Speciality Chemicals Magazine October_November 2018

Publishing Director: Jon Fellows 

Operations Director: Andrew Stevens 

Head of Production: Charles Dragazis 

Editor-in-chief: Charlotte Niemiec 

editor@specchemonline.com 

US editor: Gregory Morris 

gdlm@enterpriseandindustry.com 

Europe editor: Vanessa Zainzinger 

vanessa.zainzinger@gmail.com 

Asia editor: Aya Kawanishi 

ayakwns@gmail.com 

Project Manager: Steph Cotter 

Design: Jon Bishop 

Commercial Manager: Russell Priestley 

russell.priestley@specchemonline.com 

North American Sales: Ben Jones 

bjones@centurygloballlc.com 

Japan & South Korea Sales: 

(Mizo) Sadao Mizoguchi 

mijinc7@ybb.ne.jp 

@specchemmags 

Speciality Chemicals Magazine is published 

by TRMG Ltd. 

TRMG Ltd 

Winchester Court 

1 Forum Place, Hatfield 

Herts, AL10 0RN, UK 

Tel: +44 (0)1707 273999 

www.trmg.co.uk 

While every effort is made to ensure the 

accuracy of this publication, TRMG Ltd and 

the editor cannot accept liability for any 

statement or error contained herein. 

© Speciality Chemicals Magazine 2018 

SUBMISSION GUIDELINES 

Speciality Chemicals Magazine welcomes 

contributions from academia and industry. 

• News and commentaries, up to 200 words 

with one accompanying table or graphic; 

• Feature articles, typically up to 800 words 

with two tables or graphics. 

Submissions should be made by email to the editor 

(editor@specchemonline.com). We will let you know 

within three weeks if your contribution has been 

accepted for publication. All submissions are subject 

to review by the editor. If accepted, content may be 

edited and/or abridged, to ensure it is in line with 

the values, requirements and style of the magazine. 

Articles not accept for the magazine might be 

considered for online publication only. Online 

publications may also be included in our fortnightly 

newsletter. 

Feature articles must have a technical (rather 

than marketing or promotional) focus. They may 

concentrate on a specific industry sector (for 

example, pharmaceuticals, agrichemicals, cosmetics 

and personal care) but should be understandable 

to experts in all fields. To this end, please start your 

main article with a brief explanation of the topic 

and define abbreviations that might not be widely 

known. Where appropriate, facts cited in your 

article should be referenced. Intelligent insights into 

the state and future of industry are encouraged. 

Headings should be no longer than 12 words 

and a short stand-first is required, summarising 

the content of the article and giving the name 

and affiliation of the author, in under 30 words. 

Figures and tables should be numbered and each 

should be provided with a caption. Text should be 

submitted in Word format. Bar charts, line graphs 

and other graphical representations of data should 

be provided as separate files in an editable format 

(for example, xls). Chemical formulae should be 

provided in PDF format and photographs must have 

a minimum 300 dpi to enable colour printing. 

www.specchemonline.com 

Bigger, better, bolder 

Welcome to our CPhI issue! As companies gear up for one of the largest 

events in our industry, Speciality Chemicals Magazine has been busy 

making some changes behind the scenes. 

From January 2019, we’ll be increasing the number of issues we print 

from six per year to 10, to more effectively reach our 51,000+ readership. 

To ensure our coverage remains truly global, we’re also welcoming on 

board three new editors. 

Gregory DL Morris is assuming the role of US editor. He has been a 

working journalist in energy, chemicals, finance and transport for 30 years, 

first learning his craft on manual typewriters. He’s reported from all 50 

US states and eight Canadian provinces, as well as 17 countries on five 

continents. He is a native New Yorker and graduate of Cornell University. 

Vanessa Zainzinger will look after the Europe desk. A science 

journalist, she has covered chemical regulation, research and risk 

assessment in Europe and around the globe since 2013. She works 

as a freelance writer and editor across publications dedicated to 

chemicals, with particular skills in writing about chemical risk and 

regulation for lay audiences, in popular science magazines. She has 

been a full-time editor at Chemical Watch, covering biocides, food 

contact materials and cosmetics. Vanessa lives in Hertfordshire, UK, but 

was born and raised in Austria. 

And Aya Kawanishi will report on Asia developments. Fluent in both 

Japanese and English, she has been writing high quality news articles in 

both languages for print and online media since 2012. She is a science 

writer at Nature Research, Asia Research News and others. Her interests 

are in science, health and the environment. 

I encourage you to get in touch with them with any questions, press 

releases or news. 

In this issue, don’t miss our CPhI preview, which explores the 

themes at the upcoming show and features exclusive interviews with 

attending companies. 

I’ll see you in Madrid! 

Charlotte Niemiec 

EDITOR-IN-CHIEF

Bienvenido a Madrid! 

CPhI Worldwide: 9-11 October 2018 

Welcome to the 29th CPhI 

Worldwide, the global platform 

for following pharma trends, 

finding pharma products and 

meeting pharma people. 

This year, CPhI will be hosted in 

the landscape of one of Europe’s 

burgeoning biotech and pharma 

hubs, Madrid. It promises to 

be an unmissable opportunity 

to discover the latest and most 

innovative advancements, catch 

up with old contacts and form 

vital new partnerships that will 

push the industry to the next 

level. In the words of Orhan 

Caglayan, brand director at CPhI 

Worldwide: “CPhI Worldwide 

2018 returns in what has been 

a particularly successful year for 

pharma. As an industry, we’ve 

seen a truly stellar year for new 

drugs – with an outstanding 46 

FDA approvals in 2017 and many 

more expected. With the approval 

of Luxturna heralding a new age 

of fast-tracked gene therapies, 

growth in the artificial intelligence 

(AI) sector and advances in 3D 

printing, pharma is expecting a 

time of even greater collaboration 

and innovation. This year, we 

are especially excited to open 

our doors to our colleagues in 

the biomanufacturing community 

with our new, bio-focused event, 

BioLIVE. Here at CPhI Worldwide, 

we look forward to welcoming our 

guests and providing a platform 

for building relationships that 

drive business growth.” 

Event overview and highlights 

After the triumphant events of 

last year’s CPhI Worldwide, the 

forum returns to see distinguished 

pharma executives from all 

over the world come together 

for three days of collaboration, 

information dissemination and 

discussions that will shape the 

future of the industry. Building 

on last year’s success, which saw 

a record 45,000 senior pharma 

professionals in attendance, CPhI 

Worldwide 2018 will host 2,500+ 

exhibitors in 20 easy-to-find 

zones covering the end-to-end 

supply chain, from ingredients, 

APIs, excipients, contract services, 

packaging, machinery and 

more. A handy “one-to-one 

matchmaking programme” 

allows attendees to connect with 

exhibitors before the event and 

facilitates meetings on the day, 

ensuring key contacts are made 

by all. 

Away from the pharmaceutical 

ingredients hall, attendees will 

also have access to co-located 

events, allowing them to easily 

locate exhibitors ready to meet 

their business needs. 

 

www.specchemonline.com

• ICSE connects the 

pharmaceutical community with 

contract service providers – with 

representatives from clinical trials 

services, logistics providers, data 

managers, CROs and CDMOs; 

• InnoPack allows buyers 

to investigate the newest 

innovations in pharma 

packaging solutions, including 

anti-tampering devices, drugstable 

barrier solutions and 

single dose applicator systems; 

• P-MEC Europe features 

international exhibitors 

and manufacturers from 

pharmaceutical equipment 

companies focused on 

instrumental analysis, measuring 

and testing technologies, 

materials testing, laboratory and 

quality control; and 

• Finished Dose Formulation 

(FDF) brings together every 

aspect of the finished dosage 

supply chain, from Big Pharma 

and CMO to in/out licensing and 

dossier specialists. 

In a year that has seen rapid 

advancement in the biologics field, 

CPhI Worldwide will host pioneers 

from the bio-industry, including 

top industry executives, R&D’s 

innovative thinkers and bio-service 

providers, at the new BioLIVE 

event. Focused on examining the 

intersections between business and 

biotech, BioLIVE will host special 

sessions on the emerging role of 

AI, tackling the workforce shortage 

and the technical and scientific 

innovations that are shaping the 

industry today. Industry thoughtleaders 

will exhibit their groundbreaking 

ideas and technologies, 

ready to grow partnerships in the 

most efficient way. 

Eric Lagner, president and 

managing partner of Bioplan 

Associates, expressed his 

enthusiasm for the event: “There is 

great potential in bringing the bio 

community together, running at 

the same time as CPhI Worldwide. 

The launch of BioLIVE will help 

accelerate the development of 

the bio supply chain, improve 

knowledge exchange and 

create a more collaborative bio/ 

pharma environment.” P 


P Beyond the exhibition, 

attendees will have instant access 

to the latest pharma news in the 

media gallery. A series of Pharma 

Insight Briefings provide the 

go-to space for pharmaceutical 

professionals looking to explore 

emerging therapeutic areas 

and new business opportunities. 

In these in-depth, high value 

seminars, unbiased information 

on trends, industry developments 

and the latest regulatory insights 

will be shared, encouraging 

attendees to develop strategies 

that will grow their business. 

Meanwhile, a snap shot of the 

most interesting, innovative and 

game-changing products coming 

to the market can be found in the 

Innovation Gallery. For a more 

in-depth look, register for an 

Innovation Tour, where the CPhI 

exhibition floor will be explained 

with inside information on API 

selection and successful generic 

formulation development. 

CPhI’s Women in 

Leadership Forum 

On Wednesday 10 October, the 

forum will return for the fifth 

year, in what has been described 

by attendees as a “wonderful 

opportunity to think outside of the 

box, in an industry dominated by 

men”. Serving as an exceptional 

networking opportunity, the 

forum allows women to share 

their experiences, expertise 

and leadership techniques. The 

platform brings together female 

senior executives from across 

the pharma industry to facilitate 

conversation around how women 

can work with their peers and 

colleagues to diversify pharma. 

Additionally, this year CPhI 

will play host to the Big Data 

and Machine Learning Summit 

– Europe, on Wednesday 10 

October, in collaboration with The 

Innovation Enterprise. Covering 

key topics such as the role of 

big data in the supply chain and 

analytics in drug development 

and discovery, this conference will 

bring together forward-thinking 

researchers and data scientists to 

discuss their latest findings. 

Following the incredible success 

and popularity of last year’s 

awards, a greatly expanded CPhI 

Pharma Awards Gala Dinner 

will take place on Tuesday 9 

October in a glitzy ceremony at 

the Eurostar Madrid Tower, with 

500 influential pharma guests 

expected. Among the most 

famed accolades in the pharma 

industry, former winners of the 

CPhI Awards feature a “who’s 

who” of pharma executives. Last 

year, CPhI received over 200 

applications and a total of 17 

commendations will be awarded 

to celebrate the innovation and 

skill shown in the pharma 

industry today. 

