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In this issue… Outsourcing Biocides Reactor Technology Electronic Chemicals FINE & SPECIALITY CHEMICALS INDUSTRY

November 2016 Volume 36 No. 8

HERE COMES THE SUN Solar cells reviewed


Peracetic Acid A unique and versatile biocidal disinfectant A biocidal and industrial disinfectant for use in circulation cleaning and industrial sanitisation across a diverse range of industries including I&I, food & beverage, dairy, water treatment, healthcare and agriculture. Airedale Chemical Peracetic Acid 5%, 15% and Defra approved solutions are now listed under the active substances & suppliers Article 95 of the Biocidal Products Regulation. Use biocides safely. Always read the label and product information before use.

Key advantages include: · Chlorine Free · Highly effective bactericide · No residual · Minimal pH dependence · Long shelf life · Quenching not required

Airedale Mills, Skipton Road, Cross Hills, Keighley, West Yorkshire. BD20 7BX United Kingdom For more information on Peracetic Acid or if you would like to speak to a member of our team please contact us today.

Email: Tel: +44 (0)1535 637 876 Web:




OUTSOURCING 16-23 16 Contract Manufacturing Explained

Daniel Marr, head of marketing for chemical manufacturer, Airedale Chemical, uncovers the mystery surrounding the secretive world of contract manufacturing.

18 Pharmaceutical Contract Manufacturing Market Remains Strong, but Could Face Headwinds Growth of the overall contract manufacturing market appears to remain healthy as we head into the last quarter of 2016. However, there are interesting trends that could impact some segments. Nigel Walker, Managing Director at That’s Nice LLC & Nice Insight, reports.

22 A Bright Future for Small Molecules

Small molecule innovation may have been overshadowed by developments in biological drugs, but the versatility and specific properties of these products will ensure that they will continue to be the backbone of the pharma sector for many years to come. Dr Matthew Moorcroft, VP Global Marketing at Cambrex, believes that his company’s research proves small molecules have a bright future.


Preserving Agents for Ophthalmic Products: New Approaches to a Neglected Biocide Application

Dr Oliver Seidelmann, manager at ChiroBlock, and Dörte von Deylen, researcher at the Braunschweig University, shed some light on new developments in the field of eye remedies preservation.

26 Happy Families

Richard Elsmore and Samantha Wright of JSC International review the Product family options under the Biocidal Product Regulation.

30 Ban of Methylisothiazolinone in Consumer Goods and Detergents? Nicolas Gallacier, of LANXESS Deutschland GmbH, explains the new labelling and legal implementations surrounding the EU Commission’s reassessment of the safety of MIT earlier this year.



42 CPhI Worldwide Review

The 27th meeting of CPhI Worldwide in Barcelona last month brought together more than 42,000 attendees. They travelled from 158 countries to see 2,582 exhibitors.

44 Vienna to Host BIOCIDES 2016 Biocides Europe 2016 will focus on key aspects of EU Regulation 528/2012, concerning the approval of active substances and authorization of biocidal products.

SOCMA SPECIAL FEATURE 46-61 46 Start Spreadin’ the News…


47 Expect EPA Resources to Play Major Role in TSCA Implementation

32 SiC Advanced-Flow Reactors for Highly Corrosive Media

48 SOCMA Members Seeing Increased Business in Toll Manufacturing

Olivier Lobet and Alessandra Vizza of Corning Reactor Technologies review how companies are at last taking a new approach to manufacturing, building facilities to make chemicals in a different way.

36 Industry 4.0 Delivers Significantly Increased Competitiveness As Industry 4.0 leads to the creation of more ‘smart factories’, Dr Dirk Kirschneck, Managing Director of Microinnova Engineering GmbH, considers its impact on the fine chemicals industry.

50 SOCMA Members Reaping Benefits of ChemStewards Management Portal 52 Depressed Oil Prices Pressuring Specialty Chemical Companies to Reduce Costs, Improve Efficiency 54 SOCMA Members Have Positive Outlook for 2017 for Specialty Chemical Manufacturing in US, EU


56 Sustainability Culture Runs Deep at Fairmount Santrol’s Alpha Resins

38 Next Generation Solar Power: Building Integrated Photovoltaics

58 Breaking Down TPP and the ‘Brexit’ Impact on TTIP

Solar energy has the potential to account for as much as 50% of the world’s total energy consumption. We take a look at the emerging market for building-integrated photovoltaics, which offer the opportunity “to turn buildings into power stations”.

60 Cambrex Projects Strong Growth for API Manufacturers


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62 3


Always look on the bright side…


Sarah Harding, PhD T: +44 (0) 1727 814 400 E:

BUSINESS DEVELOPMENT MANAGER Ellie Bruni T: +44 (0) 1372 364 135 E:


Andy Clow T: +44 (0) 1727 814 510 E:

“In the middle of difficulty lies opportunity” (Albert Einstein)



Dreene Khan T: +44 (0) 1727 814 522 E:

s I welcome you to the final issue of 2016, I can’t help reflecting on what an incredible year it’s been. With a new US President, looming Brexit, the ever-fluctuating Asia Pacific market, volatile oil prices, and the unceasingly shifting business silhouette with non-stop mergers and acquisitions, it might often feel as if we’ll never find a stable footing again. Yet, in brighter, more optimistic moments (perhaps a few days after you’ve come home from that latest arduous business trip!) Sarah Harding, PhD I hope we can also see that there are opportunities rising from the landscape. Editor While in recent history the US chemical industry has been pro-Republican, the sector – as well as US academic and scientific communities – expressed a strong backing for Democrat Hilary Clinton in this election. As news broke across the world that, in fact, Donald Trump had triumphed, there was a general impression of disbelief, Challenges with fossil fuels have been a driving global markets reacted (but then rallied quickly), and social factor for greener energy solutions, which have obviously media quaked from the shock. Yet, whatever your political benefited our environment and world, but also opened persuasion, there is reason to be positive. Trump has the way to novel and exciting business opportunities in suggested that he will cut corporation taxes by more than their own right. The International Energy Agency (IEA) half, and offer greater tax benefits for US-manufactured announced at the end of October that it was significantly products sold in the US market. Both actions have the increasing its 5-year growth forecast for renewables, potential to relieve some of the strain on struggling which have surpassed coal to become the largest source chemical companies and, as we all know, what happens of installed power capacity in the world. Led by wind and in US industry has considerable potential to reverberate solar, the IEA says that renewables represent more than around the world. At the same time, Trump has suggested half the new power capacity around the world. abolishing the Environmental Protection Agency (EPA), A fluctuating Asia Pacific market means there will be which he believes hampers business… but any legislative ups as well as downs. As our experience grows, we will changes would need to pass Congress, and hopefully any hopefully get better at distinguishing and predicting the proposed variations would be tempered to ensure that two, and manage to perfect our riding of the dragon. It is advances made in the past decades were not undone. unlikely that this unstable market will calm significantly Meanwhile, the UK’s Chemical Industries Association has over the next year, but as more global majors develop published a Brexit manifesto (, partnerships with local companies and continually which points out that continued tariff-free access between improve their understanding of the region, there is the UK and EU is achievable in the long term through a free reason to believe that all stakeholders may develop in a trade agreement but, as a transition arrangement, the UK positive and profitable manner. could simply apply to retain its Customs Union membership. And all these divestments, mergers and acquisitions – The Association went on to point out with impressive believe it or not, they do more than just keeping lawyers positivity that, considering possible opportunities of employed! They are streamlining our industry, making us leaving the EU, it is feasible that the UK’s pragmatic and stronger, more focussed and more robust. In other words, proportionate approach to regulation could actually offer we will be better equipped to deal with more changes… advantages for innovation and investment. with more opportunities… in the future.


Nancy Strong T: +44 (0)1372 364 137 E:


Jamie Mitchell T: +44 (0)1727 814 400 E:


Ben Jones Century Global, LLC T: +1 610 225 2396 E:


Sadao Mizoguchi MIJ Inc T: +81 3 3331 2051 E:

Disclaimer The Publisher cannot be held responsible or, in any way, liable for errors or omissions, during input or printing of any material supplied or contained herein although the utmost care is taken to ensure that information contained is accurate and up to date. The Publisher also cannot be held liable for any claims made by advertisers or in contributions from individuals or companies submitted for inclusion within this publication. The opinions expressed are not necessarily those of the Editor or Mack Brooks Speciality Publishing. Copyright Entire contents copyright © Mack Brooks Speciality Publishing 2016. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means without the prior permission of the publisher. Annual Subscription UK: 1 year – £125.00, 2 years – £225.00 Overseas: 1 year – £141.00, 2 years – £254.00 Post-free throughout the world. Single copy, £38.00 including postage. Speciality Chemicals Magazine is published by MackBrooks Speciality Publishing Ltd, Romeland House, Romeland Hill, St Albans, Hertfordshire, AL3 4ET, UK T: +44 (0) 1727 814 400 F: +44 (0) 1727 831 033 ISSN 0262-2262 Follow us on Twitter Join the discussion on LinkedIn



Speciality Chemicals Magazine welcomes contributions from academia and industry. News and commentaries, up to 500 words with one or two accompanying tables or graphics. Feature articles, about 1500 words with up to four tables or graphics. Corporate social responsibility stories, up to 150 words with one graphic.

cosmetics and personal care) but should be comprehensive 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.

