commitment to the world – Taking responsibility 

Crucell’s mission to bring innovation to global 

health reflects a deep commitment to improving 

the lives of people worldwide. We see this as part 

of our corporate social responsibility (CSR)—a 

responsibility that underpins everything we do as 

a global organization and as individuals united by 

a common purpose. For several years we have been 

working to develop our approach to CSR, with the 

goal of maximizing our contribution to society and 

minimizing our environmental impact. This report 

highlights the recent steps we have taken on our 

journey and outlines the road ahead. 

33

34 


Taking responsibility for a better world 

Crucell is making great strides with the 

implementation of a comprehensive policy 

for integrating sustainability practices in our 

organization. In 2009, we outlined our CSR 4P 

policy framework incorporating the four ‘Ps’ 

of Performance, People, Planet and Philanthropy. 

In 2010, we focused on bringing this policy to life 

in our global organization, with substantial success. 

A first step in this process was to establish a CSR Working Group, which 

is responsible for driving continuous progress in the four P-categories. 

With strong support from Crucell’s Management Board and many Crucell 

employees worldwide, this group has risen to the challenge of introducing 

a consistent approach to CSR development, information management 

and reporting. Despite the complexity of harmonizing data and 

definitions across departments and sites, close to full data coverage has 

been achieved. This will enable us to measure our progress and further 

improve both target setting and reporting in the years ahead. 

At the same time, we have been seizing opportunities for increasing 

our contribution to society right here and now. The rapid evolution 

of ‘Footprint’, our community outreach program, is one exciting 

example of this. The introduction of global learning and development 

programs for Crucell employees is another. Wherever possible, we 

have achieved quick wins regarding our environmental impact, while 

working towards a more comprehensive approach in the longer term. 

Looking to the future, we are delighted that talks we held with Johnson 

& Johnson during 2010 have resulted in Crucell becoming the center 

of excellence for vaccines within the world’s largest and possibly most 

respected healthcare company. As a member of the Johnson & Johnson 

Family of Companies, we can do so much more to make the world we 

live in a healthier and safer place. This is our core business, our passion 

and a key component of our CSR program. 


On the threshold of this new era, we have compiled this report in order 

to update our stakeholders on the current status of our CSR program, the 

contribution we made to society during 2010 and our plans for the future. 

About this report 

The information in this report covers the global Crucell organization 

during the full calendar year 2010, unless otherwise stated. Crucell has 

not sought external verification of the information presented here as 

our current priority is to facilitate the smooth working of our newly 

implemented systems for CSR development. 

Contents 

CSR highlights in 2010 35 

Our CSR policy 36 

Performance 40 

People 51 

Planet 58 

Philanthropy 62 

Appendix 70


CSR highlights in 2010 

y A CSR Working Group was established in the first quarter of 2010 

and has driven the implementation of Crucell’s global policy for 

evidence-based CSR development and reporting. 

y The initial set of ambitions, targets and key performance indicators 

in the CSR 4P framework categories of Performance, People, Planet 

and Philanthropy have been reviewed, revised and expanded 

where necessary. 

y A centralized system for CSR information management has been 

developed and rolled out worldwide, and company-wide data 

collected for baseline assessments. 

y For the second successive year, Crucell was listed on the Dow Jones 

Sustainability Index (DJSI) in 2010 and showed strong progress on 

the Dutch ‘Transparency Benchmark’. 

y Crucell CEO Ronald Brus was nominated by the vaccine industry 

of industrialized countries to represent the constituency on the 

Board of the GAVI Alliance, a public-private partnership dedicated 

to improving access to new and underused vaccines in the world’s 

poorest countries. 

y Hundreds of talented people were recruited and further operational 

improvements were made in order to boost Crucell’s capacity to 

bring innovation to global health. 

y A range of global initiatives were launched to foster employees’ 

learning and development, which has been identified as the CSR 

priority with respect to human resources. 

y Crucell made important advances towards responsible supply 

chain management. 

y Crucell partnered the International Pediatric Association, 

the nongovernmental organization (NGO) Friendship and other 

organizations in their great efforts to support national vaccination 

programs in developing countries, as well as other NGOs such as 

the Max Foundation. 

y ‘Footprint’, Crucell’s community outreach program, expanded in 

scope and impact. Two field trips made an indelible impression on 

the lives of participating employees from different Crucell offices 

around the world, as well as the people living in disadvantaged 

communities in South Africa and Bangladesh. 

y The success of Crucell’s collaboration with Johnson & Johnson on 

research and development (R&D) projects during 2010 prompted both 

parties to explore the possibility of closer ties. This led to Crucell 

joining the Johnson & Johnson Family of Companies in February 2011, 

in what we see as an exciting advance for world health. 

“ Our CSR program is a concerted effort 

to ensure that we maximize the benefits 

we bring to society while minimizing 

our environmental footprint.” 

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36 


Our CSR policy 

Because we care 

To protect, care for and contribute to society in the fullest possible sense 

and to the best of our ability: that is the essence of Crucell’s CSR policy. 

These principles of protection, care and contribution are a logical 

extension of our mission to bring innovation to global health, focusing 

especially on the prevention of infectious diseases. 

Crucell’s core business is the discovery, development and delivery 

of innovative solutions for major health threats. Our specialty is the 

creation of much-needed immunization products: vaccines that safely 

and effectively mobilize the body’s own immune defenses against 

infections, and antibodies that provide ‘ready-made’ immune protection 

against invading microbes. After clean water, immunization is believed 

to be the most cost-effective health intervention and its key role in 

promoting the socioeconomic development of countries is becoming 

increasingly clear. 

The world population is predicted to reach 7 billion in 2011 and protecting 

these billions of individuals from infectious diseases is more important 

and challenging than ever. Trends such as climate change, globalization, 

urbanization, wider travel and population aging are presenting new 

opportunities for infectious pathogens to thrive and spread. 

Doing our utmost to tackle this problem is our primary responsibility 

and our privilege. It lies at the heart of our approach to CSR. At the 

same time, we recognize that Crucell—as a global business with many 

stakeholders—has wider social responsibilities. 

As our business expands in line with our ambitions, our impact on 

the world around us will increase. Our CSR program is a concerted effort 

to ensure that we maximize the benefits we bring to society while 

minimizing our environmental footprint. Achieving the optimal balance 

is a challenge that calls for a proactive approach and ongoing, careful 

evaluation of our activities and their effects. 


Our stakeholders 

Crucell works to bring significant benefit to the lives of people 

worldwide. This requires constructive interaction with a large 

number of stakeholders, including employees, legislators, 

investors, policy makers, business partners, licensees, suppliers, 

customers and organizations dedicated to sustainability issues. 

Our external stakeholders are far too numerous to mention, but 

in the interests of transparency here is a shortlist of key examples. 

y Legislators: US Food and Drug Administration, European 

Medicines Agency, and national regulatory authorities. 

y Policy makers: World Health Organization (WHO), 

Pan American Health Organization (PAHO), GAVI Alliance. 

y Business partners: Johnson & Johnson, DSM Biologics, 

Merck, Novartis, sanofi pasteur, Wyeth and MedImmune. 

y Customers: Supranational purchasing organizations such 

as Unicef (on behalf of developing countries); public and/or 

private health organizations in developed countries. 

y Sustainability organizatons: Dow Jones Sustainability Index, 

Carbon Disclosure Project. 

Stepwise progress 

Crucell sees CSR development as a continuous process and aims 

for steady progression. When we launched our global CSR program 

in 2008, our priority was to raise awareness and support for this 

initiative throughout our own organization, as well as starting 

a dialogue with our external stakeholders about our ambition to 

focus more on CSR performance and transparency. 

In 2009, we made the transition from this ambition to a strategy for 

CSR development, and outlined the 4P framework for a global CSR 

policy (see page 40) based on the four categories of Performance, 

People, Planet and Philanthropy. An initial set of ambitions, targets


and key performance indicators (KPIs) was formulated for each 

category. Of these, five were earmarked for special effort: CSR 

information management improvement, transparency objectives, 

responsible supply chain, CO 2 footprint and water use. Ambitious 

longer-term objectives were set for several of these indicators 

(see table 1). 

In 2010, we embarked on the implementation of our global CSR 

policy, including the roll-out of systems that will enable us to monitor, 

evaluate and improve our CSR performance and report on this in 

a transparent way. 

“ To protect, care for and contribute to 

society in the fullest possible sense and 

to the best of our ability: that is the 

essence of Crucell’s CSR policy.” 

Table 1: Crucell’s ‘top-five’ ambitions for CSR development 

KPI Target achieved in 2010 Target for 2011 Target for longer term 

CSR information 

management improvement 

Roll out Reporting Manual 

Transparency objectives Remain in DJSI 2 

Report based on 100% company coverage 

Improve CSR web page 

Set action plans for long term and set 

quantitative targets for EHS 1 

Further improve CSR web page and continue 

to develop reporting practices 

Responsible supply chain Extend global procurement policy Train all relevant employees 

80% of top 100 vendors sign Supplier Code 

of Conduct (CSR declaration) and take part 

in CSR assessment 

Define in 2011 

2015: GRI 3 A rating 

Monitor and maintain training level 

100% supplier coverage and monitoring 

of target group in 2011 

CO2 footprint Baseline setting Quantitative ambition setting 2020: 15% relative reduction 4 

Water use Baseline setting (100% company coverage) Quantitative ambition setting 2020: 10% relative reduction 4 

1 EHS–environment, health and safety. 

2 DJSI–Dow Jones Sustainability Indexes. 

3 GRI–Global Reporting Initiative. 

4 Relative to workforce size expressed in full-time equivalents. 

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The 4P framework of Crucell’s CSR Policy 

Performance 

Saving lives 

Innovation 

Responsible supply chain 

Transparency 

Emissions to air 

Emissions to water 

Consumption 

Recycling 

Planet 


People 

Responsible employer 

Health & safety 

Business conduct 

Sector sustainability 

initiatives 

Contributing to science 

Access to healthcare 

NGO partnerships 

Community outreach 

Philanthropy 

Clarity and leadership 

Crucell’s CSR policy 4P framework (see left) summarizes the main ways 

we strive to make a positive difference to society: 

y by performing at our best as a business dedicated to healthcare 

innovation; 

y by taking the best possible care of the people we work with, 

inside and outside the company; 

y by doing whatever we can to preserve and protect the earth’s 

precious resources; 

y and by contributing even more than we are required to do as 

a company with an intrinsically CSR-oriented mission. 

The four categories of Performance, People, Planet and Philanthropy 

are each further subdivided into a variety of themes, which represent 

a range of related responsibilities. Themes can be added over time 

to reflect our evolving responsibilities, as this is a dynamic framework. 

This classification system is somewhat artificial, as there is considerable 

overlap and interdependence among the P-categories and their 

component themes. However, it serves as a useful reminder of the 

many different facets of our CSR strategy and provides a clear overview of 

what we, as a socially responsible company, stand for and strive towards. 

A practical advantage of the 4P framework is that it breaks the enormous 

task of CSR development and reporting into manageable portions. Early in 

2010, one or more leaders (‘P-owners’) were appointed for each P-category. 

They have taken real ownership for progress in their area, providing crucial 

inspiration and direction as well as coordinating the flow of information. 

This approach fosters transparency, clarity and focus, which helps 

the P-owners—in consultation with top-level management—to define 

realistic but challenging targets for the coming years. This step is vital 

for achieving the continuous progress we strive for and ensuring that 

our CSR strategy delivers tangible benefits for society. Adding real 

value is our goal.