Prospective attendees of CPhI 

Worldwide are invited to explore 

the event planning tools available 

online for a smoother experience. 

Remember to download the 

CPhI Worldwide app, which 

provides exhibitors and attendees 

with a timetable of the day’s 

activities, a list of exhibitors and 

their hall location. Meanwhile, 

CPhI Online provides up-todate 

pharma news to help 

keep abreast of recent trends in 

preparation for the conference. £ 

Register online for CPhI 

Worldwide 2018 at: 

www.cphi.com/europe 

 


Saltigo’s synthesis 

services 

Saltigo GmbH, a subsidiary 

of speciality chemicals 

company Lanxess, is 

showcasing its wide-ranging 

services for the exclusive 

synthesis of active chemical 

ingredients and intermediates. 

Saltigo offers a wide 

range of services aimed at 

regulated industries, such as 

the pharmaceutical sector, as 

well as the manufacture of ISO 

products. This includes activities 

such as the custom synthesis of 

regulatory starting materials for 

syntheses under GMP conditions 

– and other precursors. “Our 

extensive process development 

expertise, together with the 

piloting and production options 

at ZeTO, our Central Organics 

Pilot Plant, make Saltigo an 

increasingly sought-after 

partner for new, chemically 

challenging syntheses,” said 

Saltigo’s head of New Business 

Development, Guido Giffels. “The 

company’s broad technology base 

also offers attractive solutions 

for other fine chemical segments 

such as flavours and fragrances, 

performance chemicals or 

electronic chemicals. We are very 

involved in these segments,” 

he added. 

“We are constantly striving 

to extend our chemistry and 

process technology portfolio. 

This is important for us to grow 

our project pipeline with new, 

innovative synthesis tasks,” 

Giffels continued. 

Saltigo is working on optimising 

existing technical packages by 

improving space-time yields or 

simplifying processing sequences. 

It is also developing entirely new 

processes following consultation 

with its customers. This ensures that 

sufficient product volumes – for 

requirements such as clinical trials 

of an active ingredient or other use 

tests – are available quickly and 

reliably, with smooth upscaling 

to industrial volumes. 

Saltigo is acting as a fullservice 

provider in custom 

manufacturing. The Lanxess 

subsidiary’s service portfolio 

extends across the entire 

value chain – from synthesis 

planning through process 

development and piloting to 

campaign planning, standard 

production and supply chain 

optimisation in consultation 

with its customers. Saltigo can 

also help with the registration 

of new substances. In this way, 

the company supports them 

all the way through to market 

readiness of the end products 

and beyond. 

Visit Saltigo on stand 

10B110 

S An 8m 3 glass-lined vessel at the reactor 

level in the ultramodern multipurpose 

cGMP plant 010 of Saltigo in Leverkusen for 

manufacturing APIs and intermediates. 

 


usiness succession. For larger 

firms it was the mergers rearranging 

the top of the league 

tables and how that played out 

against falling crop prices. 

“At least US$15 billion (12.9 

billion) has already been lost 

in the corn sector,” said Alex 

Polinsky, ex-Syngenta and now a 

tolling consultant. “The growers 

are the ones who get hurt. In 

Brazil they are cutting down 

rainforest to put more acres under 

cultivation, but that is not what we 

need. We need better yield. Even 

in the US the current yield is 170 

bushels/acre. We need more like 

250 to 300.” 

How that can be achieved also 

figured the number 300. “The big 

merged companies need to put 

US$300 to $500 million (258 to 

430 million) into basic research 

and development,” said Polinsky, 

noting ruefully that this has not 

been happening. 

“In the last seven years only 25 

new active ingredients [have been] 

introduced,” he lamented. “That 

is not going to cut it against the 

resilience of Mother Nature. She 

has been around for billions of 

years and our industry only about 

100. Everything works for a few 

years and then the weeds and 

pests come back.” 

DeLisi recalled: “Ten years ago, 

everyone had some blue-sky 

chemistry going on. No obligation, 

just a mandate to go play and 

report back in a few years if 

anything was found. Those days 

are gone.” 

Polinsky ran the numbers. “At 

US$3 corn, no one can make 

money. With the customary 

10% spent on development, 

agrichemical companies are only 

spending US$100 to US$200 

million (86 to 172 million). 

That is not enough to bring new 

molecules. That is a big part of why 

pharmaceutical companies spun 

off their agrichemical businesses – 

they felt they were a drag on 

their profitability.” 

Jerry Green, president of Green 

Ways Consulting, recently released 

a white paper about mergers 

and the effects on innovation. “It 

is critical that the industry invests 

in new chemistry,” he stated. 

“In the meantime, the mergers 

are buying time by recombining 

their portfolios. New chemistry 

may come from the shuffle and 

integration, but we are going to 

need some breakthroughs to keep 

the chemical era going.” 

Other business practices figure 

into the equation as well. Arysta 

LifeScience, one of the largest 

agrichemical companies in the 

world, differentiates itself by being 

light on assets and relying upon toll 

manufacturers. Rich Dombkowski, 

director of manufacturing and 

quality for Arysta, detailed how that 

lean system relies upon toll-site 

managers who are plant managers 

of other companies’ operations. 

“We have 10 of them to cover 

about 20 to 25 toll sites,” he said, 

“and they are our key link. They 

are the last ones to see the final 

formulation go into the bottle. The 

next person to see it will be the 

customer. So the toll-site manager 

is the one to hold the manufacturer 

accountable. They are not there 

to call in observations to the 

head office, they are on site and 

making decisions. Whenever we 

have a start or stop or change, 

an important shipment, or any 

other concern, they are there 

as often and as long as they 

need to be.” £ 

By Gregory DL Morris, reporting 

from Specialty & Agro Chemicals 

America, held in Charleston, South 

Carolina, US on 5-7 September 

2018. 

GREGORY DL MORRIS 

US Editor 


API manufacturing: 

the benefits of continuous processing 

In this article, Mark Muldowney, head of technology and innovation 

at Sterling Pharma Solutions, discusses the challenges that 

companies must overcome in order to realise the benefits of 

continuous processing and what it could mean for the industry 

moving forward. 

In recent years, companies across 

the pharmaceutical industry have 

started to explore the use of 

continuous processing, specifically 

flow chemistry, in the manufacture 

of active pharmaceutical 

ingredients (APIs). This is primarily 

because of its potential to provide 

safer, faster and more sustainable 

manufacturing processes due to the 

increased control it gives operators 

over reaction parameters. 

However, before companies start 

investing in continuous processing, 

it’s important to assess its viability 

in terms of return on investment 

(ROI), its suitability for your product 

portfolio and availability of the 

required expertise. 

The current landscape 

Continuous processing is an 

alternative manufacturing method 

to traditional batch manufacturing. 

The flow reactors used in some 

continuous processing plants 

are a complex network of pipes 

with a small internal volumeto-surface-area 

ratio, allowing 

reactions to take place on a much 

smaller scale. While continuous 

processing has long been adopted 

in the production of commodity 

chemicals, the process is yet to be 

explored to a significant degree 

by the pharmaceutical industry. 

This might be because producing 

pharmaceuticals requires several 

more reaction and purification 

steps in order to reach the final 

result, which adds to the complexity 

of production. 

In addition, the regulatory 

landscape surrounding the 

production of pharmaceuticals 

is far stricter than the one 

surrounding commodity chemicals, 

not to mention that the adoption 

of continuous processing 

requires a shift in mindset for the 

pharmaceutical industry, which 

has been successfully using batch 

production for more than 100 

years. Put simply, the adoption 

of continuous processing in the 

commodity chemical industry 

has been driven by the potential 

for cost savings, whereas for 

the pharmaceutical industry the 

focus needs to be on the ability 

to achieve improved reaction 

conditions and carry out reactions 

in a safer manner. 

Continuous processing in 

practice: the potential 

The chemical reactions in 

continuous flow processing take 

place in more compact reactors 

than in batch production. 

These reduced volumes allow 

the operator to gain greater

control over parameters such 

as concentration, temperature 

and pressure. This not only 

allows manufacturers to achieve 

previously unattainable conditions, 

but also mitigates the risk of 

handling hazardous chemicals 

that produce large volumes of 

unstable bi-products. In batch 

production, operators must wait 

until the entire process is complete 

before they can quench any 

unstable products, whereas in 

continuous processing this can 

happen in real-time, reducing the 

likelihood of adverse reactions. 

But these chemicals still need 

to be handled correctly and it 

is essential to have the right 

expertise in place. Used correctly, 

continuous processing could make 

handling hazardous chemicals 

much safer, but it can only be 

successful when combined with 

robust and scaleable chemistry, 

systematic process design 

and efficient process analytic 

technology (PAT). The process is 

also easily automated, leaving 

less room for human error. In 

addition, as a flow reactor runs 

uninterrupted until completion, 

there is less likelihood of quality 

variations and discrepancies 

in process reliability, which 

means less likelihood of costly 

batch dumping. 

As well as the quality assurance 

benefits, removing the need to 

stop production between batches 

can help to minimise labour. This, 

added to the fact that reactions 

can run 24/7, means there are 

also potentially significant savings 

to be made in terms of time. 

However, it is worth considering 

the impact this will have on 

internal operations. While time 

to market may be reduced for 

each API, turnaround times 

between projects may increase 

due to the need to thoroughly 

clean flow reactors to avoid 

cross contamination. 

The challenges 

Although the potential benefits are 

numerous, continuous processing is 

not a silver bullet. There are several 

challenges that pharmaceutical 

companies need to overcome 

in order for it to be a viable 

alternative to batch production. 

The biggest and most obvious 

barrier to implementing 

continuous processing is the 

upfront investment required 

to purchase the necessary 

equipment. While there 

are savings to be made by 

introducing less labour-intensive 

processes, the cost of flow 

equipment is high. This means 

that the decision to adopt this type 

of manufacturing often comes 

down to economic viability. 

Beyond the initial investment 

into laboratory equipment for 

proof-of-concept (POC) work, 

companies then need to invest in 

similar equipment that will allow 

them to scale-up for commercial 

manufacture. This usually means 

changing suppliers as many 

simply do not supply both smallscale 

lab and plant equipment, 

although the flow equipment can 

be stacked to allow commercial 

scale manufacturing. 

Product suitability is another 

important consideration as flow 

reactor pipes are more suited to 

certain types of APIs. The pipe 

network is designed to ensure 

adequate mixing of materials, 

but this can be problematic 

when handling solids. If a 

mixture precipitates out there is 

a high probability of blockages. 