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Speciality Chemicals Magazine 36.08 November 2016

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Clariant has opened a new polypropylene catalyst production facility in Louisville, KY. Developed and implemented in cooperation with CB&I, the Louisville site is Clariant’s largest US production hub for catalysts and marks a further investment by Clariant to accelerate growth in North America. In addition to its Catalysts business, Clariant focuses in the US on supporting customers through its Oil Services and Industrial & Consumer Specialties businesses.

SOCMA has announced their new CEO and President, Jennifer Abril. Jennifer comes from the International Fragrance Association, where she was President and Executive Director for 8 years.

Grannus has selected Haldor Topsoe to provide engineering services for the production of ammonia at its regional-scale advanced plant being built in California. The new plant features a patented, ultra-low NOX emission natural gas to ammonia process. Haldor Topsoe will license its ammonia loop, shift catalyst and sulfur guard technologies for the production of high purity ammonia. In addition, Haldor Topsoe will prepare process design packages for the hydrogen to ammonia process. This will be the first ammonia plant to be built in California in more than 60 years and will be operational in 2019.

Envigo (UK) has launched a dedicated Science and Technology Advisory Group (STAG), to run across their services in pharma, research models, crop protection and chemicals testing. The STAG has a core membership for the first 3 years, after which members will rotate on 2-year cycles to ensure a regular impetus of new ideas. External partnerships are also being explored, including collaborations with academia. One area showing particular promise is non-animal testing for toxicology.

Scientists at OCSiAl, Envigo and Intertek have collaborated to conduct research and testing on potentially hazardous properties of single wall carbon nanotubes (SWCNT), resulting in a technical and highly detailed analysis, specifications of risk management, and the first REACH registration for SWCNT. REACH registration will support OCSiAl’s drive to further scale up its nanotube manufacturing volumes and boost the company’s presence in the European market.

Solvay is building a Technyl polyamide compounding unit in San Luis Potosí, Mexico. The new facility is expected to become operational in the third quarter of 2017 to regional and North American automotive and consumer goods markets. To minimize investment cost and time to market, Solvay is partnering with Chunil Engineering, one of its major customers. Solvay is planning additional investments to serve the NAFTA2 market.


Speciality Chemicals Magazine 36.08 November 2016


The European Commission has launched a 3-year project “BioBase4SME” to support development of the biobased economy in North West Europe. The €5.83 million project will help start-ups and Small and Medium Enterprises (SMEs) by offering training, innovation biocamps and innovation coupons worth up to €100,000 that can be traded for technological assistance. The BioBase4SME partnership includes eight organisations from Belgium, France, Germany, Ireland, the Netherlands and UK.

Clariant is broadening collaborations with the Engineering Plastics division of Shinkong Synthetic Fibers Corp to promote Clariant's non-halogenated flame retardants in China. Shinkong Engineering Plastics belongs to Taiwan’s Shinkong Group, a supplier of plastics in the electronics, home appliances and automotive industries. Its halogenfree compounds based on Clariant's flame retardants are experiencing rising demand as more manufacturers eliminate components with bromine and PVC due to environmental regulations.

GE Healthcare has opened a $7.4 million Fast Trak Bioprocessing Technology and Training Centre in South Korea. The new 2,200 m2 unit will support South Korea’s rapidly expanding biopharma industry, helping manufacturers increase production efficiency, reduce cost, and bring products to market faster. It adds to GE’s existing network of Fast Trak Centres in the USA, Sweden, India and China (and their satellites in Turkey, Japan and Singapore).

BASF is ramping up its biological crop protection business in Australia with a $1 million-plus upgrade of its inoculant production plant on NSW’s Central Coast. The site is a key point for products that use beneficial bacteria, parasites and enzymes to combat pests and diseases in horticulture and broad-acre crops. Upgrading the facility will almost double the number of ‘growth chambers’ on site, where biological ingredients are cultivated. The expansion will also contribute to the company’s international supply of recently-released biological insecticide, Velifer, for the glasshouse and covered horticulture market.

Real IPM is a Kenyan biopesticide company that has developed a pioneering fruit fly control, based on a natural insect-killing fungus – Metarhizium (Met) 69. With funding from USAid and Rockefeller, Real IPM is using Met 69 as a powder in traps, or sprayed on soil and tree canopies. Met 69 has the potential to address the overwhelming fruit fly problem for mango growers in Kenya, as some of the 60,000 plus small farmers across the country are starting to reduce their reliance on chemicals and use alternative controls, in the hope of reaching quality standards required for western markets.

Thailand LAB INTERNATIONAL 2016 attracted more than 9,000 visitors from 55 countries. Associate Professor Weerapong Paesuwan, Permanent Secretary for the Ministry of Science and Technology in Thailand commented, “Thailand LAB INTERNATIONAL 2016 is harmonized with government policy to transform Thailand to an innovation-driven economy, using science, research and technology as tools towards commercialization.”

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CORDENPHARMA COMPLETES NEW HIGHLY POTENT API PROCESS BAY As part of a long-term growth strategy, CordenPharma has strengthened development and manufacturing capabilities for API offerings across its Highly Potent & Oncology Platform. The new API process bay, now installed in CordenPharma Colorado (USA), is designed to handle a wide range of chemistries and unit operations with flexible and scalable components. This complements the existing infrastructure at CordenPharma Colorado, which is equipped to handle highly potent compounds up to OEB Level 5, spanning development to commercial-scale. “With this new investment, CordenPharma is uniquely positioned to provide pharma customers with the most comprehensive Highly Potent & Oncology service in the industry spanning the entire API and Drug Product supply chain at any stage from development to commercialization,” commented Dr Michael Quirmbach, Vice President of Global Sales & Marketing, CordenPharma International.

Johnson Matthey recently announced that its Annan site in the UK (pictured) has been approved for GMP manufacturing, following extensive refurbishment of the facilities that were acquired at the end of 2014. This significant investment has allowed Johnson Matthey to expand its large volume capacity for controlled substance APIs and custom manufacturing services. This development was the latest in a series of expansions, as part of the Fine Chemicals Division’s ongoing growth strategy. During the past year, the company has expanded its facilities in Cambridge, UK, to add to its European Custom Pharma Solutions offering, which was strengthened further by the acquisition of the Pharmorphix solid form sciences business from Sigma Aldrich.

ENVIGO LAUNCHES HEPATOTOXICITY TESTING Since 1980, more than 30 drugs have been withdrawn because of hepatotoxicity, and many others have seen severe restrictions placed upon their use. Clearly, the pharma industry is concerned not to progress compounds that show any potential for drug induced liver injury (DILI). To address this need, Envigo has launched an integrated program of in vitro technologies that help predict the likelihood of compounds causing DILI. The technologies consist of three key tests – covalent binding, reactive metabolite formation and time dependent inhibition of CYP enzymes. The program can be run in full, using all of its tests, or can be conducted using single assays as required. “Envigo’s battery of in vitro tests, typically using human cells, enables our customers to determine if a compound carries a DILI liability… This allows our customers to make more informed choices as to whether they should progress the compound. The de-risking approach serves to increase patient safety, provides confidence to invest and aids the in/out-licensing of new drugs”, commented Guy Webber, Scientific Manager of the In Vitro and Drug-Drug Interaction Sciences Group at Envigo. “If a compound comes up negative in these assays, we use this data, in conjunction with other information, such as lipophilicity, transporter inhibition, structural alert analysis and likely human dose, to make an educated assessment as to whether a compound may carry a DILI liability or not”.


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FDA APPROVES AMGEN’S AMJEVITA, A HUMIRA BIOSIMILAR Amgen has received approval from the US FDA for Amjevita (adalimumabatto), a biosimilar to Humira (adalimumab), AbbVie’s anti-TNF monoclonal antibody. Amjevita has been approved for the treatment of moderate-tosevere rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-tosevere chronic plaque psoriasis, adult moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis. The FDA’s approval of Amjevita is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrate Amjevita is biosimilar to Humira. It has been approved as a biosimilar, not as an interchangeable product.

FDA TO SPEED UP GENERICS APPROVALS In anticipation of the expiry of the Generic Drug User Fee Act (GDUFA) next year, the FDA has issued recommendations for GDUFA II (2018–2022). Two major changes are proposed: to simplify the system so all ANDAs and ANDA amendments fall within a single review scheme, to streamline administration and promote efficiency; and to create faster review goals for priority submissions (10 months for an ANDA, 8 months for priority review). The speed at which FDA reviews and approves ANDAs has been a hot topic lately, particularly as at least 315 generics have doubled in price since 2010 and many of those seeing price increases do not have competition. The changes proposed for GDUFA II may go some way to clearing the backlog of 4,000 generic applications currently awaiting FDA approval.