Organization and governance 

A CSR Working Group comprising the P-owners and several Crucell 

employees with a special advisory role was established in the first quarter 

of 2010. It is a diverse group of senior managers representing a wide 

range of disciplines and different Crucell sites. Members of the CSR 

Working Group gather information from all levels and parts of the 

organization. They also initiate improvements with support and 

advice from the Management Board. Overall ownership of CSR has 

been taken on by Chief Executive Officer Ronald Brus, ensuring 

top-level support for its ongoing development. 

The CSR Working Group meets on a quarterly basis to discuss progress 

and formulate plans for the future. Cees de Jong, Crucell’s Chief 

Operating Officer, chaired these meetings in 2010 and reported 

on their outcomes at meetings of the Management Board. This 

participation reflects the importance Crucell’s top management 

places on CSR, and ensures governance of the program at 

Management Board level. 

Bringing our CSR policy to life 

While strong leadership is essential for driving our CSR program, its 

success will depend on how firmly it can be embedded in the fabric 

of our organization and brought to life. That was our priority over 

the past year. 

In the next section of this report, we focus on each of the P-categories 

in turn, describing our current level of achievement, the actions 

undertaken in 2010, our progress relative to the targets and 

ambitions formulated in 2009, and our priorities for the future. 

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Performance 

The P-category we call ‘Performance’ embraces four social responsibilities 

that we see as being central to our core business and our mission: 

innovation, saving lives, responsible supply chain management and 

transparency, by which we mean the responsibility to evaluate and 

report on our CSR activities in a comprehensive and systematic way. 

Transparency is, of course, an overarching principle in our CSR program 

and applies equally to all categories in the 4P policy framework. 

We have chosen to include it in the category most closely allied with 

our core business because we see transparency as a tool for strategic 

decision making, as well as a key responsibility towards our 

stakeholders. As a company dedicated to making a meaningful 

difference to people’s lives, we want the fullest possible understanding 

of our impact on society and our planet. 

Under the leadership of the Performance P-owner, whose function in the 

organization is Director Global Procurement, a large number of Crucell 

employees have contributed to the gathering and analysis of information 

relevant to the initial set of key performance indicators (KPIs), targets 

and ambitions that were defined for this P-category in 2010 (see table 2). 

The P-owner’s expertise in the field of Procurement was especially 

valuable for developing a strategy for responsible supply chain 

management, which is one of five KPIs for which we have set 

particularly ambitious objectives. 

Besides a responsible supply chain, the other KPIs we have selected to 

measure our contribution in the Performance category are: prevention 

of illness and deaths, the number of pipeline products, research and 

development (R&D) expenses, animal welfare, CSR management 

improvement, and transparency objectives (relating to benchmarks 

such as the Dow Jones Sustainability Index, the Carbon Disclosure 

Project and the Transparency Benchmark). These indicators form the 

basis of the following discussion of activities and outcomes in the 

Performance category during 2010. 




2 Figure based on Crucell’s top five vaccines in terms of sales volumes: 

Quinvaxem®, Hepavax-Gene®, Epaxal®, Vivotif® and Inflexal® V. 


Saving lives 

During 2010, Crucell delivered 105 million doses of vaccines to people 

around the world, with the majority going to infants in developing 

countries. Together, the vaccines we have on the market prevent 

twelve major infectious diseases: childhood infections, travel and 

endemic illnesses, and respiratory disease. Allowing for the fact 

that some vaccines inevitably go to waste, we can estimate that 

a Crucell vaccine was given to 190 individuals every minute during 

2010 1 —a thought that makes us proud. 

However, we believe that the best measure of our impact on global 

health is not the number of doses we supply, but the number of deaths 

and cases of disease we prevent each year. In other words, how many 

people would have become sick or died if they had not received our 

vaccine? This can be estimated by combining sales figures with data 

on vaccine efficacy (how well a vaccine works), disease incidence 

(the expected number of new cases in a population) and case fatality 

(the death rate among infected patients). 

Based on the best available evidence for these parameters, and 

assuming a 2% vaccine waste rate, Crucell’s ‘top-five’ vaccines prevented 

more than 3.6 million cases of infectious disease and 809,823 deaths in 

2010 2 . This was similar to our health impact in 2009, when we prevented 

more than 3.6 million cases of disease and over 819,000 deaths. 

We did not meet our target of continuous improvement in the prevention 

of illness and deaths, as overall product sales were slightly lower in 

2010 than 2009. Higher sales of travel and endemic vaccines were more 

than offset by lower sales of our seasonal influenza vaccine (due to the 

limited availability of flu antigen and weaker overall demand) as well 

as the temporary suspension of Quinvaxem® shipments, as explained 

on page 46.


Innovation 

While we are already preventing an estimated 3.6 million cases 

of infectious disease and saving over 809,000 lives with our existing 

portfolio of marketed vaccines, we want to do much more. Ongoing 

innovation is the key to realizing this ambition. 

Crucell’s broad research and development (R&D) pipeline currently 

includes twelve investigational products, of which nine are candidate 

vaccines and three are antibody-based immunization products. All are 

based on Crucell’s innovative proprietary technologies, which provide 

unique opportunities for combating major threats to human health. 

These threats include some of the world’s most powerful and elusive 

killers, such as tuberculosis, HIV/AIDS and malaria. The first two were 

responsible for 1.7 and 1.8 million deaths, respectively, in 2009, while 

malaria affected 225 million people in 2009 and claims almost one million 

lives annually. These enormous numbers highlight the importance and 

urgency of our promising vaccine research in these disease areas. 

Table 2: Performance KPIs and targets going forward 

KPI Quantitative/Qualitative Target 

Prevention of illness and death Continuous improvement 

Report annually 

Number of pipeline products Report annually 

Animal welfare Continuous improvement 3Rs 1 

R&D expenses Report annually 

CSR information management improvement 2011: Set action plans and set quantitative targets for EHS 2 

Responsible supply chain 2011: Train all relevant employees in responsible supply chain management 

2011: 80% of top 100 vendors sign Supplier Code of Conduct (CSR declaration) 

and take part in CSR assessment 

Beyond 2011: Full coverage and monitoring of supplier target group 

Transparency objectives 2011: Further improve CSR web page and continue to develop reporting practices 

1 3Rs–Reduce, Refine and Replace. 

2 EHS–Environment, health and safety. 

3 GRI–Global Reporting Initiative. 

Quantitative 

Qualitative 

2015: GRI 3 A rating 

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In the influenza field, our research teams are working on a trio of programs 

aimed at registering a better seasonal flu vaccine by 2014 and 

developing products that will revolutionize the approach to influenza 

prevention and treatment in the longer term. Influenza currently kills 

an estimated 345,000 people annually and imposes a heavy burden 

on society in terms of lost productivity and healthcare costs. The 

emergence of a lethal influenza virus with pandemic potential could 

push the death toll into tens of millions. 

For the 55,000 people—especially children—who die of rabies each year, 

we are developing a monoclonal antibody (mAb) product in partnership 

with sanofi pasteur. People who are bitten by a rabid animal can be 

saved by immediate injection of rabies antibodies and vaccine, both of 

which exist, but the blood-derived antibodies now available are in short 

supply and too expensive for most developing countries, where the 

need is greatest. Our rabies mAb product is poised to enter a large 

Phase II clinical trial in India in the first half of 2011, after showing 

very promising results in other clinical settings and populations. 

These are just some examples of the ways in which Crucell is working 

on medical solutions that really matter. A full overview of our pipeline 

products is given on page 13, and more information is available on 

the R&D section of our website. 

Animal welfare 

Before any candidate medical product can be given to humans, it 

must be rigorously tested in pre-clinical (non-human) models. Crucell 

performs animal testing to the minimum extent that is required by 

law. We conduct essential safety studies in animals in accordance with 

the highest international standards, which are designed to prevent or 

minimize any suffering of the animals tested. Simultaneously, we apply 

the 3R principles—Reduce, Refine and Replace—to pre-clinical studies 

involving animals. Crucell has been working over many years to replace 

animal tests with cell-based assays, and these efforts have already 

resulted in the significant reduction of animal testing. 


€100.0 mln 

Research and development investment in 2010 

compared to €70.2 mln in 2009. 

“ Crucell invested heavily in the 

advancement and expansion of 

pipeline programs in 2010.”


R&D progress 

Crucell invested heavily in the advancement and expansion of pipeline 

programs in 2010. In line with our guidance to the financial market, 

R&D expenses increased by more than a third to €100.0 million, 

compared to €70.2 million in 2009. The rise was predominantly due 

to an increase in clinical development spending, reflecting progress 

in clinical trials and significant investments in our in-house product 

development capabilities. 

Development of our pipeline during 2010 was accelerated by a strategic 

collaboration with Johnson & Johnson, signed in September 2009. Under 

the terms of this agreement, Johnson & Johnson will finance a significant 

part of Crucell’s existing R&D program aimed at discovery, development 

and commercialization of a monoclonal antibody product for the universal 

prevention and treatment of influenza. This program is based on Crucell’s 

discovery of a new class of antibodies with the unprecedented ability 

to neutralize a broad range of influenza virus strains. 

The strategic collaboration also provided funding for four new discovery 

programs in areas where Crucell’s innovative science and technologies 

show significant potential to make an important difference to global 

health. One of these was specified at the time the agreement was 

signed, and two others were decided jointly by the collaboration 

partners on the basis of exploratory work by Crucell’s Innovation 

& Discovery Laboratory (I&DL) teams in the course of 2010. 

In the first of the new discovery programs, Crucell scientists are using 

the knowledge generated in our flu antibodies program to design 

a vaccine with the potential to provide lifelong protection against 

influenza, regardless of the causal virus strain. A universal flu vaccine 

would eliminate the need to formulate new flu vaccines year after year, 

and would at last provide a defense against a lethal new influenza 

virus with pandemic potential. Work started on this exciting project 

at the beginning of 2010. 

The second discovery program, launched in June, focuses on the design 

of a vaccine to prevent severe respiratory infections caused by all of the 

most common strains of respiratory syncytial virus (RSV). Infants and 

the elderly are especially vulnerable to life-threatening illness caused 

by RSV, which currently claims an estimated 160,000 lives annually. 

RSV-induced disease is the last major childhood illness for which no 

preventive vaccine is available. 

The third new discovery program, announced in November, targets the 

development and commercialization of a therapeutic vaccine against 

human papillomavirus (HPV). Around 250,000 men and women with 

chronic HPV infection die each year. 

Another R&D highlight during 2010 was the launch of Crucell’s in-house 

FluCell program: a new frontier for seasonal influenza vaccines. Inflexal® 

V, our current flu vaccine, is both highly effective and very well tolerated 

thanks to its underlying virosomal technology. Now we are working 

to combine this innovative approach to vaccine design with our highdensity 

PER.C6® cell–based production system. This will enable us 

to manufacture unlimited supplies of high-quality flu vaccine more 

efficiently, more cost-effectively and starting earlier in the flu season. 

The traditional production method grows the viruses used for flu vaccines 

in chicken eggs—a slow and laborious method that does not lend itself 

to high-volume manufacturing, as we saw during the recent pandemic. 

The fact that we now have three influenza programs in the pipeline 

illustrates Crucell’s approach to innovation. We seize opportunities 

to make a difference in the near future while simultaneously working 

towards breakthrough products that will take considerably longer 

to develop, test and bring to market. 

