EXCELLENCE - Pharma

March/Arpil 2009 Volume 5 Number 2 

The global magazine for the pharmaceutical and biopharmaceutical industry 

OPERATIONAL 

EXCELLENCE 

Lean Manufacturing for Pharma 

EASTERN EUROPE 

Bucking the Recession 

PROCESS TECHNOLOGY 

The Complete Picture? 

SHOW PREVIEWS 

ACHEMA, INTERPHEX and MEDTEC 

OUTSOURCING 

How the Internet can Improve Services 

www. pharma- mag. com

BD Medical - Pharmaceutical Systems 

Your confidence, 

our commitment 

BD Medical - Pharmaceutical Systems 

is a leading provider of high-quality, clinically-proven 

prefillable parenteral delivery systems. 

We are committed to earning our customers’ confidence 

by providing innovative drug delivery technologies, 

utilizing global manufacturing and a high level 

of technical expertise. 

BD Medical 

Pharmaceutical Systems 

11, rue Aristide Bergès 

38800 Le Pont de Claix 

France 

Tel: +33 (0)4 76 68 36 36 

Fax: +33 (0)4 76 68 35 05 

www.bd.com/Pharmaceuticals

30 

outsouRcing — iMpRoving custoMeR satisfaction 

Sanjiv Gossain, Cognizant Technology Solutions. 

How web technologies are being used by the outsourcing industry to improve 

customer service and satisfaction. 

pRocess inputs — opeRational excellence 

Günter Jagschies, GE Healthcare Life Sciences. 

How lean-enabling technologies can play a pivotal role in significantly reducing 

waste and, ultimately, costs. 

MaRketing — ManufactuRing betteR pRofits? 

Michael Kelly and Susan Bolge, Consumer Health Sciences. 

Why marketing research and outcomes research will benefit from alliance and 

collaboration. 

easteRn euRope — positive vibes 

Monika Stefanczyk 

In times of economic difficulties, there are always regions that profit from the 

misfortune of others. The CEE is one such region: Eastern Europe’s outsourcing 

industry is flourishing. 

pRocess technology — pRoduction pRobleMs 

Dr Jamie Weiss, Kepner-Tregoe. 

For every problem there is a solution. But sometimes there is a problem for 

every solution — especially when corrective measures are implemented without 

considering the repercussions further down the process chain. 

26 36 50 

call for entries now... 

contact miranda@via-medialtd.com 

34 

strap goes contents here 

www.pharma-mag.com 

ReseaRch Money available 

I discussed the recession in the last issue. So let’s take 

a more optimistic approach. How would you like £6 

million? It could come in useful, I suppose. Well, the 

UK Government is looking to give the pharmaceutical 

industry this sum for information it probably already has! 

The Government’s Technology Strategy Board 

— the body responsible for allocating public money 

to technology research — is encouraging the 

pharmaceutical industry to bid for £6 million of new 

funding. This new funding competition will support 

research into the security weaknesses of complex 

information systems — the technology systems that 

underpin our digital world. 

As information systems become more complex, to 

support our growing demand for richer business and 

personal services, they are becoming increasingly 

vulnerable — and this means more risk for us all. 

If we don’t accurately understand or manage the 

increasing complexity of the technology that delivers 

our information, we cannot predict where weaknesses 

might occur — nor introduce appropriate methods 

of protection. This competition will fund research into 

new technology-inspired tools, techniques and services 

that will help us to model the growth of these complex 

information systems. 

Because pharmaceutical companies’ expertise in 

these techniques (often used in drug development) can 

offer valuable insight into how new ideas in this area 

could work in real industry environments, the sector’s 

experience could be applied when developing ways to 

model the growth of complex information infrastructure. 

In March and April, the Technology Strategy Board is 

providing support to those new to the process through 

a series of information days and workshops in the UK. 

It has also established a separate “fast-track” 

channel for any SMEs bidding for less than £150,000. 

This channel is available for a longer period of time, 

but is a significantly shorter process. Participants 

may bid as many times as they like — while finetuning 

their proposals based on feedback from the 

Technology Strategy Board — until they become 

suitable for investment. 

Visit www.networksecurityip.org. And good luck! 

Graham Lampard 

Comment 05 

News — General Round-Up 06 

News — ACHEMA Preview 10 

News — INTERPHEX Preview 12 

News — MEDTEC Preview 14 

Drug Delivery — Valois 34 

Process Technology — Kemutec 40 

Product News 46 

People/Calendar 49 

Final Word 50 

March/April 2009

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CONTRIbUTORS 

Contributing Editor 

Graham Lampard 

+44 20 7096 7182 

graham@via-medialtd.com 

Editorial Director 

Kevin Robinson 

+44 (0) 1392 202 591 

kevin@via-medialtd.com 

Art Director/Production 

Paul Andrews 

Tel. +44 (0) 1372 471 549 

paul@via-medialtd.com 

Web Designer/Marketing Manager 

Claire Day 

Tel. +44 (0) 1372 471 547 

claire@via-medialtd.com 

Editorial Advisory Board 

Publisher 

Miranda Docherty 

+44 (0) 1372 471 542 

miranda@via-medialtd.com 

Group Publisher 

Simon Jones 

+44 (0) 1372 471 541 

simon@via-medialtd.com 

Financial Controller 

Catherine Swainson 

+44 (0) 1372 471 540 

catherine@via-medialtd.com 

The Editorial Advisory Board of Pharma comprises a distinguished panel of experts 

from various parts of the pharmaceutical industry. They review technical manuscripts, 

suggest topics for inclusion, recommend subject matter and potential authors, and act 

as the quality control department for the magazine’s editorial content and direction. 

Rory Budihandojo 

Computer Validation 

Manager 

Boehringer Ingelheim 

Patrick Crowley 

Vice President 

Product Line Extensions 

GSK (US) 

Doug Dean 

Partner, Pharmaceuticals/ 

Life Sciences 

IBM Business Consulting 

Services 

Maik W. Jornitz 

Group Vice President 

Global Product 

Management, Bioprocess 

Sartorius North America Inc. 

Jim McKiernan 

Chief Executive Officer 

McKiernan Associates 

GmbH 

Gino Martini 

Director, Strategic 

Technologies 

GSK (UK) 

Maireadh Pedersen 

VP, Business Development 

– Pharmaceuticals 

Teraview 

Ray Rowe 

Chief Scientist/Prof of 

Industrial Pharmaceutics 

Intelligensys/Uni of Bradford 

Harald Stahl 

Technical Marketing 

Manager 

Niro Pharma Systems 

Geoff Tovey 

Visiting Professor 

Dept of Pharmacy 

King’s College 

Peter Murin 

Chief Executive Officer 

Halocarbon Products Corp. 

Rudy Winklhofer 

Account Director, Europe 

ABI Marketing Public 

Relations. 

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ecent talks have been about the 

recession, economic downturn, 

credit crunch and so on. However, 

the pharma giant Pfizer made 

a remarkable start to 2009. Pfizer acquired 

its rival big pharma company Wyeth for 

approximately $68bn for stock and cash. This 

acquisition is said to be one of the biggest in 

the pharmaceutical history. However, would it 

have been better for Pfizer to acquire Amgen 

instead of Wyeth? 

Pfizer Acquires Wyeth: 

Behind the Scenes 

Pfizer faces tough competition from generics 

after the expiry of its blockbuster drug Lipitor, 

in 2011. Lipitor, a cholesterol treatment drug, 

generates around $13 billion a year, but is facing 

patent expiration in 2011. And the company 

is set to face big challenges by 2012, not 

only from generics, but also from investors 

because of the decline in its R&D productivity. 

Though its pipeline has 200 products, there are 

no blockbusters to even dent the $30 billion 

expected to be lost through the patent expiry of 

13 drugs by 2014. 

Wyeth is also facing similar challenges from 

generic drugs for its antidepressant drug Effexor, 

which generates around $3.92 billion annual 

revenues. Wyeth was planning to take 

over Crucell, a Dutch vaccine company, 

but with Pfizer taking over Wyeth, those 

plans have been dropped. 

The combined pharmaceutical company 

(Pfizer and Wyeth) will be one of the biggest 

in history and is expected to maintain the top 

position for the next 5 years. This acquisition 

will enhance the pipeline of products for 

therapeutic areas such as Alzheimer’s disease, 

autoimmune disease, inflammation, oncology, 

pain and others. Pfizer is expected to become 

the top player in vaccines, biotherapeutics, 

animal health and the consumer market, and 

will have more than 15 products with $1 billion 

each in annual revenue. This strategic move 

from Pfizer also brings out a new business 

model, wherein no one product would generate 

more than 10% of the total company revenues. 

This is to move away from the dependence on 

a single blockbuster molecule: Lipitor generates 

25% of the company’s revenues. 

What Next? 

Most of the big pharmaceutical companies are 

facing decline in revenues and earnings in the 

next 5 years. The merger of Pfizer and Wyeth 

may be contagious and will trigger some big 

M&A activity in the pharmaceutical industry in 

the coming weeks. The pharmaceutical industry 

is one of the cash-rich industries that has yet to 

see the ravages of the current economic gloom. 

Though plagued with R&D challenges, 

patent expiries, generic competition 

and high drug attrition rates, 

pharmaceutical companies 

have resorted to various 

crisis management strategies 

to stay afloat during trying 

times. One of these strategies 

is M&A activity. With Pfizer taking 

a strong and bold step in this 

direction, there may be other 

companies to follow. 

Future M&A Activities 

Sanofi-Aventis deal with vaccines, 

which makes Crucell a potential buy. 

Sanofi-Aventis could look at strengthening 

its position in the vaccines area and has been 

vying for top position among the pharma 

strap goes comment here 


PfIzER/WYETH: INdICATIVE 

Of POOR HEALTH 

Frost & Sullivan analyst A Shabeer Hussain, Programme Leader, Pharmaceutical and Biotechnology, Healthcare 

Group, looks at the reasons for Pfizer’s acquisition of Wyeth, and suggests it bodes ill for the industry. 

companies. Though this may be a distant dream 

— in light of the Pfizer/Wyeth deal — it could 

forge one with Bristol-Myers Squibb (B-MS ) 

which, if it happens, would push Sanofi-Aventis 

to number two after Pfizer. 

Eli-Lilly and Takeda have been collaborating in 

the antidiabetic drugs area and Eli-Lilly may find 

it beneficial to acquire or merge with Takeda. 

Johnson & Johnson has a good basis for 

acquiring Vertex Pharmaceuticals because of the 

impressive past deals with Vertex and also the 

exciting pipeline consisting of drug candidates 

for cystic fibrosis and rheumatoid arthritis. B-MS 

and Amgen can forge a deal in the future as 

B-MS is always active in M&A activities and 

Amgen’s biotech pipeline can boost B-MS’s 

position in the pharma industry. 

Healthy Industry? 

Such M&A deals in the industry are not new 

and Pfizer has been part of larger deals in the 

past — such as Pharmacia. Although the deal 

may have brought good news for investors, 

an insight into the health of the pharma market 

reveals interesting facts. As blockbusters fall off 

patent, organic growth has occurred, but pharma 

companies have resorted to inorganic growth 

through M&A. However, this growth cannot 

form a sustainable business model for long. It is 

a stopgap arrangement: for Pfizer to stay afloat 

during Lipitor patent expiration — and with Wyeth 

facing similar circumstances — it had to give into 

this deal to prevent itself from sinking too. 

The prime question emerging from such M&A 

activities is ‘Are these favouring innovation?’ 

Analysis reveals that ‘innovation’ is not the 

primary focus for these companies — and such 

activities are just crisis management measures. 

These short-term arrangements enhance their 

stock price and are purely business-oriented, 

not innovation-oriented. Such massive deals are 

not a healthy sign, but are clear pointers to the 

ill-health of the drug industry. 

More information 

www.frost.com 

March/April 2009

news 


Dishman to Expand Operations in India and China 

The Dishman Group of Ahmedabad, India, has announced capital investments 

of more than $33 million; $20 million in the current financial year and 

$13 million planned for fiscal year 2009, which begins in April. The global 

pharmaceutical services provider will see significant expansion of its 

capabilities and offerings this year, with the addition of a high-potency facility 

near Dishman’s headquarters in the district of Ahmedabad and a new plant 

in Shanghai, China. The facility in India is a state-of-the-art, 4300 m 2 plant 

catering to cytotoxic and non-cytotoxic highly active substances, and one of 

the largest and most flexible custom manufacturing high-potency facilities 

in the world. In Bavla, the plant will be managed and operated by Dishman 

subsidiary, Switzerland-based Carbogen Amcis AG, and is scheduled to be 

operational by mid-2009. 

The facility in Shanghai will include a production plant, a warehouse, 

its own dedicated on-site utilities and administrative/quality control offices. 

Construction of the facility is under way and is expected to be fully staffed and 

operational by the second quarter of 2009. “The new facilities in India and 

China will enable customers to collaborate with Dishman as a sole technical 

partner from early stage development to market supply, without volume 

limitations. The addition of the plant in India offers customers a seamless 

approach to high-potency research and development, process optimization and 

commercial manufacturing,” said Jay Vyas, Managing Director of Dishman. 

The company places a strong focus on safety and security, with an emphasis 

on risk management strategy, which provides redundancy of supply in multiple 

Asian sites and countries and also provides ease of Asian collaboration. 

“Additional locations and infrastructure provide secure options that maximize 

speed, flexibility and cost advantages for customers with the same safety and 

quality standards, globally,” said Vyas. 

March/April 2009 

DHL Expands into Contract Packing and Kitting 

DHL Exel Supply Chain, a leading logistics services provider, has continued the 

expansion of its contract cGMP (current Good Manufacturing Practice) packing 

and kitting offering, which will now be available as a standalone service within its 

healthcare warehouses and distribution centres across the UK. The solution has 

been offered for the past 12 years for customers seeking consolidated warehousing 

and packaging activities, providing improved efficiency and reduced waste. Owing 

to increased capacity, DHL is now able to offer hand-based assembly, rework 

and co-packing as a standalone service to new and existing customers, covering 

pharmaceuticals, drug delivery systems, medical devices, surgical consumables and 

sample pack preparation. The solution includes secondary packaging, reworking, 

kitting and late customization to market or customer specific requirements. DHL is 

licensed by the Medicines and Healthcare Products Regulatory Agency to conduct 

a range of cGMP packaging services. It also has a number of Qualified Persons to 

release products following packaging activities. Jonathan Blamey, Vice President 

Product Development Healthcare, DHL Exel Supply Chain EMEA, said: “At DHL, we 

take pride in understanding our customers and offering tailored solutions according 

to their needs. This solution enhances our current healthcare offering, allowing 

more customers to utilize assembly and packaging, combined with storage and 

distribution, to deliver an integrated supply chain. This provides increased flexibility 

and responsiveness to market requirements.” Caroline Fox, Technical Services 

Manager Healthcare, DHL Exel Supply Chain UK, commented: “The solution offers 

our customers a cost-effective and consolidated supply chain that is backed by the 

expertise and knowledge of the world’s leading logistics services provider. For many 

customers, having a complete packaging and distribution service under one roof 

means reduced operating costs, with greater supply chain control and visibility.” For 

more information, visit www.dhl.co.uk. 

GE Collaborates in Indian Plasma Fractionation 

Celestial Biologicals Limited (CBL), an associate company of Intas 

Biopharmaceuticals Limited, and GE Healthcare, are to set up India’s first 

GMP-compliant Plasma Fractionation facility in Ahmedabad. The facility will 

be first of its kind in India. The collaboration will include the appropriate 

technology, products, processes and project development to establish the 

Plasma Fractionation facility. The model being developed in India is replicable in 

other developing economies that are currently dependent on imported plasma 

products. The facility will be fully functional by early 2010. GE Healthcare was 

chosen as the preferred partner for the project for its technological expertise 

and the company’s platform solution. “With a comprehensive life sciences 

facility such as CBL, a diverse range of solutions and process support are 

required. GE Healthcare demonstrated an attractive proposition because, as 

a key healthcare and life sciences infrastructure provider, they presented a 

holistic approach to cater for multiple aspects of CBL projects seamlessly,” 

said Dr Urmish Chudgar, Managing Director, Intas Biopharmaceuticals Limited. 

Under this collaboration, CBL and GE Healthcare will jointly set up a pilot Plasma 

Fractionation facility of approximately 15,000–40,000 L capacity for at least four 

products at CBL’s existing GMP-compliant facility. The companies plan to scaleup 

the Plasma Fractionation facility to a capacity of 300,000 L at the same time.

Vacuum Mixer Dryer with Conical Floor 

As a specialist supplier of 

mixers and dryers for dry, wet 

and paste-like goods, amixon 

manufactures vacuum mixer 

dryers, reactors and vertical 

twin- and single-shaft mixers. 

Because of its all-over mixing 

movement, the machine is 

capable of achieving extremely 

short drying times, evaporating 

any liquid from the mixture in a 

very short period of time. Now, 

amixon offers a new generation 

of vacuum mixer dryers: the 

AMT series. Machines in the 

AMT series differ from previous 

models because of their conical floor, which allows complete and automatic selfemptying 

to be achieved with free-flowing material. A further benefit is that because 

of a patented, helical-ribbon mixing tool, even mixing is also achieved in the cone. 

A three-dimensional movement of the mixture is achieved as it moves upwards at 

the periphery and then downwards again in the centre. The mixer, the helical ribbon, 

the mixing arms and the mixing shaft are all heated, so that drying is extremely fast, 

gentle and even. The tank is vacuum- and pressure proof, which means that pressuredependent 

reactions can also be managed. 