The EMA has accepted for review a marketing authorization application from Samsung Bioepis, the JV between Samsung BioLogics and Biogen, for SB3, a biosimilar to Herceptin (trastuzumab), Roche’s monoclonal antibody for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. SB3 is Samsung Bioepis’ fifth biosimilar candidate submitted to the EMA, following SB4 (etanercept), SB2 (infliximab), SB9 (insulin glargine) and SB5 (adalimumab). SB4 and SB2 have already received regulatory approval from the EC. If approved, marketing and distribution in Europe will be handled by Merck & Co, which is known as MSD outside of the US and Canada.

The FDA has granted accelerated approval to Lartruvo (olaratumab; a platelet-derived growth factor receptor-alpha blocking antibody) with doxorubicin to treat adults with certain types of soft tissue sarcoma. Lartruvo plus doxorubicin is approved for patients who cannot be cured with radiation or surgery, and who have a type of sarcoma for which an anthracycline (chemotherapy) is an appropriate treatment.

EMA ACCEPTS FILING FOR INSULIN GLARGINE, A LANTUS BIOSIMILAR Mylan and Biocon report that the EMA has accepted for review Mylan’s marketing authorization application for insulin glargine, a long-acting insulin analogue used to treat adults with Type 2 diabetes and adults and paediatric patients with Type 1 diabetes for the control of high blood sugar. Biocon and Mylan are exclusive partners on a portfolio of biosimilars and insulin analogues; glargine is one of three insulin analogues being co-developed for the global marketplace. The filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing Mylan’s and Biocon’s Insulin glargine with Lantus. The PK study demonstrated PK and PD bioequivalence of Mylan’s and Biocon’s insulin glargine relative to that of the reference drug Lantus.

OCALIVA RECOMMENDED FOR CONDITIONAL APPROVAL The EMA has recommended granting a conditional marketing authorization to Ocaliva (obeticholic acid; a semi-synthetic bile acid that activates the farnesoid X receptor, which controls the production of bile) for primary biliary cirrhosis. Ocaliva is to be used in combination with ursodeoxycholic acid (UDCA) in patients who have not responded adequately to UDCA, or on its own in adults unable to tolerate UDCA. Conditional approval is one of EMA’s main mechanisms to facilitate earlier access by patients to medicines that fulfil unmet medical needs. It allows the Agency to recommend a medicine for marketing authorization before the availability of confirmatory clinical trial data, if the benefits of making this medicine available to patients immediately outweigh the risks inherent in the lack of comprehensive data. There are limited other treatments available for patients with primary biliary cholangitis. Liver transplantation can significantly improve a patient’s chance of survival; however this is a long and complex operation only suitable for patients who have advanced liver disease.

Dr Jörg Blumhoff succeeds Dr Bodo Schulze as MD of ORGANICA Feinchemie GmbH Wolfen After working for 42 years in Wolfen, and having co-founded ORGANICA in 1995, Managing Director Dr Bodo Schulze retires at the beginning of 2017. Dr Jörg Blumhoff, also a Chemist, will take over management of ORGANICA from 1st January 2017. Dr Schulze takes leave of ORGANICA with the knowledge that 2016 was the company’s most successful year in its 22-year history. Starting with 35 employees, a turnover of €1.9 million, and mainly focusing on chemicals for the imaging industry, Dr Schulze led ORGANICA to become a global, recognized expert in custom synthesis of advanced organic intermediates. Now with 89 people and a turnover of around €15 million, ORGANICA is supplying high quality, tailor-made products to customers all over the world, in a range of industrial sectors. Dr Blumhoff intends to continue growing the business by investing in new equipment and continually improving the capacities at ORGANICA. To ensure a smooth transition, Dr Bodo Schulze will remain available as a consultant. Dr Jörg Blumhoff

Dr Bodo Schulze




The US EPA and the California Department of Pesticide Regulation have approved Pace International’s BioSpectra 100SC for postharvest applications in citrus and stone fruit. While new to the postharvest fruit industry, this technology has been used for food preservation for over 40 years. It is approved as a food additive by the EU and WHO, and by individual countries as a fungal biocontrol product. Nevertheless, the addition of BioSpectra to Pace International’s range of decay control solutions is a milestone for their postharvest portfolio.

The Biocides Products Regulation (BPR) stipulates that chemicals such as disinfectants, pest control products and preservatives must be approved by the European Chemicals Agency (ECHA). This month, Airedale Chemical received that approval for the manufacture of peracetic acid (PAA), demonstrating the company and its family of PAA products meet the stringent requirements set out by the governing body. Airedale is currently the only UK manufacturer of PAA to be directly approved by ECHA.




Bayer CropScience’s Luna fungicide is now approved for use on a wider range of crops in California, giving growers added flexibility. Luna Sensation: for tree nuts, pome fruit, stone fruit, citrus, strawberries, carrots, leafy, brassica, fruiting and cucurbit vegetables. Luna Experience: for grapes, tree nuts, cucurbit vegetables and hops. Luna Tranquility: for potatoes, bulb crops, tomatoes, pome fruit, strawberries and caneberries/bushberries.

Stockton’s biofungicide Timorex Gold is now registered in Florida, bringing the number of its registrations throughout the US to 30. The product is now registered in the US states of Alabama, Arizona, Arkansas, Colorado, Delaware, Florida, Georgia, Indiana, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Jersey, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin.

A plea seeking an immediate ban on 19 pesticides, as recommended by an expert panel on the grounds that they are carcinogenic, has been moved to India’s Delhi High Court. It is claimed that the bans were accepted by the government, but have not been implemented. Accusations of ‘conflict of interest’ have been levied against an expert committee involved in the matter. The case is listed for hearing on 7th December.

HIGH-EFFICIENCY CONTROL OF SOIL INSECTS Conventional insecticides can be inefficient against soil insects because the molecules are not specifically prepared for soil applications, might not reach target organisms, and may degrade when exposed to sunlight. DuPont Crop Protection has launched Mustang Dupont, which contains zetamethrin EW, a stable and active ingredient. It is ideal for treatments with fallow soil surfaces, and it is recommended for controlling cutworms and bug horns, along with weevil borers. The EW formulation is an oil in water emulsion, distinguished by high solubility and retention in the fallow. Yet it may also be washed away easily, lessening its environmental impact, and it does not undergo photodegradation under the sun. DuPont Crop Protection claims that Mustang DuPont has four features that make it an agent of choice as a soil insecticide for sunflower, corn, soybeans or cotton crops: Levels of purification of pyrethroid isomer used in its formulation, Octanol / water coefficient, in relation to its action and stability, Levels of solubility and availability to penetrate fallow and quickly reach the habitat of the species to be controlled, and not adhering to fallow, Level of penetration into the cuticle of insects, which improves control efficiencies, particularly caterpillars present in soils with high load fallow.

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DOW AGROSCIENCES PROMOTES SUSTAINABILITY IN BRAZIL The Dow AgroSciences Responsible Application Program for Small Farmers was developed to promote responsibility during the application of agrochemicals and guarantee the sustainability of farming. Created in partnership with the Paulista State University of Botucatu in Brazil, the program aims to strengthen the quality and safety of agrochemical applications. Post-graduates and PhD students of Agronomy of Unesp have taken part in the program to train participants in the concepts of responsible application using practical simulations. “The main goal of the Responsible Application Program is to present to farmers the concepts of good practices on the application of agrochemicals. Besides raising awareness and pushing the adoption of these initiatives to optimize resources, this program aims to reduce the impact of agrochemicals on the environment,” commented the coordinator of Good Agricultural Practices at Dow AgroSciences, Ana Cristina Pinheiro. Since its start, the program has trained nearly 12,500 professionals in the field on the importance of agricultural practices, focusing on technology application.


BASF LAUNCHES NEW ENZYME PRODUCT LINE BASF has launched a new enzyme product line, Lavergy, complementing its offering to the detergents and cleaning industry. Global trends for higher concentrated product formats, and pressures to save time, water and energy, create market needs for liquid formats that perform at low temperatures. BASF’s new protease is a high-performance alternative to established market standards in liquid laundry detergents, especially at low temperatures between 20° and 30°C. Lavergy Pro 104 L has been proven in independent tests by the Hohenstein Institute to enable superior removal of specific stains such as egg, blood, and milk types. BASF says that the combination of Sokalan HP 20 – the BASF polymer that boosts detergency of clay and oxidizable/bleachable stains – and Lavergy Pro 104 L will offer more choices to BASF’s customers in a world of consumers and retailers who expect sustainable, high-performance solutions. “With our new concept ‘Next level of low temperature washing’ we offer our customers superior efficacy, differentiating performance and broad formulation compatibility,” says Sören Hildebrandt, Senior Vice President Home Care and Formulation Technologies Europe at BASF. “For consumers, this means energy saving without compromising on washing performance.”