This means operators have to 

dismantle their entire kit, which 

can have a knock-on impact 

on timelines. There is specific 

equipment designed to handle 

solids, which shakes to ensure 

continuous movement, but this 

machinery is more complex in 

nature than a simple flow reactor. 

The future: supply chain 

collaboration 

It is absolutely essential that 

companies invest time into 

understanding continuous 

processing before deciding to 

introduce new technologies. 

While there are huge potential 

benefits, companies need to 

build a good business case for 

adopting flow chemistry. 

The right expertise is as important 

as the correct equipment, which 

is leading to the formation of 

supply chain partnerships between 

drug developers and contract 

manufacturers. Such collaboration 

will allow the industry to successfully 

test the potential of continuous 

manufacturing, while mitigating risk 

and containing costs. £ 

CONTACT 

Mark Muldowney 

Head of Technology 

and Innovation 

Sterling Pharma Solutions 

www.sterlingpharmasolutions.com 


Siegfried – well 

positioned in a dynamic 

growth market 

Siegfried, a global contract manufacturing 

organisation, has recently expanded 

its facilities in the US and Europe to 

strengthen its worldwide network of cGMP 

manufacturing sites. Speciality Chemicals 

Magazine spoke to Marianne Späne, 

EVP global head of business development, 

to learn more about the company’s 

growing capabilities. 

What has driven the recent 

developments at Siegfried? 

Creating and manufacturing 

formulations is our passion. Over 

the last eight years, our ‘Transform’ 

strategy has allowed us to develop 

fully integrated services for both 

drug substance and drug product. 

This simplifies our clients’ workflows 

and sets us apart from other 

suppliers of development and 

production services. With our broad 

manufacturing capabilities across 

nine global sites, a partnership with 

Siegfried delivers the support our 

clients need throughout the entire 

life cycle of their products. 

What can you offer clients 

through your integrated 

services? 

Siegfried’s integrated services 

represent the bringing together 

of chemical and pharmaceutical 

manufacture under one 

organisation. It’s this, along with 

our extensive technical capability 

and experience, that enables us 

to meet the unique challenges 

faced by our varied clients. Our 

drug substance offerings include 

custom development and contract 

manufacturing for APIs and 

intermediates, supported by our 

extensive in-house portfolio of APIs 

(consisting of opiates, controlled 

and other chemical substances) and 

independent patented technologies. 

Drug product clients benefit from 

our proven track record in the 

area of complex oral drug delivery 

systems. With the acquisition of two 

dedicated drug product sites, AMP 

(Irvine, US) and Hameln Pharma 

(Hameln, Germany), we have 

extensive capabilities within the 

sterile filling drug delivery business. 

We also offer custom development 

and manufacturing, in-house 

development and a portfolio of 

dosage form products. From the 

manufacture of high-potency APIs, 

bridging technologies such as 

spray drying, to the development of 

formulations, our integrated services 

allow us to add value to our client’s 

business at every stage of their 

product’s life cycle. 

How can Siegfried’s 

integrated services create 

value for clients? 

Creating value for our customers 

requires us to be at the forefront 

of new technologies. Through 

 


our ‘Transform’ strategy, we have 

developed a worldwide network 

of chemical manufacturing cGMP 

sites with diverse capabilities. With 

the acquisition of BASF Custom 

Synthesis and part of its API 

business, we can now offer expertise 

in hydrogenation, azide chemistry, 

phosgenation, high pressure 

reactions and the handling of 

halogens (Cl/Br/I). In addition, we 

have high containment capabilities 

with complex bridging technologies, 

including spray drying. Spray-dried 

dispersion (SDD) of an API brings 

benefits including greater control 

over particle size and enhanced 

bioavailability. Our drug product 

manufacturing sites in Irvine and 

Hameln have the latest technology 

for aseptic filling processes. 

Embracing and integrating new 

technologies across our drug 

substance and drug product 

sectors further supports our 

mission to be a world-class service 

partner for development and 

manufacture, improving the 

quality of life for patients. We are 

proud of our close work with 

clients to optimise their chemical 

processes and formulations through 

innovative technology. 

What do the recent expansions 

mean for Siegfried’s clients? 

Our spray drying capabilities 

have recently been expanded, 

advancing Siegfried into a marketleading 

position. We are also 

expanding our manufacturing site 

at our headquarters in Zofingen, 

Switzerland with the addition of 

40 new laboratory workstations, 

enhancing our analytical 

capabilities and supporting our 

CDMO network activities. Finally, 

we have added a qualified prefilled 

syringe (PFS) line at our site in 

Irvine and a qualified vial line at our 

site in Hameln. In addition, a new 

ophthalmic line will be implemented 

in Irvine. These allow us to comply 

with the specific requirements 

for the manufacture of biologics 

and parenteral dosage forms 

including ophthalmics. What these 

expansions mean for our customers 

is that we are able to target the 

leading-edge design space of 

pharmaceutical formulations and 

can produce existing commercial 

product more effectively. 

How do you maintain 

regulatory compliance across 

your global network? 

At Siegfried, we aim to have the 

same Swiss quality running through 

the core of all our worldwide sites. 

One outcome of our ‘Transform’ 

strategy has been the addition to 

our global network of a versatile 

manufacturing facility in Nantong, 

China, which became operational 

in 2015. The Nantong facility is 

an important contributor to our 

fully integrated services, increasing 

value for clients by offering lower 

cost options throughout an API life 

cycle, from pre- to post-patent. 

Compliance is a top priority and 

adherence to the most rigorous 

requirements and quality guidelines 

ensures our outstanding track 

record with both regulatory 

authorities and customers. The 

Nantong facility meets all the 

requisite compliance requirements 

of the Chinese CFDA, the EMEA 

and US FDA (site inspection 

expected in 2019). The site also 

includes a thermal oxidiser and 

waste water treatment facility, 

allowing us to meet exceptional 

safety and environmental standards. 

What does the future 

hold for Siegfried? 

With our extensive investments 

in pilot and commercial 

pharmaceutical spray-drying, as 

well as lab scale development 

equipment, we are well equipped to 

guide our clients through all stages 

of product life cycle from early 

development to commercialisation. 

With our ‘Evolve’ strategy, we 

are focusing on technology and 

finished dosage forms to ensure 

that we stay at the forefront of 

developments in the industry and 

expand our global drug product 

footprint. We plan to further 

enhance our technology base in 

bridging technologies such as 

micronisation, lyophilisation and 

spray drying, as well as adding 

new skill sets to our global network 

of production facilities. Through 

backward integration and by 

reaching critical size in the drug 

product sector, we plan to add 

even more value for our clients. We 

are excited about these ongoing 

developments and, as a result of 

them, we believe our clients can 

always expect more with Siegfried 

as their preferred partner. £ 


China’s MAH scheme: 

speeding drugs to market 

It’s been two years since the roll-out of China’s pilot Marketing 

Authorisation Holder (MAH) scheme, which allows the licence 

holders of a drug to sell in China using a contract manufacturer, 

instead of manufacturing the drug themselves. Yu Lu, vice president 

of Business Operations at WuXi STA Pharmaceutical, explains how 

the scheme is benefiting the company. 

The MAH scheme, introduced 

in 2016 and approved by the 

State Council to be piloted in 10 

provinces and municipalities, 

will be rolled out nationally by 

the end of 2018. For WuXi STA 

Pharmaceuticals, the scheme has 

proved a remarkable success. 

The company is a small molecule 

contract and development 

manufacturing organisation 

(CDMO) with offices in Shanghai, 

Waigaiqao and Jinshan, 

Changzhou and Wuxi City – 

and San Diego in the US. It is a 

subsidiary of the successful global 

pharmaceutical and medical 

device technology platform 

company, WuXi AppTec. 

WuXi STA is in the midst of 

building a new model for its drug 

development, manufacturing 

and commercialisation partners 

by providing an end-to-end 

integrated services platform that 

is speeding up the way drug 

products are developed. Last year, 

a merger with WuXi AppTec’s 

Pharmaceutical Development 

Services division enabled it to 

provide fully-integrated small 

molecule active pharmaceutical 

ingredient (API) and drug 

product solutions, which has 

resulted in “a seamless chemistry, 

manufacturing and control (CMC) 

working process” Lu says. The 

company now offers all R&D and 

manufacturing services on the 

same site. 

“Having the full range of 

services available located in one 

regional area – something that 

has not previously been done by 

another CDMO – allows for a 

quicker drug development process 

and speeds up timelines for 

customers,” Lu adds. 

Success with Ganovo 

and Elunate 

And the MAH scheme is bolstering 

the company’s success. “WuXi 

STA is leading the way for the 

contract services sector in China 

and has been instrumental in 

the overall success of the MAH 

pilot programme,” Yu says. 

“Over the last few years, we have 

collaborated with Chinese biotech 

company Ascletis Pharma to 

develop and manufacture its novel 

hepatitis C treatment, ‘Ganovo’. 

Earlier this year, the drug was 

approved to market in China, 

marking a critical milestone in the 

history of Chinese pharma, as it 

was the first drug to be produced 

commercially under the scheme,” 

Lu explains. 

Ganovo is the first direct-acting 

anti-viral agent (DAA) developed 

by a domestic company in China. It

inhibits the hepatitis C virus (HCV) 

NS3/4A protease that is critical to 

HCV replication. In the phase III 

clinical trial conducted in China, it 

demonstrated a cure rate of 97% in 

genotype 1 non-cirrhotic patients, 

with a 12-week treatment duration. 

WuXi STA supported the process 

R&D, process optimisation and 

process validation of the Ganovo 

API, as well as the new drug 

application (NDA) submission 

and approval, via the company’s 

technology platform and global 

standard quality systems. 

Another success of the MAH 

scheme is a second drug 

approval, that of the oncology 

therapy ‘fruquintinib’, marketed 

as ‘Elunate’ by Hutchinson 

MediPharma (ChiMed) for 

previously-treated colorectal 

cancer. Again, WuXi supported the 

process optimisation and process 

validation of the API, as well as the 

NDA submission and approval. 

It also supported fruquintinib 

capsules’ clinical research trials 

in the US and another subsidiary 

of WuXi AppTec, WuXi SMO, has 

provided services from phase I to 

phase III clinical research over the 

past six years. 

In July this year, WuXi STA 

signed a development and 

manufacturing agreement with 

Antengene to manufacture 

oncology drugs, providing an 

integrated solution in process R&D 

and manufacturing – using the 

MAH scheme to accelerate new 

drug development. Antengene is 

a biopharmaceutical company 

focused on the development of new 

drugs in China and the Asia-Pacific 

region. The company’s pipeline 

includes several clinical-stage drug 

candidates, covering therapeutic 

areas from solid tumours, 

hematologic malignancies to 

viral infections. 