Investigational vaccines we already have in clinical trials made 

important progress during 2010. For example, in May the recombinant 

malaria vaccine Crucell is developing in collaboration with the US 

National Institute of Allergy and Infectious Diseases entered a new 

phase I trial in Burkina Faso, Africa. This is the first trial of the vaccine 

in a population living in an area where malaria is endemic. In October, 

we were delighted to announce the start of a new phase II clinical trial 

of the tuberculosis vaccine we are developing together with the Aeras 

Global TB Vaccine Foundation. The trial will evaluate the safety and 

efficacy of this promising vaccine candidate in infants previously 

immunized with Bacille Calmette Guérin (BCG) vaccine. BCG is the 

only available TB vaccine, but has very limited efficacy. 

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Quinvaxem® in Uniject: simply better 

Crucell has embarked on a development project that will make 

Quinvaxem® pentavalent vaccine available in Uniject, an innovative 

vaccine injection system. The nonprofit organization PATH developed 

Uniject over 20 years ago with the aim of simplifying vaccine delivery, 

which the World Health Organization (WHO) sees as a key strategy 

for helping developing countries to improve their national 

immunization programs and reach populations in remote areas. 

The Uniject device is essentially a small plastic bubble attached to a 

fine, short needle and fitted with an auto-disable mechanism so that 

it can be used only once. The bubble will be filled with a single dose of 

Quinvaxem® at Crucell’s new manufacturing facility in Korea, where 

a state-of-the-art filling and inspection line will be created for this 

purpose. From there, the factory-filled devices will be shipped to the 

growing number of countries that are choosing Crucell’s five-in-one 

vaccine to protect their children against diphtheria, tetanus, pertussis, 

hepatitis B and Haemophilus influenzae type B (Hib), a leading cause 

of severe pneumonia and meningitis. 

Because the Uniject device needs no assembly or preparation in 

the field, it is ideal for countries with limited healthcare resources 

and a poor infrastructure. It is much faster and easier to use than the 

standard needle and syringe system, delivering the correct vaccine 

dose with a simple squeeze of the bubble. Medical staff can therefore 

administer more vaccines during an immunization session, with less 

risk of error, and even non-traditional healthcare workers can safely 

administer the vaccine after a short training. The auto-disable feature 

is important for preventing the spread of HIV and other infectious 

diseases. Uniject also reduces the vaccine wastage associated with 

multi-dose vials. Finally, its light weight and compact size facilitate 

transport to hard-to-reach areas. These benefits are proven, as Uniject 

has already been used to deliver hepatitis B and tetanus vaccines to 

over 73 million women and children in developing countries. Beckton- 

Dickinson (BD), with whom Crucell collaborates on the Uniject 

project, continues to further develop and improve the device. 


Prototype Uniject device 

Crucell’s commitment to the Uniject project reflects the breadth 

of our efforts to bring innovation to global health. We know that 

improving access to lifesaving vaccines depends on programmatic 

innovations as well as new vaccines. 

Crucell developed Quinvaxem®to meet the specific immunization 

needs of the world’s poorest countries, where delivering the WHOrecommended 

package of vaccines to all children under five is a 

major challenge. When it was introduced in 2006, the only other 

available pentavalent vaccine came in two vials and had to be 

reconstituted in the field. The Quinvaxem® fully liquid formulation 

simplified vaccine delivery because it is ready for use as soon as 

the vial is opened. Putting Quinvaxem® into Uniject will make 

delivery simpler again, further improving vaccine coverage and 

cost-effectiveness. The introduction of one of the key EPI 1 vaccines 

in BD Uniject also brings environmental advantages: no need for 

separate transport of syringes and vials, ease of disposal and reduction 

of toxic substance emissions during burning of waste. This development 

is the next logical step in an ongoing process of innovation. 

“PATH is thrilled that Crucell is making this significant commitment,” 

Steve Brooke from PATH told key opinion leaders at the International 

Pediatric Association (IPA) Congress in South Africa last August. 

Crucell announced its Uniject plans at the conference and invited 

feedback from potential users. This followed a meeting of the WHO 

group focusing on new and underutilized vaccines implementation 

(NUVI) in June, where stakeholders were surveyed on the benefits 

and constraints for pentavalent vaccine in Uniject. The WHO 

consultation at Technet, which explores technological innovations, 

provided another opportunity for dialogue and debate in December. 

Participation in such meetings helps us to understand and meet 

local needs, for example regarding packaging. 

1 EPI stands for Expanded Program on Immunization, the WHO strategy 

for making vaccines available to all children worldwide.


Recruitment and operational improvements in our R&D groups were a high 

priority during 2010. Dr Jerald Sadoff, a veteran of vaccine development 

and former director of the Aeras Global TB Vaccine Foundation, joined 

Crucell as Chief Medical Officer & Head of Development in March 2010. 

He brings with him a wealth of experience and enthusiasm to take 

Crucell’s pipeline products to market in the shortest possible time. 

While working on the discovery and development of new vaccines 

and antibody products, Crucell also invests in programs that will 

increase the value and reach of existing products. A prime example 

of this sort of lifecycle development is our project to make Quinvaxem® 

available in Uniject, an ingenious vaccine delivery device designed 

to meet the immunization needs of developing countries (see box). 

Other examples are our efforts to launch Epaxal® hepatitis A vaccine 

on the US market and our R&D program to add a sixth vaccine to 

the Quinvaxem® combination. 

Success and setback 

A total of 68.9 million doses of Quinvaxem® vaccine, Crucell’s lead 

product, were delivered to developing countries in 2010, compared to 

64.3 million in 2009. Quinvaxem® is a fully liquid pentavalent (five-inone) 

vaccine that protects against five major childhood diseases. It 

was developed specifically to meet the needs of countries with limited 

resources and is making a major contribution towards achieving the 

United Nations Millennium Development Goal of reducing the mortality 

rate among children under five by two-thirds between 1990 and 2015. 

In 2010, Vietnam joined the growing number of recipient countries 

after the Vietnamese health authorities registered Quinvaxem® for use 

in the national immunization program. The first shipment was sent to 

Vietnam in April 2010—a month in which we shipped a record number 

of Quinvaxem® doses. 

Fill and finish operations started at our new Korean production facility mid-2010. 

Quinvaxem® vaccines sold 

(Doses in million units) 

6.3 

21.9 

39.6 

64.3 68.9 

2006 2007 2008 2009 2010 

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Unfortunately, this success was followed by a setback later in the year. 

Despite our stringent quality and safety procedures, a microbiological 

contamination occurred at the Shingal plant in Korea where we 

manufacture Quinvaxem®, leading us to temporarily suspend all 

shipments of vaccines from this facility at the end of October 2010 and 

launch a thorough investigation. Shipments of noncontaminated stock 

of Quinvaxem® were resumed in December 2010. Full-scale commercial 

production of the vaccine recommenced at the Shingal facility at the 

start of February 2011, after the Korean regulatory authorities 

inspected the plant and declared it to be safe. 

This experience emphasizes the challenges and dilemmas inherent 

in our industry. Suspending the delivery of lifesaving vaccines as 

a precautionary measure was a painful choice and had significant 

financial consequences, but the alternative was unthinkable. We are 

not prepared to accept the slightest risk that a Crucell vaccine could 

cause harm. 


During 2010 we made excellent progress on the project to relocate 

Crucell’s Korean production facility from the Shingal site in Yongin City 

to the Incheon Free Economic Zone. Operational testing of the Incheon 

production facility began in March 2010 and progressed rapidly from 

simulated test runs to validation testing of the real production process, 

which generates data on product consistency for submission to the 

regulatory authorities. These consistency runs have been completed 

successfully and we expect to receive regulatory approval of the 

Incheon facility in the second half of 2011. 

With a capacity of over 100 million doses annually, the new facility will 

enable us to significantly increase production volumes and efficiency 

in order to meet anticipated further growth in demand for Quinvaxem® 

pentavalent vaccine and our hepatitis B vaccine Hepavax-Gene®, 

which is also produced in Korea. 

A new era 

The landmark event of 2010 was Johnson & Johnson making a 

recommended cash offer to acquire Crucell N.V. at a price of €24.75 per share. 

The offer was formally made on 8 December 2010, and was declared 

unconditional on 22 February 2011, after more than 95% of the issued and 

outstanding share capital of Crucell was tendered for the offered price. 

The agreement makes Crucell the center for vaccines within the Johnson 

& Johnson Family of Companies, ushering in an exciting new era for 

our organization and—above all—for human health. We are delighted 

by the prospect of pursuing our mission with the support of Johnson 

& Johnson, an organization that shares our passion for healthcare 

innovation, our values and our commitment to care for people. 

“We are an excellent fit and together we can make a much greater 

difference to the lives of people worldwide,” says Crucell’s CEO Ronald 

Brus. “Johnson & Johnson is fully committed to investing in Crucell in 

order to accelerate our programs. What’s more, its management clearly 

values and wants to foster Crucell’s innovative and entrepreneurial 

spirit. This trust and respect is the key to a successful relationship.”



Responsible supply chain management was identified in 2009 as 

one of five priority areas for CSR development. Crucell wants to make 

sustainability issues an integral aspect of our choice of suppliers and 

our relationship with them, and we have charted a clear course towards 

this goal. The progress made in 2010 well exceeds our expectations. 

In 2009, we laid the basis for active management of our supply 

chain, from a CSR perspective, by professionalizing our procurement 

organization and introducing a global procurement policy. The main 

target set for 2010 was to incorporate industry best practices for 

responsible supply chain management, as defined by the Pharmaceutical 

Supply Chain Initiative (PSCI), into our procurement policy and practice. 

Rather than simply reproducing the PSCI best practices in Crucell’s 

procurement guidelines, a team led by Crucell’s Global Procurement 

director has developed a Suppliers’ Code of Conduct focusing on 

the PSCI principles that are most important and relevant for Crucell 

and our vendors. This Code is a declaration of Crucell’s commitment 

to sustainability and what we expect of our suppliers. It is designed 

to encourage dialogue with suppliers, instead of a ‘checklist’ or 

compliancy mentality. For this reason, the Code incorporates Crucellspecific 

ambitions relating to sustainability as well as guidelines 

for best practice. 

Working together 

Over the past year, this focus on dialogue has become central to our 

vision and strategy for responsible supply chain management. We want 

to engage our suppliers in an open conversation about sustainability 

practices, challenges and opportunities. By sharing our experiences 

and working together, we believe we can help the organizations 

that supply us with goods and services to make CSR improvements 

that benefit Crucell—and ultimately, of course, our planet. 

Two new initiatives were launched in 2010 to foster the kind of 

dialogue and improvements we aspire to. One focuses on supplier 

assessment, the other on supplier participation in Crucell-led 

efforts to promote good sustainability practices in line with our 

CSR objectives. 

Good things come in small packages 

During 2010, a multifunctional team at Crucell worked together 

with suppliers on a project to deliver our pentavalent paediatric 

vaccine Quinvaxem® in smaller glass vials. The new vials contain 

the same volume of vaccine and are made of the same glass as 

before, so this change raises no regulatory or health issues. Each 

vial is 1 gram lighter and we expect to fit 17% more vials in the 

containers used for shipping. This significantly reduces energy 

used for transportation and makes more efficient use of the cold 

chain, which in developing countries is particularly limited. Smaller 

vials also mean less raw material and less waste. The wide range 

of benefits associated with this development highlights the 

breadth of Crucell’s CSR efforts and the overlap among the 4P 

categories. We will start shipping Quinvaxem® in the new vials 

in September 2011. 

“ With a capacity of over 100 million 

doses annually, the new facility will 

enable us to significantly increase 

production volumes and efficiency 

in order to meet anticipated further 

growth in demand for our Quinvaxem® 

pentavalent vaccine and our hepatitis B 

vaccine Hepavax-Gene®, which is also 

produced in Korea.” 