The AMT mixer dryer reactor is suitable for drying powders, suspensions, 

pastes and doughs. Cutting rotors can accelerate the mixing and drying process 

and, at the same time, perform deagglomeration. As a further option, the tanks 

can be fitted with a heated inspection door that creates dead space. As the 

patented mixing tool is only fixed and driven at the top, it is not necessary to 

extend the shaft right through the product. Machines in the AMT series were 

developed to fulfil high-level hygiene requirements; they can be used as sterile 

equipment/reactors and comply FDA regulations, EHEDG requirements and 3a 

sanitary standards. Available in 23 (100–40,000 L), each vacuum mixer dryer 

and reactor is customized according to customer requirements and process 

parameters (www.amixon.de). 

Please visit amixon at the ACHEMA, Frankfurt, Germany, May 11-15, 2009, 

Hall 6 Booth E3-E6 

Phico Awarded £1 Million for Trials 

Phico Therapeutics has been granted a Wellcome Trust Strategic Translational 

Award totalling £1.03 million to cover Phase I and II trials of its lead 

candidate, SASPject PT1.2, for the decolonization of MRSA and S. aureus. 

PT1.2 is based on a new class of antibacterial proteins called SASPs, which 

bind to bacterial DNA and resulting in rapid “speed of kill.” If successful, 

PT1.2 will provide a major new weapon in the fight against MRSA and 

other bacterial infections. Dr Ted Bianco, Director of Technology Transfer 

at the Wellcome Trust commented: “There is an urgent need to develop 

innovative ways to manage the transmission of antibiotic-resistant bacteria 

in the hospital and care-home environments. The approach being taken by 

Dr Fairhead and colleagues is imaginative and original. If successful, this 

technology may provide an important new tool in the fight against MRSA and 

other pathogenic bacteria.” 

Flic Gabbay, a Senior Partner in TranScrip and Chairman of Phico has been 

instrumental in assisting Phico with the strategic development of the portfolio 

— at board level, within the development decision making processes and, 

with assistance from her team, supporting the successful award application. 

According to Dr Gabbay: “I am very proud of the team effort to help facilitate 

the development of the product, which addresses the continuing twin 

problems of transmission and drug-resistance. We are delighted that the 

Wellcome Trust sees the potential of PT1.2. This award will enable Phico 

to conduct Phase I and II clinical trials, with results expected in the third 

quarters of 2009 and 2010, respectively.” It is anticipated that TranScrip 

Partners will continue to provide strategic and operational support to Phico 

(www.wellcome.ac.uk). 

Conical mixer dryer, 

Reactor 

for all dry, moist and suspended materials – 

also for sterile materials! 

Range from 100 liters to 40,000 liters 

Steril Reactor 

Extremely powerful mixing-drying – 

for powder and even for highty viscous goods 

Ideal heat transmission – vessel, shaft and mixing 

device are fully temperature-controlled 

Ideal protection of the materials through low speeds 

Heated spiral mixing tool is only supported and 

driven from above 

Manhole on the side or above is temperature 

controlled 

Very high residual emptying rates – 

up to 99,999 % 

amixon GmbH 

33106 Paderborn · Halberstädter Straße 55 · Germany 

Phone: +49 5251 688888-0 · Telefax: 688888-999 

eMail: info@amixon.de · www.amixon.com 

© AMT 01/2008 2C/GB

news 


Successful Data Capture in Remote Areas 

Pilot work undertaken by Cmed (Horsham, UK) with GSK demonstrated the 

utility of Cmed’s intelligent Data Acquisition and Management system in a 

challenging geographic setting — specifically, Burkino Faso, Mali, Kenya 

and Tanzania. Given that one of GSK’s objectives is to discover, develop 

and make available new drugs and vaccines for the treatment or prevention 

of diseases in the developing world, they looked to move away from a 

dependence on traditional web-eDC, which is negatively affected by the 

vagaries of Internet connectivity in remote areas. GSK were keen to explore 

the use of Cmed’s Timaeus system, its comprehensive functionality and its 

geographic versatility in that setting. A single system, which both captures 

and manages paper and electronic data, Timaeus is a “next generation” 

application with an architecture that allows wireless communication by all 

types of low and high bandwidth mobile (cell) phone technologies. Not only 

is it able to function with good Internet connectivity, via web-eDC, but its 

ability to communicate over a small bandwidth means it is also able to cope 

with the restricted Internet connectivity increasingly found in practice. The 

consequent extremely low bandwidth needed to communicate means that 

Timaeus can operate in areas of interest where Internet access is, at best, 

problematic. The pilot was deemed by all to be “a complete success” with a 

clear demonstration that data can be captured electronically — both reliably 

and comprehensively — in geographic areas with limited or no access to the 

Internet. “We are extremely grateful for the support and confidence shown 

in both Cmed and Timaeus by a company like GSK,” said David Connelly, 

CEO of Cmed. He added: “We have demonstrated the ability to capture 

and wirelessly stream clinical data from many remote geographic areas, 

with obvious benefits to data quality and timeliness. The positive reaction 

from investigator sites was also a real added bonus.” Write to contact@ 

cmedresearch.com for more information. 

Invitrogen + Applied Biosystems = LIFE 

Invitrogen Corporation and Applied Biosystems Inc. have merged to form 

Life Technologies Corporation and will be traded on the NASDAQ Global 

Select Market under the ticker symbol, LIFE. “This is an exciting time 

in the history of Invitrogen and Applied Biosystems,” said Greg Lucier, 

Chairman and Chief Executive Officer of Life Technologies. “By combining 

these two highly respected brands, we are not only creating a stronger 

company, but an industry thought leader, uniquely positioned to help 

our customers accelerate and drive new discoveries and commercial 

applications. “On behalf of the new management team, I want to welcome 

all employees to our new company,” Lucier added. “I am confident that 

together we will change the future of life science.” For more information, 

visit www.invitrogen.com. 


Foster Fosters a New Name 

Foster Pharma, a business unit of Foster Corporation, has changed its name to 

Delivery Science, reflecting the unit’s specific core competency in melt extrusion 

and markets served. Delivery Science specializes in the melt extrusion blending 

of active ingredients and polymers, and provides contract process development, 

scale up and manufacturing services in a cGMP cleanroom environment. The 

company serves start-up through to top tier companies in pharmaceutical, 

combination medical device and nutritional markets. Services include blending 

APIs for oral, implantable, subcutaneous, transmucosal or transdermal dosage 

forms. Finished forms of custom blended materials include pellets, powder, fibres 

and film (www.fostercorporation.com). 

TTP Completes AZ Automation Project 

TTP LabTech (Royston, UK) has successfully completed a major laboratory 

automation project with AstraZeneca. The project, which took more than 

3 years to complete, involved the design and build of a fully automated 

system for salt and polymorph screening of novel compounds. The system 

completed its SAT (site acceptance test) late last year before coming online 

at AstraZeneca’s research facility in Södertälje, Sweden. This unique 

system for synthesizing and analysing crystalline materials was designed in 

partnership between AstraZeneca and TTP LabTech. The overall objectives 

were to increase throughput, to explore experimental space efficiently and 

reliably and to automate the analysis of huge amounts of data. The project 

has been undertaken in stages, the first of which was a prototyping stage. 

This stage helped to minimize risk by tackling those design elements 

that carried the greatest number of unknowns, early in the project. The 

next stage was the full design and build of a single screening machine to 

demonstrate control, functionality and consistency of the basic automated 

polymorph screening processes. Now, TTP LabTech has been asked to 

replicate the entire system to double the overall throughput. 

Dr Philip Blenkinsop, MD, TTP LabTech commented: “This has been 

a very challenging project for TTP LabTech, requiring a number of novel 

solutions to be developed from both a hardware and software perspective. 

The completion of the first system is a real milestone and we look forward 

to delivering the next system with the next year.” The AstraZeneca Project 

Manager, Matti Ahlqvist commented: “Working in partnership with TTP 

LabTech has resulted in an excellent solution. We set a very demanding 

specification and are delighted that virtually all the functionality has been 

achieved. Now that the first system is up and running for our drug projects, 

we look forward to the delivery of the second system and further increasing 

throughput.” For more information, visit www.ttplabtech.com. 

TTP LabTech successfully delivers a fully automated chemistry 

system for salt and polymorph screening to AstraZeneca.

strap goes here 


02.03.09 

DIAGNOSING 

FROM A 

DISTANCE 

THE GLOBAL 

RISE OF TELECARE 

MONITORING 

READ MORE AT INVESTINYORKSHIRE.COM/SHARE 

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March/April 2009

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ACHEMA 2009 PREPARES 

fOR TAkE Off 

ore than 3100 exhibitors 

from 50 countries have 

already booked exhibition 

space at ACHEMA 

2009 — the leading international event 

for chemical engineering, environmental 

protection and biotechnology. It takes 

place at the Frankfurt Messe in Frankfurt 

am Main, Germany, from 11–15 May and 

runs alongside an international congress 

comprising 900 lectures focused on stateof-the-art 

developments. 

“ACHEMA 2009 continues to be the 

world’s largest industry event and, once 

again, looks to be on course to attract 

more than 150,000 visitors from 100 

different countries,” explained Mike Day, UK 

and Ireland representative for ACHEMA. 

“The event is truly a global showcase 

for manufacturers and distributors alike 

because it attracts large numbers of 

buyers and senior executives from around 

the world.” Already, more than 600 

suppliers have taken exhibition space, 

with three halls now fully booked. The British contingent, currently 

66 exhibitors, is easily the largest international group, followed by 

Italy, the US, Switzerland, China and France. ACHEMA 2009 is also 

receiving support from a number of UK-based professional bodies and 


government agencies, including the Institution 

of Chemical Engineers, GAMBICA and UKTI. 

Jacqui Cressey, Marketing Manager, IChemE 

Publications, which is the hub for chemical, 

biochemical and process engineering 

professionals worldwide, said: “IChemE views 

ACHEMA’s delegates as a key audience to 

engage with about communicating all aspects 

of chemical, process, biochemical and 

related engineering. As well as promoting the 

advancement of both the science and practice 

of chemical engineering within the profession, 

IChemE aims to increase the public recognition 

of chemical engineering, both in terms of what 

chemical and process engineers do and the 

benefits that their work brings to society.” 

GAMBICA, the trade association that 

represents the interests of companies in the 

instrumentation, control, automation and 

laboratory technology industry in the UK, 

will once again — with assistance from UK 

Trade and Investment — continue to support 

British companies exhibiting at ACHEMA 

2009. Tim Collins, GAMBICA’s director of the 

laboratory technology sector commented: “The benefits of exhibiting 

at ACHEMA are enormous; if you are looking for new business 

partners or to meet existing ones, the show is a must.” Visit 

www.achema.de for more information. 

ANALYSETTE 22 MICROTEC PLUS 

The measuring cells of the new Analysette 22 MicroTec plus 

from Fritsch are located in convenient cartridges that, during the 

switch from wet to dry measurements, can be exchanged without 

tools! And when the cartridge is not being used, it’s stored in the 

corresponding dispersion unit. With the Analysette 22 MicroTec 

plus, technicians can choose between two individual measuring 

ranges or combine them. This provides maximum flexibility 

and an overall measuring range from 0.08–2000 µm, with an 

outstanding resolution of up to 108 measuring channels. The wet 

dispersion unit is equipped with a very powerful centrifugal pump 

for the optimal transport of high concentration/heavy particles 

through the measurement system. With the help of an intelligent 

liquid-level-sensor, three individual amounts of liquids can be 

set by default and, in addition, common organic solvents can be 

used as suspension liquids. All this, combined with an effective 

and variable ultrasonic system linked to flexible software, which 

also manages complex measurement sequences, results in a 

powerful, fully automatic and reproducible system that will tackle 

challenging dispersion and measurement requirements as well. 

Visit FRITSCH GmbH at ACHEMA (Hall 6.1, Booth J9–J12) or, 

online, at www.fritsch-laser.com.



March/April 2009

show preview 


Covering the Life 

SCienCeS SpeCtrum 

NTERPHEX is the world’s most aspect of drug manufacturing, from process 

trusted source for leading-edge 

technology, education and sourcing 

development through to delivery to market. 

of the products and services that Education 

drive scientific innovation for Life Sciences The INTERPHEX Conference will feature 

manufacturing. It covers drug development three days of comprehensive educational 

through to market — accelerating regulated opportunities to reflect the trends and challenges 

products for patient care globally — and takes facing pharmaceutical and biopharmaceutical 

place from March 17–19 at the Jacob K. Javits professionals today. Attendees can choose from 

Convention Center, New York, NY, USA. more than 70 sessions and workshops to help 

The exhibition comprises four major 

them acquire valuable knowledge and gain a 

segments: Facilities, Outsourcing & Contract 

Services, Information Technology and 

competitive edge. 

Manufacturing/Processing. Visitors will find More information 

technology solutions and education for every www.interphex.com 

igh performance half page ad 26/2/09 15:00 Page 1 


Exhibition Hours 

Tuesday, March 17 

10:00 am – 5:00 pm 

Wednesday, March 18 

10:00 am – 5:00 pm 

Thursday, March 19 

10:00 am – 3:00 pm 

Conference Hours 

Tuesday, March 17 

9:00 am – 4:15 pm 

Wednesday, March 18 

9:00 am – 4:15 pm 

Thursday, March 19 

9:00 am – 11:15 am 

High Performance ingredients for 

Pharmaceuticals... 

Looking to enhance the bioavailability, delivery and efficacy of your dosage 

form? With Croda’s high purity lipid actives and functional excipients you 

can optimise the performance of your topical, oral and parenteral 

formulations. 

Key product ranges include: 

� Super Refined ® polyethylene glycols 

� Super Refined ® vegetable oils 

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� Pharmaceutical grade omega 3 

fatty acids 

� Pharmaceutical grade polyethylene 

glycols 

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Europe,Africa, Middle East 

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� Self-emulsifying waxes 

� Medilan range of medical 

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� Surfactants, solubilisers 

and emulsifiers 

North America 

Croda Inc, USA 

Tel +1 732 417 0800 

email:marketing@crodausa.com 

Latin America 

Croda Brasil Ltda 

Tel +55 (0) 19 3765 3500 

email:marketing@croda.com.br 

Asia Pacific 

Croda Singapore Pte Ltd 

Tel +65 65 519 600 

email:sales@croda.com.sg

QUICk 

dISCONNECT 

COUPLINGS 

Biopharmaceutical process engineers seeking a secure and 

cost-effective aseptic disconnect from equipment now have 

a reliable, easy-to-use solution: the HFC39 Series couplings 

from Colder Products Company. Extensively tested for 

biocompatibility and performance, the HFC39 Series 

couplings are designed to prevent external organisms from 

entering through the connector and into the flow path during 

disconnection. 

When integrated into presterilized single-use systems, 

the HFC39’s automatic shut-off valves allow an aseptic 

disconnection by closing off the flow path prior to fully 

disconnecting. For the first time, operators can complete 

an aseptic break between silicone tubing assemblies. The 

valve design also eliminates the need for pinch clamps 

or tubing welders. “Biopharmaceutical manufacturers 

have been using HFC39 connections for years, proving 

the product’s reliability,” said John Boehm, Business Unit 

Manager, Bioprocessing, Colder Products Company. “Now 

we have validated its aseptic disconnect capability, giving 

bioprocessors the confidence to use the HFC39 in their 

most critical applications.” 

The Container Closure Integrity Test, using the Microbial 

ingress testing, was performed at Northview Laboratories. 

The Barrier Challenge and Biocompatibility tests on the 

materials of construction were performed by NAMSA 

Laboratories. A full Validation Report Package is available at 

www.colder.com. 

The plastic components of the HFC39 couplings are 

made from polysulfone and the seals are made from 

platinum-cured silicone. Both meet USP Class VI standards 

and will withstand autoclave, EtO, Gamma or E-Beam 

sterilization methods. The couplings function reliably with 

working pressure from vacuum to 125 psi (8.6 bar), and 

in temperatures from -40 °F to 280 °F (-40–138 °C). The 

HFC39 couplings have a 3/8″ (9.5 mm) diameter flow path 

and are available with hose barbs for 1/4″, 3/8″ and 1/2″ 

(6.4 mm, 9.5 mm and 12.7 mm) tubing. 

show preview 


NEW MOISTURE/SOLIdS ANALYSER 

Arizona Instrument has added the Computrac MAX 4000 to its line of moisture 

and solids analysers. The analyser builds on the successes of its predecessor, 

the Computrac MAX 2000, with a more user friendly interface and a slew of 

additional features designed to offer the end-user faster throughput, greater 

control of testing conditions and more comprehensive test data. 

It features a full colour screen that displays separate graphs for rate of 

moisture evolution and total moisture evolution. It also features a full ten 

digit alphanumeric keypad for entering sample information. The MAX 4000 

facilitates faster throughput via a forced air cooling system that allows the 

instrument to cool from test temperature to idle temperature, 25% faster than 

previous models. It also features a Temperature Ramp Rate Control option 

that allows the user to control the rate at which the instrument heats from idle 

to test temperature. There are also a number of new options for test ending 

criteria that offer the user greater flexibility and control. 

Also featured is a web server option that allows test results to be 

downloaded and test parameters to be uploaded via a local intranet. Using the 

new USB port, test results can be captured directly from an instrument using 

an external flash memory device. The USB port can interface directly with a 

barcode reader, a printer, or a nitrogen control module. 

The Parameter Expert option of the MAX® 4000 assists the end-user in 

the development of repeatable, sample specific test parameters. Start the 

Parameter Expert program, follow the on-screen prompts and, after a few 

tests, the instrument will return an optimal parameter set for the sample. 