Together with CosmeticBusiness Poland, HPCI (Home and Personal Care Ingredients) CEE Exhibition and Conference took place in Warsaw, Poland, from 28 th to 29 th September. More than 250 companies from 30 countries gathered at the event, which more than doubled last year’s attendance figures. “With visitors coming from 34 different countries (90% from Poland and its neighbouring countries such as the Ukraine, Slovakia and Czech Republic) HPCI CEE is the perfect location for meeting industry professionals from the Personal Care and Home Care Industry in the CEE region”, says Siegfried Fischer, HPCI CEE Exhibition and Conference director. “Some 80% of the exhibitors (HPCI CEE) have already reserved their space for 2017.”


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Bacuri butter is a nourishing ingredient that increases energy production at the cellular level and delivers deep skin hydration. It is rich in minerals such as magnesium, zinc and calcium and contains vitamins D2, E and K. As well as having a high nutritional value, bacuri butter is also a source of tryptophan amino acid which, in the presence of light, is metabolized into biologically active compounds such as serotonin, a neurotransmitter that is associated with a sense of wellbeing. “Unlike most synthetic anti-aging ingredients, the bacuri butter not only reduces the appearance of wrinkles and fine lines, but acts directly on cell metabolism by improving the skin’s barrier function and reducing transepidermal water loss. The result is an energized, well-nourished skin,” says Juliana Frutoso, Business Manager at Beraca. As an additional benefit, bacuri butter plays an important social and economic role in the Amazon region. The ingredient is sourced from local communities that use bacuri pulp for sweets, ice creams and juices, but discard the seeds. By identifying the potential of the butter extracted from bacuri seeds for the cosmetic industry, Beraca has empowered these communities to turn waste into an extra source of income.


LONZA PRESENTS LATEST POLYGLYCEROL ESTER TO ASIAN MARKET At in-cosmetics Asia, which took place from 8 th to 10 th November in Bangkok, Thailand, Lonza Consumer Care led an Innovation Seminar on new opportunities for polyglyceryl technologies in cleansing systems. In addition, Lonza presented to the Asian market its latest polyglyceryl ester, Polyaldo 10-1-CC, which delivers mild and high-performing foam boost in personal care surfactant cleansing systems. Victor Low, Global Marketing Manager – Chassis, says that polyglyceryl esters, particularly Polyaldo 10-1-CC, have been shown to help support good foam structure with low to no irritation in cleansing systems. According to Mr Low, polyglyceryl ester technology is an imaginative and consumer-relevant way to boost the efficiency of personal care products such as baby shampoos, hand washes and facial cleaners.

ASHLAND INTRODUCES NEW ANTI-AGING PRODUCT Cultivated in Asia for more than 4,000 years, Nelumbo nucifera (the ‘sacred lotus’) is revered for its cultural and medicinal values. Using its proprietary Zeta Fraction technology, Ashland has captured the biologically active ingredients of this plant in their new product, a Harmoniance serum fraction that contains the continuous phase of the intracellular colloidal dispersion from the whole living plant. The composition of this patented ingredient includes phenolic compounds, carbohydrates, free amino acids, electrolytes, and microelements. Ashland says that Zeta Fraction technology is probably the only technology with the capability to harness the full potential of living plants. The process, which requires special proprietary equipment, starts with separation of live plants into a stable intracellular colloidal dispersion and fibre-enriched material. The dispersion is then separated into different fractions. The process, which is totally solvent-free, consumes minimal energy, and creates no waste, generates highly reproducible ingredients capable of targeting multiple biological pathways.

BRINGING SPARKLE TO THE UK Just in time for Christmas, Cornelius (European distributor) is bringing US-based Watson Inc’s natural edible glitter products to the UK. Edible glitter is made from gum Arabic – the sap of the Acacia tree – with colours produced from a wide range of sources including cabbage juice, algae, carrots, radish, turmeric and annatto. Mary Watson from Watson Inc said, “Consumers appear to be equating artificial and unhealthy and are likely to turn away from product labels with unfamiliar ingredients. Watson says that consumers are looking for product descriptions that are familiar to them and that they associate with ingredients they would find in their own kitchens. As a result, many consumers are looking for products that are ‘free from’ artificial colours and flavourings today.”

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Clariant Unveils New Heat Transfer Products and an Intelligent Chemical Management System Clariant has introduced three additions to its Antifrogen and Protectogen ranges of heat transfer products. Antifrogen SOLAR and Antifrogen GEO are for solar thermal systems and geothermal applications, respectively. Their third new product, Protectogen N ECO, provides an economical answer for heat transfer in numerous applications. Antifrogen SOLAR, a propylene glycol-based aqueous product, protects metal components against corrosion and maintains its fluidity at low temperatures. In its ready-to-use version, it has a frost resistance of -28°C and a maximum permanent use temperature of +150°C. Antifrogen GEO is a concentrate based on monoethylene glycol, offering long-lasting protection against frost, corrosion and lime scale. It meets requirements of heat transfer fluids in shallow geothermal energy applications. Protectogen N ECO is based on monoethylene glycol containing an effective combination of inhibitors for long- lasting protection against frost and corrosion in many different systems (e.g. industrial, hot water heating, refrigeration and air conditioning systems, heat pump systems, wind turbines, railway vehicles). Permanent usage temperatures range from -50 to +100 °C. Separately, Clariant has announced the development of VERITRAX, the first intelligent digital chemical management system for the oil and gas industry. VERITRAX offers oil and gas producers a pioneering, fully transparent, automatic chemical control, monitoring and ordering system that optimizes

chemical management tasks and labour-intensive processes, resulting in reduced overall operating costs. Clariant says the support platform takes advantage of industry-leading automation and cloud-based technologies to optimize the chemical supply chain, ensure maximum production up-time, and provide producers with an unprecedented understanding and control of their chemical spend. The system can be fully integrated into existing production set-ups such as SCADA and DCS systems. It provides a continuous real-time data flow that is delivered directly to a laptop or smartphone. Jon Rogers, Global Head of Clariant Oil Services, commented, “The priorities for the oil and gas industry are risk management, production efficiency and cost optimization. Information technology is playing an increasingly important role for oil and gas companies as they look for ways to optimize all aspects of their operations. VERITRAX can deliver both cost reduction and increases in operational efficiency to our business partners.”



AkzoNobel NV, Royal DSM, Google and Philips have agreed to source power from renewable energy projects for part of their operations in the Netherlands. The conglomerate will buy electricity from Windpark Krammer, which was established by two co-operatives together with 4,000 members in the Zeeland province and the island of Goeree-Overflakkee. The four companies will source 350,000,000 kWh a year once Windpark Krammer becomes operational in 2019.

Spanish energy giant Repsol will be selling its Teak, Samaan and Poui oilfields in Trinidad for US$125 million, although the company said that it will not be pulling out of the country completely. Repsol acquired the fields, located off the south-eastern coast of Trinidad, for US$229 million in 2005. Repsol initially declined to name the buyer until the transaction was complete, but rumours abound that Anglo-French energy company Perenco will acquire the assets.

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BASF ANNOUNCES IN-ROADS TO AUTOMOTIVES BASF has developed a way of manufacturing pipes by blow molding with their high-temperature polyamide Ultramid Endure D5G3 BM, which addresses the problems of high pressures at high temperatures between the turbocharger and the charge air cooler (also known as the intercooler; cooler air burns fuel more efficiently). MANN+HUMMEL, a development partner and equipment supplier to the automotive industry, used Ultramid Endure D5G3 BM to develop a new charge air duct for the BMW Group’s 2.0-liter four-cylinder turbo engine. It is being used in the BMW 4, 5 and 7 series, as well as in the X3, X4 and X5 models. Meanwhile, in a separate venture, a new concept vehicle jointly developed by BASF and the Hyundai Motor Company combines key solutions from the chemical industry with purposeful aerodynamic design and specialized highperformance technologies. While high-performance cars generally contain carbon fibre reinforced polymer to reduce weight, BASF and Hyundai explored alternatives.

For example, BASF’s Elastolit rigid integral foam and reaction injection molding systems developed for body panels permit the realization of even those most challenging designs like the fender and spoiler of the RN30. BASF’s Infinergy, the world’s first expanded thermoplastic polyurethane, is combined with an elastic coating for use in the roll bar padding of the RN30 because of its long-term durability and outstanding resilience. BASF has also developed a breakthrough technology, Hydraulan 406 ESI, which fulfils demanding legislative requirements by extending the durability of the brake elastomer. These and other BASF products are used to strengthen the floor, optimize interior design, and even contribute to sustainability. “We are very proud to be a vital part of the RN30,” said Raimar Jahn, President of Performance Materials at BASF. “Based on our great partnership and our innovation power, Hyundai Motor has invited us to demonstrate the capabilities of our materials in this unique concept.”

ELIX POLYMERS FOR LIGHT-WEIGHT AUTOS LIX Polymers has introduced a new generation ABS/PC blend to meet the needs of the automotive industry. ELIX Ultra HH 4115 HI ABS/PC can help to achieve major weight reductions through lower density, as well as delivering cost savings, processing benefits, very low emissions and odour when compared to PC/ABS. The automotive industry’s ongoing search for weight reductions, is currently driving the trend to replace PC/ABS parts with ABS/PC blends, especially for interior parts. ELIX Polymers Ultra HH4115HI ABS/PC material has several advantages compared to a PC/ABS: lower density, low emission and odour, high flowability and impact strength, excellent processability and good paintability. It is envisaged for use in door panel parts, instrument panel parts, centre console trim, seating parts, interior and exterior pillars and luggage compartment trims. ELIX Ultra HH 4115HI has already been tested and approved by several Automotive OEMs, including BMW, AUDI and GM. Further tests and approvals at other OEMs are ongoing.