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In order to conduct our business in a responsible way, we need to know 

more about the social and environmental impact of the companies in 

our supply chain. This will enable us to make the best choices and support 

our suppliers who may need help to develop their own sustainability 

practices. An online tool for gathering information about our vendors’ 

practices and aspirations with respect to CSR was developed in 2010 

and will be implemented in 2011. 

In March 2011, Crucell held the first of a series of CSR workshops for 

core groups of Crucell suppliers in three regions: Korea, Switzerland and 

the Netherlands. These are the three major locations in terms of Crucell’s 

manufacturing and procurement volumes. Our aim is to bring the 

groups together annually to explore green ideas and work together 


on developing sustainability practices. From our supply base, we 

have selected those suppliers that seem most willing and able to work 

with us on improvements that will deliver real benefit. The innovative 

concept for the workshop includes inspiring speakers, organic catering, 

and full CO 2 compensation for the event, including associated travel. 

As our ideas about responsible supply chain management have evolved 

during 2010, we have decided to refine our initial target (set in 2009) 

to achieve 100% supplier coverage and monitoring in 2011. Sending 

a Supplier Code of Conduct and questionnaire to each and every one 

of our thousands of suppliers is unlikely to lead to more than superficial 

communication, whereas we are aiming for real engagement and 

follow-up. Our revised target is to start rolling out the Suppliers’ Code 

of Conduct and the vendor assessment questionnaire to a sample of 

around 100 key suppliers in 2011. The feedback we receive should give 

us a good indication of the impact our CSR program can have. We will 

report on our findings in 2012. 

There is an interesting story behind the substantial results delivered 

in 2010. Students from Hogeschool Rotterdam, a Dutch tertiary college, 

were invited to work with the Global Procurement department on 

development of the Suppliers’ Code of Conduct, vendor assessment tool 

and Supplier Day program. This arrangement was mutually beneficial, 

giving the students valuable experience in a corporate environment 

while enabling Crucell to make faster progress towards our goal of 

responsible supply chain management. 

Training our people 

Having made great strides in 2010, we are well on track to train all 

relevant Crucell employees in best practices for responsible supply 

chain management in 2011, as targeted. In preparation for this next 

step, the people in our Procurement organization were given an 

update on Crucell’s CSR ambitions at a global event held in 2010.


Responsible choices 

Our successful cool-box recycling program in Sweden is an example 

of how smart supply chain management can combine environmental 

and financial benefits. This local initiative encourages vaccine customers 

to return the cool boxes in which they receive the products. Normally, 

these temperature-controlled boxes are thrown away after a single use. 

Crucell pays for the return transport, which costs about 50% of the new 

box price, and reuses each container up to four times before disposing 

of it responsibly. The average monthly return rate in 2010 was 89%— 

a great response and much higher than the 60% expected when the 

program was launched in 2009. Our Swedish organization sent out 

around 30,000 boxes of vaccines last year and purchased only around 

6,700 replacements, so the program substantially cuts down on both 

waste and expenses. 

CSR information management 

The better we understand the impact our organization has, the better 

choices we can make as a business that is committed to delivering 

sustainable profit, measured in human and financial terms. 

Comprehensive and reliable information about our global activities 

and effects is essential in order to run Crucell with ‘a warm heart and 

a cool head’ and communicate transparently with our stakeholders. 

Therefore, improving CSR information management was identified 

in 2009 as one of our top-five priorities for the coming years. 

The main targets set for 2010 were to roll out the Reporting Manual— 

an information tool custom-built to fit Crucell’s organization and CSR 

policy—and achieve 100% company coverage regarding data collection. 

We have reached this goal for nearly all indicators, thanks to a 

tremendous effort from Crucell people at all levels and parts of 

our organization. 

The senior managers who shouldered responsibility for each of the 4P 

policy areas (P-owners) at the global level have shown real ownership 

and leadership. They, in turn, have received great support from a 

growing band of enthusiastic CSR supporters from the local affiliates. 

The active involvement of the Chief Operating Officer in Crucell’s CSR 

Working Group sessions (held four times in 2010) has been invaluable 

for ensuring the alignment of this program with the Management 

Board’s vision and strategy for Crucell. 

“ The better we understand the impact our 

organization has, the better choices we 

can make as a business that is committed 

to delivering sustainable profit, measured 

in human and financial terms.” 

‘Rolling out’ a Reporting Manual may sound easy and effortless, 

but it was far from that. People grappled with the challenge of finding 

consistent definitions for key performance indicators (KPIs) and 

meaningful parameters for measuring outcomes. Training sessions 

and data collection had to be fitted into our employees’ already busy 

work days. However, by the end of 2010 a system for consistent and 

comprehensive reporting of information relevant to our CSR ambitions 

was in place, and company-wide data collection was on track. 

This establishes a 2010 baseline for our CSR performance, against 

which progress towards our ambitions can be evaluated over time. 

The insights we gain in the process will help us to refine and develop 

our CSR activities and ambitions. We see this as a continuous 

feedback loop enabling steady improvement. 

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50 


Our fledgling system for CSR information management has its teething 

problems, of course. Looking at the 2010 data, we see some gaps 

and surprising differences across sites, which need to be investigated 

further. This uneven or uncertain quality of reporting mainly applies 

to specific quantitative KPIs in the categories of People and Planet. 

More intensive training may be required in these areas to ensure these 

KPIs mean the same thing to everyone contributing data. We are also 

thinking about the creation of incentive schemes to encourage and 

improve reporting. We will continue to develop, refine and improve 

our data collection methodology, scope and KPI set as we grow as 

an organization. 

As targeted, we will move on to formulating quantitative ambitions 

for environment, health and safety (EHS) parameters in 2011. 

Transparency 

A commitment to transparent communication with all stakeholders 

is fundamental to Crucell’s CSR policy. We measure our performance 

in this regard against external benchmarks and our own targets for 

CSR development. In line with our ambitions, Crucell continued to 

show good performance and progress on major external benchmarks 

of transparency and sustainability in 2010. 

We are especially proud that Crucell was relisted on the Dow Jones 

Sustainability Index (DJSI) on September 9, 2010, for the second successive 

year. This significant achievement is in line with our target, expressed in 

2009, to remain in the DJSI family of indexes—the leading benchmarks 

for sustainable investment. The Dow Jones Sustainability Indexes 

were introduced in 1999 to indicate international corporations that 

have made sustainability an integral part of their business strategy. 

Companies are included on the basis of best-in-class performance. 

To find out more about the DJSI, go to www.sustainability-index.com. 


Crucell participated in the Carbon Disclosure Project (CDP) in 2010, 

as in the previous year. This project is a worldwide, investor-driven 

initiative encouraging multinational corporations to report on their 

environmental impact, specifically in relation to carbon emissions 

and climate change. Our participation reflects our ambition to 

measure and manage Crucell’s carbon footprint. For more information 

about the CDP, go to www.cdproject.net. 

In the Netherlands, where Crucell has its global headquarters, Crucell 

is listed on the Transparantiebenchmark (Transparency Benchmark), 

an index published by the Dutch Ministry of Economic Affairs, Innovation 

and Agriculture. The Transparency Benchmark criteria were changed 

considerably in 2010 compared with the previous years, the index was 

expanded to include the country’s 500 largest companies and the rating 

scale was increased from 100 to 200 points. The Ministry expected the 

new criteria to have a negative impact on scores. Nevertheless, Crucell 

showed good progress on the benchmark in 2010, scoring 96 out of 

200 points compared with 38 out of 100 points in 2009. This substantial 

growth continues the trend seen since 2008. 

Crucell continues to make progress towards the goal of reporting 

on our CSR activities in accordance with Global Reporting Initiative 

(GRI) criteria and verified by external audit. The improvements in 

CSR information management implemented in 2010 take us a step 

further in this direction.


People 

Crucell is committed to conducting business with integrity, in a way 

that respects the rights and needs of our large network of stakeholders, 

inside and outside the company. As a company dedicated to bringing 

innovation to global health, we recognize the importance of creating 

a working environment that attracts and retains talented people 

and fosters their ongoing development. 

In this section we describe what Crucell is doing to live up to its 

responsibilities towards people, focusing on three main themes: 

being a responsible employer, health and safety, and good 

business conduct. 

Crucell’s VP Global Human Resources has taken on ownership of 

the ‘People’ category within the CSR policy framework. He has driven 

Crucell’s efforts to improve CSR performance and reporting in the 

area of people and organization during 2010. In consultation with 

the Management Board, the CSR Working Group has refined and 

expanded the initial set of key performance indicators (KPIs) for the 

People category (see table 3) and formulated qualitative targets 

corresponding to these indicators. 

Thanks to efforts from Crucell employees worldwide, the ambition 

to collect relevant People KPI data from all parts of the organization 

was achieved in 2010, giving us a better overview of our global 

organization and a baseline to evaluate further progress. 

Being a responsible employer 

Crucell can only fulfill its mission through the concerted efforts of the 

people making up our global organization. With their creativity, passion 

and drive, Crucell employees make a difference that matters—especially 

to the millions of individuals who lead healthy and productive lives 

because of the innovative products we deliver. Taking the best possible 

care of Crucell’s employees is therefore a responsibility with wide 

implications, and one we embrace. 

1 Excluding insourced staff in China. 

In line with Crucell’s growing ambitions, recruitment was a high priority 

over the past year. We are determined to accelerate our pipeline programs 

in order to bring new products to market faster, thereby increasing our 

impact on global health. The total workforce expanded to 1398 1 in 2010, 

representing a 12% increase from 2009. Most of the new employees 

are based in the Netherlands and Switzerland, where Crucell’s research 

and development (R&D) activities are located. Crucell remains an 

organization of relatively young people, with the average employee 

age being 40. 

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Table 3: People KPIs and targets going forward 


Number of employees by gender Continue focus on equal-opportunity human resource management worldwide 

Average age of employees Report annually 

Number of women in management Fair and equitable representation 

Number of nationalities Focus on cross-cultural teams 

Total number of accidents 2011: LTC rate of 0.4 or less 

Of the people who joined Crucell in 2010, 250 were recruited through 

referral and the strong employer’s reputation on the labor market. 

We actively encourage our employees to talk to their contacts about job 

opportunities at Crucell or recommend suitable candidates. As talent 

attracts talent, this has proven to be an efficient and effective means 

to develop Crucell’s capabilities in specialist areas. We also see it as an 

indicator of employee satisfaction, the key prerequisite for achieving our 

ambition to become an ‘employer of choice’. For this reason, the number 

of ‘own recruits’ has been added to the list of People KPIs and will be 

reported annually. Crucell aims to maximize the number of ‘own recruits’. 

Another new KPI is absenteeism: the percentage of days missed from 

work (apart from planned leave). Our first experience with collecting 


2015: LTC rate below 0.2 

Employee turnover Voluntary turnover rate no more than 10% of workforce, excluding temporary staff 

% employees receiving regular 

performance reviews 

> 95% 

Number of own recruits 1 Report annually 

Absenteeism 1 Set criteria in 2011 

1 New KPI added in 2010. 

Quantitative 

Qualitative 


these data in 2010 has pointed to the need to sharpen definitions, 

which we will do in 2011. We are interested in this parameter 

as a global measure of our employees’ health, well-being and 

job satisfaction. 

Voluntary employee turnover in 2010 was 12.93%. We aim to work 

proactively to minimize the number of people who choose to leave 

the company, with a target of less than 10% voluntary turnover. 

To achieve this, Crucell will continue to focus on creating the sort 

of working environment that not only inspires and empowers our 

employees, but also provides ample opportunities for learning 

and development within the organization.


Developing talent 

Crucell is investing heavily in the skills and competencies of its people. 