Shari Houtler 

Marketing Manager 

T. +1 602 470 1414 

F. +1 602 281 1744 

E. marketing@azic.com 

www.azic.com 

OSHA RECOMMENdS INdUSTRIAL VACUUMS 

AS PART Of A SOLId MAINTENANCE PLAN 

Following the recent increase in combustible-dust related explosions, 

the Occupational Safety and Health Administration is now standing on 

the doorsteps of many pharmaceutical facilities. With plant managers 

looking to bulk up maintenance and safety plans, industrial vacuum 

manufacturer Nilfisk CFM will be on hand at Interphex 2009 (Booth #1565) 

to answer maintenance questions and showcase several of the company’s 

pharmaceutical vacuums, including the new Nilfisk CFM 118 EXP, which will 

be demonstrated live at 10 am, 1 pm, and 4 pm daily. 

Available in two electric models, the 118EXP is designed to collect dry 

materials while the 118 EXPW is equipped for picking up liquids and other 

wet hazardous materials. Both are composed entirely of 304 stainless-steel 

and equipped with conductive accessories to eliminate percussion arcing 

and static charge. Most importantly, the 118 EXP-series has undergone 

extensive testing and is CSA approved for use in Class I, Group D and 

Class II, Groups E, F and G environments. 

In addition to the Nilfisk CFM 118EXP, the company will also display 

these popular pharmaceutical vacuums: the IVT 1000 with Safe-Pak, 

GM80, Nilfisk CFM 3156 and Nilfisk CFM 3508. 


T. + l 800 645 3475 

www.stop-the-dust.com 

March/April 2009

show preview 


MEdTEC: 

THE INSIdE TRACk 

Want to know how to be a world leader in medical innovation? Need to know how technology transfer can support the 

medical device industry? Or do you require an update on future EU legislation for medical devices? Then all the answers 

to these — and lots more questions — will be revealed at the MEDTEC UK 2009 Conference. 

eing held on 25–26 March 2009 at the Birmingham NEC 

as part of the MEDTEC UK medical device manufacturing 

technologies exhibition, the MEDTEC UK Conference 

once again offers an unrivalled line-up of industry leading 

presentations on the most important issues impacting the medical devices 

sector. The conference is taking place alongside Advanced Manufacturing 

UK, which incorporates various manufacturing-focused events, such as 

MTEC Sensors, Measurement & Instrumentation, Machine Building & 

Automation, VTX Vision Technology Exhibition, 3C Contamination Control & 

Cleanroom Products, Practical Vacuum & Surfaces UK and the new Green 

Manufacturing Exhibition and Conference. 

3Cs 

The 3C (Contamination Control and Cleanroom Products) Exhibition is 

for those involved in the protection and prevention of particle infection 

to personnel, products or the environment. The leading UK-based 

suppliers of cleanroom technology, associated products and services 

will be on hand so that visitors can see, test and compare the best 

solutions for their contamination prevention needs. Meet with suppliers 


who understand the requirements and needs of your industry, from 

automotive to medical, food and beverage to microelectronics and 

everything in between. 

MEDTEC Conference 

The issues under discussion at the MEDTEC Conference are designed to 

provide every medical device industry professional with the inside track 

on the latest global thinking, developments and strategies to ensure 

they remain at the top of the information tree. The keynote addresses 

(innovation, technology transfer and legislation) will be complemented by a 

comprehensive series of sessions focusing on “Regulation” and “Effective 

Medical Devices and Diagnostic Development” on Wednesday 25 March, 

and “Regulation: Part 2” and “Testing Medical Devices” on Thursday 26 

March. Chaired by Peter Schroeer, Director of Europe Quality Systems 

and Regulatory Affairs at Ethicon Endo Surgery, a Johnson & Johnson 

company, the programme on Wednesday 25 March will open with the 

following keynotes: 

• “What it Takes to be a World Leader in Medical Innovations,” by 

Martyn Howgill, Executive Director of InHealth. His presentation will

look at anticipating the needs of patients, medical delivery systems 

and those who pay (Deming, Stanford Biodesign model; the power of 

diversity), balancing rights and responsibilities (ethical clarity), accessing 

capital (innovations can’t help patients unless they are manufactured), 

entering the healthcare system (distribution channels and comparative 

effectiveness) and recognizing opportunities (Kurzweil and exponential 

change, DNA sequencing costs, nanotechnology, prevention and 

diagnosis, and artificial intelligence). 

• “The Role of Technology Transfer in Supporting the Medical Device 

Industry,” by Dr Matthew Killeen, Technology Analyst at London 

Technology Network. He will highlight key therapeutic areas, core medical 

device technologies, the competitiveness of the UK’s medical device 

industry, the technology landscape of university-based medical device 

research, future trends and emerging technologies. He will also use case 

study examples to illustrate the role of technology transfer and brokerage 

organizations in supporting the translation of publicly funded research 

to the growth of the medical device industry, and he will ask whether 

university-based research is equipped to meet industrial demands. 

Wednesday’s programme will continue with sessions dedicated to the topic 

of regulation and will be chaired by Johnson & Johnson’s Peter Schroeer: 

• “Conducting Clinical Trials Under the Revision,” Dr Peter Wall, Principal 

Consultant, Isca Healthcare Research. 

• “How the Amendments to the MDD Affect Manufacturers,” Henry Sibun, 

Manager, Medical and Health Services, TUV Product Service. 

• “Directives Revision: Changes to the Regulatory Framework for 

Combination Products,” Sharon Frank, Director Regulatory Affairs EMEA, 

Cordis (a Johnson & Johnson Company). 

• “The Future of Medical Device Labelling in Europe,” Mika Reinikainen, 

Managing Director, AbNovo. 

• “The Recast of the Medical Device Directive,” Peter Schroeer. 

Also on Wednesday, the effective medical device and diagnostic 

development sessions — chaired by Jan Pietzsch, Cons. Assistant 

Professor at Stanford University and President of Wing Tech Inc. — will 

start with an introduction by InHealth’s Martyn Howgill and embrace the 

following: 

• Device and diagnostic development: a roadmap 

• Needs assessment and risk analysis 

• Formulation/concept and feasibility 

• Design and development/verification and validation 

• Final validation/product launch preparation 

• Product launch and post-launch assessment. 

On Day Two, Thursday 26 March, the opening chairman’s address by 

Andrew Vaughan, Consultant, AJV Regulatory Services, will be followed 

by the keynote on “The Future of the EU Legislation on Medical Devices” 

by Elisabethann Wright, Counsel, Hogan & Hartson LLP. These will be 

followed by a series of focused sessions: 

• “Assessing and Addressing the Impact of REACH,” Jesús Rueda 

Rodríguez, Regulatory Affairs Manager of the European Diagnostic 

Manufacturers Association. 

• “Environmental Compliance: The Challenges,” Andrew Vaughan. 

• “Eco-Innovation for Medical Devices and the EuP Directive,” Jamie 

O’Hare, Researcher, University of Bath and Consultant for Environ UK. 

• “Vigilance as a Part of a Post-Market Surveillance Plan,” Jeremy Tinkler, 

Director of Regulatory Affairs, MedPass International. 

• “Post-Market Surveillance Requirements in Europe,” Dr Stefan Menzl, 

Director, Regulatory Affairs, Compliance and Clinical Research, 

EMEA, AMO. 

show preview 


ThE issUEs UNDEr DisCUssiON aT ThE MEDTEC 

CoNFERENCE ARE DESIgNED To PRovIDE EvERy 

MEDiCal DEviCE iNDUsTry PrOfEssiONal 

WiTh ThE iNsiDE TraCK ON ThE laTEsT GlObal 

ThiNKiNG, DEvElOPMENTs aND sTraTEGiEs. 

Tecvac Biomedical Coatings 

Tecvac Limited will show a complete range of biocompatible, wear-resistant, 

high lubricity coatings on the Medilink West Midlands stand. Tecvac Ltd, part 

of the Wallwork Heat Treatment Group, based at Swavesey (Cambridge, UK), 

specializes in Nitron coatings using ‘biologically inert’ ultra-hard materials 

such as titanium nitride, and biocompatibles such as pure gold and silver, 

to coat implants, medical instruments, probes and accessories. Tecvac has 

also recently developed a set of new, low temperature plasma processing 

technologies that allow plastic surfaces to be sterilized, coated or modified to 

the highest clinical standards, to ensure biocompatible solutions. A full range of 

metallurgical and analytical services is supported by the latest heat treatment 

techniques, with controlled environments and advanced cleaning systems 

to ensure that any implants, probes or core materials used for components 

or instruments can be coated to the best performance standards. Tecvac’s 

flexible low friction coatings replicate the smoothest mirror finish and have 

been specified in knee and hip applications for very long periods, with complete 

clinical histories. 

Tecvac’s PVD coating technology allows very thin, high integrity, high 

adhesion coatings of very hard and often very lubricious materials to be 

applied to metal surfaces, including titanium, steel, nickel and aluminium. 

These coatings, between 1 and 30 (or more) microns, extend from superhard 

Titanium Nitride (TiN) and Chromium Nitride (CrN) — some three times 

as hard as high quality chrome plate — to highly lubricious (and extremely 

hard) diamond-like carbon coatings with very low coefficients of friction, as 

low as 0.01. These DLC coatings are both inert and highly wear-resistant, 

with hardness values of up to 4500 HV (45 GPA), and are more than four 

times as hard as chrome plate. DLC coatings are compatible with human 

tissue, with a unique combination of lubricity and high hardness, which can 

radically improve the performance of implants, prostheses, the moving parts of 

medical instruments and artificial joint components. Tecvac’s PVD technology 

also allows many other elements — such as molybdenum, yttrium, carbon, 

aluminium, gold, silver and various carbides or nitrides — to be deposited to 

meet special requirements. 

For more information 

Tecvac’s Coatings and Services 

Ian Haggan or Andy Fox 

Tel. +44 1954 233 700 

www.tecvac.com 

Titanium nitride coated knee component. 

March/April 2009

show strap preview goes here 


Running concurrently, the testing medical devices sessions on Thursday 

will be chaired by Janette Benaddi, Chief Executive Officer of Medvance, 

and will embrace the following: 

• “Requirements for Good Testing Practices (MDD, IVDD, EN ISO/IEC 

17025, GLP),” Jean-Pierre Boutrand, General Manager, Scientific Director 

Biomatech, a NAMSA Division. 

• “Clinical Investigation of Medical Devices for CE Marking: Designing an 

Appropriate Clinical Trial,” Janette Benaddi. 

• “Risk Management: A Process for Sustainability,” Paul Lafferty, Principal 

Consultant, Quintiles. 

• “A Systematic Approach to Biocompatibility,” Ken Brummitt, Principal 

Research Engineer, DePuy International (a Johnson & Johnson 

company). 

• “Information Systems to Support Medical Device Design,” Sarah Egan, 

Product Manager and Senior Information Author, Granta Design. 

• “Investigational Device Exemptions: Obtaining US FDA Approval for 

Conducting Clinical Studies to Get Market Approval,” Tedd Gosian, 

President, Medvance. 

World-Beating 

The West Midlands medical technology cluster will be out in force at 

MEDTEC 2009, raising the bar in patient care, medical proficiency and 

healthcare service, with innovative technologies, brilliant concepts and lifechanging 

applications. Ten inspirational and rapidly developing companies 

have been chosen by medical and healthcare industry specialist, 

MedilinkWM, to benefit from the bespoke branded pods, where they 

March/April Nov/Dec 2008 2009 

can reach a national audience of more than 2600 purchasers, specifiers, 

engineers and end-users, supported by Advantage West Midlands. 

Award-winning precision metal pressings manufacturer, Clamason 

Industries Ltd, will announce its new contract with the world’s third largest 

drugs company, Sanofi-Aventis, at MEDTEC and showcase its work 

for the pharmaceutical giant — displaying the new SoloStar insulin pen 

that contains its highly complex indexing washer that allows the user to 

accurately dial and dispense the correct dosage of insulin. 

The UK’s largest independent silicone compounder and manufacturer, 

Primasil Silicones Ltd, brings an innovative new laser etching process 

to MEDTEC, which allows vital information to be displayed on platinumcured 

silicone tubing. For the first time, part numbers, batch numbers or 

use by dates can be permanently etched onto a medical tube, safely and 

efficiently using a unique process — “SureTrace” — which has no effect 

on the performance of the tube. The Football Association’s approved 

cardiology screening specialist, Physiological Measurements Ltd, will 

exhibit its brand new mobile VO2 Max testing and motion analysis to 

MEDTEC, demonstrating how the new service, in addition to ECG and 

echocardiogram services, provides comprehensive diagnostic testing for all 

professional athletes. 

Expanding their operation in Coventry, Advanced Therapeutic Materials 

Ltd is developing a radically improved delivery process of compression 

therapy, a tailor-made garment for sufferers of conditions including 

ulceration, lymphoedema and DVT. MEDTEC visitors can find out about 

advanced 3D imaging and unique prescription software that is being trialled 

by clinicians to produce seamless compression garments that can deliver 

precise pressures accurately and reliably over the whole treatment area. 

And the leading manufacturer of springs, clips, stampings, wire shapes 

and subassemblies, Albion Springs, will be tempting visitors with its flexible 

manufacturing service. 

Zybert Computing’s Secure Portable Office Key (SPOK) makes its debut 

at MEDTEC, in a bid to transform data access and protection in healthcare 

services. Allowing authorized clinicians to access patient records from 

any global location, without leaving a trace of the confidential data, the 

SPOK initiates an encrypted and secure connection to the specific data 

required, without copying the record. Removing the need for a central 

database, the SPOK enhances the reliability and effectiveness of data 

management in a changing healthcare service. And, making its mark at 

MEDTEC, Micro Spring & Presswork is a specialist manufacturer of a 

wide range of springs, presswork and assemblies for the medical industry, 

while Magellan Technology is set to launch an RFID-based low cost 

mobile phone for mobile health workers, currently being trialled by a key 

UK health organization. This development by Magellan Technology builds 

on its successful technologies for the management of orthopaedic loaner 

kits, which are currently being rolled out worldwide by Zimmer and Stryker, 

using RFID tags and systems within the clinical and inventory management 

processes in hospitals. MedilinkWM’s CEO Tony Davis said: “The West 

Midlands’ medical technology sector is renowned for its exceptional 

expertise, skill-base and innovative culture. In today’s global market, the 

entrepreneurial spirit, inventiveness and passion on display on our stand 

are in huge demand, which is demonstrated by the worldwide success of 

these companies.” 

For further information 

Visit www.medtecukshow.com and www.advancedmanufacturinguk.com for full 

details, including session abstracts and speaker biographies.

Don’t 

get lost 

on the 

road to 

API. 

Let 

be your guide. 

You are familiar with the detours that can delay arrival at API success. Unexpected 

chemical, manufacturing and regulatory obstacles can slow down the process, but 

Aptuit can be your global guide. 

Our team of API experts anticipates what might obstruct the way, creating the structures 

and protocols that result in tight control throughout the process. Our worldwide 

resources in Europe, the U.S. and our R&D and manufacturing facility in India, Aptuit 

Laurus provides round-the-clock services. It is a differentiator that works to your 

advantage. 

With Aptuit as your guide, you can count on a streamlined synthesis route that is 

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Take a more direct route to API with Aptuit as your navigator. 

strap goes QA/QC here 


For more information, please call +1 816-767-3900 North America, +44 131-451-2451 Europe or visit www.aptuit.com 

March/April Nov/Dec 2008 2009

strap outsourcing goes here 


GLObAL dELIVERY 

THE IMPACT Of THE 

SERVICES CLOUd 

Sanjiv Gossain, UK Managing Director of Cognizant Technology solutions, explains how web 2.0 

technologies are being used by the outsourcing industry to improve customer service and satisfaction. 

ncreasingly, companies want 

a provider that can nimbly shift 

tasks and labour among its 

own global network of work 

centres”, BusinessWeek, November 2007. The 

shift from multinational to transnational to global 

corporations is well under way, and the need for 

borderless business collaboration is becoming 

ever more vital. 

Today’s business climate is, increasingly, 

neither time nor location based, meaning 

that companies must build strong global 

capability themselves or through a network 

of suppliers to compete. One method being 

used to strengthen links between partners in 

remote locations is the adoption of web 2.0 

technology. Once solely the domain of the 

consumer, enterprises are now taking web 2.0 

principles and ideas and applying them to the 

business world. In particular, outsourcing firms 

and their customers have a lot to gain from 

creating bespoke online networking platforms 

to improve the quality and speed of globally 

delivered projects. 

Evolution of Outsourcing 

When pharmaceutical firms first started 

to outsource business and IT functions, 


their primary goal was cost cutting — with 

outsourcers using imported, low-cost labour to 

supplement existing staff. Through the offshore 

relocation, cost-effectiveness immediately 

improved, but the model was insufficiently 

equipped to perform anything beyond basic 

engagements. When inadequate results were 

delivered on more complex projects, the 

immediate need to revise and resolve meant that 

any short-term cost savings disappeared. 

The latest model of outsourcing puts longterm 

business impact at its core. Characterized 

by seamless integration between provider and 

customer, IT providers taking this approach 

combine the cost-effectiveness of offshore 

production and on-the-ground expertise needed 

two manage projects at the highest level. 

The one element that continues to contribute 

to the outsourcing industry’s rapid growth — 

apart from the availability of talent — is, of 

course, their improved results. Competition 

amongst outsourcing providers is intense and 

outsourcers continue to drive down costs 

through developing, utilizing and maximizing 

resources in India, China, Europe, North and 

South America. With these resources spreading 

throughout the globe, their efficient use is 

crucial in generating competitive advantage — 

and advanced collaboration over the Internet is 

key to this process. 

During the last few years, consumer web 2.0 

technologies have redefined how the Internet 

can be used to connect remote individuals, 

and the business world has taken note. 

Developments like blogs, wikis, VoIP and IM, and 

websites such as eBay, YouTube, Facebook and 

MySpace have all contributed towards a historic 

shift towards online networking and collaborative 

content generation. 