Good news for 

foreign companies 

The scheme has several 

advantages for international 

companies, Lu says. “For 

international companies looking 

to enter the Chinese market, 

they can now use a contract 

manufacturer to progress their 

own products through clinical 

development, rather than having 

to build a manufacturing facility 

themselves or use the import 

route,” she says. “This provides 

them with a much lower barrier 

to reach the market and helps 

to bring innovative products to 

China faster.” 

Furthermore, as WuXi’s 

facilities have passed inspections 

from global regulatory bodies, 

the company can now offer 

international customers parallel 

approvals for new drugs for both 

China, the world’s third largest 

pharmaceutical market, and 

Western markets. £ 


Private equity seeks depth 

and diversity in acquisitions 

Strategic planning on business succession took centre stage at the 

Specialty & Agro Chemicals America conference held 5-7 September 

in Charleston, South Carolina. Gregory DL Morris reports. 

For all the furore over megamergers 

among speciality and 

agrichemical companies in recent 

years, such transactions are quite 

few. The majority of companies in 

this industry are small to mid-sized 

and privately owned. That means 

business succession is an 

essential consideration. 

According to the global 

consulting firm Ernst & Young 

(E&Y), more than 80% of 

businesses will change hands 

within 10 years. While 44% of 

owners say their businesses are 

totally dependent on a successor, 

62% have not chosen one. Only 

3% of all family businesses 

will survive beyond the third 

generation, E&Y found. 

Increasingly, privately-held 

companies are turning to private 

equity as a way to maintain 

continuity as well as ensure capital 

availability. One such transaction 

was presented as a case study at 

the conference. 

MFG Chemical has four 

manufacturing facilities in the US: 

three in Dalton, Georgia and one in 

Pasadena, Texas that was acquired 

in March. They include 31 stainless, 

glass-lined steel and Hastelloy 

reactors ranging from 1,000 to 

10,000 gallons. Manufacturing is 

supported by a fully-equipped pilot 

testing facility and a laboratory 

for collaborative development 

work. With 150 employees, the 

company is a member of the Society 

of Chemical Manufacturers and 

Affiliates (SOCMA) and was an early 

adopter of ChemStewards and ISO 

9001 certification. 

The company was founded 

in 1979 and has an established 

record in developing and 

manufacturing a range of amides, 

esters, imidazolines, polymers 

and surfactants, among other 

chemistries. End-market applications 

include agriculture, lubricants, 

mining, oilfield, personal care, pulp 

and paper and water treatment. 

“About half of our production 

is speciality chemicals and half 

is custom manufacture,” Keith 

Arnold, president and CEO of 

MFG told Speciality Chemicals 

Magazine. “We are shifting quite a 

bit of volume from our Dalton lines 

to the new facility in Pasadena. It 

was built by Lonza in 1977 and 

really is a top notch asset. Some of 

the components are a little small 

but all in excellent shape. We are 

putting in 10,000 and 20,000 

gallon reactors and expect to have 

them all in operation in the first 

quarter of 2019.” 

In 2017, MFG sold itself to Platte 

River Equity, a private equity firm 

based in Denver. Platte River focuses 

its investment on four industrial 

sectors it considers interrelated: 

agriculture and chemicals, energy 

and infrastructure, aerospace 

and transportation, and metals 

and minerals. 

Platte River’s strategy is to invest 

in leading niche companies and 

SKeith Arnold, President and CEO, 

MFG Chemical. 

SAerial photo of MFG Chemical’s newly acquired plant in Pasadena, Texas, one of North America’s 

largest producers of sodium dioctyl sulfosuccinate and biggest consumers of maleic anhydride. 

SMFG Chemical’s Dalton, GA plant is one of the company’s 

four speciality and custom chemical manufacturing plants. 

SThis MFG farm tank has 44,000 gallon 

holding tanks located in Dalton, GA. 

 


to focus on driving organic and 

acquisition growth using prudent 

levels of debt. The firm has raised 

more than US$1.3 billion of 

committed equity capital and, 

notably, the firm’s principals are the 

largest collective investors across all 

of its funds. 

“A lot of family-owned businesses 

face change in the second or third 

generation,” said Arnold. “The exit 

strategy can be an acquisition by 

one of the publicly traded strategic 

companies, but speciality chemicals 

are well suited for recapitalisation by 

private equity.” 

Arnold explained that for all the 

benefits of multi-generational family 

ownership, everyone in the family 

is likely to get a salary and benefits 

in addition to their ownership stake. 

“In contrast, the private-equity 

owners take no salary or benefits. 

They get their return when the 

company is sold.” 

Every transaction is structured 

differently and, in some cases, a 

member of the investment team 

may join the board of the portfolio 

company or take another more 

active role. Similarly, different 

private-equity firms have varying 

policies about debt. 

“We do not put a lot of leverage 

on our acquisitions,” said Kristian 

M Whalen, managing director 

of Platte River. “We don’t use 

mezzanine debt or subordinated 

debt, only senior. And even in that 

we are much more modest than 

our peers in private equity.” 

Whalen also noted the different 

approach that private equity in 

general – and his firm in particular 

– takes to investments in contrast 

to venture capital. “Out of any 10 

investments by venture capital, those 

managers generally expect two or 

three wins as well as a few losses. 

That is not us. Every investment 

matters to us.” 

The front end of that is a serious 

focus on due diligence and 

valuation. “We like diversity in 

manufacturing capability as well 

as in markets,” said Whalen. “That 

enhances the ability for the operator 

to pass along costs. In our business 

there is a lot of focus on [return] 

multiples, but we believe that is a 

reflection of the depth of the team at 

a portfolio company. By that I mean 

not just the owners but the character 

of the company. It is qualitative, not 

just quantitative.” 

Beyond that, Whalen said that in 

potential portfolio companies Platte 

River is “looking for businesses that 

are at an inflection point. We are 

not looking for just GDP-level growth 

over time. There has to be a reason 

for us to believe we can get in and 

help drive above-market growth.” £ 

By Gregory DL Morris, reporting 

from Specialty & Agro Chemicals 

America, held in Charleston, 

South Carolina, US on 5-7 

September 2018. 

RKris Whalen, managing director, 

Platte River Equity and chairman of the 

Board of MFG Chemical. 


Lonza Pharma & Biotech: 

solving the API supply shortfall 

As an insecure supply chain for early intermediates threatens API 

production, Sean Diver, director of business development at Lonza 

Pharma & Biotech, tells Speciality Chemicals Magazine about the 

company’s new initiative to fill the gap. 

The topic of pharmaceutical supply 

chain security is not a new one for 

the industry, but it has long been 

focused on the cGMP portion of 

the supply chain. However, the 

conversation has recently expanded 

to include the API precursors – 

specifically the supply of non-cGMP 

materials – or ‘early intermediates’– 

for API production. 

Over the last few decades, raw 

materials and intermediates for API 

supply chains have been mostly 

dominated by producers based in 

India and China. There have been a 

number of instances of supply and/ 

or quality issues in recent years that 

is calling these supply chains into 

question. Today, pharmaceutical 

companies’ concerns over security 

of supply and quality of ingredients 

from Eastern producers is leading 

them to seek new suppliers of early 

intermediates – including from 

suppliers based in the West. 

Shifting towards cGMP 

How did we get to this point? 

Starting in the late 1990s, global 

chemical capacity expanded 

dramatically, leading most 

production of non-cGMP materials 

to companies in India and China, 

while Western producers largely 

focused on downstream cGMP 

manufacturing. In the next decade, 

suppliers in India also shifted their 

focus toward cGMP manufacturing, 

leaving supply chains for non-cGMP 

materials even more dependent on 

suppliers from China. The value 

downstream manufacturers gained 

from this arrangement was driven 

by attractive prices. 

But over the last few years, the 

supply security of non-cGMP 

materials has changed significantly. 

Many manufacturing facilities have 

closed due to poor environmental 

conditions and, as supply security 

decreases, prices have risen. As a 

result, some customers have found 

themselves with no qualified source 

of non-cGMP materials. Also, 

over-reliance on a small number of 

producers can contribute to supply 

shortages – for example, when a 

Chinese API manufacturer’s facility 

exploded in October 2016, a global 

shortage of an antibiotic drug 

occurred, because that site was the 

sole source of the drug. 

Improving supply chain values 

Lonza Pharma & Biotech is well 

positioned to address this growing 

supply and quality concern with the 

launch of its ‘early intermediates’ 

offer. Early intermediates supply 

reflects a century-long legacy 

of chemical synthesis at Visp, 

Switzerland and over four decades 

of experience producing APIs 

and their ISO level and cGMP 

intermediates. This offer leverages 

an internal initiative in that the 

company has steadily shifted the 

production of both ISO level and 

cGMP intermediates in-house at its 

extensive chemical production facility 

in Visp. This facility provides more 

than 600m 3 of chemical capacity 

for the supply non-cGMP, ISOcertified 

early intermediates to 

companies under customised 

agreements to improve the value 

of their supply chains. 

As global API supply chains 

continue to evolve and producers 

seek new beneficial arrangements 

with suppliers, Lonza Pharma & 

Biotech is dedicated to producing 

early intermediates and APIs to 

ensure uninterrupted supply of lifesaving 

medicines and encourage 

innovation in bringing new 

medicines to market. £ 

Visit Lonza Pharma & Biotech at 

CPhI Worldwide, Hall 3, Stand 3F30 


Integration, construction, investment 

Strategic investments made this year are positioning 

CordenPharma as an industry-leading, global pharmaceutical 

CDMO. Dr Michael Quirmbach, chief business officer, speaks to 

Speciality Chemicals Magazine about its key investment projects. 

CordenPharma has devoted 

2018 to further expanding and 

strengthening its world-class 

service offerings organised under 

its five Technology Platforms by 

completing strategic key investment 

projects. It began the year by 

integrating its state-of-the-art 

manufacturing facility from Pfizer 

into its Highly Potent & Oncology 

platform. The facility, which was 

acquired at the end of 2017 

(named CordenPharma Boulder) is 

close to the existing manufacturing 

facility, CordenPharma Colorado 

(US), and complements the 

company’s capabilities. With 

this set up, CordenPharma has 

become an industry leader and 

prime supplier in this segment, 

able to supply highly potent API 

quantities at any scale and potency, 

while meeting the most stringent 

industry standards as certified by 

consultancy SafeBridge. 