Our Global Human Resources (HR) team has developed a long-term 

strategy for people development and identified this as a key CSR priority 

for taking Crucell where it wants to go. 

Implementation of this strategy started in 2010 and great strides have 

been made. A Global Manager Learning & Development was appointed 

in May, reflecting the importance we attach to building a ‘continuous 

learning’ culture at Crucell. In collaboration with other key stakeholders, 

the Global HR team has launched two global training programs for 

Crucell managers at various levels. One program focuses on developing 

people’s project management skills, the other on helping managers to 

develop financial and business acumen. Crucell employees have asked 

for this kind of support and this dovetails with the company’s 

strategic goals. 

With a view to providing a gateway to learning and development 

opportunities for all Crucell employees, the Global HR department launched 

an online People Development Portal in July 2010. The basic launch 

version will be progressively enriched and expanded over the coming 

years. The idea is to offer our people a toolkit that will help them to reflect 

on their learning potential and seize opportunities for development. 

Crucell ran a leadership training for managers in Switzerland and the 

Netherlands in 2010, as part of an ongoing program established in 2008. 

We see a vital role in our organization for good leaders who can inspire 

and empower their teams of people to excel. 

An essential aspect of this leadership role is conducting regular 

performance reviews, which when done well provide people with feedback 

that will enable them to achieve their full potential. In 2010, about 95% 

of Crucell employees received regular performance reviews. Our aim 

is to ensure all employees receive regular performance reviews, and to 

increase their added value for both the employee and the company. 

Diversity and equal opportunity 

Crucell sees the value of diversity and strives to foster this through 

our recruitment practices and organizational structure, for example 

by building cross-functional and cross-site teams. Our site in the 

Netherlands employs people of 24 nationalities, closely followed by 

Switzerland with 23. This rich cultural mix fosters the cross-fertilization 

of ideas, as well as fun. 

Looking at the numbers of male and female employees in 2010, we see 

that Crucell has a reasonably balanced workforce in terms of gender 

(more than 47% females in 2010, compared with 45% in 2009). There 

was a substantially greater year-on-year increase (20% versus 10%) 

in the number of women compared with men. 

In our 2009 report, we noted the relatively low number of women in 

senior management positions as a point for attention. It is encouraging 

to see that the number of female employees with senior management 

roles increased by 45% in 2010 compared with 2009, bringing the total 

number to 84. 

Crucell is an equal-opportunity employer. We are committed to 

recruiting and promoting employees on the basis of talent and ability, 

without negative or positive discrimination on the basis of gender, 

race or age. 

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We value both gender and ethnic diversity and accordingly act as an equal opportunity employer. 

The characteristics of our workforce are as follows: 

2010 


China Italy Korea Netherlands Spain Sweden Switzerland UK USA Total 

Number of male employees 8 9 172 216 34 34 245 9 14 741 

Number of female employees 35 8 49 222 49 71 184 26 13 657 

Total number of employees 43 17 221 438 83 105 429 35 27 1,398 

Average age of employees 28 47 35 37 45 46 40 38 45 40 

Number of women in management 3 2 6 42 3 5 18 0 5 84 

Number of nationalities per location 1 1 4 24 2 1 23 3 7 n/a 

2009 

Number of male employees 9 10 169 181 33 43 218 6 12 681 

Number of female employees 41 8 50 177 40 78 151 15 7 567 

Total number of employees 50 18 219 358 73 121 369 21 19 1,248 

Average age of employees 30 46 36 36 45 45 40 40 44 40 

Number of women in management 1 2 5 27 3 4 14 0 2 58 

Number of nationalities per location 1 1 4 20 2 7 20 3 5 n/a 

2008 

Number of male employees 9 12 167 139 30 45 225 n/a 11 638 

Number of female employees 26 10 44 114 39 88 159 n/a 8 488 

Total number of employees 35 22 211 253 69 133 384 n/a 1 19 1,126 

Average age of employees 31 44 35 36 46 45 42 n/a 43 40 

Number of women in management 3 3 4 23 2 10 10 n/a 3 58 

Number of nationalities per location 2 1 3 19 2 4 10 n/a 5 n/a 

1 Not applicable, as Crucell’s UK organization was launched in October 2009.


Male/female ratio of Crucell employees in 2010 

53% 

Male 

Female 

47% 

Number of nationalities per Crucell office in 2010 

China 1 

Italy 1 

Korea 4 

Netherlands 24 

Spain 2 

Sweden 1 

Switzerland 23 

UK 3 

USA 7 

Health and safety 

Crucell invests in protecting the health, safety and well-being of our 

employees. This is both a moral obligation and essential for building 

a strong and sustainable business. 

For several years, Crucell has been working systematically to enhance 

workplace safety, focusing especially on accident prevention and 

preparedness. To ensure a coordinated approach, we have created the 

position of Global Head of Environment Health & Safety (EHS) and 

introduced a global EHS policy based on international standards and 

certification requirements. Safety officers have been appointed at our sites 

worldwide and sent to DuPont safety training, the gold standard in the 

chemicals and biopharmaceuticals industry. They take responsibility at the 

local level for introducing best practices and monitoring workplace safety. 

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Safety improvement: a case study 

In January 2011, a Crucell technician had a serious accident while 

handling glassware in one of our production facilities. The worker 

was pushing a tray of bottles sprayed with antiseptic under the 

laminar flow hood (air-control barrier) of a sterile handling unit. 

The bottles toppled and fell, and the technician suffered a deep 

cut as he tried and failed to catch them in his gloved hands. 

His colleagues had received safety training and responded 

appropriately, most probably saving his life. 

If we examine the risk factors in this situation—the wet and 

slippery glassware, the laminar hood, the sterile gloves, the tray 

and handling method—we see that they are all related to Good 

Manufacturing Practice (GMP) in our industry. Biopharmaceutical 

production must be conducted under highly sterile and controlled 

conditions in order to ensure the safety of the people who receive 

our products. However, this can potentially create unsafe 

conditions for production workers. The challenge we face is 

to safeguard both our employees and products. 

Our safety and process experts meet this sort of challenge by 

analyzing the precise circumstances in which accidents occur and 

looking for GMP-compliant technical workarounds, or ways to 

avoid unsafe process steps altogether. At the same time, they focus 

on raising employees’ awareness of workplace risks and how to 

respond if an accident does occur. 

1 The OSHA defines the LTC as the number of accidents resulting in at least one whole 

shift absence, per hours worked by 100 employees in 12 months (200,000 hours). 


One of the tasks of safety officers is to collect data on accidents, 

with the aim of gaining a better understanding of risk factors and how 

to manage them. In our 2009 CSR report, we published accident data 

collected independently at our five manufacturing and/or development 

sites (covering 90% of the workforce) but noted the limitations of these 

data. For example, countries used different definitions and ways 

of measuring accidents. 

In 2010, we focused on taking EHS information management to the next 

level by introducing a global reporting system based on harmonized 

criteria. Access to more detailed information, collected from our production 

and R&D facilities using the same definitions, will give us greater power 

to continuously improve safety, using a ‘plan-do-check-act’ approach. 

We are well on track towards this goal. A clear procedure for accident 

reporting, analysis and follow-up with corrective action has been 

introduced. An EHS Reporting Manual has been developed, local 

safety officers have been trained in its use and full-year data based 

on consistent criteria have been collected and analyzed. A reporting 

infrastructure has been established and is working well: local data 

are reported to the global EHS manager, who gives regular updates 

to the Chief Operating Officer (safety data on a monthly basis, 

other information quarterly). 

Accident reporting 

Agreeing on a consistent definition of reportable accidents was a 

challenge. After considerable debate, we have decided to adopt the 

United States’ Occupational Safety and Health Administration (OSHA) 

definition of lost time case rate (LTC) 1 , excluding accidents that occur 

on the way to or from work and excluding medical conditions (such 

as fainting at work). Using consistent definitions allow trends to 

be followed. 

Analysis of the LTC among Crucell employees at our five main sites over 

the period 2009–2010 (see graph) suggests that accident frequency has


been dropping. Whole-year LTC values 

decreased from 0.75 in 2009 to 0.40 in 2010. 

The target we have set for this KPI is to 

maintain or improve an LTC of 0.40 in 2011, 

which is the industry average. By 2015 we 

want to achieve a rate below 0.2. 

Increasing safety awareness 

Crucell’s approach to improving workplace 

safety starts with accident preparedness: 

anticipating accidents that could occur and 

making sure that people know what action 

to take if they do. The importance of this is 

highlighted by a serious accident that occurred 

recently in one of our production facilities 

(see box left). 

Accident frequency 

(in LTC values) 

0.75 

0.40 

2009 2010 

Our new reporting system provides a tool for 

understanding why accidents happen, so that we can take corrective 

action and prevent further occurrences. Ideally, we want to identify 

unsafe situations before any accident occurs. Reports of ‘near misses’ 

(narrowly avoided accidents) are perhaps the most valuable information 

for managing risks and preventing accidents. 

Our accident data are classified into four groups according to the 

severity of their outcomes: near miss, first aid, medical treatment and 

fatality. On the basis of the assumed frequency of events in each 

category, we could expect to receive far more reports of near misses 

than serious accidents. Our data show the opposite pattern, suggesting 

that a relatively small proportion of near misses are being reported. 

We encourage every employee to report unsafe situations and near 

misses. With a view to raising the general level of safety awareness 

in the organization, we will hold a series of safety workshops for 

managers in 2011. They will be asked to act as role models and adopt 

a number of best practices in order to foster a culture of sustainable 

safety awareness. 

Other initiatives 

Crucell promotes the health and well-being of employees in other 

ways. Here are just a few examples of recent developments: 

y In Switzerland, improvements to the production line for Vivotif®, 

Crucell’s vaccine against typhoid fever, have made work more 

comfortable and pleasant for our people, as well as more efficient. 

y Our Spanish site has significantly improved security in order to 

increase the protection of our people and our products. 

y Free vaccination against seasonal influenza is offered to employees 

and their families each year, in countries where this is feasible 

and appropriate. In Korea, employees identified as being at risk of 

hepatitis A were also offered free vaccination with Crucell’s Epaxal® 

vaccine in 2010, while Crucell’s travel vaccines were made available 

to employees and their families in the Netherlands and Switzerland. 

Good business conduct 

Crucell adheres to high standards of ethics and transparency in dealing 

with all stakeholders. We take our legal and ethical obligations very 

seriously. Crucell’s Code of Conduct guides employees in the high 

standards of behavior expected of them and their obligation to act 

with integrity at all times. 

The Code of Conduct urges employees to report any behavior or 

action that may be in breach of this code. A procedure for reporting 

non-compliance is in place and compliance offers have been 

appointed worldwide. 

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Planet 

As a company dedicated to fostering the health and well-being of 

people worldwide, Crucell is very conscious of its responsibility to care 

for the planet—our shared home. We are actively working to integrate 

environmental awareness into our strategic decision making and 

routine work practices so that we can live up to this responsibility. 

Our aim is to maximize our productivity—and thereby our health 

impact—while minimizing our environmental footprint. 

In 2009, we defined an initial set of KPIs for measuring our progress 

towards this goal. We also set targets for reducing energy and water 

consumption, minimizing our carbon footprint and improving waste 

management, basing these targets on the data then available in the 

organization. At the same time, we pointed out the need for more 

comprehensive and reliable data. 

Table 4: Planet KPIs and targets going forward 


Total water use 

Waste water 


With the development and implementation of the CSR Reporting 

Manual in 2010, we now have what we aimed for: company-wide 

data on relevant Planet KPIs, collected for the full calendar year using 

consistent criteria. This gives us a solid baseline for future reporting 

and target setting. 