Speciality Chemicals Magazine 36.08 November 2016 15


CONTRACT MANUFACTURING EXPLAINED Daniel Marr, head of marketing for chemical manufacturer, Airedale Chemical, uncovers the mystery surrounding the secretive world of contract manufacturing.


he world of contract manufacturing can seem a clandestine and complicated one, shrouded in secrecy and potential pitfalls. The truth is that outsourcing some areas of a company’s chemical blending and manufacture can be the best solution for many operations.

Contract manufacturing explained

Contract manufacturing is when one business produces a product for another company based on a provided formula, framework or design. It is a particularly useful method in the chemical, food and beverage, and medical industries. In addition, other types of business seek technical support from outside agencies, given the need to change and test formulations on a fairly regular basis. This may include, for example, those in the metal treatment sector, water treatment facilities and detergent manufacturers, or agrochemical industries.

Is contract manufacturing for me?

There are several reasons why contract manufacturing is fast becoming a popular option for so many businesses using chemical blends, providing a service that they cannot effectively fill for themselves. The need to push for innovation is likely to be the major driver in these companies that are leading the way in the use of contract manufacturing. In most market places there is a pressure to differentiate products from the competition, with constant demands for products that work faster, cost less, are safer to use and work more effectively, leading to the introduction of a number of new products and formulations to ‘test’ the market. Using a contract manufacturer allows companies to create a new product or formula without the expense and risk of committing to that product before first gathering an idea of how well it works and how it will be accepted by users. Essentially, the perpetual need for faster, cheaper, safer, better products is fuelling a surge in contract manufacturing and the flexibility that it brings.

Investment in production facilities is not the only major expense in developing new products. It requires huge revenue, time and knowledge to deal with new applications. Employing a contract manufacturer removes these headaches and brings in additional guidance on what exactly is legally required to develop and launch a new product, making it an expense on a par with those of production facilities.

Reducing cost and commitment

Ask the experts

Contract manufacturing can lower manufacturing costs as there is no need to invest in facilities and resources. This is particularly useful if trialling a product or producing a ‘limited edition’ as it eliminates the need for new plant that would only be required for a short length of time. Using existing facilities at another business removes the associated costs. Not only does contract manufacturing reduce the need for capital expenditure, it also removes the set up time for such facilities and resources, meaning the time-to-market can be significantly reduced – a major advantage when getting a new product out, particularly if it means beating a competitor to the marketplace.

Playing by the rules

Alongside nuclear and oil and gas, chemical companies are the most highly regulated by the Health, Safety and Environment (HSE). The amount of red tape and regulations in place is staggering, and many companies do not have the necessary certifications or resources in place to develop and manufacture the solution they desire. Contract manufacturing comes into its own when manufacturers are able to produce exactly what they want under the roof of a certified and approved company without having to go through the time and expense of gaining these approvals themselves.

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Size matters

Physical capacity is also an influencing factor. Contract manufacturing is a good way to test out small batches of a new product, but is also ideal for producing formulas on a larger scale that many companies are not equipped to handle. Companies experiencing rapid growth often turn to contract manufacturing to deal with the challenges presented by scalability and coping with insufficient time and assets to deal with increased demand. As an example, Airedale Chemical offers production and storage facilities with a capacity of around 1.2 million litres at any one time. This is an unrealistic figure for many businesses with smaller-scale facilities.

When utilizing contract manufacturing suppliers, clients may also tap into expertise that may not be available internally at their own sites. This is a real advantage in the chemical industry. Where available, clients may utilize the contract manufacturer’s research and development laboratories, quality control facilities, new product development capabilities, formula benchmarking instrumentation and chemical augmentation technology. All of these are highly specialist areas that few manufacturers have access to within their own organizations.

Any contract manufacturer should allow the buyer to maintain exclusive control over intellectual property.


What are the challenges?

As with all transactions involving intellectual property, buyers can be nervous. Contract manufacturers are well-used to handling corporate concerns and confidentiality is paramount, with watertight contracts and legally binding non-disclosure agreements in place to ensure secret formulae and exclusive recipes never leave the four walls of the contract manufacturer’s site. The nuances of these non-disclosure agreements may vary from customer to customer based on their individual requirements. For example, which countries they supply to, the type of product being handled, and the length of contract can all differ greatly from one company to another. The details of the non-disclosure agreement should be shared with all relevant staff so those involved understand the details and importance of adhering to this critical document. Any contract manufacturer should allow the buyer to maintain exclusive control over the intellectual property of the product. Ensure this is addressed in any agreements before signing on the dotted line, as losing control of it during this process could mean a loss of advantage in the market place.

Choosing a contract manufacturer

It is common practice for a buyer to meet with a number of potential suppliers before making a final decision. Ensure that you not only meet the sales representative armed with the flashy presentation, but also the production team and technical experts – the ones who will be dealing with your products on a day-to-day basis. Visit the site and its facilities to get a genuine feel for the company and what it can offer you. Some contract manufacturing facilities allow the customer flexible access to their laboratories. For example, our chemists liaise closely with customers, enabling an in-house overview of production, and giving a sense of comfort to the customer who still feels in control of the process. Don’t be shy in asking for references. Use the experience of others to help guide your own decision. There are also more official endorsements that anyone looking for a reliable and trustworthy contract manufacturer should look for. Companies which are ISO9001 and ISO4001 accredited will have demonstrated their absolute commitment to meeting only the highest quality and environmental standards. It is also advisable to seek a company that is REACH regulated. This ensures your contract manufacturer has shown high levels of consideration in protecting people and the environment, responsibility for managing potential risks, and encouraging innovation in the industry.

A growing service

Due to companies and brands continuing to drive diversity and innovation, the past few years have seen contract manufacturing grow substantially, and we forecast this expansion to continue. Even large companies are showing unwillingness to make big investments in today’s political and economic climate. Yet they still need to stay on top of their game and ahead of the competition, so must forge ahead with new developments and innovations. Contract manufacturing facilities provide the ideal solution for businesses that still want to move forward without making the huge investment in time, expertise and facilities to continue evolving.

CONTACT Daniel Marr, BA Hons Head of Marketing Airedale Chemical Keighley West Yorkshire, UK e: t: +44 (0) 1535 637 876

Speciality Chemicals Magazine 36.08 November 2016 17


Pharmaceutical Contract Manufacturing Market Remains Strong, but Could Face Headwinds Growth of the overall contract manufacturing market appears to remain healthy as we head into the last quarter of 2016. However, there are interesting trends that could impact some segments. Nigel Walker, Managing Director at That’s Nice LLC & Nice Insight, reports. Healthy growth

The value of the global pharmaceutical contract manufacturing market, currently valued at $58 billion, is predicted to reach approximately $84 billion by 2020/21.1,2 Mordor intelligence estimates the market is growing at a CAGR of 6.4%.1 The research firm also estimates that contract manufacturing of solid dosage formulations accounted for greater than 40% of sales in 2014, while the injectable segment will grow at the fastest rate (CAGR of 12.37%) over the next five years. With respect to geography, the United States was the largest market in 2014, but India is the fastest growing.1 Trends driving this growth include a high level of investment in innovation, which is leading to a very healthy pipeline of novel medications. The heightened level of growth also correlates with pressures to reduce the cost and time of development and commercialization of new drugs; even leading to consolidation among biopharma companies. The need, in many cases, for specialized manufacturing and/or development capabilities is another important driver, particularly with respect to the production, final formulation, as well as packaging of highly potent APIs and the delivery of drug substances with challenging properties (i.e., poor solubility and bioavailability).2 The growing number of emerging/small and mediumsized pharma companies that lack development and manufacturing infrastructure is also contributing to the healthy state of the pharmaceutical contract manufacturing market.2 There are some negative drivers impacting the overall market as well, such as the push by many (bio)pharmaceutical companies to simplify their supply chains by reducing their number of outsourcing partners.1

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Increased spending

The increase in anticipated spending of participants in Nice Insight’s 2016 CDMO Outsourcing Survey, of nearly 600 professionals in the pharmaceutical and biopharmaceutical industries, supports the growth estimates discussed above: 75% predict that their companies will increase expenditures on contract services over the next five years. A large percentage (69%) also expect to increase the number of CDMOs they work for in the coming years.3 It is worth noting that the percentage of respondents whose companies spent more than $50 million annually on outsourcing, which remained fairly stable at 23% to 24% from 2012 to 20143, nearly tripled to 71% in 2015.4 This rise was accompanied by a significant decline in the percentages of respondents whose companies spent less than $10 million and $10 to $50 million on outsourcing (16% and 62% down to 3% and 23% from 2014 to 2015, respectively). 3, 5

Consolidation and internal investments are headwinds

While these numbers indicate a promising near-term future for the CDMO market, recent M&A activity amongst (bio)pharma companies, the acquisition of contract service providers by sponsor firms to achieve vertical integration and significant investment, particularly by biologic drug manufacturers in internal production capabilities, could have negative consequences for CDMOs further down the road. Companies that have only invested in internal development programs have not been as profitable as those that have expanded their pipelines by acquiring companies with promising candidates.4 Consolidation means fewer potential customers and a more competitive environment for CDMOs.