Highly potent drug products 

On the Drug Product side, 

CordenPharma also completed 

the construction of a non- 

GMP development facility at 

CordenPharma Plankstadt, near 

Heidelberg, Germany, for the 

development of highly potent oral 

solid dosage forms. The company 

is now uniquely positioned 

to provide development and 

manufacturing services at any 

stage and scale for highly potent 

and oncology products. 

In addition, it is in the process 

of completing the final installation 

and qualification of a new 

manufacturing line dedicated to 

producing veterinary drug products 

at the Plankstadt facility. The line 

is intended to handle large-scale 

batch sizes (up to 500kg) to supply 

a complex innovation product 

for the veterinary and human 

health market. The expansion 

of production capabilities at the 

facility is the result of a new, 

long-term custom manufacturing 

agreement for an animal health 

application signed in 2017. 

Construction is expected to be 

completed by the end of the third 

quarter of 2018, with commercial 

supply for the global launch 

campaign planned to start in the 

first quarter of next year. 

Investing in Italy 

Finally, a 20 million (US$23.2 

million) investment at 

CordenPharma Caponago in 

Italy, towards the construction of 

a new commercial aseptic fill and 

finish plant, is in the final stage of 

completion. The new facility, which 

comprises two highly flexible filling 

lines allowing the manufacture 

of a broad range of vials, prefilled 

syringes and cartridges by 

using nest and tub technology, 

remains on track for completion 

this year. One of the new lines 

is already operational, with a 

successful PAI FDA inspection for 

two products, which will increase 

the manufacturing capacity up to 

two million vials/year, along with 

pre-filled syringes and additional 

lyophilisation capacity. £ 

CONTACT 

www.cordenpharma.com 

The company will announce 

these major company 

developments and key 

investment projects at CPhI 

Worldwide, Stand 7F30, 

being held in Madrid on 

9-11 October. 

 


Does fear of QbD slow 

breakthrough therapy 

drugs’ speed to market? 

As pharma continues to evolve, the drive to pursue new cuttingedge 

drugs will become even greater. Piramal Pharma Solutions 

discusses how, for those companies competing to push the 

boundaries of innovation, a fear of implementing Quality by Design 

(QbD) might end up being the biggest threat in its race to the finish. 

The pharmaceutical industry’s 

evolution from one that relies on the 

high revenue of blockbuster drugs 

to one that focuses on the unmet 

needs of smaller patient populations 

has changed the paradigm of drug 

development. It has also driven 

a rise in innovation over the past 

several years, due to the advances 

in technology that have generated 

new opportunities in the laboratory 

and in the body. Scientists learn 

more and more each day about 

how to produce products that can 

transform patient care. 

The breakthrough therapy drug 

designation (BTD) made possible by 

the Food and Drug Administration’s 

(FDA) Safety and Innovation Act in 

2012 creates even more potential 

for the treatment of many diseases. 

Its ‘fast-track’ status paves the 

way for novel drugs to make it to 

market more quickly. However, 

while the review process is expedited 

for a BTD, the expectation of the 

FDA remains unchanged when it 

comes to safety and efficacy. Proof 

of a drug’s “profound clinical 

effect” must be accompanied by a 

development and manufacturing 

strategy that can deliver a consistent 

level of quality in the face of any 

market demand. 

An approach well known for its 

emphasis on process understanding, 

process control and risk mitigation 

is Quality by Design (QbD). While 

there are many benefits to QbD, 

there is longstanding scepticism 

about applying its tools and 

principles to drug development. 

This is due not only to the time and 

financial commitment required 

for successful implementation 

but also because of an industry 

that is well known for being risk 

averse. Nonetheless, as pharma 

continues to evolve, the drive to 

pursue new cutting-edge drugs will 

become even greater. For those 

companies competing to push the 

boundaries of innovation, a fear of 

implementing QbD might end up 

being the biggest threat in its race to 

the finish. 

The rocky road of a 

breakthrough therapy 

designation 

As pharma navigates this new 

era, a company developing one 

of these niche drugs may find 

exciting early promise in the 

preliminary clinical evidence. 

If these results demonstrate a 

dramatic impact on patients with 

serious or life-threatening disease, 

a company may submit evidence 

 


to the FDA that it has a potential 

‘breakthrough’ drug. If granted, 

this designation expedites the 

review and approval process for 

a drug that also demonstrates 

“substantial improvement over 

existing therapies on one or more 

clinically significant endpoints.” 

As of March 2017, 505 total 

requests have been made to the 

FDA for BTD, with 170 of those 

requests granted. Approximately 55 

of these BTDs have been approved. 

Nevertheless, navigating the 


process for any drug on a ‘fasttrack’ 

status can be extremely 

challenging. This is especially true 

if you do not have the tools and 

resources in place to identify and 

control any possible risks to the 

safety and efficacy of the product 

along the way. 

Even if clinical data supports 

the submission of a new drug 

application (NDA) or biologics 

licence application (BLA), a 

manufacturer must be ready to 

present its chemical, manufacturing 

and control (CMC) information 

to regulators. 

The FDA needs this before it 

can provide approval as CMC 

data ensures the appropriate 

regulatory compliant manufacturing 

capabilities will be in place to 

meet market demand. Receiving 

breakthrough status also requires 

information about the product’s 

critical quality attributes (CQAs), 

critical process parameters (CPPs), 

validation and launch plans, and 

even a post-approval lifecycle 

management plan. 

In a traditional development 

timeline, it takes approximately 

88 months before a drug reaches 

market approval, while a BTD 

can take as little as 53 months or 

sooner. This significantly reduces the 

time a manufacturer can dedicate 

to completing CMC development 

activities, creating a formulation 

and establishing a manufacturing 

process that can consistently deliver 

a safe and effective product. As 

Janet Woodcock, director of the 

Center for Drug Evaluation and 

Research (CDER), noted at the 

Well-Characterised Biotechnology 

Products (WCBP) symposium in 

2014, demonstrating efficacy of a 

drug is not the biggest challenge in 

the breakthrough drug programme; 

the biggest challenge is ensuring 

quality manufacturing and access 

to the necessary diagnostics. This 

is where QbD can serve as an 

extremely valuable approach. 

Pharmaceutical manufacturing is 

already complex, but when you add 

in the pressures of bringing a BTD 

to market, it can become even more 

challenging. Through this systematic 

approach to process development, 

manufacturers can have confidence 

that the safety and efficacy of 

their product will be maintained 

throughout production, regardless of 

the timeline it is on. 

QbD on your side 

Principally, QbD is a scientific, 

logical and pre-emptive system that 

incorporates quality control into 

each and every step of the drug 


process. Most often, it is deviations, 

such as out-of-range specifications/ 

parameters, low yields, etc., 

that negatively affect a drug 

development timeline. 

This is due to not having control 

strategies and a proper design 

space – the multidimensional 

combination and interaction of input 

variables and process parameters 

that have been demonstrated to 

provide assurance of quality. P 


P When a company seeks to 

drastically shorten its development 

timeline, it puts itself at an even 

greater risk for error. However, 

through QbD, a company can 

gain a better understanding of the 

impact certain parameters can 

have on product quality and, as 

a result, build in controls at these 

critical points. 

With QbD, a target product 

profile (TPP) is defined at the initial 

stages of development, which 

describes the desired performance 

of a product based on specific 

criteria, such as: clinical aspects; 

dosage strength; delivery mode; 

pharmacokinetics; drug product 

quality criteria; and container 

closure system. 

From there, the manufacturer 

defines the quality target product 

profile in order to define the 

design criteria for the product and 

to identify the CQAs. Through 

the application of various risk 

assessment methods (for example, 

flowcharts, quality risk assessments, 

failure mode effects analyses), 

the critical process parameters 

that could affect the CQAs are 

determined. The combination and 

interaction of these variables creates 

what is known as a product’s 

design space. Other tools, such as 

design of experiments and process 

analytical technology, can also be 

used in a QbD approach. While 

they are not necessary, these tools 

can shorten the development time 

if applied correctly and contribute 

to the development of the design 

space. A manufacturer can work 

with – and make changes within 

– the design space after a product 

has gone to market without 

seeking approval from regulatory 

authorities. This manufacturing 

flexibility is often touted as one of 

the key advantages of the QbD 

approach, although the agency has 

yet to clearly define how this can be 

used to reduce regulatory change 

burdens in a practical way. Any 

changes made after approval that 

are outside the scope of the design 

space would initiate a regulatory 

post-approval change process. 

Afterwards, a control strategy 

is put in place for monitoring 

and to ensure a consistent level 

of quality is maintained. This 

can be accomplished through a 

heightened scrutiny phase (HSP) 

that occurs post approval. During 

this phase, process/manufacturing 

and release testing data are 

subjected to increased sampling 

and testing, the results of which 

are monitored and evaluated for 

any out-of-trend results. If any 

are detected, adjustments within 

the design space can be made as 

needed. Once a preset statistically 

significant number of batches 

have been successfully completed 

during this HSP (in other words, 

all products produced meet the 

established specifications), then 

the design space should be 

expected to continue to produce 

quality product. At this point, the 

additional testing needed during 

the HSP may be removed or 

relaxed and more routine testing 

can be applied going forward. 

Regardless of how simple or 

complex a manufacturer wants to 

make its approach, the main goal 

of QbD is to think about the entire 

manufacturing process ahead of 

time in order to reduce variability 

and defects in a product. It is this 

heightened focus on quality that 

puts QbD in such a favourable light 

with the FDA. While the agency 

has not required QbD in product 

filings, it may see processes 

designed with the approach as 

more reliable since the process 

helps assure quality specifications 

are met more consistently. £ 

This article was written by Vince 

Ammoscato, MSC, vice president, 

Site Head and Charles J Stankovic, 

PhD, MBA, manager of Regulatory 

Affairs, Piramal Pharma Solutions. 

 


Green, clean chelates 

Following the global phase-out of phosphates, used to remove 

hard water ions, AkzoNobel Specialty Chemicals explores the 

search for environmentally-friendly effective alternatives. 

Removing hard water ions such 

as calcium and magnesium is a 

key part of many industrial and 

domestic processes that involve 

the use of water – including 

consumers at home using 

automatic dishwashers. If these 

ions are not removed, insoluble 

deposits build up, resulting 

in dirty dishes and industrial 

equipment that can become 

fouled up with scale. 

For many years, hard water 

ions in laundry and dishwashing 

detergents were removed using 

phosphates. However, these have 

been phased out in most markets 

around the world as they lead 

to ‘eutrophication’ – the overenrichment 

of water bodies 

with minerals and nutrients 

that induce excessive growth 

of plants and algae, causing 

oxygen depletion. 