Companies in the pharmaceutical industry, 

learning from the rapid evolution and massive 

success of these consumer services, are 

now looking to incorporate similar techniques 

into their own business models, blurring the 

boundaries between consumer and enterprise 

IT. An early example of this is streaming 

online video, which is now commonly used to 

disseminate information throughout a business, 

having been popularized by sites such as 

YouTube or the BBC iPlayer. 

Taking these principles further, forwardthinking 

organizations are developing structured 

platforms — sometimes referred to as the 

“Services Cloud” — that foster a collaborative, 

real-time, knowledge-sharing portal through 

which they can deliver significant time-to-market, 

JUDGEMENT aND CrEaTiviTy CaN 

CoME FRoM ANy ASPECT oF THE 

oRgANIzATIoN, So To LEvERAgE 

aND MaxiMizE iNTEllECTUal CaPiTal, 

oRgANIzATIoNS NEED To DEvELoP A 

lEaDErshiP MODEl ThaT ENCOUraGEs 

iNDiviDUals TO sharE iNsiGhTs.

cost and transformational value to clients. In 

this way, web 2.0 is helping to move global 

outsourcing forward by ensuring that clients are 

given the best possible level of service, and are 

able to profit from new, more collaborative ways 

of working. It allows outsourcers to develop 

new levels of customer intimacy and satisfaction 

and, if correctly implemented, can result in 

dramatically reduced interaction costs, but with 

an improved result, made possible by drawing 

upon a global pool of talent and using the ability 

to track project performance in real-time. 

The Services Cloud 

Real-time collaboration on specific projects 

between global, regional and local development 

centres through one central portal is the first 

benefit of a web 2.0 platform. Consultants 

across the globe are encouraged to collaborate 

to solve specific business problems using the 

best delivery resources, regardless of location. 

For example, a developer in China, a tester in 

Hungary, a designer in Chennai and an analyst 

in the US can collaborate in real-time to execute 

a project for a European-based pharmaceutical 

company, using tools such as web conferencing 

and IM to overcome physical distance. These 

tools make it easier for colleagues to simulate 

face-to-face conversation and reduce the 

possibility of any misunderstandings. This is very 

similar to an open-source development, except 

that it is a defined project, with set deliverables 

and a particular process to follow. Within such a 

virtual work environment, remote colleagues can 

use their combined experience, knowledge and 

creativity, avoid duplication of work and complete 

the given task more quickly. 

Collaboration like this gives clients a global 

pool of knowledge from which they can draw 

appropriate resources, even if a project is 

primarily being delivered by staff working in 

just one offshore location. In today’s hypercompetitive 

IT market, the ability to tap and 

share intellectual capital increasingly separates 

the market leaders from the rest. This is 

especially true when operating on a global 

basis, where constantly moving projects 

are simultaneously worked on in multiple 

locations. In these situations it’s imperative that 

managers trust remote staff and understand 

that whilst asleep, progress, decisions and 

possibly mistakes will be made. This puts a 

premium on employee empowerment, with 

consultants across the globe being trusted to 

make the right decisions. 

Sanjiv Gossain 

Judgement and creativity can come from 

any aspect of the organization, so to leverage 

and maximize intellectual capital, organizations 

need to develop a leadership model that 

encourages individuals to share insights. This 

has the potential to improve the knowledge of 

all onshore and offshore agents, meaning clients 

can expect better results, while employees learn 

on the job from talent pools located elsewhere. 

Here, web-based, participative community 

models can be built, using wikis, forums, blogs 

and social bookmarking. 

As an example, at Cognizant we now have 

more than 10,000 regular bloggers, which 

attract two million page views per month 

and 17,000 active commenters. Our wikis 

have reached 8000 pages, with more than 

100 different communities, while the social 

bookmarking system is now in excess of 

75,000 bookmarks. This sharing of knowledge 

has helped to improve the timeliness and 

quality of responses to customers, while also 

bridging geographic boundaries and reinforcing 

our own corporate values and identity. 

The above techniques help consultants 

improve their quality of work and speed of final 

delivery, but what else does web 2.0 bring to 

pharmaceutical institutions using outsourced 

services? Aside from faster, better results, the 

main benefit comes from the ability to gain 

outsourcing 


valuable insight into each project as it happens, 

using the platform to capture, measure and 

display consultants’ performance in real-time. 

In the same way that a consumer can track 

the precise status of an order with an online 

retailer such as Amazon.com, banks that have 

gone down the outsourcing route can be given 

direct access to their service provider’s system, 

where they can log-in and check up on the 

progress of any particular project at any time. 

Reporting can also be improved as clients get 

real-time visibility of their projects 24 hours a 

day, compared with the periodic and static 

reports issued in the past. As a result, the 

provider can develop a much greater sense of 

transparency and trust. 

Conclusion 

Global delivery represents the future of the 

outsourcing industry, but efficient use of 

remote resource is essential to maximize 

the potential benefits. By partnering with 

outsourcers who have adapted their business 

to incorporate these modern ways of working, 

pharmaceutical companies can move quickly 

to generate valuable competitive advantage. 

web 2.0 technology makes the best use of 

an organization’s intellectual capital — taking 

quality, efficiency and productivity of service to 

new levels. 

March/April 2009

operational excellence 


SECURING THE fUTURE 

Of PHARMA THROUGH 

OPERATIONAL EXCELLENCE 

Günter Jagschies, PhD, Senior Director, Strategic Customer Relations, gE Healthcare Life Sciences, reviews how 

lean-enabling technologies can play a pivotal role in significantly reducing waste and, ultimately, costs. 

ith economic pressures and a 

smaller pipeline of blockbuster 

drugs, bio/pharmaceutical 

manufacturers must reduce 

the costs of development and production. While 

wholesale cost-reducing measures can play their 

part in the short-term, a longer-term strategy is to 

achieve operational excellence. Many industries, 

such as the food and automotive, have adopted 

the principles of high volume/low profit operations 

for a number of decades. 1,2 Two questions 

remain to be answered: why has it taken so long 

for the bio/pharmaceutical industries to make a 

similar transition, and why have such processes 

and methodologies finally become important to 

drug manufacturers? 

The bio/pharmaceutical industries have 

witnessed a number of new challenges in the 

last few years. Looking back, we can certainly 

see that companies face the usual requirement 

to grow revenues and profits; but we also see 

developing pressure on drug prices as the large 

healthcare providers (both public and private) 

re-evaluate many of the therapies they purchase 

and use. Bio/pharmaceutical manufacturers are 

also facing rising sales and marketing costs as 

well as certain operational costs (energy and raw 

materials). It is a challenging economic climate 

for all industries. They are also having to manage 

substantial financial risks, such as deciding 

whether to build new facilities or use existing 

plants that are more adaptable and flexible to 

changing manufacturing needs. Additionally, the 

threat of bio/generics remains a serious risk to the 

income of branded products — particularly from 

the emerging economies of Asia. We now have 

a situation where manufacturers must implement 

operational improvements to ensure they remain 

competitive on a global scale. 

While this seems like a tall order, the 

industries are meeting these challenges 

head on by consolidating and embracing the 

concepts of Lean and operational excellence. 

Such approaches include the use of process 

analytical technology, platform-based processes 


and disposable production components, 

all of which can reduce time-to-market and 

the costs of development and manufacture, 

through increasing product and process quality, 

and reducing waste — the keys to achieving 

“operational excellence.” 

Achieving World-Class 

Performance 

Operational excellence describes the goal 

of achieving superior yields, lead-times and 

throughput, while eliminating waste. It is a 

systematic approach to attaining world-class 

performance in productivity, quality and delivery 

of services and/or goods. Two effective tools 

for achieving this are Lean and Six Sigma. GE 

Healthcare Life Sciences is one of the companies 

at the forefront of Lean-enabling technology, 

anticipating some of the industry pressures a 

few years ago and implementing a program of 

Lean initiatives. It recognized that their rapid pace 

of growth created many process improvement 

opportunities. Other companies have also been 

heavily investing in operational excellence tools. 

Lean can be broadly described through five 

principles: 

• Define value — from the end-user’s point of view. 

• Identify the value stream — develop an 

understanding of how value flows to the 

product/service/person/object that is moving 

through the process. 

• Establish flow — creating a situation where the 

product/service/person/object moving through 

the process does so with no interruptions or 

issues. 

• Examine ‘pull’ from the end-user — until 

something needs doing from that perspective, 

don’t do it. 

• Describe perfection — it’s the aim that can 

never be achieved, but processes will be 

improved by trying. 

The main focus of Lean-enabling technologies 

is to reduce waste, which can occur through 

overproduction, transportation, inventory, defects 

and under-utilization, amongst other issues. Figure 1 

Figure 1: The benefits of implementing Lean and Six Sigma. 

shows where time and money can be saved when 

implementing operational excellence tools. 

The Future of Biopharmaceuticals 

Many experts in the biopharmaceutical industry 

agree that the future lies in MAbs (monoclonal 

antibodies) (Figure 2). The debate that exists is 

based on what scale production of MAbs should 

be; some people already believe that we are not 

far off continuous manufacturing at the multiton 

scale. In his case study of very large-scale 

monoclonal antibody production, Kelley looked at 

a single-branded product need of up to 10,000 

kg/year. 3 He concluded that such production 

is possible with current technology and saw 

little or no need to turn to unproven alternatives 

simply for cost reasons. In our own study that 

looked at the production-scale of currently 

marketed biopharmaceuticals, we saw at least 

four recognizable trends that would reduce 

average production scales for novel protein 

drugs, and concluded that the future of antibody 

manufacturing would need to offer solutions for a 

small group of therapeutics at the ton-scale and 

much more economical production of proteins 

at 50–500 kg volumes — achievable through 

operational excellence. 4

Are We at a Crossroads? 

In an increasingly competitive market, the 

biopharmaceutical industry must quickly respond 

to a number of tough decisions. With processes 

such as cell culture improving to generate 

increased yields and the development towards 

multi-product/multi-scale manufacturing across 

multiple sites, we must ask ourselves if we really 

need to invest in new and expensive technology 

to meet current and future manufacturing 

demands; or should we just look at continuous 

improvement of current techniques, technologies 

and operations? While it is important to push 

the boundaries of new technologies, the general 

consensus in the industry suggests that much 

more can be done by maximizing the potential 

of current products; that is, squeezing out 

waste and implementing operational excellence 

principles. 3,7 

During the last decade, innovations from 

chromatography suppliers, such as GE 

Healthcare, have helped biomanufacturers to 

overcome many issues, providing dedicated tools 

for difficult challenges, such as media screening 

and column packing, and resins that can cope 

with high titres and specific purification issues — 

providing higher productivity. But what about the 

next decade? Where does the industry need to 

focus? We envisage that in the coming decade 

there will be an increasing need for MAbs as 

therapeutics, product titres for MAbs will reach 

levels of 5 g/L or greater and certain diseases, 

such as influenza, will require greater speed to 

develop and produce vaccines to minimize the 

impact of pandemics. 

Table I highlights our research into current 

industry best performances, summarizing 

our findings and providing an indication of 

where the industry stands today and the 

improvements that may be achievable. 

Implementing Lean can help you find ways to 

create better process flow, reduce downtime 

and stoppages, and reduce non-productive 

activities such as changeover time between 

production campaigns, cleaning procedures, 

or the preparation of equipment and process 

buffers. However, Lean and Lean-enabling 

tools can also be used in process development 

and optimization. One example is HTPD (High 

Throughput Process Development) on filter 

plates, which allows identification of the most 

appropriate chromatography conditions for a 

process by running a series of experiments in 

a very short period of time, helping to define 

the design space and limits of operation. 11 

This also helps to select the most appropriate 

chromatography resins for each step. 

Figure 2: How monoclonal antibodies are driving the industry. 5,6 

Figure 3 highlights how Lean concepts can 

be applied to a chromatographic process step 

to improve on first generation tools. In our 

interpretation, we assume that only the loading of 

material to be purified, the removal of impurities 

from the bound product in several wash and strip 

steps, and the elution of the purified intermediate 

product are essential value-adding activities. 

Preparation of resin slurry and column packing as 

well as cleaning (CIP) and equilibration are not. 

Disposable Technology 

One of the main features of Lean is to critically 

review process steps; for example, if the same 

quality result can be achieved with one less 

step, process engineers can implement Lean to 

remove unnecessary operations. For example, by 

applying at least three chromatography steps to 

purify protein pharmaceuticals such as antibodies 

is still considered sacrosanct by many. However, 

there are at least two published variations of 

a two-step chromatography process with the 

promise to meet quality objectives in many of 

the cases where they have been applied. 9,10 

Two-step purification methods may not reduce 

the direct costs by much, relative to other 

improvements, but by taking a holistic view, you 

can see smaller buffer volumes will be required 

and, consequently, buffer preparation and 

storage requirements are reduced. 

operational excellence 


There are many benefits to implementing a 

disposable technology program, with reduction 

and elimination of 

• validation 

• cross-contamination 

• laborious cleaning processes. 

Furthermore, disposable technology can help 

to lower operating costs: it allows for smaller 

technology footprints, increased yields (through 

optimized productivity) and faster time-to-market. 

One example of disposable technology is the 

AKTA ready Liquid Chromatography system 

designed for process scale-up and production 

for Phase I-III drug development and full scale 

production. It is part of GE Healthcare’s portfolio 

of ReadyToProcess solutions and operates 

with ready-to-use disposable flowpaths and 

pre-packed, pre-qualified chromatography 

columns: this eliminates the risk of crosscontamination 

as well as the need for cleaning 

and cleaning validation. 

Other ReadyToProcess products include 

the WAVE Bioreactor and WAVE Mixer used in 

combination with the disposable CellBag for 

upstream applications. Also, connections to 

assembly components, such as media bags 

and tubing for upstream and downstream 

applications, can be made more economic, 

safer and simpler with ReadyMate disposable 

aseptic connectors. All of the products are 

General Best in Class Metrics Specific Best in Class Metrics 

– Facility utilization = 80-100% 

– Cost = 15% CoS (100 USD/g) 

– Process yield = 70-80% 

– Time = 10 days upstream 

2 days downstream 

strap operational goes excellence here 


Figure 3: Lean applied to chromatography, comparing a classic step with 1st generation tools and a modern step with current tools. 

designed to provide maximum flexibility and 

to simplify and speed up bioprocessing 

for scalable and smooth operations from 

fermentation through to purification. Such 

technology helps to achieve operational 

excellence through the removal of unnecessary 

steps, whilst at the same time allowing facilities 

to become incredibly flexible and adaptable to 

the changing needs of the market. 

Conclusion 

There is absolutely no doubt that bio/ 

pharmaceutical manufacturers must critically 

evaluate their processes to determine if 

they are running at an optimum level. For 

biopharmaceuticals, a switch and focus to the 

mass production of monoclonal antibodies 

means that it is now more important than ever to 

ensure that development and manufacture is as 

efficient and economical as possible. ‘Trimming 

the excess fat’ enables manufacturers to do 

more with less — and will result in reduced costs, 

increased productivity and, ultimately, delivering 

much better value for money. 

A couple of trends to keep an eye on during 

the coming decade are 

1. efficient manufacturing of biopharmaceutical 

proteins at widely varying scale and fast 

changing schedules 

2. small-scale, flexible technologies for rapid 

experimentation and efficient production of 

small volumes used in testing, clinical trials and 

small patient populations. 

Disposable solutions and “ready-to-use” 

products offer the required manufacturing 

flexibility to cope with the changing demands 

of the industry, while both upstream and 


downstream processes are becoming 

increasingly integrated and more industryfriendly. 

Continued improvements in 

chromatography (capacity, throughput and 

quality) and membranes (such as reduced 

need for filter area) will be complemented with 

numerous approaches to improve ease-of-use 

and increase efficiency. 

Suppliers to the bio/pharmaceutical 

industry will need to take these trends and 

developments into account, and companies 

such as GE Healthcare will be working closely 

with the industry to provide the necessary 

tools to achieve operational excellence. But we 

are not just looking at short-term issues. It is 

important to recognize the challenges facing bio/ 

pharmaceutical production during the course 

of the next decade, which includes flexible 

development and manufacturing, multi-product 

facilities, and tackling the issues of biosimilars 

and generics. 

Regardless of whether you are a contract 

manufacturer or produce your own bio/ 

pharmaceuticals, there are huge pressures on 

the industry to develop operational excellence 

— and the current economic climate prevents 

investing vast sums into completely redesigning 

development and manufacturing processes. 

But naturally, the global issue remains to never 

lose sight of the overriding need to provide 

innovative medicines. 


Günter Jagschies, PhD 

Senior Director, Strategic Customer Relations 

GE Healthcare, Uppsala, Sweden. 

guenter.jagschies@ge.com 

References 

1. V. Bornsztejn and M. Ebbens, “Leaning the 

way in Bioprocess,” www1.gelifesciences. 

com. 

2. http://en.wikipedia.org/wiki/Sakichi_Toyoda. 

3. B. Kelley, “Very Large Scale Monoclonal 

Antibody Purification: The Case for 

Conventional Unit Operations,” Biotechnol. 

Prog. 2007, 23, 995-1008. 

4. G. Jagschies, “Quo vadis? — where are we 

heading biopharma?” BioPharm International, 

in print. 

5. Biotechnology Medicines Survey (2004) 

www.phrma.org. 

6. Biotechnology Medicines Survey (2006) 

www.phrma.org. 

7. C. Driscoll, “A Lean Version of Lean,” www. 

contractpharma.com (June 2006). 

8. G. Jagschies, K. Lacki, et al., “Accelerated 

Development of a Downstream Purification 

Process for Production of a Monoclonal 

Antibody: a case study”, presented at 

Recovery of Biological Products XIII, Quebec, 

Canada, June 2008. 

9. “Anion Exchange Purification of Mabs: Weak 

Partitioning Chromatography,” S. Vunnum, 

presented at ACS, BIOT Division, San 

Francisco, September 2006. 