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O U T S OUR C I N G (Bio)pharma companies that have grown through acquisition are also focusing on simplifying their supply chains by using fewer partners. They are especially seeking those that can support their projects from the development phase through clinical trials, on to commercial API production and drug product formulation. Acquisitions of CDMOs by (bio)pharma companies, such as Pfizer’s purchase of Hospira (including its contract parenteral drug manufacturing operations, now Pfizer CentreOne) is also affecting the CDMO market. In 2015, approximately one-third of the pharmaceutical industry’s cost of goods for drug product manufacturing was attributed to outsourced manufacturing.6 That number isn’t expected to increase, either. While outsourcing by small and medium-sized pharma companies remains strong, spending by big pharma on contract services has actually declined from 60% of new NME approvals in 2006, to 20% in 2015.7 At the same time, internal investment in manufacturing capabilities has increased. The 25 largest (bio)pharmaceutical companies increased their spending on facilities and equipment by 13% in 2013 and 11% in 2014.6 PharmSource also reports that overall, big pharma has spent close to $100 billion on biologics manufacturing capabilities (cell-culture, microbial fermentation production and final filling of parenteral formulations) over the last five years.7 With this level of investment, it appears that biopharmaceutical companies that have established sufficient internal capacity may not have to rely on CDMOs for manufacturing.7

Achieving preferred status makes a difference

CDMOs are responding to these changing market conditions in a number of ways. Perhaps most noticeable has been the M&A activity in this sector.8 CMOs have been transforming themselves into CDMOs through the acquisition of competitors with complementary capabilities (specialized technologies, larger/smaller volume equipment, development or final filling, etc.) or geographic footprints. The goal in many cases is to establish a suite of capabilities similar to that which their customers have internally, but with technical, cost and efficiency advantages. As mentioned above, there are fewer very large (bio)pharmaceutical companies; those that remain are consolidating their supplier bases. Therefore, offering integrated services is becoming imperative for CDMOs. This trend is also reflected in the results of the 2016 Nice Insight CDMO Outsourcing Survey; 43% of respondents seek “preferred suppliers”, up from 35% the previous year. In addition, the preference for “tactical suppliers,” the more traditional type of relationship, dropped from 35% to 31%.3,5 CDMOs that have integrated offerings, are willing to work under creative costsharing or other contractual conditions and provide a combination of unique technical solutions will have real competitive advantage. Gaining preferred partnership status is not a guarantee of ongoing business. However, CDMOs, whether they are in preferred/strategic partnerships or involved in simpler tactical relationships, must maintain a high level of performance or customers will look elsewhere. For instance, 50% of survey respondents indicated that they would switch CDMOs if they do not continually meet quality expectations.3

2016 Nice Insight CDMO Survey respondent profile

In 2016, That’s Nice separated its annual outsourcing survey into two separate questionnaires for the contract manufacturing and research markets. These sectors were divided in order to gain more tailored insight into specific trends and issues. The manufacturing survey was also expanded to include CDMOs in recognition of the growing number of CMOs that have, through acquisition and internal investments, transformed themselves into service providers that offer integrated services from development through commercial manufacturing. A total of 587 respondents, including professionals at all levels of (bio) pharmaceutical companies participated in the 2016 Nice Insight CDMO Outsourcing Survey. The largest percentage (39%) are key decision-makers (executive/management positions) in their organizations. Another 18%, 13% and 10% of the survey respondents hold positions in R&D, formulation and analytical; development, production and manufacturing; and operations and engineering functions, respectively.3 In addition, the respondents come from companies of all sizes. Large (>$5 billion in annual sales), medium ($500 million to $5 billion), small ($100 to $500 million) and emerging (<$100 million) firms are represented by 36%, 43%, 12% and 9% of participants, respectively. The survey also covers all major geographic pharmaceutical markets: 56% of respondents are from North America, 28% from Asia and 16% from Europe.3 Based on this respondent profile, it can be confidently concluded that the results of the 2016 Nice Insight CDMO Outsourcing Survey reflect the conditions in the global pharmaceutical contract development and manufacturing sector.



1. 2. 3. 4. 5. 6. 7. 8.

Nigel Walker Managing Director That’s Nice LLC 89 Fifth Avenue New York, NY, USA t: +1 212 366 4455

Mordor Intelligence Press Release, August 2016, Visiongain Press Release, August 2016, The 2016 Nice Insight Contract Development & Manufacturing Survey. M Jewell, “M&A to enter ‘pharmerging’ markets,” The Pharma Letter, July 2016. Nice Insight’s Annual Pharmaceutical and Biotechnology Outsourcing Survey 2015. J Miller. Pharm Tech 2015:39;26-211. J Miller. Pharm Tech 2016:40 (Outsourcing Resources Supplement). N Walker. Pharm Manuf, Jan. 2016.

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A BRIGHT FUTURE FOR SMALL MOLECULES Small molecule innovation may have been overshadowed by developments in biological drugs, but the versatility and specific properties of these products will ensure that they will continue to be the backbone of the pharma sector for many years to come. Dr Matthew Moorcroft, VP Global Marketing at Cambrex, believes that his company’s research proves small molecules have a bright future.


‘small molecule’ is generally defined as an organic compound with a low molecular weight (usually less than 500 daltons). This diminutive size enables the molecule to rapidly diffuse across cell membranes, allowing it to reach intracellular sites of action. As a result, the vast majority of pharmaceuticals are small molecules. However, the end of the traditional blockbuster model in the pharmaceutical industry, together with strong growth in the biologics sector, have made the small molecule market seem distinctly unfashionable in recent years.

PHASE I 1995
































1995 2005 2010

52 38 35





2013 2014 2015

41 39 72

Figure 1: New entrants per year

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In comparison to the 1980s-1990s and the existence of mature 50 to 100 metric tonne (mt) blockbuster products, the last few years has shown an evolution of the industry. While there may be a fall in the volume demand at the top end of the range, small molecule drugs that are in the region of 1 to 10 metric tonne volumes – and in some cases even less – can be ‘blockbusters’ in the sense they can command in excess of US$500 million in sales, Cambrex VP Global Marketing, Matthew Moorcroft contends. “This is especially true for drugs used in oncology indications where the pricing per pill is orders of magnitude higher than drugs used in more chronic indications such as hyperlipidaemia and diabetes,” he says. “Not all orphan drugs are low volumes – indeed some are taken in high doses and consumed daily.” Of the 45 new molecular entities (NMEs) approved by the US FDA during 2015, 33 were small molecules and 12 were biologics. This was the highest number of approvals in the period from 1999 to 2016, and there are currently more chemical molecules in every phase of drug development than at any time in the last 15 years (Figure 1). Twenty-one of the 45 NMEs were approved to treat orphan diseases and 27 were designated in one or more expedited categories of Fast Track, Breakthrough, Priority Review, and/or Accelerated Approval. “We believe that small molecules have shown their versatility,” says Moorcroft. “They started life as the classic blockbusters and have moved on to include more targeted therapies or orphan drugs. Their surprising longevity comes from their unique and enviable ability to be formulated into pills and tablets. “We believe an effect of this evolution has been a requirement for contract manufacturers to be flexible enough to be able to produce APIs in a range from kilograms to hundreds of metric tonnes to satisfy the wide variety of demand. A CMO needs to monitor these trends and invest in capacity to stay ahead and anticipate changing customer needs.” To this end, Cambrex decided to look at volume trends in the 408 small molecules launched in the US over the past 15 years. An interval period of five years was chosen to give enough data points for a quantitative study. To avoid any annual anomalies, the data from two consecutive years were combined, giving a final data set of 209 small molecules – around half the total number of approvals – which the company believed would be sufficient to identify any emerging trends. The study was also limited to the US market, since most drugs are launched first in the US with subsequent launches in Europe and Japan, followed by the rest of the world. This allowed the exclusion of misleading data arising from differences in disease prevalence/epidemiology in more populous markets such as India and China that can result in large uptake of some products. However, it can be assumed that volumes for the five major European markets and Japan would be similar to those recorded in the US, Cambrex says. The trend in volume evolution shows a clear decline in the numbers of NCEs with volume ranges above 10 mt and below 10kg, while those reaching their peak volumes in the ranges 10kg to 1mt and 1 to 10mt are stable or increasing. In 2014/2015, 12 out of 27 NCEs were forecast to reach peak volumes of 1mt. It became clear that the spread of volumes is becoming narrower and that there is more clustering around the middle volumes now compared with 15 years ago, says Moorcroft (Figure 2). Another trend to emerge from the data analysis was the reduction in the size of patient population sizes, in line with the increasing focus of orphan