The use of phosphates in 

dishwashing detergents was 

banned in the US in 2010. It was 

the start of a series of similar rules 

around the world, including parts 

of China, and culminated in a ban 

in Europe in January 2017. This 

has led to a drive to find suitable 

replacements that have equivalent 

or better performance but which 

are also readily biodegradable. 

Zeolites, which are microporous, 

aluminosilicate minerals commonly 

used as commercial adsorbents and 

catalysts, were considered an early 

potential for replacement. However, 

they are not biodegradable and 

can leave behind residue – 

a particular problem for 

dishwashing applications. 

Other alternatives to phosphates 

include citrates and gluconates, 

but these have lower performance 

because they are weak chelates 

with limited dispersion properties. 

Seeking the best alternative 

One of the best replacements 

identified so far are 

aminocarboxylate- 

P 


P based chelating agents, 

including tetrasodium glutamate 

diacetate (GDLA) and trisodium 

methylglycine diacetate (MGDA). 

They are highly effective for 

controlling water hardness ions in 

processes that use water. They also 

have applications ranging from 

stabilising metal catalysts in 

pulp bleaching to improving 

personal care, food and 

pharmaceutical formulations. 

They can be used as drop-in 

replacements for phosphates in 

most cleaning applications and they 

outperform other alternatives such 

as citrates, gluconates and zeolites, 

as they form stronger bonds with 

hard water ions. GLDA is ideal 

for liquid applications because of 

its high solubility, while MGDA is 

ideal for solid applications, such as 

dishwashing tablets. 

Greener chelates 

from AkzoNobel 

AkzoNobel Specialty Chemicals 

is currently the only company to 

offer a full range of biodegradable 

chelating agents, which are sold 

under the ‘Dissolvine’ brand, when 

it introduced MGDA in 2016. 

The company has also 

been focusing on a series of 

collaborations to encourage the 

use of greener chelates and also 

for the development of more 

sustainable routes to chelate 

production that uses renewable 

raw materials. 

At the end of 2017, the 

company signed a strategic 

supply partnership with Shanghai 

Hutchison White Cat, advocating 

a green upgrade of dishwashing 

products with the aim of ensuring 

food safety in China. In the coming 

two years, AkzoNobel will be the 

exclusive supplier to Hutchison 

White Cat, delivering green liquid 

chelates (glutamic acid diacetic acid 

(GLDA) and sodium salt) for use as 

a raw material in all of its industrial 

tableware cleaning products. 

Additionally, the company has 

recently signed a cooperation 

agreement with Chinese firm Anhui 

Huaheng Biotechnology (AHB) to 

target the development of chelates 

based on the amino acid alanine 

in application segments such as 

detergents and textiles. AHB is 

a global leader in alanine and 

has four production sites, with 

extensive R&D, technology and 

manufacturing expertise. It was the 

first company in the world to use a 

fermentation process for alanine. 


also recently signed an application 

agreement with startup firm 

Itaconix to evaluate and develop 

innovative bio-based polymers for 

use in the consumer and industrial 

detergents and cleaners markets 

based on itaconic acid, produced 

from citric acid. £ 

CONTACT 

Thomas Stephens, 

Global Sales & Marketing 

Director Industrial Chelates 


thomas.stephens@akzonobel.com 

www.akzonobel.com/ 

specialtychemicals 

 


P animal alternatives or IATA for 

the regulatory review of chemicals 

or pesticides around the world. 

Therefore, defining a methodology 

to meet the needs of multiple 

regulators in different jurisdictions 

can be complex. 

Start at the beginning 

In order to define an appropriate 

methodology to assess skin 

sensitisation potential, it is important 

to fully understand the nature of 

the test substance. A number of 

considerations can influence the 

approach selected, for example: 

• Is the substance a metal or 

biologic allergen? These do 

not bind covalently to the skin, 

so DPRA cannot be used, while 

LLNA may be justified if evidence 

suggests it is appropriate; 

• Is the substance one of unknown 

or variable composition, complex 

reaction products or biological 

origin (UVCB)? In silico and DPRA 

are not applicable for UVCBs, and 

standard assessment of potency 

from in vitro methods is not 

possible. OECD 442D and OECD 

442E can be performed, but LLNA 

may be necessary, even if the test 

results are negative; 

• Could the substance be a preor 

pro-hapten (in other words, 

requiring abiotic or metabolic 

activation in order to be a skin 

sensitiser)? 

• How soluble is the substance 

in recommended solvents for 

the test methods? While a 

high Log P value may give 

an indication of potentially 

poor solubility – and the first 

versions of OECD test guidelines 

442D and E stated limitations 

of high Log P values – the tests 

may be appropriate if adequate 

solubility/suspendability of 

the substance can be 

demonstrated experimentally. 

From the examples above, it 

is clear that having a deep 

understanding of the applicability 

of test methods for different types 

of substances is important for 

success, as is having insight built 

from experience of applying these 

tests to many different entities. 

Identifying how many 

KEs to test for 

One of the big questions in 

defining IATA for a specific 

substance is whether all the in vitro 

tests are necessary or if one or two 

are sufficient in light of the other 

evidence available. Envigo has 

developed a checklist for use in 

EU REACH submissions to help 

with this decision-making, 

although the approach used 

ultimately rests on what will best 

enable an effective and informed 

weight-of-evidence argument 

to be made, based on all the 

data provided. 

The acceptance and use of 

OECD test guidelines 442C, 

442D and 442E by regulators 

is helping to drive the 3Rs of 

reduction, replacement and 

refinement of animal testing for 

skin sensitisation. The effective and 

efficient use of these tests as part 

of an IATA argument for regulatory 

submission requires robust 

scientific thinking, expertise in 

designing and conducting studies, 

as well as in depth insight and 

tailoring of approaches to match 

the needs of different regulators 

around the globe. £ 

Envigo provides essential 

research services, models and 

products for pharmaceutical, crop 

protection and chemical companies 

as well as universities, governments 

and other research organisations. 

 


Nanoparticles: 

no small matter 

Translational science and research organisation, 

Fera Science Ltd, explains the roadmap to a future 

reaping the benefits of nanotechnology. 

Though usually associated with 

modern science, nanoparticles 

have been discussed as far back 

as fourth century Rome and 

were first described in scientific 

terms by Michael Faraday in his 

1847 paper. Today, these minute 

particles have many potential uses, 

including in crop protection. 

Nanoparticles are particles 

between one and 100 nanometers 

(nm) in size surrounded by an 

interfacial layer comprising ions, 

inorganic and organic molecules. 

A nanoparticle behaves like an 

independent unit with respect to its 

transport and is commonly used 

in many areas of innovation, from 

zinc oxide nanoparticles in sun 

creams that block ultraviolet rays, 

to detecting harmful compounds in 

agrichemicals such as pesticides. 

S The potential for the use of nanoparticles 

in water treatment such as water filtration 

is too compelling to ignore, despite the 

potential risks. 

Nanotechnology and 

agrichemicals 

Developments in nanotechnology 

will have a huge impact on the 

agricultural sector, which is heavily 

reliant on continuous innovation to 

ensure crop protection. 

One example of this is the work 

by Yang Hongshun, assistant 

professor from the National 

University of Singapore’s 

Food Science and Technology 

Programme, who has developed 

a strategy to detect pesticides 

during screening procedures 

using polystyrene coated 

magnetic nanoparticles. 

The technique adds the particles to 

a liquid sample of vegetable crops. 

Their magnetic core effectively 

attracts traces of pyrethroids and 

extracts them for analysis. As 

researchers can reuse the particles 

as many as thirty times using this 

method, the screening process is 

more time- and cost-efficient than 

traditional screening methods. 

Using nanotechnology in 

agrichemicals will also help to 

increase crop yields. Formulating 

chemicals with nanoparticles 

could improve their targeted delivery 

and efficiency. However, there is 

little comprehensive research that 

compares the benefits and risks of 

nanoagrichemicals with conventional 

plant protection products. 

By shrinking pesticide droplets 

to a minuscule size, there is broad 

consensus – from industry 

and academia to the 

Environmental Protection Agency – 

that the amount of toxins 

sprayed onto crops could be 

significantly reduced. 

Smaller droplets have a higher 

total surface area, which gives 

them greater contact with crop 

pests. In addition, these tiny 

particles can be modified so 

that their physical shell can 

better withstand degradation 

in the environment, offering 

more durable protection than 

conventional pesticides. However, 

this shell can change what had 

been considered as predictable 

physical properties, such as how 

soluble the chemical is in water. 

Hazards 

As their huge surface area to 

volume ratio makes nanoparticles 

significantly more reactive, they 

have extremely high mobility, 

allowing them to react with a 

large number of molecules in a 

very short timescale. 

This means that nanoparticles 

can be used to remove sediment, 

chemical effluents, charged 

particles and even kill bacteria 

by releasing silver ions. However, 

 


‘Nanoparticles react 

with a large number 

of molecules in a very 

short timescale’ 

some of these benefits may also 

pose risks to the environment if 

nanoparticles are inadvertently 

released, either during prescribed 

use or accidentally through spills 

or steam released during the 

manufacturing process. 

Some synthetic nanoparticles 

could be directly toxic to 

microbes, plants and animals, 

where others may provide a 

secondary risk. For example, 

silver ions released to kill bacteria 

during water treatment will 

devastate biological populations, 

with knock-on effects to the entire 

ecosystem. Silver ions effectively 

kill bacteria, removing a food 

source for other organisms further 

up the food chain. 

The antimicrobial property 

of silver nanoparticles has 

been previously used against 

human pathogens. However, 

there is a growing interest to 

make use of this property for 

plant disease management. 

If silver nanoparticles prove 

to be efficient, the damage 

caused by agrichemicals to the 

environment and the potential 

threat to public health would be 

dramatically minimised. However, 

given the bacteria-killing power 

of silver ions, the use of these 

nanoparticles may also do more 

harm than good, so extensive 

testing is necessary to ensure 

their safety. 

Higher tier testing 

An aquatic mesocosm is a 

limited body of water replicating 

natural conditions, in which real 

life environmental factors can 

be simulated and manipulated. 

They are the most realistic testing 

option for the agrichemical 

industry and are considered the 

top tier of the risk assessment 

process when determining the 

safety of new products. 

Mesocosm testing methods 

provide several advantages, 

particularly for the agrichemical 

industry. Gradients of interest, 

like temperature and pH 

level, can be controlled and 

manipulated to help understand 

the effects of different chemicals 

on the environment. 

For a method to be innovative, 

it needs to look at the bigger 

picture. Although nanoparticle 

strategies have the potential 

to provide fast and efficient 

results, a substantial amount 

of research must still be 

performed to confirm whether the 

technology will be a boon or bane 

for farmers, consumers and 

the environment. 