Reporting methodology 

As targeted, the findings reported here are based on 100% data coverage 

for our global organization in 2010. We took a pragmatic approach 

to achieving this target, focusing primarily on collecting data from our 

five manufacturing and/or development sites, which together employ 

over 90% of the total workforce and account for almost all of 

Crucell’s environmental impact. Solid data were also obtained from 

a representative marketing and sales office and extrapolated to 

cover the remaining offices in order to calculate our carbon footprint. 

Relative reduction 1 of 10% from 2010 baseline by 2020 

Monitor and minimize 

Total energy use See CO2 footprint 

CO2 footprint Relative reduction 1 of 15% from 2010 baseline by 2020 

Number, sort and impact of accidents 2011: LTC rate of 0.4 or less 

Amount and characteristics of waste 

and disposal method 

1 Relative to workforce size expressed in full-time equivalents (FTEs). 

Quantitative 

Qualitative 


Develop and/or refine waste minimization programs on all sites


Total energy consumption 

(in kWh, million) 

59.3 

62.7 

61.1 

88.4 

2007 2008 2009 2010 

Total water consumption 

(in m 3 ) 

201,523 

231,834 

221,320 

312,259 

2007 2008 2009 2010 

Crucell’s marketing and sales offices were found to account for less 

than 1% of total CO 2 emissions, confirming the validity of the method 

used for data collection and the importance of focusing our Planet 

efforts on the five production-related sites. 

To safeguard the reliability of data, the managers responsible for data 

delivery have been trained in KPI definitions and CSR reporting rules. 

For example, they are instructed to report quantities and units 

as invoiced, without conversion. Any estimates must be indicated 

as such, and assumptions or algorithms must be documented. 

Pilot studies were conducted during 2010 to evaluate the quality 

of the data being collected, identify any problem areas and adapt 

the reporting methodology as needed. For example, the initial waste 

classification system was simplified in the course of the year to promote 

the consistency and value of reporting. We will report amounts of waste 

in three major categories: solid waste, special waste and recycled 

quantities. Waste water has been added to our KPI set. 

The EHS Reporting Manual has been developed progressively over the 

year and will continue to evolve as we learn by doing. We extend our 

thanks to all who have put so much time, energy and enthusiasm into 

this project. What they have produced, under the leadership of our 

global EHS director, is an indispensable tool for understanding and 

progressively improving Crucell’s relationship with the planet. 

Energy savings and safety: a dilemma 

A dilemma we face in our industry is that what makes sense from 

an environmental point of view can conflict with our responsibility 

to provide safe biopharmaceutical products. It seems logical to 

save energy by shutting down the air conditioning in our production 

facilities overnight or at the weekend. However, maintaining 

a constant and clean environment is essential for safeguarding 

against microbial contamination and ensuring the quality of the 

product. The energy gain from a temporary shutdown is outweighed 

by the energy that would be required to restore the correct 

environment and the time-consuming quality assurance tests 

that would be needed. 

Energy consumption 

Crucell’s global organization consumed a total of 88.4 million kilowatt 

hours (kWh) of energy in 2010. This represents a 44.6% increase 

compared to the previous year (see graph). 

Energy use includes electricity, natural gas, oil, and other fuels such 

as gasoline and diesel, all of which are converted to kWh. Electricity 

(from the grid) is Crucell’s primary source of energy. Crucell’s total 

energy consumption in 2010 was equivalent to that of approximately 

4,935 average households (consuming 17,906 kWh). 

Parallel operations in Korea account for most of the increase in total 

energy consumption in 2010 compared with 2009. Our new Korean 

manufacturing facility on the Incheon site became fully operational 

in validation mode in 2010, while commercial production continued 

at the facility on the Shingal site. The latter will be decommissioned 

once the Incheon facility receives regulatory approval. 

The Incheon vaccine plant has around twice the capacity of the 

Shingal facility and has been engineered for highly efficient production. 

Manufacturing larger volumes more efficiently translates into significant 

gains in eco-efficiency. That is exactly what Crucell strives for: greater 

output—and health impact—with lower energy use. 

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Higher occupancy at our sites in Switzerland and the Netherlands also 

played a role in the greater energy consumption. 

In Switzerland, total energy consumption increased by around a third in 

2010 versus 2009. This reflects the fact that two formerly decommissioned 

buildings were brought on line again in the summer to house groups 

working on product process development and activities related to 

taking our Epaxal® vaccine to the USA. Expansion of these groups is part 

of Crucell’s strategy for accelerating pipeline growth. This also explains 

rising energy use in the Netherlands, where we significantly increased 

our R&D capabilities and activities in 2010. An additional building was 

rented to accommodate the rapidly growing workforce and provide 

space for new laboratories. 

1,2 Relative to workforce size expressed in full-time equivalents (FTEs). 


Water management 

Crucell has decided to measure both total water consumption and 

waste water. 

Total water consumption in 2010 was 312,259 cubic meters, which 

was 41.1% higher than in 2009. Water is sourced from the grid, except 

for Madrid, Spain, where we operate a well on our premises. 

In 2010 Crucell generated 156,643 cubic meters of waste water. 

The addition of this new parameter to our KPI set reflects the high 

potential we see to decrease overall water consumption by optimizing 

water management in our production facilities. 

The large increase in total water consumption during 2010 can 

be explained by the significant expansion of manufacturing and 

development operations, as discussed in the section on energy 

consumption. The observation that water consumption increased 

to a lesser extent than energy consumption might therefore reflect 

the success of recent efforts to improve water management, 

for example at facilities in Switzerland and Spain. 

At one of our production facilities in Switzerland, fresh water intake 

for plant steam generation has been cut substantially by optimizing the 

working of the steam and condensate system. The maximal amount 

of recoverable water is now being returned to the boiler. Besides saving 

water, this saves energy (as the recovered water requires less heating) 

and cuts down on water conditioning chemicals. 

Crucell’s production plant in Madrid installed a new system for purified 

water production in 2010. The old system supplied 50% purified water 

and 50% concentrate (water with impurities), which was used to water 

plants on the site. The output from the new system is 85% purified 

water, decreasing waste to 15%. 

Improving water use is one of the top-five ambitions relating to CSR 

that we identified in 2009. We are targeting a 10% relative reduction 

in water use by 2020. 1


Waste 

Outcomes of our waste generation analysis for the global organization 

in 2010 are as follows: 

y Solid waste: 754,420 kilograms. 

y Special waste: 52,995 kilograms (representing 7% of total waste). 

y Recycled waste: 203,596 kilograms (representing 27% of total waste). 

Now that we have a good overview of the amounts and types of waste 

generated in our global organization, as well as the disposal method, 

we can start to develop and implement waste minimization programs. 

A workshop with EHS managers was held in March 2011 to spark ideas. 

Packaging 

Crucell continuously explores options for improving packaging, especially 

in ways that benefit both the environment and our customers. One of the 

success stories is our project to deliver Crucell’s Quinvaxem® pentavalent 

vaccine in smaller vials, which means less raw material, less weight 

to be transported and more efficient use of cold chain storage (for more 

details see the section on responsible supply chain management). 

In 2010 our regulatory team set out to reduce the size of the boxes carrying 

two vials of Dukoral® cholera vaccine, which are considerably oversized. 

Smaller volumes would facilitate transport and cold storage, as well 

as saving packaging material. The team was disappointed to hear from 

the Canadian regulatory authorities that they could not carry out their 

plan. The information printed on the boxes must be in both English and 

French, and of a specified font size. These regulatory requirements— 

designed to promote safe use of the product—could not be met using a 

smaller box. This dilemma is an example of the complexity of factors that 

must be taken into consideration in the highly regulated vaccines industry. 

Carbon footprint 

Crucell’s carbon footprint in 2010 was just over 21,000 tonnes CO 2 

(21,120.61 tonnes). The carbon footprint was calculated using the 

Greenhouse Gas Protocol and accompanying conversion factors 

(to account for different energy mixes) per country. The most recent 

conversion factors were sourced from the UK Department for 

Environment, Food and Rural Affairs (DEFRA). Reducing our carbon 

footprint is one of the top-five CSR ambitions formulated in 2009. We 

are targeting a 15% relative reduction 2 from the baseline set in 2010. 

Planting the seed 

For years, Crucell’s organization in Spain has taken a creative 

approach to recycling plastic packaging material that would 

otherwise go to waste. The large plastic containers in which 

syringes are delivered to Crucell are ideal for re-use as seedling 

trays. Crucell Spain sells the boxes to a nursery for this purpose. 

Though this is a relatively small-scale activity, it is a good 

example of the kind of CSR thinking Crucell wants to promote. 

A large volume of plastic is recycled in this way every year. 

Crucell Sweden shows the same spirit with its vaccine cool-box 

recycling program. 

“ Crucell continuously explores options 

for improving packaging, especially in 

ways that benefit both the environment 

and our customers.” 

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Philanthropy 

Besides doing the very best we can to discover, develop, manufacture 

and market innovative products that protect people’s health and 

well-being, we look for extra ways to make a positive difference to 

the lives of people worldwide. 

For reporting purposes, we group these noncommercial efforts under 

the heading of ‘Philanthropy’. This is a broad category that embraces 

everything from community outreach projects and efforts to 

improve healthcare access to the sharing of scientific knowledge 

and participation in sector sustainability initiatives. 


Community outreach 

Footprint 

Crucell encourages and facilitates employees’ involvement in 

philanthropic projects, in the belief that this benefits those who give 

help as well as those who receive it. This is the philosophy behind our 

global CSR outreach program ‘Footprint’, which gives Crucell employees 

an opportunity to visit disadvantaged communities where Crucell is 

working in partnership with local organizations to make a major 

difference to people’s lives. 

In last year’s report we introduced two of these partners: the South 

African Tuberculosis Vaccine Initiative (SATVI) and the nongovernmental 

organization (NGO) Friendship. SATVI conducts clinical trials of the 

tuberculosis vaccine Crucell is developing in collaboration with the Aeras 

Global TB Vaccine Foundation. Friendship is doing wonderful work— 

with Crucell’s support—to extend the reach of the government’s routine 

vaccination program in the remote northern districts of Bangladesh. 

Many children in this poor and inaccessible part of the country have 

been missing out on vaccinations prescribed by the national Expanded 

Program on Immunization (EPI). 

In the course of 2010, we enlarged the scope of these CSR outreach 

efforts to include support for the Max Foundation, a nonprofit 

organization that carries out small-scale projects to provide clean 

drinking water to communities in the southern part of Bangladesh. 

Crucell has so far sent three teams of Crucell volunteers to take part 

in these local projects and see for themselves the challenges faced 

by people living in the world’s poorest and most needy communities. 

The employees have returned to work with a new understanding of the 

devastating effect infectious diseases have on communities without


adequate access to childhood vaccines and clean water, as well as 

the importance of what they are doing in their daily work as Crucell 

employees to give the people in these communities a future. 

A blog entry posted on our Global Intranet by the Footprint team 

during the latest field trip says it all: “We took the ambulance boat 

along the chars to an EPI session set up by Friendship in collaboration 

with local governmental agents. When we arrived there was a long 

queue of mothers with very young babies in their arms. And there 

we saw it, the babies were getting Quinvaxem®! With funding from 

Crucell, Friendship has set up a cold chain to enable children in these 

remote char areas to be immunized. Even though all these tiny babies 

had to cry when they were injected, we were thrilled to know that 

it would significantly increase their chances of growing up into 

healthy teenagers.” 