O U T S OUR C I N G diseases and targeted therapies. The average population targeted has fallen from 13 million in 1999-2000, when a significant proportion on the approvals were for indications such as obesity, diabetes, GERD and hyperlipidaemia, to just 6 million in 2014-15, when the NCEs were targeting conditions such as multiple myeloma, cystic fibrosis and thyroid cancer. In terms of clinical potency, there has been little change from 1999 to 2015, with the majority of drugs still in the 1 to 100g per patient per year range. However, there was a slight increase in the number of lower dose NCEs below 1g per patient per year, according to the study. “From these data we don’t see any real trend in reduced dosages to patients; if there is a trend to targeted medicines we haven’t seen that show up yet in the doses that patients are actually taking,” says Moorcroft. There has also been little change in tablet unit sizes: 10 to 50mg continues to be the most frequent dose size, although the 50 to 250mg size range is gradually increasing in popularity. The main conclusions of the Cambrex research is that the changing volume requirements and manufacturing conditions require CMOs to ensure they are equipped to deal with the current and future crop of small molecule therapeutics. The trend towards concentration of average

Number of NCEs

Large-scale > 10mt





Number of NCEs

Mid-scale 1-10mt


Number of NCEs




Small-scale 10kg-1mt 1999-00




Number of NCEs

Pilot-scale <10kg

It is important for a world-class CMO to be able to offer a range of manufacturing options.. volume requirements actually lends itself more to CMOs than to captive manufacturing at big pharma, the company states, given that CMOs are used to handling multiple customer projects, with varying volume requirements and chemistries, and have adapted accordingly. “We believe this is one reason pharmaceutical companies continue to adopt outsourcing at CMOs over internal production,” says Moorcroft. “It is important for a world-class CMO to be able to offer a range of manufacturing options to cover the life-cycle of the drug on the market – from introduction to maturity, as well as the option to manufacture key late-stage intermediates and starting materials should security of supply or regulation be a pre-requisite. “CMOs will therefore continue to monitor industry trends at the clinical pipeline level and invest in their facilities appropriately.” The reformulation of existing drugs is also a key growth area and one that deserves particular attention from CMOs, as supply of API into repurposed or reformulated drugs requires them to act quickly and responsively, for example, to meet the need for rapid supply of small volumes of API for product development and launch purposes or the technical and regulatory expertise to support the customer during registration and commercial supply. Cambrex is unusual among CMOs in that it is able to supply NCE API to innovator customers as well as supplying generic API for reformulated products. Cambrex has invested strongly in small molecule capacity and infrastructure over the past five years. In total, since 2011 the company has invested US$150 million, and in 2016 announced a further US$50 million expansion of its large-scale API facility in Charles City, Iowa. “We believe our investment closely follows the trends seen in the industry and by establishing the right capacity and capabilities demanded by our customers we can handle a variety of projects and chemistries while allowing flexibility in the supply chain and volume fluctuations,” says Moorcroft. Specifically, the new investment scheduled for 2016/17 at Charles City has resulted in a new Pharma 3 large-scale plant with six reactors, now on stream. The company is also planning to add 300 gallon and 500 gallon reactors to its pilot plant in 2017. Meanwhile, at the mid-scale, its Pharma 4 suite is now ready for fit out andt has the capability to add 500 to 2,000 gallon reactors and would be ready to go with a lead time of about six months. This expansion follows a 50% increase in custom development capacity at Karlskoga in Sweden, and an expansion of the analytical development team in its Tallinn subsidiary. It has also added a new 6m3 production capacity and further expansion is ongoing to add 12m3 vessels to this new cGMP multi-purpose production line. “A few years ago you’d have been forgiven for thinking that the rise of biologics and monoclonal antibodies a decade ago in oncology meant that small molecule use in this indication was over. In fact, far from it,” argues Moorcroft. “When compared with biologics, peptides and oligonucleotidebased medicines, small molecules will continue to be the back-bone of the pharmaceutical industry in many therapies driven by patient preference for oral dosing, lower manufacturing costs and ease of transportation.”






Matthew J. Moorcroft, PhD Vice President | Global Marketing Cambrex East Rutherford, NJ, USA e:

Figure 2: Trends in volume evolution

Speciality Chemicals Magazine 36.08 November 2016 23


Preserving Agents for Ophthalmic Products: New Approaches to a Neglected Biocide Application Dr Oliver Seidelmann, manager at ChiroBlock, and Dörte von Deylen, researcher at the Braunschweig University, shed some light on new developments in the field of eye remedies preservation. Protecting the Vulnerable Eye

Apart from the mucosa, the eye is the only entrance gate for microbes to the uninjured human body. Consequently, all foreign material that is intended to be applied to the eye has to be sterile. This applies both to ophthalmic drugs and to solid state adjuvants such as contact lenses.1 While it is practical to manufacture these remedies in a sterile manner, it is much more difficult to keep them free of pathogens once the packaging has been opened. The use of single-dose containers is the safest solution, and these are widely used for critical applications such as surgery. However, multidose and multiuse systems are generally much more beneficial for budgets and for the environment. This presents us with the challenge of keeping multi-dose systems free of microbes. Adding preservatives might be the first logical answer – but considering possible side effects, a preservative-free multi-dosage container would be preferred. Nearly all of the large players are working to achieve this goal – a number of formulations are already on the market. However, they are technologically complex and complexity, again, is costly. With no cheap and feasible alternative available, preservatives have been added to ophthalmic products for decades.2 In most cases they successfully inhibit the growth of microorganisms. There would be limited drive for further developments if there were not a number of concerns linked with these compounds. By the very nature of preservatives, they are toxic to cells, more often than not also damaging non-pathogenic tissue. On the other hand, the ‘safer’ compounds are likely to be less effective at controlling microorganisms, leading to the need for more than one preservative, which in turn may lead to new problems in the fields of toxicology, compound interaction and regulatory issues. Table 1 gives an overview of prominent ophthalmic preservatives with their typical limitations. Today, benzalkonium chloride (BAC), amidines and polyquarternium-1 (PQ-1) are the most widely used preservatives in ophthalmica and in multi-purpose solutions (MPS) for the care of soft contact lenses (CL). Compound group

Preserving agents

Drawbacks / Limitations

Benzalkonium chloride (BAC)

Cornea damage Dry-eye syndrome (even blindness)

Polyquarternium-1 (PQ-1)

Not effective against prominent fungi (e.g. Asp. brasiliensis)

Mercury compounds

Thiomersal Phenyl mercuriate

Neurotoxic Nephrotoxic (heavy metal)


Methyl-4-hydroxybenzoate Propyl-4-hydroxybenzoate

Potentially sensitizing Hormone-like properties Potentially carcinogenic


Chlorhexidine Polihexanide

Cartilage toxicity Slow effect

Oxidizing Agents

Oxy-chloro complexes Sodium perborate e.g. Purite

Light as activator required Non-specific action – potentially dangerous to all healthy tissues


Buffered, metal containing multi component solutions (Disodium EDTA, zinc, boric acid), e.g. SofZia

Multi-component system Heavy metals Toxicity of boric acid No approval in the EU

Quarternary ammonium compounds

Table 1 – Currently used preservatives for ophthalmic products

24 Speciality Chemicals Magazine 36.08 November 2016

Preservatives: Boon or bane?

Serious side effects are being observed with products containing BAC and amidines. Keratitis is probably the most dangerous consequence of ophthalmica or MPS containing these preservatives.3 With a reported incidence of four cases out of 10,000 CL users, these side effects are rare but they may result in very serious consequences; sometimes even the total loss of sight.4 The main reasons for these severe eye infections are assumed to be the lipophilic properties of amphiphilic preservatives. Their lipophilic molecule segments enter cell walls and not only kill bacteria, but also break down the natural barrier of the cornea, allowing pathogens to migrate into the eye. The toxicity of prominent examples of MPS has been investigated in detail.5 As a consequence, several MPS, such as ReNu and Complete Moisture Plus had to be removed from the market. On the other hand, the safer polycationic and non-amphiphilic PQ-1 products are not effective against a number of ubiquitous microorganisms, especially amoebae and fungi. Hence, they often need supplements such as boronic acids in order to be fully effective. Boronic acid is, in turn, also toxic and its approval as a drug excipient in Germany was withdrawn for most applications in 1984. While these safety and efficacy problems are serious enough, regulatory issues and bacterial resistance add further problems with known preservatives. For example, regulatory requirements have changed significantly since BAC and PQ-1 were developed several decades ago. BAC first appeared as a disinfectant in the 1930s, and PQ-1 in the 1970s.6 Adding these compounds as preservatives to drugs automatically qualifies them as excepients with all regulatory consequences. Whereas 50 years ago there were nearly no regulatory requirements for these products, modern excipients are required to be manufactured and handled in nearly the same way as APIs.7 The global International Pharmaceutical Excipients Council provides guidelines on this topic, and their EXCiPACT spring-off has developed a demanding certification scheme for excipient suppliers. BAC and PQ-1 are far from being structurally clearly defined molecules (Figure 1). This adds variability parameters to the quality management of these compounds. PQ-1 is the result of a hardly controllable polymerization reaction yielding dozens of polymers of different size and with a barely known impurity profile. This polymer mix is extremely hygroscopic and, hence, difficult to handle. All these facts do not predestine these compounds as favourable excipients from a regulatory point of view, especially regarding the requirements of homogeneity, consistent concomitant composition and known impurity profile.8

Figure 1 – Structures of old and new (poly) cationic preserving agents

B I OC I D E S Finally, some microorganisms have developed resistance to old-fashioned preservatives.9 Formulations that contain agents at low concentrations, such as ophthalmica or cosmetics, especially facilitate the development of resistance. Authorities and industrial consortia recognise the need to foster the development of new, better biocides and to prevent resistance.10 In September 2016, the FDA banned a number of preservatives, such as triclosan, from body washes. Ironically – with no new preservatives being available – these agents may be replaced by BAC, which has been exempted from the ban.