10. “Current and future advances in development 

of downstream processes for purification of 

monoclonal antibodies,” H. J. Johansson, 

presented at IBC Bioprocess International 

Conference, San Francisco, November 2006. 

Capto, MabSelect, MabSelect SuRe, PreDictor, 

ReadyToProcess, Sepharose, are trademarks 

of GE Healthcare companies. 

11. G. Jagschies, K. Lacki, et al., “Accelerated 

Development of a Downstream Purification 

Process for Production of a Monoclonal 

Antibody: a case study,” presented at 

Recovery of Biological Products XIII, Quebec, 

Canada, June 2008.

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March/April 2009

strap marketing goes here 


MARkETING: 

RESEARCH ANd 

OUTCOMES AbOUNd 

e hear a lot about the 

importance of greater 

collaboration between 

marketing and development. But the value 

of partnering marketing research and 

outcomes research for brand marketing and 

for the benefit of each function goes largely 

unrecognized. In fact, in most pharma/ 

biotech companies, the two functions 

typically work in isolation — unaware of 

each other’s research priorities — often 

tapping the same sources and rarely 

planning collaborative research. But as 

both groups face increased pressure to 

maximize the value of their research with 

ever-shrinking budgets they are beginning to 

realize that collaboration can offer significant 

opportunities, reduce costs, and boost value 

for each function and for the company. 

Where MR and OR 

Functions Overlap 

In the simplest terms, the focus of market 

research is to produce analyses that 

inform and monitor marketing strategy. In 

contrast, outcomes research publishes 

information to demonstrate a product’s 

cost-effectiveness and value to insurers, 

physicians, pharmacists, patients and 

regulators. Outcomes researchers use 

data from surveys, literature searches and 

R&D to measure the burden of illness on 

society, work productivity and quality of 


life, and analyse the impact of healthcare 

interventions on patient outcomes. 

While their goals differ, both groups use 

data to drive their functional priorities and 

support the marketing of a brand. Often 

they use the same data, such as quantitative 

surveys and transactional databases from 

common sources. Despite tapping into these 

common sources, it is rare that the two 

groups collaborate to conduct joint research. 

This lack of collaboration can lead to 

inefficiencies that, in extreme cases, can lead 

each department to commission separate 

research on the same topic. 

Benefits of Collaboration 

There are benefits for both marketing 

research and outcomes research 

in collaboration. By learning each 

department’s plans and strategies, 

marketing and outcomes researchers 

can identify partnership opportunities to 

conduct joint research, or leverage research 

already conducted for other purposes. 

Shared data and communications also 

strengthen the results of each function 

— achieving better-designed surveys, 

more comprehensive journal articles and 

a stronger, more definitive rationale for 

reimbursement. The other compelling 

reason for the partnership is a practical one 

— saving time and costs. In a time when 

growing research demands are being put 

on ever-shrinking budgets, the collaboration 

provides an opportunity to share research 

costs across both functional areas. 

What’s in it for marketing research? 

Tapping into the scientific insight of 

outcomes researchers — who typically have 

greater access to scientific data and key 

opinion leaders — can bring additional values 

to a marketing research survey. With input 

from outcomes research, marketing research 

can often improve the overall design of the 

survey and quality of information collected. 

Their insight helps marketing researchers 

define disease criteria, utilize appropriate and 

validated measurement criteria and ensure

What’s marketing research got to do with outcomes research? 

More than you think. Opportunities abound in collaboration as 

Michael Kelly, President, and Susan Bolge, PhD, Senior Director of 

Outcomes research, Consumer health sciences, explain. 

that research inputs are aligned with current 

published literature. 

The involvement of marketing research in 

outcomes research work also helps to ensure 

that all communications incorporate brand 

marketing messages. For outcomes research, 

input from marketing research can be used 

to improve the quality, credibility and value of 

journal articles and presentations at medical 

conferences. Most likely, marketing research 

has access to existing data sources that were 

originally commissioned to identify marketing 

opportunities, but can be leveraged further to 

support key outcomes research objectives. 

Road Map to Collaboration 

To fully leverage survey information for 

an outcomes research publication, four 

important factors need to be taken into 

consideration when designing a survey. 

1. The first is recognizing the importance 

of using validated scales. These are a 

series of survey questions that, when 

asked using specific order and wording, 

have been accepted by the scientific 

community as appropriate to measure 

specific concepts. 

2. The second is taking additional time and 

effort to gain Institutional Review Board 

(IRB) approval of the study design before 

it goes into the field. IRB approval is more 

often being required by journals for any 

published data. 

3. The third is involving key opinion 

leaders early. Opinion leaders provide a 

tremendous resource during the survey 

design phase and will benefit themselves 

from knowledge of the survey when they 

act as lead author in the publication. 

4. And finally, and more generally, planning 

ahead is crucial. Approaching the 

survey with hypotheses and planning for 

unexpected results will ensure that the 

final results are useful for both marketing 

research and outcomes research objectives. 

Collecting and 

Using Data Efficiently 

When either research function needs 

specific data, researchers are tasked to 

find the best, most efficient source of 

high-quality data that fits their project 

schedule and budget. Before considering 

original marketing research, they research 

existing sources. One credible source of 

current patient health data is Consumer 

Health Sciences’ (CHS) annual, syndicated 

National Health and Wellness Survey 

(NHWS) — the largest self-reported 

patient database of its kind. The NHWS 

provides insight into the current market 

for medications and patient-reported 

outcomes in more than 100 therapy areas. 

Marketing and outcomes researchers can 

acquire specific segments of the survey 

and have CHS conduct original research on 

strap marketing goes here 


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Animée par Hosted by 

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3 - 4 June 2009

the survey’s respondents to quickly and 

efficiently address their research priorities. 

CHS and its staff scientists also provide 

outcomes research analysis and consulting, 

and will author abstracts, manuscripts, 

presentations and posters. In addition, they 

evaluate and suggest ways the data can be 

leveraged across MR and OR functions. 

A single survey like the NHWS can be 

used by both outcomes research and market 

research for more advanced purposes than 

sizing a market and improving physician 

diagnoses. For market researchers, 

multivariate analyses on the survey results 

can lead to broader insights that have 

a direct impact on marketing strategy. 

Segmentation techniques, for example, 

can be conducted by market research to 

identify homogeneous patient targets for an 

upcoming consumer campaign. 

On the outcomes research side, statistical 

analyses can be conducted to measure 

the burden of illness, the overall patient 

quality of life, work productivity loss and 

healthcare utilization of different patient 

groups. In isolation, each of these analyses 

provides support to help justify the need for 

pharmaceutical therapy. Taken collectively, 

however, these measures can be powerful 

inputs to provide financial justification for 

reimbursement by payers. They can be 

used to demonstrate the true value of 

pharmaceutical therapy on improving the 

direct and indirect costs of patients with a 

specific condition. 

Conclusion 

Greater communication between outcomes 

researchers and marketing researchers, along 

with utilizing the most cost-efficient, highquality 

resources, are the keys to gaining 

value and leveraging costs for each function. 

By communicating research priorities 

and identifying opportunities for survey 

collaboration, each function will benefit with 

information that is more scientifically rigorous, 

more aligned with marketing strategy and 

more cost-effective for the company. 

Common Questions Researchers Ask 

Market Research 

• What is the size of the treated and untreated patient population in my therapy area? 

• What are the marketing opportunities for my product in development? 

• Is there an opportunity for my product in a new patient type that we are considering? 

• Are there new opportunities for a pipeline or inline brand? 

• How do patients on my brand differ from patients on competitive brands? 

marketing 


Outcomes Research 

• What are the prevalence and the unmet needs of a disease state? 

• What is the burden of illness of the patient population in my therapy area? 

• What is the impact of treatment on improving a patient’s quality of life, work productivity and overall healthcare 

utilization? 

• Does pharmaceutical therapy reduce the overall cost of treating a patient for a specific condition? 

How a Research Partnership Identified Misdiagnosed Bipolar Patients 

A study of depression patients who participated in the NHWS illustrates how a survey can be used to support the 

objectives of outcomes research, market research and brand marketing. The marketing research priority of the 

survey was to identify what proportion of the diagnosed unipolar depression population in the US should have 

been diagnosed with bipolar depression, and to determine the key drivers of misdiagnosis. The outcomes research 

objective was to determine key markers during patient visits that could be used by clinicians to identify patients who 

should be diagnosed as bipolar and to quantify the economic and humanistic burden of misdiagnosis. 

Respondents to the syndicated online survey of 1500 patients, who were diagnosed with unipolar depression, 

were recruited from the NHWS database. Two key contributions were made by outcomes research. The first was 

the identification criteria for manic symptoms, using the Diagnostic and Statistical Manual of Mental Disorders, 

Fourth Edition (DSM-IV). Specific survey questions were crafted using these criteria to identify the bipolar subset in 

the sample. The second contribution was the inclusion of the Psychological General Well-Being (PGWB) scale — a 

validated scale of 22 questions designed to measure individuals’ subjective feelings of well-being or distress. 

This scale was critical to provide a side-by-side comparison of the quality of life of both the unipolar and bipolar 

depression populations. 

With this survey — and the contributions made by both functional areas — marketing research was able to size 

the misdiagnosed bipolar population in the US and determine the key drivers that lead to misdiagnosis. The results 

support the case for targeting this patient population. The population was large enough to justify the added marketing 

communication resources required to educate physicians on how to improve their diagnosis. 

Outcomes research was able to identify key markers that would help physicians identify potential misdiagnosed 

bipolar patients during an office visit. Specifically, misdiagnosed patients were more likely to be diagnosed with 

anxiety and to experience a poor quality of life. By publishing these results in peer-reviewed journals, outcomes 

researchers make the information available to physicians, which can help to improve diagnoses and, with the support 

of marketing and sales efforts, ultimately increase the use of bipolar therapy. 

References 

Results were published in the following articles and posters, co-authored by 

a CHS scientist: 

1. Awad AG, Rajagopalan K, Bolge SC, McDonnell DD. Quality of Life of Misdiagnosed 

Patients with Bipolar Disorder. Prim Care Companion J Clin Psychiatry; 9(3):195-202. 

2. Bolge SC, Thompson T, Bourne E, Nanry K. Characteristics and symptomatology of 

patients diagnosed with unipolar depression at risk for undiagnosed bipolar disorder: a 

bipolar survey. CNS Spectr; 13(3):216-24. 

3. Nanry K, Bolge S, Bourne E, Thompson T, Leadbetter R. Misdiagnosed bipolar 

disorder: patient characteristics and symptomology [Poster]. 19th US 

Psychiatric & Mental Health Congress, New Orleans, LA, November 2006. 

4. Rajagopalan K, Bolge SC. Quality of life: misdiagnosed bipolar vs depression 

and bipolar disorder [Poster]. 4th European Stanley Conference on 

Bipolar Disorder, Aarhus, Denmark, September 2004. 

March/April 2009

eastern europe 


CzeCh RepubliC and poland 

attRaCtive loCations foR phaRma 

ccording to analysis carried out 

by PMR and described in the 

recent report, “Pharmaceutical 

Contract Manufacturing and API 

Sourcing in Central and Eastern Europe,” 

the most attractive countries in the region for 

finding partners for contract manufacturing 

and API sourcing are the Czech Republic and 

Poland. One of the main advantages of the 

CEE (Central and Eastern Europe) region as a 

whole, above China and India — which pose 

a serious competitive threat — is the much 

lower level of counterfeiting, which will be 

minimized by impending EU legislation. 

The drying up of R&D pipelines, overinvestment 

in previous decades, regulatory 

hurdles, which delay new approvals, and 

the losing of patent protection on many of 

their blockbuster products, have forced 

manufacturers to sell their production plants 

and reduce their workforces. As a consequence 

— made worse by the global financial crisis 

— big pharma companies are tapping into the 

global contract manufacturing market more and 

more, including the CEE area. 

Countries Tried and Tested 

The pharmaceutical industry in the Czech 

Republic is one of the most developed of the 

CEE countries. There are many companies 

that specialize in API sourcing and contract 

manufacturing. The biotechnology industry is 

developing rapidly and providing a platform for 

specialization. There are also many companies 

focusing on the manufacture of dietary 

supplements under contract. 

Pharmaceutical companies looking 

for sourcing and contract manufacturing 

opportunities may also benefit from the Polish 

pharmaceutical industry, where they can find 

companies with a long tradition of producing 

natural pharmaceutical raw materials, along 


with products based on biotech methods and 

chemically manufactured API and finished 

dosage forms. Other advantages of the 

country’s economy include the prominent 

role of science and highly ethical corporate 

behaviour. Both the Czech Republic and 

Poland are members of the Pharmaceutical 

Inspection Convention and Pharmaceutical 

Inspection Co-operation Scheme (jointly 

referred to as the PIC/S), which guarantees 

a high level of implementation of the 

internationally recognized GMP rules. 

API Competitive Edge Lost 

The more prohibitive operating costs of the 

GMP-compliant off-patent API production 

— in general, some 25% of site operating 

costs — as well as a dramatic increase in 

other industry-related regulations, has made 

European API manufacturers increasingly 

uncompetitive, in terms of the costs of API 

production, during the last 20–30 years. As 

a result, many European API producers have 

been squeezed out by competition from Asia. 

The situation has been exacerbated by the 

fact that, in many cases, EU regulations have 

not kept pace with dramatic changes in the 

marketplace. The lack of proper oversight, 

control and inspection of, for example, 

importers of API from Asia, has encouraged 

the non-compliant and illegal trading of such 

substances in Europe. 

At present, one of the main advantages 

of companies based in the CEE region — 

particularly those that are members of the 

EU, given the considerable competitive threat 

posed by China and India — is the much lower 

level of counterfeiting. This is complemented 

by their cultural and geographical proximity to 

Western companies, combined with labour 

costs, which are still lower than those of 

Western countries. 

EU Finds Solution to Counterfeit API 

Methods of producing counterfeit drugs have 

become increasingly sophisticated. For example, 

some 10–20 years ago, most counterfeit drugs 

did not contain any APIs. Now, although there 

are many counterfeit APIs, another trend has 

appeared: an increasing number of counterfeit 

drugs have real APIs. It is estimated that there 

are some 5000 rogue APIs manufacturers 

in China, and about 3000 of them are not 

even Chinese GMP compliant. The European 

countries in which counterfeit drugs are most 

widespread are Russia and Ukraine. 

In December 2008, a number of amendments 

to Directive 2001/83/EC were proposed. Certain 

changes also pertain to API; their main objective 

being to make medicines on the European market 

safer by imposing stricter requirements on APIs 

imported from third countries. First, manufacturers 

of medicinal products will be obliged to audit all 

companies that manufacture the API they use. In 

addition, various proposed measures will ensure 

that imported APIs have been manufactured 

in accordance with rules that establish safety 

standards, matching those in the EU. 

Member states will also have to improve 

inspections. This concerns, in particular, 

those countries in which the level of public 

health protection — in terms of the regulatory 

framework, control and supervision — does 

not match the EU. All in all, we believe that the 

regulations will increase the competitiveness of 

EU-based companies, in terms of quality, and 

will compel some manufacturers to switch to 

EU API suppliers more frequently, to simplify 

supply chains. 


Monika Stefanczyk 

Head Pharmaceutical Market Analyst 

T. +48 12 618 90 57 

E. monika.stefanczyk@pmrpublications.com

eastern europe 


Romanian maRket satuRated 

fter an impressive increase of 

approximately 30% a year between 

2004 and 2006, the growth rate 

of the Romanian pharmaceutical 

market declined by 11% in Leu, in 2007, and 

the estimated growth figure for 2008 is about 

8% year on year. Between 2008 and 2010, the 

Romanian market will grow by approximately 

9.5% year on year to almost €2.4 billion in 2010, 

according to PMR’s new report, “Pharmaceutical 

Market in Romania 2008. Development 

Forecasts 2008–2010.” 

Vibrant Growth 

In recent years, the Romanian pharmaceutical 

market has passed through a period of 

growth, following the general trend of the 

Romanian economy. Romania’s accession 

to the EU, in January 2007, set the tone for 

the development of all its economic markets, 

not just pharmaceuticals. All of the major 

regulatory changes on the market were aimed 

at harmonization with EU directives, and the 

attitude of the authorities has turned more 

towards transparency and openness. EU 

accession removed border taxes and led to 

an increase in competition and more imported 

generic drugs. Furthermore, the number of 

registered medicines rose as a result of the 

simplification of the registration procedure for 

new medicines from the EU. 

The market has matured in the last 2 years, 

and growth, which was seen to be general 

between 2004 and 2006, was more specific to 

therapeutic categories, such as cardiovascular 

and oncology. In 2007, the retail market 

increased by 19% in value terms. Conversely, 

the hospital market declined by 20% because 

some health programmes switched from hospital 

to retail. Last year, the retail market represented 

85% of the total market, and it is predicted that 

this figure will continue to rise — to about 90% in 

2010 (Figure 1). 

After an increase of approximately 30% per 

year between 2004 and 2006, the growth rate 

of the market declined by 11% to €1.8 billion in 

2007, and the estimated growth figure for 2008 is 

about 8% year on year. Between 2008 and 2010, 

the Romanian market will grow by approximately 

9.5% year on year to almost €2.4 billion in 2010. 

Potential 

The cardiovascular drug market has grown more 

rapidly than the overall market: in 2007, it grew 

Share of retail and hospital market as a proportion of total pharmaceutical market value in Romania, 2008-2010 

e – estimate 

f – forecast 

Figure 1: Share of retail and hospital market as a proportion of total pharmaceutical market value in 

Romania, 2008-2010. 