Fera’s mesocosm facility 

provides agrichemical 

manufacturers with a state-of-theart 

test bed that closely mimics 

the real-life edge of water bodies. 

This extreme likeness to natural 

aquatic ecosystems will ensure 

that the impact of any plant 

protection chemicals containing 

nanoparticles is thoroughly 

tested in a real-life, edge-of-field 

water body simulation to protect 

the environment, allowing the 

ground-breaking benefits to be 

safely implemented. £ 


Next-generation 

catalysts 

The abundant sources of shale gas in North America have become 

increasingly accessible in the past decade and the US chemical and oil 

and gas industries are searching for more efficient catalytic processes 

to convert the natural gas into higher-value materials. Scientists at 

the US Department of Energy’s (DoE) Argonne National Laboratory 

are using their unique facilities and expertise to help companies 

understand and improve how their catalysts aid in this transformation. 

Shale gas, found in shale rock 

formations created hundreds of 

millions of years ago, is relatively 

inexpensive and contains gases, 

such as methane and propane, that 

act as building blocks for chemicalbased 

products like plastics and 

pharmaceuticals. Industries now 

have the opportunity to take 

advantage of this new feedstock 

supply and the infrastructure at 

national laboratories like Argonne 

helps companies discover new 

catalysts using resources that are 

not accessible in the private sector. 

Argonne scientists use X-ray 

spectroscopy at the Advanced 

Photon Source (APS), a DoE 

Office of Science User Facility, 

to characterise catalysts and 

discover how they change during 

reactions. The lab is equipped with 

instrumentation to perform in situ 

and operando characterisation, 

allowing companies to observe the 

reactions in real time to uncover 

areas of inefficiency. 

“We mimic real-world conditions 

at the APS using specially-designed 

reactors that can be placed directly 

on the beamline,” said chemist 

Max Delferro, group leader of 

the catalysis programme within 

Argonne’s Chemical Sciences & 

Engineering division. 

These X-ray capabilities enable 

the development of better catalysts 

with longer lifetimes and greater 

selectivity. “We want to understand 

how the catalysts change during the 

reactions so that we can rationally 

design next-generation catalysts,” 

said Greg Halder, business 

development executive in Argonne’s 

Technology Commercialisation and 

Partnerships division. 

Observing multiple reactions 

To speed up discoveries, Argonne 

utilises a high-throughput robotic 

synthesis and catalyst testing 

platform that enables parallel 

experimentation. Using this 

setup, the group can observe 

multiple reactions happening 

simultaneously over a wide range 

of conditions. 

 


‘We are trying to develop catalysts 

from earth-abundant metals, like 

iron, vanadium and cobalt, that 

perform the same transformation.’ 

The scientists are also using 

novel techniques to synthesise 

the catalysts. In addition to more 

common synthesis methods 

involving nanoparticles, they use 

new approaches such as atomic 

layer deposition to control the 

surface structure of the catalysts 

down to individual atoms. The 

scientists use these capabilities to 

precisely disperse atoms in different 

arrangements over the surface 

of catalyst support materials, 

encouraging them to react with 

specific molecules in the shale gas. 

“With more atoms exposed to the 

reaction conditions, we get higher 

activity and selectivity,” said Delferro. 

The group recently showed 

that supported organoplatinum, 

synthesised using new strategies 

in organometallic chemistry, 

successfully catalysed the 

hydrogenation of nitroarenes to the 

respective aniline, an industrially 

important building-block in 

the agrichemical, pigment and 

pharmaceutical industries. 

To see the details of the catalysts’ 

surfaces, the group performs 

microscopy at the Center for 

Nanoscale Materials (CNM), 

another DoE Office of Science User 

Facility. The equipment at CNM can 

map single ions on the surfaces of 

the catalysts, and the Argonne staff 

provide users with a wide range 

of expertise in microscopic and 

analytical techniques. 

“We want to translate fundamental 

knowledge into new catalysts and 

manufacturing processes viable for 

industry,” said Halder. 

All of these approaches give 

Argonne’s industry partners an 

extremely detailed view of their 

catalysts’ performance. The 

users can then combine 

P 


P the data obtained from the 

reaction characterisations with 

the capabilities of the Argonne 

Leadership Computing Facility 

(ALCF), a user facility housing Mira, 

the ninth-fastest supercomputer in 

the world. 

Computers aid development 

Scientists run computer programs 

at ALCF to find reaction pathways, 

quantify energy barriers that 

catalysts must overcome and 

predict thermodynamic properties 

of specific reactions. The programs 

can also find correlations between 

the performance of a catalyst and 

its physical or chemical properties, 

accelerating development. 

“Computational analysis helps us 

understand the mechanisms that 

allow certain catalysts to work,” 

said Delferro. 

In addition to working with 

companies directly, Argonne 

scientists perform research that 

leads to cheaper, more recyclable 

and sustainable catalytic materials. 

Currently, industry widely uses 

noble metals such as platinum 

and iridium as catalysts. “These 

materials are expensive and 

rare,” said Delferro, “so we are 

trying to develop catalysts from 

earth-abundant metals, like iron, 

vanadium and cobalt, that perform 

the same transformation.” 

The group recently demonstrated 

that vanadium can act as a catalyst 

for the hydrogenation of alkynes 

and alkenes, a process used in a 

variety of applications from coal 

processing to producing liquid oils 

for the food industry. 

Converting alkanes 

Earlier this year, the group also 

developed a new catalyst to convert 

alkanes, a family of commercially 

important hydrocarbons found 

in shale gas, to alkenes, a more 

useful class of hydrocarbons for 

manufacturing polymers such as 

polyethylene and polypropylene. The 

researchers continue to investigate 

other compounds that could be 

useful to the chemical industry. 

“One of the main goals is to 

transfer the knowledge from the 

basic energy sciences side to the 

markets,” said Delferro. 

The integrated team of chemists, 

engineers, materials scientists, 

physicists and computational 

scientists at Argonne are working 

side-by-side with companies in 

industries ranging from oil and gas 

processing to biofuels to develop the 

next generation of catalysts. 

According to a 2016 report from 

the National Academy of Sciences: 

“In order to maximise the benefits 

and take advantage of today’s 

inexpensive source of natural gas 

and natural gas liquids to create 

investments and jobs in the US, it is 

important to develop new and more 

efficient processes related to catalytic 

conversion of natural gas to highervalue 

materials.” 

With their premier facilities 

and fundamental understanding 

of catalytic reactions, Argonne 

scientists are responding to this 

need. Their capabilities accelerate 

the discovery of materials and 

their research helps to leverage 

this newly-tapped resource to 

give the US industry a competitive 

technological advantage. £ 

CONTACT 

Argonne 

partners@anl.gov 

www.anl.gov 

 


Strength through specialisation 

Founded 112 years ago, Biesterfeld is one of the largest distributors 

of plastics, rubber and basic and speciality chemicals in the world. 

Since becoming a separate 

business division 20 years ago, 

Biesterfeld Spezialchemie GmbH’s 

dynamic development has made 

it one of the world’s leading 

distributors of speciality chemicals 

and solutions. 

Active market engagement and 

market development, combined 

with strong innovative capability, 

are the hallmarks of Biesterfeld 

Spezialchemie and are the driving 

force behind the company’s 

growth. As a trading partner 

with many of the world’s leading 

suppliers, its distribution network 

has a presence across the whole 

of Europe. Its specialist staff have 

exceptional expertise in chemical 

applications and formulations, 

and the company’s extensive 

product portfolio focuses on the 

requirements of selected industries, 

including cosmetics, healthcare, 

paints and coatings, adhesives, 

polyurethane, composites, 

construction, nutrition, electrical, 

electronics and energy. 

By having local sites and 

warehouses, Biesterfeld ensures 

that products and information 

flow quickly and effectively, while 

being able to identify individual 

requirements and respond to them 

without delay. The distributor’s 

Pan-European activities also give 

it an expert eye when it comes 

to understanding developments 

across the entire European 

market. Biesterfeld, the specialist 

with its technical experts, has a 

presence throughout Europe, from 

the Benelux countries, France, 

Germany and Italy, to Austria, 

Spain, Switzerland and Turkey and 

many Eastern European countries 

such as Bulgaria, Croatia, the 

Czech Republic, Estonia, Hungary, 

Latvia, Lithuania, Poland, Romania, 

Russia, Slovakia and Ukraine. 

Organic Synthesis market 

segment 

One of Biesterfeld Spezialchemie’s 

highly specialised segments is 

Organic Synthesis. The technical 

experts in this segment offer a 

multitude of fine and speciality 

chemicals, which are used as 

intermediates in chemical synthesis. 

“Our portfolio covers the 

supply of intermediates such as 

pyridines and piperidines, phasetransfer 

catalysts and fluorine 

compounds for a wide range of 

applications and market segments. 

These include markets such as 

pharma, flavour and fragrance, 

agrichemicals, polymers and 

personal care. We also develop 

customer-specific products. 

Working with our suppliers, we can 

develop a tailored intermediate 

for our customers, to meet their 

exact needs”, says Dr Fritjof 

Weidner, market manager P 


P Organic Synthesis, Biesterfeld 

Spezialchemie. He adds: “Our 

expertise and knowledge of 

the market, combined with our 

close working relationship with 

innovative partners, enables us 

to meet current market demands 

with our flexible product portfolio, 

which we can customise whenever 

required. We have an in-depth 

and extensive knowledge of 

our customers’ requirements, 

and can therefore supply the 

raw materials they need, with 

the quality, packaging and 

delivery time demanded by the 

application involved.” 

REACH for intermediates 

REACH, the EU regulation 

concerning the Registration, 

Evaluation, Authorisation and 

Restriction of Chemicals, has been 

in full force since May 2018. It 

affects all the operational activities 

of every distributor in the entire 

chemicals industry. To comply with 

the REACH regulation, Biesterfeld 

has already completed registration 

for 120 materials, of which seven 

are registered as Full, and the rest 

are registered as Intermediates 

in accordance with Article 18. 

Biesterfeld is currently working on 

submission dossiers for another 70 

materials for registration. 

“Our REACH expertise gives 

our customers real added value 

and an additional service, for 

example, when it comes to 

delivery reliability for our available 

products”, Dr Weidner says. 

“At the moment, the market for 

the products used in organic 

synthesis is increasingly affected 

by shortages of raw materials and 

a simultaneous high demand. 