Table 5: Philanthropy KPIs and targets going forward 


Number of doses donated Report annually 

Global policy for disaster relief (donations) 

Support of sector sustainability initiatives Participation in DJSI 1 , CDP 2 and Transparency Benchmark to end due to delisting 

Continue participation in GRI 3 

NGO partnerships New Footprint field trips scheduled for 2011 

1 DJSI – Dow Jones Sustainability Indexes. 

2 CDP – Carbon Disclosure Project. 

3 GRI – Global Reporting Initiative. 

Quantitative 

Qualitative 

“ I went into this experience really not having 

a clue what to expect… and it was amazing! 

The cliché term of a ‘once in a lifetime 

opportunity’ is really the only way I can 

describe my experience in Bangladesh.” 

Further strengthen current NGO partnerships 

Explore potential new partnerships 

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Whenever possible, the Footprint volunteers have provided practical help 

during these field trips, for example by painting the children’s ward of 

a hospital in South Africa or helping to dig a well in Bangladesh. They 

arrived with suitcases laden with small gifts—from coloring sets, jewelry, 

sweets and toys to large boxes of disinfectant solutions and plasters— 

which were received like treasures by excited children and parents. 

What the volunteers took away with them was equally treasured. 

One field trip member points out: “I went into this experience really 

not having a clue what to expect… and it was amazing! The cliché term 

of a ‘once in a lifetime opportunity’ is really the only way I can describe 

my experience in Bangladesh.” 


All Crucell employees can apply to take part in the Footprint field trips, 

and teams are carefully chosen to include people with different job 

functions and from different countries. They share their experiences 

with their colleagues on their return, thereby creating a ripple-on 

effect that is helping to raise the overall level of CSR awareness and 

enthusiasm in our organization. 

Community outreach in Korea 

In 2010, our Korean colleagues continued their efforts to make life 

a bit brighter for children taking part in the ‘Dream Start’ program, 

a government health and welfare program targeting children from 

low-income families. 

Many of these children live in urban squats and lack access to even 

basic amenities like hot water, which means they are often teased and 

rejected at school. In 2009, Crucell volunteers were inspired to organize 

a ‘bath day’, combining a trip to the public baths with games, presents 

and a barbeque. This successful formula was repeated again in February 

2010, providing a day of warmth and fun in the middle of winter. 

Around 20 Crucell employees and 25 Dream Start children participated. 

In the heat and humidity of July 2010, Crucell volunteers took the Dream 

Start collaboration a step further by organizing a ‘clean-up day’ for two 

families living in Seongnam-si, one of the poorest neighborhoods in 

the city. The teams put up fresh wallpaper, renovated the floors and 

cleaned both houses. “It was a great joy to see the kids playing around 

in a clean and tidy home,” was how one volunteer summed up the day. 

“What my colleagues did might seem like a small contribution to 

improving the lives of people in this squalid area, but it is a great start 

and I am very proud of all of them,” said Sang Jeom Ahn, General 

Manager of Crucell Korea. This example highlights the importance 

of local as well as global CSR initiatives.


Runa Khan, Executive Director Friendship 

“Let me tell you a true story… On char Bhatiborial under Sundarganj, 

Gaibandha, a young girl is already a mother at the age of 16. Khadija 

Begum was 15 when she married Shomizuddin. She had never 

received medical treatment or visited a doctor and had not received 

her tetanus injection (TT). She was not even aware that adolescent 

girls should receive three doses of TT under the Government 

Expanded Program on Immunization (EPI) to minimize the risk 

of infection during delivery. 

To her knowledge, the government has never held an EPI session at 

Bhatiborial and she does not recall a health worker ever visiting the 

char for health education. The closest family welfare center was 

approximately 3 hours away. To get there, she would have to walk 

2 kilometers over sand, wait for a boat that may come only twice 

a week (and not even at a fixed time), and then take a van ride, 

making her journey both tiring and costly. 

In May 2010, when she was about 4 months pregnant, a team 

showed up on her island—not only to conduct an EPI session on the 

char itself but also to inform and educate the community through 

household visits and group meetings. 

Khadija’s son, Mohammad Khairul, is now 5 months old and under 

the Friendship–Crucell EPI Support Program has received his BCG 

(tuberculosis), Quinvaxem® 1 and 2 (pertussis, diphtheria, hepatitis B, 

tetanus and Haemophilus influenzae type B), and OPV 1 and 2 (polio) 

vaccine doses. More importantly, Khadija is aware of when his next 

dose is due and will be bringing him to the center for it. If by chance 

she forgets, she is secure in the knowledge that a Friendship health 

worker will come by to remind her. 

Khadija Begum’s story is one of thousands. This outcome is made 

possible by the joint efforts of Crucell and Friendship.” 


Crucell and Friendship 

Crucell’s partnership with Friendship is a good example of how we 

work with NGOs to overcome barriers to healthcare access in developing 

countries. Crucell provides funding and scientific expertise, as well as 

practical support, to enable organizations that understand the local 

needs, culture and healthcare challenges to develop targeted solutions. 

Friendship is a value-based national organization dedicated to 

improving the lives of people living in the remote riverbank and char 

areas of northern Bangladesh. The chars (nomad islands) are isolated 

from the mainland in terms of physical distance, access to healthcare, 

and other basic resources. Rates of morbidity and mortality due to 

vaccine-preventable diseases are high, especially among children. 

The partnership between Crucell and Friendship is successfully tackling 

this problem by facilitating the government EPI program, which aims 

to deliver the WHO-recommended schedule of vaccines to all children 

under five. We focus on logistics and infrastructure, providing a riverbased 

health service system with floating hospitals, satellite clinics and 

community medics. The Friendship–Crucell program has purchased 

three boats, recruited staff who help the government healthcare 

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Crucell employees help locals dig a well in Bangladesh. 

Steven and Joke Le Poole, Directors of the Max Foundation 

“Both Crucell and the Max Foundation want to reduce child 

mortality. We use our privileged position to fund projects that 

provide high health value per euro spent. We are especially 

impressed that Crucell has the vision to support our 

non-pharmaceutical approach based on wells, latrines and 

hygiene training. We really value the cooperation with Crucell 

as far too many children still die from water-borne infectious 

diseases. Together we can make the difference. Crucell not only 

supports us but also recently visited the project in Bangladesh 

where they could see first-hand the major impact their 

program had on the local community.” 


workers to deliver the regular vaccine schedule and monitor delivery, 

trained community medics and leaders, and conducted community 

meetings to increase awareness about vaccine-preventable diseases 

and the importance of the EPI program. 

These efforts have greatly increased the rate of vaccination coverage 

in the target region. From May 2010, when the Friendship–Crucell EPI 

Support Program was inaugurated, to the end of the year, all but 50 

of the 704 planned EPI sessions were held; problems such as extreme 

rains account for the missed sessions. A total of 1809 babies received 

Quinvaxem® doses at 6, 10 and 14 weeks of age, in accordance with 

the EPI schedule. This gives them protection against five common 

and potentially deadly childhood infections. The infants were also 

vaccinated against tuberculosis, polio and measles, and received 

vitamin A, which reduces child mortality and the risk of river blindness. 

Crucell and the Max Foundation 

Crucell is proud to be supporting the Max Foundation in its work 

to save children’s lives through community-based water projects in 

Bangladesh. Since its foundation in 2004, over 200,000 people have 

been supplied with clean drinking water and sanitation. The 1,000th 

project was completed in March 2011. 

The foundation was set up by Dutch couple Steven and Joke Le Poole 

after their 8-month old son Max died from a rare viral infection. 

“They wanted to turn their loss into something positive,” says Crucell’s 

Chief Strategy Officer Arthur Lahr, who brought the Max Foundation 

to the attention of his Management Committee colleagues. 

For Crucell, partnering this NGO is a logical choice: “It is gratifying 

to be able to support a nonprofit organization that shares our drive to 

improve children’s lives. Immunization and clean water are the most 

cost-effective contributors to child health,” says CEO Ronald Brus. 

Every euro donated to the foundation goes towards microsanitation 

projects.


Bringing color to children’s lives 

Crucell employees gave generously to good causes in 2010. Here are 

two examples we particularly like. 

y Child ambassadors for Stichting Kinderpostzegels 

(Foundation for Childrens’ Stamps) sold a record number of 

stamps and cards during a lunchtime visit to Crucell’s Dutch 

site in October 2010, raising over €1,400 from employees. 

Crucell management doubled their contribution. 

y Employees in Switzerland donated money to purchase over 200 

coloring sets for the children in Bangladesh. The initiative was sparked 

by a presentation on Friendship during a general staff meeting. 

Access to healthcare 

Crucell’s work with Friendship is an example of a targeted community 

initiative to remove barriers to healthcare access. Crucell also works 

on this issue at the international and global level, through close and 

continuous engagement with a wide range of organizations. Here are 

the 2010 highlights. 

Crucell supported the International Pediatric Association (IPA) in its 

efforts to drive EPI development by empowering its members to take 

on an advocacy role. The IPA believes that pediatricians have a crucial 

role to play in advising their governments on the best vaccines and 

implementation strategies. Crucell gave the IPA an unrestricted grant 

to run an advocacy workshop during its latest international congress, 

held early August in Johannesburg, South Africa. Crucell also provided 

a follow-up grant to help in-country implementation of the best 

advocacy proposals. 

At the same conference, Crucell supported educational activities 

through the IPA. These focused on innovative strategies for simplifying 

vaccine delivery, which are seen to be key for reaching neglected 

populations. Crucell’s collaboration with the nonprofit organization 

PATH to make Quinvaxem® available in a Uniject device underlines 

our commitment to this type of innovation (see page 44). 

In November 2010, the launch of a global Coalition Against Typhoid 

(CaT) was announced by the Sabin Vaccine Institute in Washington, 

DC, which will serve as the secretariat. Crucell played a significant role 

in bringing together this worldwide collaboration of stakeholders in 

the field of typhoid fever. “Despite the availability of low-cost vaccines 

against typhoid and a WHO Strategic Advisory Group of Experts 

recommendation for their use, typhoid fever vaccination has been a 

low priority for many countries, including those most impacted by the 

disease,” said Dr Christopher Nelson, Director of the CaT secretariat. 

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Crucell was the vaccine industry representative (for the third successive 

year) on the formal advisory Program & Policy Committee of the GAVI 

Alliance, a public-private partnership with the mission to improve access 

to vaccines in the world’s poorest countries. In 2010, the committee 

played an important role in the development of a new GAVI Alliance 

strategy and business plan for the 2011–2015 period. Other key issues 

were how to prioritize new vaccine applications in order to bridge 

a funding gap, a strategy for resources mobilization, and health 

system strengthening. 

Crucell’s innovative work with international organizations dedicated 

to immunization program development paved the way for our CEO 

Ronald Brus to be nominated by the vaccine industry in industrialized 

countries to represent the constituency on the Board of the 

GAVI Alliance. 

1 Including PERCIVIA events. 


Crucell also worked on healthcare access improvements as a member of: 

y the IFPMA Biologicals & Vaccines Committee, which contributes to 

discussions with the World Health Organization (WHO) on general 

vaccination policies; 

y the advisory group for Project Optimize, a WHO/PATH collaboration 

aimed at developing innovative delivery systems to ensure that 

vaccines get to the right place, at the right time, in the right condition; 

y the European Vaccine Manufacturers (EVM), part of the European 

Federation of Pharmaceutical Industries and Associations, which is 

committed to working in partnership with EU institutions to support 

vaccine policy development and promote vaccine innovation. 

Vaccine donations 

In 2010, Crucell donated 321,000 doses of MoRu-Viraten® vaccine 

against measles and rubella to Unicef to assist earthquake victims 

in Haiti. The vaccines were shipped in August 2010. The donation 

was made as part of the emergency aid campaign organized by 

the International Federation of Pharmaceutical Manufacturers & 

Associations (IFPMA), of which Crucell is a member. 