Figure 2: Pharmaceutical market by ATC categories in terms of value in Romania, 2007. 

by more than 13% in value and by more than 

30% in volume. This market is the most extensive 

subdivision of the overall market, with sales worth 

RON 1.2 billion (about €370 million) in 2007. The 

market share of drugs used in cardiovascular 

system diseases, overall, has grown steadily in 

the last few years — from a 15% share in 2003 

to 20% in 2007. 

The leading manufacturer on the 

cardiovascular market is, without doubt, Servier, 

which has a market share of 25%. Its four drugs 

— Preductal, Prestarium, Tertensif and Detralex 

— are the best selling cardiovascular medicines 

in Romania. In second place, some distance 

behind, is Terapia Ranbaxy, followed by Pfizer, 

Krka and LaborMed. 

The potential of the cardiovascular market is 

still considerable; it is estimated that 8 million 

Romanians are in need of treatment, but only half 

are treated. For the next few years, we expect the 

market to grow further — and to remain as one 

of the leading therapeutic categories — though 

growth will not be as impressive as that which 

preceded 2007. The main growth drivers in 2008 

will be antineoplastic and immunostimulating 

agents, in addition to drugs used to combat 

diseases of the musculoskeletal system (Figure 2). 


Marketing Department, PMR Publications 

T. +48 12 618 90 20 

E. marketing@pmrpublications.com 

March/April 2009

strap eastern goes europe here 


ukRainian maRket expeCted 

to double in value 

he Ukrainian pharmaceutical 

market has been growing quite 

rapidly during the last five years — 

by 25–30% per annum, in terms 

of value, to $2.6 billion in 2007. In H1 2008, 

it had already exceeded $1.6 billion, growing 

by 42% year on year (Figure 1). Independent 

pharmaceutical analysts PMR expects the 

Ukrainian market to grow by more than 25% 

per annum between 2008 and 2010 and 

to be worth $5.7 billion in 2010. According 

to the latest PMR report, “Pharmaceutical 

Market in Ukraine 2008,” if a reimbursement 

system and health insurance had been 

implemented promptly, the market would 

have grown even more rapidly. 

Growth Forecasts 

The Ukrainian pharmaceutical market is 

the second largest, after Russia, of any of 

the CIS countries. In addition, it has been 

developing quite rapidly during the last 

few years, but there is still considerable 

potential for growth. Today, it is strongly 

influenced by the following factors: 

Ukraine’s recent membership of the WTO, 

the need to implement GMP standards 

from 2009 onwards, and the prospects for 

the introduction of an obligatory medical 

insurance system. 

According to PMR’s Head Pharmaceutical 

Analyst Monika Stefanczyk: “Despite the 

numerous obstacles on the Ukrainian 

market — which include low per capita 

drug consumption, an old-fashioned and 


inadequate healthcare system, the lack of 

a reimbursement system, a high level of 

bureaucracy, an inadequate legal framework 

and an unstable political situation — PMR is 

quite optimistic in forecasting further market 

development.” The market is considered 

to have a great deal of potential for growth 

because it is still relatively small, especially 

when you take the population into account. 

For example, the Polish market has a smaller 

population of approximately 38 million, but 

was still worth more than three times its 

Ukrainian counterpart in 2007. Stefanczyk 

added: “We have also observed factors 

such as increasing investment attractiveness 

— including an unrestricted pricing policy, 

the significant prevalence of generics and 

OTC products on the market, and Ukraine’s 

membership of the WTO.” 

Another pertinent factor is associated with 

trends on the international pharmaceutical 

market. Global manufacturers are now 

under pressure from the low price of 

generics, particularly those produced 

by Indian manufacturers. By contrast, 

Indian companies have become more 

concerned about competition from 

European and Chinese manufacturers. This 

renders the markets of the CIS countries, 

including Ukraine, of great interest to 

foreign companies looking for investment 

opportunities. 

Cardiovascular Drugs: 

Undeveloped but Promising 

Drugs that are used to treat alimentary 

tract and metabolic diseases comprise the 

largest category of the retail pharmaceutical 

market in Ukraine. In addition, drugs used for 

cardiovascular system diseases are the third 

largest category, whereas in the majority of 

European countries, such as Poland, France 

and Romania, this category is the largest, as 

e – estimate 

f – forecast 

Source: Report “Pharmaceutical market in Ukraine 2008. Development forecasts 2008-2010”, 

PMR Publications, a division of PMR Ltd., 2008 

Figure 1:Value ($ bn) and y-o-y change in the pharmaceutical market in Ukraine, 2008-2010 

well as one of the most rapidly developing 

groups of drugs. However, PMR expects 

this category to develop very dramatically 

between 2008 and 2010, at an average 

rate of 38% year on year, in terms of value. 

In 2007, sales in this category were worth 

$246 million, and in H1 2008, the category 

witnessed one of the fastest increases in 

sales value on the market. 


Marketing Department 

T. +48 12 618 90 20 

E. marketing@pmrpublications.com

27-28 April, 2009, 

Munich Marriott, 

Munich 



4th Annual 

eMarketing Summit 

Influence new and existing customers with sharper 

and more innovative eMarketing strategies 

The best way to organise your eMarketing 

teams: What should be the profile of your 

eMarketing team 

Branding: from product strategy to 

implementation: Learn new ways to better 

align your brand plan and digital tactics 

for long-term relationships between your 

customers and brands 

Successful social media marketing. 

Inspiration from other industries: 

Learn lessons from eBay, Amazon and Dell. 

Hear how financial industry embraced 

social networking. 

Physician communities and search 

behavior: Learn to engage with doctors 

online and understand what content they 

are looking for 

For the latest updates and more information visit www.eyeforpharma.com/emarketing 

March/April 2009

strap drug delivery goes here 


dispensing 

solutions 

The transition from CFC to HFA metering valves has been a complex 

issue for the pMDI industry. Nasal and pulmonary drug delivery device 

manufacturer, Valois Pharma, highlighted its innovative range of 

dispensing solutions at the recent Pharmapack 2009 show in Paris. 

he production of CFCs 

(chlorofluorocarbons), which 

deplete the ozone layer, was 

banned by developed nations 

in 1996, in accordance with the 1987 

Montreal Protocol. However, an “essential 

use” exemption was granted to the 

pharmaceutical industry, notably for 

the production of pMDIs, to allow 

replacement products using HFA to 

be brought to market. As there are 

physicochemical differences between 

the two propellants, moving to HFA meant 

that both the drug formulation and the 

components of the pressurized inhalers 

— in particular, the metering valves and 

gaskets — had to be completely 

redesigned. In addition, the US has 

introduced a total ban (effective 31 

December 2008) on the production 

and sale of CFC inhalers that contain 

albuterol; so, Valois Pharma, using 

expertise gained during a number 

of years, has developed metering 

valves that use HFA as the 

propellant, the pharmaceutical 

industry’s choice to replace 

CFCs. During the last 3 years, 

the company has made major 

investments to grow its 

capacity to create solutions 

for nasal and pulmonary 

drug delivery, such as 

building its new R&D 

centre in Le Vaudreuil 

(France), strengthening 

its R&D teams and 

devoting approximately 

7% of its annual 

revenue to new product 

development. 


Valois Pharma has launched 

several proprietary products, a 

number of which were on display 

at Pharmapack: 

• Equadel, the first patientindependent 

spray pump. 

Completely controlling 

user variability, Equadel 

allows the same 

dose and spray to be 

dispensed every time, 

irrespective of how much 

pressure is exerted by 

the patient. Its ergonomic 

design makes it a perfect 

fit for ethical drugs and, 

in particular, for New 

Molecular Entities, 

either local or systemic, 

that are dispensed 

via the nasal route. 

Equadel opens up new 

opportunities for drug 

product Life Cycle Management. 

• Freepod, a second generation 

preservative-free system (PFS). The Freepod 

pump is specially designed for use with 

preservative or partially preservative-free 

UsINg exPerTIse gAINeD 

DUrINg A NUMber oF 

yeArs, VAloIs PHArMA 

HAs DeVeloPeD MeTerINg 

VAlVes THAT Use HFA, THe 

PHArMACeUTICAl INDUsTry’s 

ProPellANT oF CHoICe. 

formulations. Robust design, easy filling and 

an array of customizations make it a safe 

and perfect fit for unpreserved over-thecounter 

nasal decongestants. 

• Landmark, an award-winning integrated 

dose indicator for pressurized metered 

dose inhalers (pMDIs), has been developed 

in compliance with FDA guidance to 

integrate a dose-counting mechanism 

into pMDI drug products. Landmark 

is designed to be adaptable to any 

pMDI actuator and valve. This patented 

mechanical dose indicator 

technology contributes to 

the improvement of patient 

compliance and safety 

while remaining both easy 

to use and cost effective. 

Landmark won an FEA 

(European Aerosol 

Federation) international 

aerosol award in 2007. 

• Prohaler, a smart dry 

powder inhaler (DPI), has 

been developed with a 

patient-based design 

approach that makes 

it highly intuitive and 

simple to use by 

all patients (such 

as asthmatics and 

patients with bronchitis). 

Its novel powder dispersion 

technology enables high lung deposition, 

even if the patient’s inhalation flow rate is 

low. Moreover, its unique patient safety 

feature avoids any risk of double-dosing 

and wasted doses. 


Visit www.valois.com/pharma

European magazine for supply chain 

professionals who are responsible for 

manufacturing, warehousing and logistics 

Each issue covers 

Supply Chain Leadership 

Logistics and 

Warehousing 

Manufacturing 

Supply Chain IT

strap process goes technology here 


solution-Caused 

pRoblems and how 

to pRevent them 


Dr Jamie Weiss, senior Consultant, Kepner-Tregoe, analyses 

the root causes of production problems and how companies 

decide how best to correct or prevent them from happening. 

MANy oF THe ToUgH ProbleMs oUr ClIeNTs AsK Us To FACIlITATe 

CAN be CHArACTerIzeD As solUTIoN-CAUseD ProbleMs. 

THAT Is, THey HAVe A ProbleM, THey FIND THe CAUse, THey PUT 

A CorreCTIVe ACTIoN IN PlACe To MAKe THe ProbleM go 

AwAy, AND All oF A sUDDeN THey HAVe A DIFFereNT ProbleM!

pharmaceutical company 

produced a compound using 

three ingredients. One of them, call 

it Substance A, had a tendency 

to stick to the machine that grinds it up, causing 

shut-downs and costing money for maintenance 

and clean-up. The producer decided that if 

Substance A was ground more finely, they could 

stop it from sticking. The change was within the 

process specifications, so they made it, and all 

their headaches went away. Shortly afterwards 

— at the sister facility that blends the three 

substances together — they opened the barrels 

of Substance A and found it caked solid, and 

only removable with a hammer and chisel. The 

finer grind solved the problem of sticking, but led 

to a new problem: caking. 

As a consultant, a major component of 

my job involves working directly with client 

companies to help them analyse the root 

causes of problems and decide how best to 

correct or prevent them. Kepner-Tregoe has 

been engaged in this for almost 50 years, and I 

have been doing it for more than 20 years. We 

train people in our analytical rational process 

methodologies; we train trainers to train others; 

we train facilitators to run investigations; and 

we consult around problem-solving processes, 

systems and the human performance system 

factors that drive them. Occasionally, a problem 

comes up that is just too hot for the client’s 

resources to handle — often for political 

reasons — and we get called in to do the 

facilitation ourselves. 

process technology 


Recognizing Solution-Caused 

Problems 

Many of the tough problems our clients ask us 

to facilitate can be characterized as solutioncaused 

problems. That is, they have a problem, 

they find the cause, they put a corrective action 

in place to make the problem go away, and 

all of a sudden they have a different problem, 

and often a much bigger one. Like the caking 

problem, the following examples — revised and 

disguised to protect client confidentiality — are 

typical solution-caused problems. 

The switch: A chewable tablet failed a 

hardness test and became too hard at 12 

months of ageing. Speculation in the company 

lab focused on how the winter weather’s 

low-humidity might have caused excessive 

March/April 2009

process strap goes technology here 


hardness. But the weather was no drier than 

previous winters, begging the question of 

why the hardness started when it did. It was 

finally discovered that, unknown to the drug 

manufacturer, a supplier had changed the starch 

content of one of the tablet’s excipients — with 

no thought to the affect on the final product — 

increasing it by more than 25%. The increase 

of the starch content, combined with the low 

humidity, caused the hardness failure. 

The fix: When ‘black specks’ appeared in an 

ingredient, the manufacturer’s analysis identified 

them as small pieces of shredded gasket 

material. These findings were sent to the supplier 

of the ingredient, who quickly responded that 

they had corrected the problem by inserting a 

704 stainless steel mesh filter to separate out the 

black specks. The black specks disappeared, 

and everyone was happy. But a month later, 

the client began noticing ‘shiny specks’ in the 

same ingredient from the same supplier. When 

analysed, these shiny specks turned out to be 

704 stainless steel. 

The improvement: A billion dollar-a-year 

drug failed appearance tests for colour, suddenly 

putting patient safety, company revenues and 

shareholder value at risk. This top-selling tablet 

was supposed to be white, but instead it was 

coming out dark yellow. Although safety and 

efficacy were determined to be uncompromised, 

the pills ‘just didn’t look right,’ especially to 

patients who had already used them. As a result, 

the manufacturer suspended production for 

more than 6 months. The cause was traced to 

a supplier who unilaterally decided to remove 

a substance with some potentially toxic effects 

from their part of the blend. They thought 

they were being good corporate citizens, but 

unknown to them, the ‘bad’ ingredient had a 

key role in stabilizing the colour; without it, colour 

varied unacceptably. 

Types of Solution-Caused 

Problems 

These kinds of issues are expensive, disruptive, 

and more common than may be suspected. 

When discovered and analysed, they lead to 

embarrassment, some finger-pointing and a lot 

of head-shaking. If we deconstruct them, we can 

see that there are different types of problems. 

Containment-Caused Problems: The 

‘stainless steel specks’ problem is an instance 

of failing to find the root cause in the first place, 

and of adopting an interim action instead of 

a permanent corrective one. Think of it as a 

containment-caused problem. The unasked 

question up front is clearly, “Why was the gasket 


material getting into the blend in the first place, 

and how could this be prevented?” Perhaps 

the gaskets have changed in size or shape 

or composition; perhaps the recommended 

replacement period has been exceeded; 

perhaps some change in the process — in 

speed, temperature or pressure — has 

subjected the gaskets to unexpected wear. The 

supplier never found the root cause — the cause 

of the cause! — and implemented a fix that did 

not act against degrading gaskets, but merely 

filtered them out after they had broken down. 

And, when installing the filters, the supplier never 

asked what might go wrong in specific enough 

detail to prevent the problem. 

Problem-Relocation Problems: In the 

‘caking problem,’ the change did solve the local 

problem of sticking, but caused a downstream 

problem of caking. Again, the failure to consider 

potential problems with the corrective action 

led to the new problem. Perhaps some were 

considered within grinding, but the range did 

not extend to mixing, leading to a change that 

would have otherwise been vetoed, had the 

proper causal analysis taken place. In addition, 

it seems clear that the specifications for grinding 

were set too broadly, allowing the product that 

was technically within specifications to fail. We 

often see this in process re-engineering or Six 

Sigma, where it goes by the name of suboptimization. 

In the problem-solving sphere, it 

looks like the old carnival game of Whack-a- 

Mole: each time you hit a symptomatic mole, it 

pops up again somewhere else! What is needed 

here is not more or harder ‘whacking,’ but 

rather a better, more precise hammer that gets 

past suppressing the symptoms to attacking 

the root cause. 

Often, issues of problem relocation have 

organizational foundations: incentive systems 

that are too locally based, the pressure to show 

quick results, and the isolation of different parts 

of the process from each other, all contribute 

to the creation of issues like this. I experienced 

one client situation where, in the course of 

tracking down a problem, we noticed that 

they had a severe back-order problem in their 

shipping department. But here’s the catch — the 

products that were slowest in going out were 

high-volume products, things they made three 

shifts a day, 24 hours a day, not the low-volume 

products that can often lag in shipping. The 

cause was an incentive program run amok that 

favoured the production and expediting of lowvolume 

‘onesie-twosies’ — and favoured them 

a bit too much. The folks in the warehouse were 

letting the rewards drive their performance, and 

drive it right into the ground. 

Opportunity-Caused Problems: The 

‘hardness failure’ and ‘appearance failure’ cases 

might better be labelled as opportunity-caused 

problems. Someone changed a variable without 

thinking that it would affect the final product. 

Once again, no one asked what might go 

wrong if they did this. After all, they were trying 

to improve the process/product, not degrade 

it; but when you are taking advantage of an 

opportunity, you are taking an action, and 

actions can have unintended consequences. 

Failure-to-Communicate Problems: All 

solution-caused problems are compounded by 

communication problems. As the guard in the

movie, Cool Hand Luke was fond of saying: 

“What we have here is a failure to communicate.” 

In the cases cited above, someone failed to 

communicate a change that could affect the 

process one or more steps downstream. 

Communication can fail within supplier 

relationships and within the same organization. 

Failure-to-Understand Change Problems: 

Whenever you introduce a change into a 

process, you are potentially introducing variation. 

It doesn’t matter whether the change comes 

from trying to solve a problem or from trying to 

optimize a process — changes cause problems, 

and change is change — it needs to be analysed 

and managed. 

How to Avoid Solution-Caused 

Problems 

Solution-caused problems are surprisingly 

pervasive, but they can be avoided. There 

are three elements required to minimize the 

occurrence of solution-caused problems and, 

if a problem does occur, to reduce its impact 

without creating more problems. 

1. An Analytical Approach 

Asking ‘what could go wrong?’ all by itself is 

a start, but just asking the question, and even 

listing a few potential problems, will not by itself 

minimize the chance of something going wrong. 

Our experience tells us that you have to be 

quite detailed about the potential problems and 

specific enough to be able to hypothesize some 

likely causes for each potential problem. 