Manufacturers cannot comply 

quickly enough with the new 

regulatory requirements, such as 

REACH, and legal environmental 

protection regulations, especially 

in China. This is resulting in ever 

more frequent production stops or 

even shutdowns. However, we can 

still provide our customers with the 

best possible service, thanks to our 

close relationships with leading 

international suppliers, primarily in 

Asia, built up by collaboration with 

them over many years.” 

Success through trust 

For Biesterfeld, which distributes 

speciality products, long-term 

partnerships based on trust are 

the foundation of its success. For 

example, this year the company 

is celebrating its 20-year business 

partnership with Jubilant Life 

Sciences, the leading manufacturer 

of pyridines and piperidines. 

Other suppliers such as Valtris 

Advanced Organics (formerly Ineos 

ChloroToluenes), Delta Finochem, 

Tosoh Finechem, Manac, Medilux 

and Dishman have also been 

successfully working together with 

Biesterfeld for many years. 

“Our sustainable and reliable 

collaboration with leading 

suppliers, combined with our 

wide-ranging portfolio, make us 

stand out from our competitors 

in Europe,” says Dr Weidner. And 

the company’s success proves he 

is right: a focus on intermediates 

and its close collaboration with 

its business partners have made 

Biesterfeld Spezialchemie’s Organic 

Synthesis segment one of the 

largest distributors of intermediates 

and fine chemicals in Europe, 

with stable, long-term customer 

relationships built up primarily in 

the German-speaking market. 

Growth planned in 

intermediates, fine and 

speciality chemicals 

The Biesterfeld Group plans to 

continue its dynamic growth in the 

future, including in the Organic 

Synthesis segment. “Alongside 

registering other raw materials 

in accordance with the REACH 

regulation, we want to extend our 

product portfolio. We will supply 

our customers across Europe with 

a wide range of intermediates, 

fine and speciality chemicals, as 

efficiently as possible,” says Dr 

Weidner, summing up the planned 

activities. Currently, the Organic 

Synthesis business division primarily 

sees opportunities for growth in 

the Western European markets 

in which it already has a strong 

presence, such as France, Italy, 

Spain and Switzerland. £ 

T Dr Fritjof Weidner, market 

manager, Organic Synthesis, 

Biesterfeld Spezialchemie. 

 


SOCMA golf outing creates buzz 

and connections in Charleston 

While there are many venues that bring together members of the 

speciality and fine chemical supply chain, there may not be one 

more popular or fun than the golf course. 

For years, leaders in the industry 

have enjoyed a casual day on the 

links where they can talk business 

and have a great time. And this 

year was no exception. 

Set against the picturesque 

backdrop of Charleston, South 

Carolina, US, more than 100 

golfers and guests connected 

with potential business partners 

at SOCMA’s 14th Annual Golf 

Tournament & Dinner. Held on 4 

September at Dunes West Golf & 

River Club, the tournament kicked 

off the Specialty & Agro Chemicals 

America show, creating a buzz that 

carried over onto the trade show 

floor the next day. 

“SOCMA has long been known 

as a convener within the speciality 

and fine chemical supply chain,” 

said SOCMA President and 

CEO, Jennifer Abril. “We were 

thrilled to offer our members and 

guests this opportunity to make 

these important connections and 

partnerships that will help them 

grow their businesses. 

“This year’s tournament once 

again supported the American 

Chemical Society Scholars 

Programme, which plays a key 

part in sustaining and growing 

our industry,” Abril said. “The 

Programme awards renewable 

scholarships to underrepresented 

minority students majoring in 

undergraduate chemistry-related 

disciplines. Through the generosity 

of our golfers, SOCMA has given 

more than US$70,000 (60,400) 

throughout the years to this 

worthwhile cause. 

“We want to thank all of our 

generous sponsors, especially 

Edgewater Capital Partners – 

including Callery, ChemQuest 

Chemicals, DanChem and Far 

Chemical, Inc – which served 

as our primary sponsor for the 

event,” Abril said. “I would also 

like to recognise our outstanding 

golf committee, as well as our 

coordinator for the event, Ben 

Jones, president of Century 

Global, LLC, for giving their time 

to make this year’s tournament 

a roaring success.” 

SOCMA will host the 2019 

Golf Tournament & Dinner on 3 

September in Charleston prior to 

the Specialty & Agro Chemicals 

America show. Please save the 

date. The location and more details 

will be forthcoming. £ 

 


T Proposed tariffs would impact even 

common drugs such as insulin. 

P What SOCMA is doing 

In addition to educational webinars, 

SOCMA has submitted comments 

and testified before the US Trade 

Representative (USTR) Section 

301 Committee on behalf of the 

speciality chemical industry. During 

testimony, SOCMA manager of 

Legal & Government Relations, 

Matthew Moedritzer, requested 

that all Chinese-origin chemicals 

be removed from the latest list of 

proposed tariffs because of the 

disproportionate impact tariffs will 

have on the speciality chemical 

sector. SOCMA was successful in 

communicating potential burdens 

and advocating for the delisting of 

chemical intermediates on List 1. It 

hopes for similar results regarding 

the proposed US List 3. 

For most industry sectors, tariffs 

mean shifting sourcing, which 

results in a rise in the price of 

imports. For chemicals, this is not 

always possible. Dissimilar to other 

industries, chemical manufacturing 

requires very costly and specialised 

infrastructure and expertise. 

Regulatory burdens and the need 

for significant capital investment 

also contribute to the inability to 

shift production. The speed, or lack 

thereof, by the US Environmental 

Protection Agency (EPA) in permit 

and pollution systems approvals 

for new sources of ingredients 

makes for a slow process and, 

in many cases, is a non-starter. 

Also, the highly regulated nature 

of this industry often requires that 

changes in raw materials and 

suppliers receive prior approval 

from US agencies and other world 

regulators. And, perhaps most 

importantly, delisting chemicals 

will hinder Beijing’s Made in China 

2025 plan. These are all important 

reasons for delisting that SOCMA 

communicated to USTR. 

What members are doing 

SOCMA members have 

cross-referenced listed 8-digit 

Harmonised Tariff Schedule (HTS) 

subheadings with goods imported 

from and exported to China. 

SOCMA used this information 

to combine metrics and provide 

the USTR with hundreds of listed 

chemicals and justifications for why 

subheadings that capture these 

chemicals should be delisted. 

If delisting efforts prove 

unsuccessful, speciality chemical 

manufacturers should then avail 

themselves of the exclusion process, 

through which the USTR grants 

exclusions on a product-specific 

basis. Although List 3 is not yet 

finalised or implemented, SOCMA 

is in the process of developing 

guidance and will assist members 

through these potentially soon-tobe-relevant 

procedures. 

Members are also developing 

corporate policies on invoicing. 

For example, if implemented, the 

10-25% Chinese surcharge could 

be rescinded within a matter of 

months. The government may 

reimburse companies for these 

tariffs. Will companies then 

reimburse customers? Suppliers 

are going to be faced with tough 

decisions regarding how to market 

products captured by List 3. 

SOCMA again is helping members 

develop policies for tariffs and 

refunds for this ill-defined period 

of time. 

Lastly, SOCMA supports efforts by 

the FDA to resolve long-standing 

concerns over Chinese intellectual 

property theft. Speciality chemical 

sectors are driven by intellectual 

property; nevertheless, these tariffs 

will create a disproportionate 

competitive disadvantage when 

combined with the fact that one-fifth 

of China’s latest retaliatory lists are 

chemicals. SOCMA also supports 

the FDA’s aim to reach zero-tariff 

trade, but imposing heavy taxation 

on domestic speciality chemical 

manufacturers – exacerbated by 

retaliatory tariffs – is not the proper 

method to achieve that goal. £ 

 


Renewing established pesticides 

Humans have been using chemicals to protect plants from pests 

and diseases since 2,500 BC, when, as records show, ancient 

Sumerians used sulphur to control mites/insects. 

However, it was really towards the 

end of the 19th century that the 

industrial use of inorganic products 

and those derived naturally, such 

as pyrethrum, became common 

and widespread. 

With the rise in the use of such 

products came increasing concerns 

about their effect on health and 

the environment. In the US, specific 

regulation of such chemicals first 

appeared in the early 1900s, 

but it was not until 1970 that the 

Environmental Protection Agency 

(EPA) was created, with the remit 

of protecting the environment and 

the health of humans and other 

animals. In Europe, the European 

Council (EC) issued its first directive 

on pesticide residues in 1976, 

with extensive regulatory activity 

beginning in the early 1990s. 

In 2017, the regulation that 

governs the marketing, sale and 

use of plant protection products 

(PPPs) is just a fact of life and a 

standard part of international 

agrichemical business. However, 

the standards imposed by 

regulation are constantly 

evolving as our scientific insight 

and knowledge increases, so 

active substances (ASs) and PPPs 

previously approved as safe 

may need to be reviewed against 

new standards. 

Current agrichemicals 

market backdrop 

The global market for PPPs is 

expected to register a compound 

annual growth rate of 5.79% 

between 2017 and 2022, driven 

by increasing food demand from a 

growing global population and the 

need to increase crop yields. 

On a broader political front, 

the EU is reviewing its current 

legislation through the Regulatory 

Fitness and Performance (REFIT) 

programme while, in the US, the 

Trump administration’s reforms 

to the EPA may also impact the 

regulatory environment. 

Challenges and opportunities 

also exist in the plant protection 

market. Important patent 

expiries are expected in the 

coming year, and M&A activity 

among agrichemical companies 

is changing the competitive 

landscape. For example, the 

merger of Dow Chemical and 

DuPont has required divestment of 

certain parts of each company’s 

business, with the US requiring 

DuPont to shed its herbicide/ 

insecticide business (acquired by 

FMC), and Brazil’s Administrative 

Council for Economic Defence 

(CADE) requiring Dow to divest 

part of its corn hybrid seed 

business, which it has sold to 

China’s CITIC Agri Fund. 

Against this backdrop, the history, 

knowledge and insight about 

established ASs could get ‘lost’, 

and such changes may pose risks 

for reauthorisation of PPPs. 

AS review and 

re-approval regulation 

In major global markets, 

regulatory approval usually 

comprises two parts: first, approval 

of the so-called AS or technicalgrade 

active ingredient (TGAI) 

and, second, approval of the 

actual end-use or formulated PPPs 

containing one or more approved 

ASs. Approvals are usually timelimited; 

therefore, both the ASs 

and the PPPs must be re-approved 

and reauthorised once approval 

lapses. The most sophisticated 

and developed programmes for 

review and re-approval of ASs 

and PPPs are in the major US and 

European markets. £ 

CONTACT 

Gary Dean 

Business Lead, Crop Protection 

Envigo Consulting 

gary.dean@envigo.com

Speciality Chemicals Magazine October_November 2018

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?