Contributing to science 

Crucell contributes to the advancement of science and healthcare 

by sharing knowledge and expertise. In 2010, Crucell participated in 58 1 

international conferences and many more seminars, informal meetings 

and media presentations. 

Our leading scientists gave over 25 1 public lectures and presentations to 

their peers on a wide range of topics, including innovative technologies 

for vaccine and antibody discovery, design and manufacturing; novel 

approaches to fighting major infectious diseases; and results emerging 

from Crucell’s research and development programs.


In 2010, Crucell once again sponsored events and symposia to facilitate 

information exchange among key opinion leaders and promote scientific 

development. One example is the Seventh Respiratory Syncytial Virus 

Symposium held in Rotterdam, the Netherlands, in December 2010. 

As well as sponsoring this meeting of leading RSV investigators, Crucell’s 

Innovation and Discovery Laboratories presented two researchers 

with a Crucell Innovation Award in recognition of their outstanding 

work in this field. 

A total of 15 scientific papers by Crucell researchers were published 

in peer-reviewed journals in 2010. 

Sector sustainability initiatives 

In 2010, Crucell participated in a number of initiatives that provide 

an objective measure of corporate performance on sustainability 

issues, including the Dow Jones Sustainability Index (DJSI), the Carbon 

Disclosure Project (CDP) and the Transparantiebenchmark (Transparency 

Benchmark), an index published by the Dutch Ministry of Economic 

Affairs, Innovation and Agriculture. See page 50. 

Crucell remains committed to making sustainability issues an integral 

part of strategic decision-making, with the aim of maximizing 

our contribution to a better world. 

Conclusion 

Corporate social responsibility (CSR) is an integral part of Crucell’s 

mission to conduct good business, for the good of humanity. 

Crucell is committed to continuous development of its approach 

to CSR reporting and the engagement of stakeholders in dialogue 

about sustainability issues. We are again pleased to have taken 

important steps in this direction during 2010. 

Crucell welcomes feedback on this report or any issues related 

to our CSR activities. Your opinion matters to us. Reactions can 

be sent to csr@crucell.com. 

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Appendix 

Performance overview 

What we said (2009 target setting) What we did (2010 actions) Where we are (2010 outcomes) Where we are going (2010 target setting) 

KPI: Prevention of illness and deaths 

Continuous improvement 


Number of pipeline products 

1 PSCI – Pharmaceutical Supply Chain Initiative. 


3 DJSI – Dow Jones Sustainability Indexes. 


Maintained similar levels of prevention 

compared with 2009 

Report annually Expanded and advanced our pipeline 

of investigational vaccines and antibodies 

Animal welfare 

Continuous improvement 3Rs 

(Reduce, Refine, Replace) 

R&D expenses 

Continued to apply 3R principles to animal 

testing for preclinical R&D 

Report annually Reported in press release (2010 financial results, 

February 7, 2011) and in this CSR report 

CSR information management improvement 

In 2010 roll out Reporting Manual 

In 2010 report with 100% 

company coverage 

In 2011 set action plans 

(quantitative targets) 


In 2010 incorporate PSCI 1 principles 

into procurement policy 

In 2011 train all relevant 

employees 

In 2011 100% supplier coverage 

& monitoring 

Transparency objectives 

GRI 2 A+ level CSR reporting in 2015 

Remain in DJSI 3 

In 2010 improve CSR web page 

Developed, finetuned and rolled out 

Reporting Manual 

Collected and analyzed company-wide data 

Produced Supplier Code of Conduct based 

on PSCI principles and incorporating 

Crucell-specific CSR ambitions and guidelines 

Created vendor assessment questionnaire 

to survey key suppliers 

Devised strategy and program for 

Crucell ‘supplier days’ (CSR workshops) 

Made substantial further progress with CSR 

reporting and performance, as measured by 

a range of external benchmarks (DJSI, CDP 4 , 

GRI and Dutch ‘Transparency Benchmark’ 5 ) 

Improved CSR page on Crucell website 


5 Transparantiebenchmark (Transparency 

Benchmark), an index published by the Dutch 

Ministry of Economic Affairs, Innovation 

and Agriculture. 

Prevented more than 3.6 million cases 

of infectious disease and 809,823 deaths 

Crucell has 12 candidate products in its 

R&D pipeline 

Essential safety studies are conducted 

to minimal extent required by law and in 

accordance with highest international standards 

Annual R&D expenses €100 mln in 2010 versus 

€70.2 mln in 2009 

A system for consistent and comprehensive 

reporting is in place 

Data coverage is 100% 

Areas where further training or reporting 

incentives are needed have been identified 

Strategy and tools are in place to engage 

key suppliers in constructive dialogue about 

Crucell’s CSR guidelines and ambitions 

Self-declared GRI level C; DJSI listing for second 

successive year; ‘Transparency Benchmark’ 

score 96/200 

Web page outlines Crucell’s CSR ambition 

and strategy, and provides links for more 

information/contact 

Quantitative 

Qualitative 

Continuous improvement 



Continuous improvement 3Rs 


2011: Set action plans and set quantitative 

targets for environment, health and safety 

(EHS) indicators 

In 2011: train all relevant employees in 

responsible supply chain management 

In 2011: 80% of top 100 vendors to sign 

Supplier Code of Conduct (CSR declaration) 

and take part in CSR assessment 

Beyond 2011: full coverage & monitoring 

of supplier target group 

Hold supplier day with focus on CSR 

in three countries in 2011 

2011: Further improve CSR web page and 

continue to develop reporting practices 

2015: GRI A rating

Crucell’s commitment to the world – Taking responsibility – Appendix 

People overview 


Number of employees by gender 

Formulate target in 2010 Achieved 100% data coverage 

and formulated target 

Average age of employees 

Report annually Achieved 100% data collection 


Number of women in management 

Formulate target in 2010 Achieved 100% data collection 


Number of nationalities 

Formulate target in 2010 Achieved 100% data collection 


Total number of accidents 

Formulate target in 2010 Defined reporting criteria, achieved 100% 

data collection and formulated target 

Employee turnover 

Formulate target in 2010 Achieved 100% data collection, refined KPI 

definition and formulated target 

Strong and successful recruitment drive 

Learning & development (L&D) identified by 

global Human Resources department as key 

CSR priority; global L&D manager appointed 

and multiple L&D initiatives launched 

Percentage of employees receiving regular performance reviews 

Formulate target in 2010 Achieved 100% data collection and 

formulated target 

Added two new KPIs to initial set: Number of own recruits* 

Absenteeism* 

1 Excluding 31 insourced staff in China. 

2 US Occupational Safety and Health Administration (OSHA) definition. 

Quantitative 

Qualitative 

Total workforce 1,398 1 

(12% increase from 2009); ~47% women 

Average age 40 years Report annually 

84 women in senior management positions, 

45% increase versus 2009 

Teams show high cultural diversity, particularly 

in the Netherlands and Switzerland 

Continue focus on equal-opportunity 

human resource management worldwide 

Fair and equitable representation 

Focus on cross-cultural teams 

Lost time case (LTC) rate 2 of 0.40 2011: LTC rate of 0.4 or less 


Voluntary turnover in 2010 was 12.93% Voluntary turnover rate no more than 10% 

of workforce, excluding temporary staff 

~95% > 95% 

250 new employees in 2010 were recruited 

by referral 

Wide variation in data across sites, suggesting 

need to sharpen definition of this new KPI 


Set criteria in 2011 


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Planet overview 


Total water use 

Relative reduction 1 of 10% by 2020 

In 2010 achieve 100% coverage 

(i.e. baseline) 

Total energy use 

See CO2 footprint 

In 2010 achieve 100% coverage 

CO2 footprint 

Relative reduction 1 of 15% by 2020 

In 2010 set baseline 

In 2011 set action plans 

Number, sort and impact of accidents 


Achieved significant water savings by installing 

a new purified water generation plant in Spain 

and improving steam boiler operations in a 

Swiss facility 

Initiated full operational testing at new Korean 

facility in addition to commercial operations 

at old site and increased activity at two 

Swiss facilities, leading to overall increase 

in water consumption 

Achieved 100% data coverage. Waste 

water was monitored and reported as an 

additional parameter 

Increased operations in Korea and Switzerland, 

leading to overall increase in energy 

consumption (see ‘water use’) 

The carbon footprint was calculated using the 

Greenhouse Gas Protocol and latest conversion 

factors sourced from the UK Department for 

Environment, Food and Rural Affairs (DEFRA) 

Formulate target in 2010 Defined reporting criteria, achieved 100% 

data collection and formulated target 

Amount and characteristics of waste and disposal method 

Implement waste minimization 

programs on all sites 

System for global data collection and analysis 

developed, piloted and refined; 2010 baseline 

established; recycling initiatives mapped 

Plan drawn up for workshop early 2011 to 

share best practices and develop waste 

minimization programs 

1 Relative to workforce size expressed in full-time equivalents (FTEs). 

Quantitative 

Qualitative 

312,259 m 3 (41.1% increase versus 2009 

due to operational increases) 

156,643 m 3 of waste water 

Total energy use: 88.4 million kWh 

(44.6% increase versus 2009 due to operational 

increases) 

Relative reduction 1 of 10% from 2010 

baseline by 2020 

Monitor and minimize waste water 

See CO2 footprint 

21,120.61 tonnes CO2 Relative reduction 1 of 15% from 2010 

baseline by 2020 

Lost time case (LTC) rate 2 of 0.40 2011: LTC rate of 0.4 or less 


Solid waste: 754,420 kg 

Special waste: 52,995 kg (7% of total waste) 

Recycled waste: 203,596 kg (27% of total waste) 

Develop and/or refine waste minimization 

programs on all sites


Philanthropy overview 


Number of doses donated 

Report annually Donated 321,000 doses of MoRu-Viraten® 

vaccine against measles and rubella to Unicef 

to assist earthquake victims in Haiti 

Support of sector sustainability initiatives 

Further Crucell involvement Participated in a range of initiatives measuring 

sustainability and CSR transparency: DJSI 1 , 

CDP 2 , GRI 3 and ‘Transparency Benchmark’ 4 


Liaise with key NGOs and 

evaluate partnership yearly 

Conducted two Footprint field trips to 

Bangladesh and planned a third trip which 

was held early in 2011 

Strengthened and expanded partnerships 

with NGOs 

Evaluated partnerships 

1 DJSI – Dow Jones Sustainability indexes. 



4 Transparantiebenchmark (Transparency Benchmark), 

an index published by the Dutch Ministry of Economic Affairs, 

Innovation and Agriculture. 

Quantitative 

Qualitative 

321,000 donated doses of MoRu-Viraten® 

vaccine were shipped in August 2010 

Self-declared GRI level C; DJSI listing 

for second successive year 

‘Transparency Benchmark’ score 96/200 

Participation in CDP 

Strong employee involvement in and 

support for community outreach activities 

Crucell–Friendship partnership is highly 

successful in helping Bangladeshi 

government to improve immunization 

coverage in remote areas 

In partnership with the Max Foundation 

(new partner in 2010) Crucell is supporting 

microsanitation projects in Bangladesh 


Global policy for disaster relief (donations) 

Participation in DJSI, CDP and Transparency 

Benchmark to end due to delisting 

Continue participation in GRI 

New Footprint fieldtrips scheduled for 2011 

Further strengthen current NGO partnerships 

Explore potential new partnerships 

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Field trips 

Impression photo’s taken by Crucell employees during Footprint 

field trips, Crucell’s CSR outreach program. 

www.crucell.com


75


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