Causes are crucial because any preventive 

action you take must be directed at the causes, 

not just at the effects. Of course, not all attempts 

at prevention will succeed perfectly. To be an 

effective preventive action, an action simply 

needs to significantly reduce the probability of 

the potential problem’s occurrence. Despite 

attempts to prevent it, should the potential 

problem actually occur, we need contingent 

actions aimed at the effect to reduce its impact. 

2. A Change Management System that 

Builds-In an Analytical Approach 

In the heat of the moment, like trying to get 

a costly line back up and running again, 

people may skip some steps to speed up 

the process. One of the first steps skipped is 

asking, “What might go wrong?” As a result, 

we find that building a ‘Potential Problem 

Analysis’ step into the SOPs is required to 

channel behaviour. It may sound cynical to say, 

but most people are not rational, unless they 

have to be, and will tend to avoid painstaking 

analysis if they can. Many corrective and 

preventive action systems — whether in the 

cGMP world of pharmaceuticals, the ISO world 

of heavy manufacturing or in other regulated 

industries (like nuclear power generation) — 

exist under applicable guidelines that require 

a change management system. Minimally, 

all changes need to be logged in a central 

registry, described and dated. More stringent 

systems should require a full experimental or 

manufacturing validation of the new component 

or process before proceeding. Such a system is 

an optimal place for potential problem analysis; 

a requirement that all changes be submitted to 

such analysis makes clear sense. 

3. A Learning Culture 

Finally, to apply potential problem analysis, the 

To APPly PoTeNTIAl ProbleM ANAlysIs, yoU MUsT bUIlD A CUlTUre 

THAT ACCePTs THe FACT THAT UNANTICIPATeD ProbleMs wIll oCCUr, 

AND belIeVes THAT IT Is beTTer To CoNsIDer THeM IN ADVANCe 

rATHer THAN To Try To reACT To THeM AFTer THey oCCUr. 

company must build a culture that accepts 

the fact that unanticipated problems will occur, 

and believes that it is better to consider them 

in advance than to try to react to them after 

they occur. It is curious to me that most people 

would not even consider going on a family 

vacation without doing some informal potential 

problem analysis, and acting upon it: have the 

newspapers and mail held, have the neighbours 

feed the pets, convert cash to traveller’s 

cheques, keep one credit card separate in case 

of robbery, etc. Yet when faced with applying 

the same kind of thinking to the launch of a new 

product or the upgrade of an existing one, they 

resist mightily. 

One subtle cause of this is in the human 

performance systems that companies structure 

to reward employees. When it comes to 

problems and potential problems, there is a 

built-in structural asymmetry. Specifically, it is 

easy to see if someone has solved a problem: 

all you have to do is look to see if the product or 

the processes associated with it are up to spec 

again. By contrast, it is close to impossible to 

process technology 


ascertain whether someone has successfully 

prevented a potential problem from occurring. 

All you have to examine is the fact of nonoccurrence, 

and that can be explained by 

assuming that there never was a potential 

problem in the first place, or that some other 

unplanned event prevented it from occurring. 

In short, you cannot prove that your preventive 

action minimized the probability of the problem 

occurring, or that your contingent action 

minimized the effects. 

We have all met people who take great pride 

in their problem-solving skills, and we may have 

been struck by the notion that these people 

would have fewer problems to solve if they 

just thought ahead. But if they did, then they 

wouldn’t have any fun problems to solve, and 

would lose the acclaim and regard that go along 

with such heroic actions. 

There are, in fact, ways to reward people for 

anticipating and preventing future problems. 

They require some clear thinking and not a 

little creativity, and their administration requires 

consistency and clarity. But if addressing 

potential problems is not seen as a valued 

activity by employees and managers, they will 

tend to avoid doing it. 

Conclusion 

Solution-caused problems are all too common 

and are an indication of an incomplete approach 

to resolving issues. Companies can quickly earn 

back multiples of time and money that they 

invest in installing the skills needed to attack 

problems, systems to track them and a mind-set 

that values preventing them. 

About the Author 

Dr Jamie Weiss (jweiss@kepner-tregoe.com ) 

is a Kepner-Tregoe senior consultant, who has 

helped pharmaceutical and medical device 

clients improve their CAPA Systems around rootcause 

analysis, issue tracking, and correctiveaction 

implementation. 

Kepner-Tregoe, Inc. has earned a worldwide 

reputation for improving business results 

through people. A global leader in effecting 

successful change and improvement, KT 

helps clients achieve lasting results through 

a proven approach of process, facilitation, 

and transfer. Focusing on the needs of the 

organization’s people, skills, capabilities, and 

performance environment, KT continues 

to find innovative ways to integrate human 

resources into an organization’s strategy, 

structure, and systems, and the processes in 

which goals are accomplished. 

March/April 2009

strap process goes technology here 


CoRking faCility foR gsk 

Kemutec Powder Technologies ltd has supplied a complete line to gsK’s r&D facility in Cork. 

emutec Powder Technologies 

has continued to demonstrate 

its ability to meet the unique 

challenges posed by its clients with 

the installation of a high specification package 

for GSK at the company’s Cork facility in the 

Republic of Ireland. It is the latest in a long line of 

machinery — including sifters and mills — that 

have been supplied to GSK’s production facilities 

worldwide, and it demonstrates Kemutec’s 

status as a preferred supplier. 

GSK had several requirements of the package 

to fulfil, central of which was to accommodate a 

multi-product process train. This was achieved 

by designing in quick change operating 

parameters, equipment speeds, type of grinding 

media and even the sieve and screen type. 

The package consists of two RB100 screw 

feeders, which lead into two KEK Series 220 

Under-Driven Cone Mills. These in turn feed into 

two KEK K650 Centrifugal Sifters. Mobile and 

sliding support mechanisms were developed to 

allow a milling or sieving operation to be added or 

removed from the process quickly and easily. The 

sifters are mounted on moveable structures, as 


GSK required them to be interchangeable with 

two existing flat-deck machines. The offset of the 

inlet flanges on the two types of sifter varied to 

a significant degree and, for this reason, custom 

sections of tubing for the screw feeders were 

designed to adapt the position of the feeders in 

relation to the sifters. The stairs in the centre of 

the assembly and the platform are also a bespoke 

design manufactured by Kemutec, and are 

moveable to allow maintenance to be carried out 

on the equipment. 

Impressively, all the machines used in the 

package are manufactured in C22 Hastelloy, 

thus accommodating the corrosive nature 

of materials and cleaning fluids. All of the 

machines were pressure designed to allow 

them to be fully flooded during CIP for product 

dissolution, providing an extremely effective 

form of cleaning. Another factor that had to be 

considered was the space available, which was 

at such a premium that a significant proportion 

of the ceiling had to be cut away in order to 

accommodate the assembly. 

Martin Thomson, Sales Director of Kemutec, 

said: “This project continues our desire as a 

company to work with GSK, and to constantly 

develop and provide solutions for their unique 

demands.” Such a versatile package has been of 

great benefit to GSK, and reflects how Kemutec 

is constantly exceeding customer expectations. 

magnetiC agitatoRs aid hygiene 

terility and ease of cleaning are 

very important in production 

processes in the biotechnology 

and pharmaceuticals industries. 

This is why modern magnetic agitators are 

indispensable in these sectors. They offer 

various benefits, such as absolute sealing, 

low maintenance requirements and more 

space on the tank cover for all types of 

connectors. The units of the BMR series 

from Zeta, a member of the Christ Water 

Technology Group, meet all requirements 

that exist today for GMP-compliant 

production — just like Zeta’s process 

systems. 

In particular, the open design of the 

magnetic impeller permits the important 

CIP (clean in place). This has been proven 

in independent studies carried out by 

the Swiss University, in Wädenswil, in 

accordance with the three methods: 

European Hygienic Engineering & Design 

Group (EHEDG), Total Organic Carbon (TOC) 

GSK’s R&D facility in Cork was fitted out by Kemutec. 

and Riboflavin. A further decisive property 

is the design of the ceramic sleeve bearing, 

whose generous dimensions and material 

combination (silicon carbide on zirconium 

oxide) offer the longest possible operating 

lifetime. Thanks to the hydrodynamic 

properties of the agitator blade and the 

patented ‘lift-off’ lubrication channels, 

wear and the release of unwanted particles 

are almost negligible. If it should become 

necessary to replace the bearing sleeves, 

this can be done easily in situ. 

These properties are also the reason for 

the increased use of the BMR magnetic 

agitators, as a reduced exposure to germs 

and bacteria can extend the shelf life of 

a product. The units are available with a 

transmittable torque of 0.3 Nm to 200 Nm 

for tanks with a maximum stirred volume 

of up to 45,000 litres. The Zeta product 

range also includes magnetic agitators for 

bioreactors, mixing units, conventionally 

sealed agitators and defoaming units. 

Further information 

sales@kemutec.com 

www.kemutec.com 


www.zeta.com. 

Photo: Christ Water Technology Group 

These BMR magnetic agitators are suitable for use 

in cell-culture fermenters with filling volumes of 2 to 

approximately 3000 litres.

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strap plant technology goes here 


phaRma plant engineeRing 

Competition in a gRowth maRket 

In the run up to ACHeMA 2009, the organizers have released a number of trend reports. Number 15 reviews 

“A New Conceptual Approach and the Trend to Disposables in biopharmaceutical Manufacturing.” 

he worldwide pharmaceutical 

market is a very lucrative place 

for drug producers, equipment 

suppliers, service providers 

and consultants. The world pharmaceutical 

market more than doubled in size between 

1998 and 2006, and the global production of 

pharmaceutical products rose to €351 billion 

in 2006 (compared with €136 billion, 16 years 

earlier). The increase in production volumes 

has been particularly impressive in Europe in 

recent years, rising from €63 billion in 1990 to 

€190 billion in 2007. France (2006 production 

volume: €34.4 billion), UK (€24.8 billion) and 

Germany (€23.7 billion) are the predominant 

pharmaceutical producers in Europe. The US, 

however, is the world market leader, with a 

39.3 % share of total production, followed by 

Europe and Japan. To satisfy demand, a number 

of capital projects have been initiated and 

completed worldwide, creating what appears 

to be the ideal growth market for companies 

that specialize in the design and delivery of 

pharmaceutical plants and equipment. 

Events in Ireland are one reason for the 

competitive nature of the market. Government 

subsidies at the end of the 1990s and the 

beginning of the new millennium helped the 

country to become the world’s sixth largest 

pharmaceutical producer within the space 

of a few years. Production volumes reached 

€14.9 billion in 2006. In the wake of these 

developments, highly capable engineering 

service providers based on the Anglo-Saxon 


model were set up. When government funding 

came to an end, the suppliers increased their 

focus on continental Europe. There is also 

another significant difference compared with 

the chemical plant design and construction 

market. The customer base ranges from 

multinational corporations, which have in-house 

production operations, to family managed SMEs 

(particularly in Germany) and specialist contract 

manufacturers. 

The products and manufacturing techniques 

can also vary considerably, ranging from 

conventional pharmaceutical active ingredients 

to biopharmaceuticals. The demands are equally 

complex, including conceptual design, basic and 

detailed engineering, project management and 

contractual terms and conditions. In general, the 

following demanding requirements differentiate 

plant engineering projects in the pharmaceutical 

sector from industries such as chemicals: 

• tight schedules (time to market) 

• conformance with GMP (Good Manufacturing 

Practice) guidelines 

• equipment quality monitoring. 

Plant engineering projects in the 

pharmaceutical industry are usually based on a 

triangular relationship between the plant owner 

(the customer), an engineering partner (such 

as a general engineering services or general 

contractor) and equipment suppliers. In the 

chemical industry, the projects are conducted 

for the most part by EPC (Engineering, 

Procurement, Construction) organizations, 

but pharmaceutical plant owners normally 

play a much more active role in the planning 

and procurement process. Projects goals 

differ considerably between the chemical and 

pharmaceutical industries. The project partners 

normally agree on the schedule, product 

quality and output in the chemical industry, 

and these items are used as acceptance 

criteria. In the pharmaceutical industry, the 

plant owner is responsible for quality and 

production volumes. The processes are often 

not dedicated to a single product, and active 

ingredients are often synthesized on lines that 

produce multiple products. 

Few Opportunities for Consolidation 

Specialized engineering service providers 

have evolved during the years, and have 

adapted to the structure and requirements 

of the industry. However, consolidation in the 

engineering services sector has taken place 

in recent years, in response to more stringent 

regulatory requirements and increasing schedule 

and cost pressures — as well as the demand 

for globally active service providers. And the 

pressure has not subsided. In the wake of the 

recent boom, chemical plant engineering service 

providers have been able to exercise greater 

influence on contractual terms and conditions, 

but competition in the pharmaceutical plant 

engineering sector remains intense. 

“Most customers still have a strong preference 

for lump-sum pricing agreements or pricing 

on actual expense with an upper cost limit 

on their projects,” explained Ralf Roepenack,

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Managing Director of the engineering firm, 

NNE Pharmaplan. In addition to fixed pricing, 

customers also try to impose penalties for 

schedule overruns or even when project team 

members are replaced. “Trust plays a crucial role 

in the pharmaceutical industry, and penalties can 

even be imposed for changes in key personnel,” 

said Robert Schwarz, Managing Director of VTU 

Engineering. It is essential for engineering service 

providers to carefully scrutinize RFQs (requests 

for quotations) as part of their risk management 

programme. “If the customer sends out 

requests for lump-sum bids, then the system/ 

plant description will have to be very detailed,” 

emphasized another planner. 

As many parts as possible must be 

prefabricated. Subsystems are produced 

as skids and modules. In contrast to the 

chemical industry, where individual solutions 

are regarded as a competitive advantage, 

there is a trend towards standardization in the 

pharmaceutical industry. “It often happens that 

similar plants in a corporation generate very 

detailed individual requirement profiles. Given 

the incessant increase in cost pressure and 

the need for regulatory compliance, we are 

forced to standardize parts,” said Dr Bernhard 

Luy, Managing Director of the pharmaceutical 

engineering company, Glatt. Very lengthy 

specifications and contracts are a constant 

source of irritation. A 1500 page specification 

for a fermenter is just one example of extreme 

attention to detail. Yet, the hope remains that 

plant-level standards will become less important 

in the future and the industry will rediscover 

the advantage of pragmatic specifications on 

increasing cost pressure. A number of suppliers 

that have to deal with very lengthy specifications 

and RFQs do not share this optimism. Christian 

Stark from Christ, which specializes in ultrapure 

water treatment systems, claims: “Both 

contractors and plant owners are contributing 

to the proliferation of specifications. Customers 

for the most part used to accept our proposals, 

but engineering firms now often generate their 

own standards.” The problem for specialist 

suppliers is that they are often reluctant to draw 

attention to incorrect RFQ documentation or 

specifications, which do not reflect the current 

state of technology for fear of being excluded 

from the evaluation process. 

Increasing Focus on Cost 

The fact that customers are increasingly cost 

aware will have an impact, not only on the project 

but also on production. It will not necessarily 

reduce the willingness to invest in technology, 


but it will focus attention on production costs. 

And there, technology is decisive. However, a 

troublesome problem always arises when you 

try to optimize a process in the pharmaceutical 

industry. The original process flow and production 

methods have been validated. The process has 

to be requalified and revalidated when changes 

are made. Many customers are unwilling to 

invest the time and effort to get this done. This is 

when the expertise of specialist engineering firms 

can help. Consultants need to have a thorough 

understanding of GMPs, so that they are able 

to assess whether a change can be introduced 

without affecting the approval and GMP status of 

a production line or product. 

A Change in Concept and 

Parametric Release 

Parametric release reflects a new fundamental 

approach to quality assurance, replacing 

end-product quality control. It represents a 

major paradigm shift in the pharmaceutical 

industry, affecting engineering and the entire 

pharmaceutical process. “As batch sizes 

continue to decrease in the pharmaceutical 

industry, the proportion of overall production 

costs, which are directly related to quality 

control, continues to increase,” explained 

Werner Zesch from international management 

consultants, Arthur D. Little. The FDA’s PAT 

(Process Analytical Technology) initiative has 

stimulated the debate. Quality assessment 

must ensure that a pharmaceutical product 

conforms to the approved release specification. 

Parametric release based on successful 

qualification, process validation and improved 

process control, combined with suitable 

monitoring, is acceptable if product quality 

is guaranteed. This approach will lead to the 

increased use of automation and analytical 

systems, and organizational changes such as 

the complete release process. 

Operational Excellence 

In the future, engineering service providers and 

equipment suppliers will have to address another 

trend in the pharmaceutical industry. Customers 

are striving for operational excellence, which will 

help them to reduce costs and ensure product 

quality. A reduction in throughput times is one 

element of this strategy. It gives producers 

greater flexibility to react to market needs. “With 

a continuous production flow that is similar 

to automotive industry practices, you can 

significantly reduce throughput times compared 

with conventional ‘campaign’ production,” 

claimed Dr Frank Stieneker, Director of the 

Pharmaceutical Process Technology Working 

Group (APV). As a result, modular design will 

become an increasingly common feature of 

system architecture. Cost pressure is not the 

only factor driving change in engineering and 

technology. New classes of active ingredients 

are also having a noticeable effect. New system 

designs are needed to meet growing market 

demand for biopharmaceuticals (world market in 

2006: €58.5 billion), because cleaning following 

the fermentation process is currently creating 

production bottlenecks. Dr Hermann Allgaier, 

Managing Director, Merckle Biotec GmbH, is 

convinced that, in the future, these processes 

will run to an increasing extent in disposables. 

The production systems, from the reactor to the 

purification filter, are thrown away rather than 

cleaned after they are used. Compared with a 

stainless steel system, the amount of cleaning 

and cleaning validation effort is drastically 

reduced. It also takes less time to construct 

these systems, because scale-up is much 

simpler. “The approach can substantially reduce 

the amount of basic and detailed engineering 

effort,” explained Allgaier. 

Conclusion 

Owners, contractors and suppliers will have 

to work more closely together in the future. 

Owners will need to take a holistic approach and 

be willing to optimize their existing processes. 

Producers will also have to be prepared to 

accept greater project risk, especially when 

the schedule is very tight. Contractors will face 

some very big challenges. They will be expected 

to provide specialist expertise, and they will 

have to retain qualified personnel. They will also 

need to balance the differing needs of SMEs 

and global corporations, which are both part of 

their customer base. At ACHEMA 2009 there 

will be many opportunities to gather information 

on the newest developments in pharma plant 

engineering and to discuss the trends that will 

affect plant owners, contractors and suppliers. 

Both the congress programme and the 

exhibition will offer various options: for instance, 

there are nearly 50 lectures on processes and 

apparatus for pharmaceutical production at the 

congress, about a third of which address the 

production of biopharmaceuticals. 


Dr Kathrin Rübberdt 

Tel. +49 6975 64 277 

Fax +49 6975 64 272 

presse@dechema.de 

www.achema.de

The Pharmaceutical Market 

Outlook to 2018 

strap country goes survey here 


Key threats and opportunities for Big Pharma and 

its responses to them 

Identify the key challenges and opportunities in the global pharma market, benchmark the growth 

strategies of leading companies and understand how the market will evolve through to 2018... 

The pharmaceutical industry must respond to a number of key challenges over the next ten years 

in order to sustain recent levels of growth. Falling levels of R&D productivity and the exposure of 

an increasing amount of blockbuster drugs to generic competition as a result of patent expiries 

are among the most notable concerns for pharma players. Recent strategies have seen a rise 

in outsourcing and the restructuring of R&D processes, with a movement away from internally 

driven R&D organizations with Centers of R&D Excellence and Disease Focused R&D Centers. 

Turbulence in the global economy is also having a significant impact 

upon the biotech industry, where externally funded companies are 

particulary vulnerable to investment downturns. 

‘The Pharmaceutical Market Outlook to 2018’ is a report 

published by Business Insights that explores the key threats 

and opportunities facing the pharma industry over the next ten 

years. This report analyses how leading companies including 

Pfizer, Roche, GSK, and Merck & Co. are optimizing their 

approaches and growth strategies to succeed in the changing 

market landscape. The performances of the top 10 pharma 

companies over the past five years are also assessed and a 

proprietary Business Insights survey evaluates the views of 

industry executives as to future market growth, biotech M&A 

activity, personalised medicine and pipeline developments. 

Identify key trends and developments in the global pharma 

landscape over the next ten years, compare the strategic 

responses of leading players and evaluate competitor sales, 

pipelines and prospects... 

For more information on this report 

email distribution@globalbusinessinsights.com 

or call Jessica Rose on +44 161 238 4044. 

March/April 2009

products 


Whether it is new equipment, machinery or plant, the latest product developments are showcased here 

Speed and Precision — Hand in Hand 

The GPC series of pipette calibration balances from Sartorius can be integrated 

into everyday lab processes flexibly and comfortably, helping the user achieve 

precise and reliable pipetting on a daily basis. 

The balances in the GPC series are ideally suited for gravimetrically testing 

the volume of any pipette size. With 6 mL and 21 mL sampling chambers, the 

series can calibrate pipettes with a volume of up to 1000 µL, depending on the 

model. If needed, larger volumes can be calibrated using the GPC65-CW or 

GPC225-CW. Sartorius also offers an optional 50 mL sampling chamber with a 

special pipette draft shield. 

Several fine details of design make this calibration balance stand out, not 

only for its precision, but also for its ease of use. For example, these models 

do not require a standard draft shield. This saves users significant time, 

as they do not need to open and close the draft shield. Another example is 

the evaporation trap, fitted as standard, which maintains the humidity at 

60%–90%, thus preventing loss of liquid from the sampling chamber. In 

addition, the modularly designed system allows users to adjust their pipette 

calibration workstation so that they can work ergonomically. 

The liquid taken up in the pipette is weighed on a balance. The balance 

transmits the weight value to a PC, where the calculations are performed, for 

example, by Sartorius’s Picaso software. The volume of the liquid is calculated 

from its weight and density and compared with the nominal volume for the 

pipette. After taking a series of measurements, the calibration results are 

printed as a GLP-compliant report. 


The new GPC series of pipette calibration balances from Sartorius.

World’s First EDI Module with Membrane Stage 

With Septron Bio-Safe, Christ now offers the world’s first EDI (electrodeionization) 

module with an integrated membrane stage. It is based upon the 

proven and patented spiral-wound technology and has an additional membrane 

stage for removal of particles and bacteria. 

The EDI module is available in a cold-water version and one that can be 

sanitized with hot water. Both are available in various sizes with outputs of 

500 to 3000 L/h. The combination of this module with a preceding reverse 

osmosis stage makes it possible — without additional ultrafiltration — to 

produce HPW (Highly Purified Water) with bacterial counts of ≤10 CFU/100 

mL. The module can be retrofitted quickly and easily on existing Osmotron 

systems and permits a considerable improvement in the microbiological safety 

of existing pure water systems. 

The cold-water version of the Septron Bio-Safe offers the benefits of high purity 

water quality and low energy costs and is particularly suitable for pharmaceutical 

applications where high efficiency and low costs are important. Long-term 

bacteria-free operation is assured by periodical replacement of the membrane 

stage during routine maintenance of the pure water system by a Christ service 

engineer. If desired, the integrity of this stage can be checked at any time. 

The membrane stage is exchanged with the aid of a special replacement 

kit that ensures contact-free handling, thus guaranteeing GMP-compliant 

operation of the system. No intervention by the user is necessary. In the hotwater-resistant 

Septron Bio-Safe, the complete system — including 

the preceding process steps — can be sanitized at >80 °C, 

resulting in even better system safety. 


www.christwater.com 

Photo: Christ Water Technology Group 

Septron Bio-Safe is the world’s first electro-deionization module with 

an integrated membrane stage. It is based on the proven and patented 

spiral-wound technology and has an additional membrane unit to remove particles 

and bacteria. 

New Biological Safety Cabinet 

Thermo Fisher Scientific Inc. has introduced the Thermo Scientific 1300 Series B2 

total exhaust biological safety cabinet. The innovative design presents advanced 

DC motor technology, increasing user safety as well as protecting samples from 

contaminants. 

Furthermore, the cabinet exceeds the highest quality and safety standard 

recommendations from NSF/ANSI 49 for the use of volatile toxic chemical and 

radionuclides in cell culture applications. The cabinets also meet the current 

recommendations of the National Institute for Operational Safety and Health 

(NIOSH) Alert for Hazardous Drug Preparation. 

The 1300 Series B2 maximizes safety and improves workflow sterility in any 

laboratory, while maintaining ease of use. It joins the full range of NSF-certified 

biological safety cabinets provided by Thermo Fisher Scientific and is available in 

4 and 6 foot-wide models. 

The safety cabinets utilize HEPA filters to maintain a clean air inflow 

and downflow across the entire sample area. Hard-ducted to the external 

environment, the 1300 Series B2 prevents recirculation of any air or gas into 

the sample chamber. Automatic adjustment of the air downflow during HEPA 

filter loading vastly improves product safety and increases filter life. It provides a 

timed UV light option, which not only reduces the risk of contamination, but also 

prevents frequent bulb replacement and reduces maintenance costs. In addition, 

cleaning is simplified by the single-piece stainless steel work tray, which 

minimizes loss of pipette tips or spills into the drain pan. 

All Class II, Type B2 biological safety cabinets are built for applications that 

require working with greater than minute quantities of volatile toxic chemicals 

strap goes products here 


University Selects Bio-Rad 

System to Screen Affinity Reagents 

The University of Toronto has 

selected Bio-Rad Laboratories’ 

ProteOn XPR36 protein interaction 

array system to screen proteinspecific 

affinity reagents, including 

antibodies and antibody fragments. 

It is part of an international 

consortium pilot study arranged 

by the SGC (Structural Genomics 

Consortium) and Human Proteome Resource 

Centre — whose goal it is to systematically 

generate high quality affinity reagents for exploration of the human proteome. The 

consortium chose the multiplexed SPR (surface plasmon resonance) instrument from 

Bio-Rad for its ability to rapidly screen biomolecular interactions. 

“The pilot project will generate a wealth of protein-specific reagents that will require 

a fast, accurate evaluation of their binding affinities,” said Renee LeMaire-Adkins, 

Marketing Manager, Protein Interaction Technology, Bio-Rad. “The design of the ProteOn 

XPR36 is ideal for this purpose as it permits the label-free kinetic analysis of six ligands 

measured against six analytes for 36 data points per experiment.” 

The result of a workshop, in March 2008, the pilot study seeks to demonstrate the 

feasibility of a variety of methods to generate better affinity reagents for specific protein 

targets. Researchers from around the world will be sending their affinity reagents to the 

University of Toronto for testing on the ProteOn and results are expected to be published 

in the first half of 2009. A second workshop will be held in March 2009 when the initial 

results will be summarized and evaluated. 

ProteOn XPR36 Protein Interaction Array System 

The ProteOn XPR36 protein interaction array system is a multiplexed SPR biosensor 

that allows users to simultaneously measure the interactions of six different ligand 

proteins with panels of six different concentrations of analyte. This yields comprehensive 

kinetic profiles in a single experiment without the need for regeneration — termed 

One-shot Kinetics. Utilizing a novel optical design and state-of-the-art microfluidics, 

the ProteOn XPR36 system provides much higher throughout for the rapid screening of 

protein interactions than traditional SPR devices. 


T. +1 800 424 6723 

E. lsg.orders.us@bio-rad.com 

and radionuclides, or the aseptic processing of hazardous drugs. However, the 

cabinet is part of a more complex containment system that is critical for user 

safety and operational efficiency. Be sure to contact a Thermo Scientific service 

representative for more information on proper installation. 


www.thermo.com/1300B2 

March/April 2009

Bringing strap products goes outsourcing here to CPhI 


ICSE - the International 

Contract Services Exhibition 

ICSE is the international stage, with in 

CPhI, for companies providing outsourcing 

services in Clinical trials, Contract research, 

Custom manu facturing, Biotechnology, IT, 

Analytical services, Packaging services and 

Logistics. ICSE represents every sector and 

major disciplines of the pharmaceutical 

industry, making it the must-attend event 

for any business or individual in the contract 

services and clinical outsourcing sector. 

Go to www.icsexpo.com for details 

on how to be part of ICSE 2009 

or e-mail icsesales@cmpi.biz. 

13-15 October 

Feria de Madrid, Spain 

THE INTERNATIONAL CONTRACT SERVICES EXHIBITION 


2009 

CLINICAL TRIALS | CONTRACT RESEARCH | BIOTECHNOLOGY | IT | CUSTOM MANUFACTURING | ANALYTICAL SERVICES | PACKAGING SERVICES | LOGISTICS

8–13 March 

Pittcon 2009 

Chicago, Illinois, USA 

www.pittcon.org 

17–19 March 

Interphex 

New York, New York, USA 

www.interphex.com 

15–17 April 

Chemspec India 2009 

Mumbai, India 

www.dmgworldmedia.co.uk 

21–23 April 

CPhI Japan 2009 

Tokyo, Japan 

www.cphi.com 

21–23 April 

ICSE/P-MEC Japan 2009 

Tokyo, Japan 

www.cphi.com 

11–15 May 

ACHEMA 2009 

Frankfurt am Main, Germany 

www.achema.de 

18–21 May 

BIO 

Atlanta, Georgia, USA 

http://convention.bio.org/ 

23–25 June 

CPhI China 

Beijing, PRC 

www.cphi.com 

24–25 June 

ExcipientFest Europe 2009 

Basel, Switzerland 

www.excipientfest.com/europe 

AGRO_Isa_210x140_Info09.qxp:605124_AGRO_Isa_185x128_EU 14.01.2009 15:56 Uhr Seite 1 

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CPhI Worldwide/ICSE/P-MEC 

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14 October 

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strap last word goes here 


CytotoxiC theRapies to 

feel the sting of geneRiCs 

Cytotoxic therapy, or chemotherapy as it is commonly known, has been the cornerstone of cancer treatment 

for many years and involves the use of drugs that are toxic to all cells — including those that are perfectly 

healthy. while relatively effective, this leads to the unpleasant side-effects commonly associated with cytotoxic 

treatment, such as vomiting, nausea, alopecia and fatigue. 

espite this — and the rise in prominence of 

targeted therapies — cytotoxics are used 

in almost all cancer types and, as a result, 

high volume sales make up the second 

largest selling class of cancer therapeutics. However, given 

the relative maturity of this therapeutic class, generics 

companies remain keen to emulate the success of several 

cytotoxic brands that have attained blockbuster sales (more 

than $1bn) in recent years, and according to independent 

market analyst Datamonitor, 1 generic incursion will cause 

a decline in total cytotoxic market value after it reaches a 

peak of $16.5bn in 2013. 2 

Cytotoxic Therapies: 

Second Largest Class 

An estimated 11 million people are affected with cancer 

worldwide; a number that is likely to rise in the future 

given the ageing nature of the global population. Lung, 

breast, prostate and colorectal cancer (CRC) are the 

four most common types of cancer, accounting for 

approximately 40% of the total. Cytotoxic agents help 

to kill cancer cells — or stop them from multiplying — 

making them applicable in almost every cancer type. 

Unfortunately, they also attack healthy cells, which leads 

to the aforementioned side-effects. However, cytotoxic 

treatment regimes remain effective, and for many years 

cytotoxic therapy has been used to treat cancer either 

alone, or in combination with other treatment types, such 

as radiotherapy. 

According to Datamonitor oncology analyst, Chandni 

Surti, sales of the 25 cytotoxic therapy cancer brands that 

are currently available in the seven major markets (7MM) 

in 2007 totalled $10bn. Even though targeted therapies 

are becoming more and more popular, cytotoxics remain 

the backbone of cancer treatment. Eleven of the 25 brands 

are approved for use in breast 

References 

1. Commercial Insight: Cytotoxic Therapy Cancer Brands 

— Looming Patent Expiries Limit Market Growth. 

2. 7MM: France, Germany, Italy, Japan, Spain, UK and US. 


cancer — the incidence of which was estimated to reach 

455,315 in the 7MM in 2008. As the incidence of cancer 

continues to rise with the ageing population, the use of 

effective cytotoxic therapies is likely to remain strong. 

Therapy Brand Market Leaders 

Sanofi-Aventis markets four out of the 25 cytotoxic therapy 

cancer brands: Eloxatin (oxaliplatin), Taxotere (docetaxel), 

Gliadel (carmustine) and TS-1 (tegafur + gimeracil + 

oteracil), which it co-develops with Taiho, making it the 

current market leader. Taken together, Eloxatin and 

Taxotere are approved for use in the four major cancer 

types, making them the top two sellers with combined 

sales of $3.8bn in 2007. 

Taxotere and TS-1 are the leading cytotoxic therapy 

cancer brands by number of approved indications. 

Taxotere is approved for use in six cancer types: 

breast cancer, gastrointestinal cancers, endometrial 

cancer, non-small cell lung cancer (NSCLC), ovarian 

cancer, and squamous cell carcinoma of the head 

and neck (SCCHN). TS-1 is currently only approved in 

Japan, where it is used to treat breast cancer, CRC, 

gastrointestinal cancers, NSCLC, pancreatic cancer and 

SCCHN. TS-1 is forecast to launch for gastric cancer in 

the US in 2010 and in the EU in 2012. 

Sanofi-Aventis’ Eloxatin is a DNA-interactive cytotoxic 

agent that is used extensively for CRC in the US, EU and 

Japan. Sales of Eloxatin generated $2bn in the 7MM in 

2007, making it the best-selling cytotoxic therapy cancer 

brand ahead of Taxotere ($1.8bn) and Eli Lilly’s Gemzar 

(gemcitabine, $1.2bn). However, patent expiries for 

these leading cytotoxic brands, Eloxatin in 2007 (EU) and 

Taxotere in 2010 (US & EU), are likely to have a significant 

impact on Sanofi-Aventis’ performance in the broader 

oncology market. Eloxatin’s patent is also set to expire in 

Japan in May 2013 and the US in August 2016. Higher 

generic erosion rates are applicable in the US compared 

with the remaining major markets, implying a greater dent 

in brand sales. In fact, the impact of generics is expected 

to reduce the cytotoxic therapy brands overall US market 

share from 56% in 2007 to 31% in 2017. 

Newer Brands Compete 

Eisai/Johnson & Johnson’s Dacogen (decitabine) and 

Celgene/Nippon Shinyaku’s Vidaza (azacitidine) are 

antimetabolite cytotoxic agents approved in the US for 

myelodysplastic syndromes (MDS), a type of blood cancer 

that can progress to leukaemia. Following its launch in 

2006, Dacogen has become a major competitive threat 

to Vidaza, which was launched earlier in 2004. Dacogen 

made $137m in 2007, allowing it to quickly catch up with 

the sales of Vidaza ($140m). 

Datamonitor forecasts Dacogen sales to grow in line 

with Vidaza during the forecast period of 2007 to 2017. 

Chandni Surti says: “Both hypomethylating agents seek 

EU approval for use in MDS and Datamonitor forecasts 

their launch to occur around the same time in 2009. The 

increase in sales forecast for Dacogen ($1.3bn) and Vidaza 

($1.2bn) helps boost sales of the total cytotoxic therapy 

cancer brand market to $14.9bn in 2017.” 

Further Information 

Matthew Dick 

T. + 44 20 7675 7824 

E. mdick@datamonitor.com

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