Progress: Slow but Existing

There has been little progress in past decades for a number of reasons. First, approval processes for new biocides have been sharpened all over the world. The two-step authorization in Europe is regulated by the Biocidal Products Regulation EU 528/2012.11 A thorough risk assessment of new compounds is required, including resistance tests. Consequently, the introduction of such a new chemical entity costs up to €1 million and takes 2 to 5 years. The subsequent approval process of products containing these new biocides is neither cheaper nor shorter. This especially applies to drugs containing new biocides as excipients. So, with approval and production requirements getting closer to those of new APIs, the question is: do the revenue and profit prospective keep pace? The market answer is as clear as discouraging: both the overall market volume and the profit margins are definitely not comparable to those of new APIs. While the general ophthalmic drug market is steadily growing, and reached a volume of nearly $22 billion in 2015, the amount of preservatives needed does not give an impressive picture.12 For example, the concentration of PQ-1 in block-buster anti-glaucomic eye drops such as Travatan is typically as low as 0.01mg/ml. The annual volume of these ophthalmica is estimated to be about 250,000 litres, resulting in a total need of only 2.5kg of PQ-1. The figures get somewhat brighter if one includes the larger market of PQ-1 containing MPS for CL. According to IMS Health, about 16 million litres are sold annually, containing a total of 80 kg PQ-1. It is not easy to recoup the enormous development and approval costs with a few kilograms of a cheap excipient. Finally, there are scientific barriers to overcome. For many years, the mode of action of BAC, amidines or PQ-1 was unclear. Consequently, the ‘rational design’ of new, better preservatives was not possible. Because of the comparatively unspecific activity, researchers assumed an interaction with the cell membranes of pathogens. Investigations on different target cells disclosed differences between PQ-1 on the one hand and amidines as well as BAC on the other. PQ-1 was found to induce K+ leakage mainly from bacteria. The amphiphilic molecules also show activity against fungi and amoeba due to lysis of cells. However, the latter also increases corneal permeability with all its, mainly negative, consequences. Eventually, it became clear that balancing antimicrobial efficacy and toxicity could be facilitated by combining structural features of the safer poly cationic PQ-1 polymers and the more active amphiphilic BAC related compounds.13 1 (BAC) 2 (PQ-1)





25.0 50.0

Activity MIC* mg/l Asp. brasiliensis (9 d)


>400.0 12.5 – 25.0

C. albicans (2 d)





P. aeruginosa (2 d)






E. coli (2 d)






Viability** % ± SD Epithelium Safety*** % ± SD

1.8 ± 5.5 93.0 ± 10.2 90.3 ± 7.0 74.9 ± 12.0 74.4 ± 10.7 7.7 ± 4.1 69.1 ± 15.2 107.1 ± 8.0 17.3 ± 6.8 26.3 ± 6.8


Minimal Inhibition Concentration MTT-test on Human corneal epithelial cells (HCE-T-cell line), c = 0.01%, t = 10 min) *** Transepithelial Electrical Resistance (TEER), c = 0.01%, t = 45 min **

Only recently, this approach resulted in a number of new, potentially promising compounds.14,15 Some of them are oligomers, others discrete smaller molecules (Figure 2). All substances contain quaternary ammonium groups, complemented by additional structural characteristics. Activity and safety are related to molar mass and the structure of the end groups. For example, the dimer 3 proved to be more active than the closely related oligomer 4. Compounds of the bis-pyridine family (e.g. 5, 6) turned out to be toxic with R1 > C14H29 and nearly inactive with R1 < C4H9. Similar effects were observed with the oligomeric PQ-1 related substance class of 7 and 8. Active and safe such polycations should not be too large and their end cap aliphatic chains have to be in the range between C10 and C16. Table 2 compares these compounds with BAC and PQ-1. Activity numbers are given as required minimal inhibition concentration (MIC) of the active compound in order to prevent microorganisms from growing. Both the viability (MTT) test as well as the Transepithelial Electrical Resistance (TEER) test indicate the safety of the compounds. The MTT test, performed on human corneal epithelial cells, shows the percentage of unaffected, still viable corneal cells after a 10 min exposure to the active agents. The TEER values, in turn, indicate the share of epithelial cells with a still intact barrier function after a 45 min exposure to the preservative. As can be seen, the new molecules are not only active against both bacteria AND fungi but they also exhibit favourable safety profiles. Furthermore, the synthesis of these compounds is straightforward, scalable and results in crystalline solids. So, the regulatory requirements of reproducible synthesis, of homogeneity and known impurity profile are being met. Other toxicity data are still missing. Nevertheless, these new generation compounds are promising candidates for preserving ophthalmica, other topical drugs and even cosmetics.


Despite all other alternatives, preservatives are likely to retain their important role in keeping ophthalmic products and MPS free of life-threatening germs. Science has shown that it is possible to develop new generations of powerful preservatives with fewer side effects. It remains unclear if the stricter biocide and excipient regulations will pave the way for these compounds to enter the market or if they are more likely to prevent new approvals of ophthalmic preservatives. The answer to this question should not be left to purely mercantile aspects. One also ought to ponder whether or not we are determined to protect our most vulnerable and precious sensory organ in a better way.

REFERENCES 1. US Pharmacopoeia Convention, Ophthalmic Ointments, 2013, USP 36–NF 31, 771 (currently under revision). 2. C Baudouin et. al, Progress in Retinal and Eye Research 2010, 29 (4), 312–334. 3. E M Messmer, Ophthalmologe 2012, 109, 1064-1070. 4. S Kilvington, J. Optometry 2010, 3 (3), 134-142. 5. N C Tanti, Investigating The Impact of MPS Released from Silicone Hydrogel Lenses on Corneal Epithelia Cells, Thesis, University of Waterloo, Ontario, Canada 2009. 6. G Domagk, Dtsch. Med. Wiss. 1935, 61, 828-832 US3931319 (1976). 7. NSF International, Good Manufacturing Practices (GMP) for Pharmaceutical Excipients, 363, 2014. 8. I B Silverstein, Pharmaceutical Technology Europe 2016, 2, 16-20. 9. G M Bruinsma et al, Journal of Antimicrobial Chemotherapy 2016, 764-766. 10. EC-Action Plan Against the Rising Threats From Antimicrobial Resistance, COM 748, 2011. 11. R Elsmore, Chimica Oggi – Chemistry Today 2016, 34(4), 51-54. 12. 13. Y T Elmer, Saudi J. Ophthalmology 2014, 28, 182-187. 14. A Strassburger, Macromol. Biosci. 2015, 15, 1710-1723. 15. PCT/EP2016067101.

CONTACT Dr Oliver Seidelmann ChiroBlock GmbH Andresenstrasse 1a 06766 Wolfen Germany e:

Table 2 – Relevant activity and safety data of (poly) cationic preserving agents

Speciality Chemicals Magazine 36.08 November 2016 25



Richard Elsmore and Samantha Wright of JSC International review the Product family options under the Biocidal Product Regulation.


he Biocidal Products Regulation (BPR)1 regulates the availability and use of biocidal products within the EU. It aims to harmonize data requirements and assessment processes for biocidal active substances and products, while ensuring protection for humans and the environment. The BPR has replaced the Biocidal Products Directive (BPD)2 since September 2013. The BPR introduces a number of new concepts that impact how biocidal products and active substances are regulated. For example, under the BPD, frame formulations allowed similar biocidal products to be grouped together. With the BPR, this concept has been broadened and expanded through the introduction of product families.

Product families vs frame formulations

The BPD frame formulation allowed similar biocidal products, containing the same active substances of the same specifications, to be assessed together. Their compositions were to present only variations from a previously authorized biocidal product, which did not affect the level of risk associated with them and their efficacy. In this context, a variation allowed a reduction in the percentage of the active substance, and/or an alteration in percentage composition of one or more non-active substances, and/or the replacement of one or more pigments, dyes or perfumes, by others presenting the same or a lower risk, and which did not decrease its efficacy. Because of these restricted variations, the Directive tended only to have limited use. Now, under the BPR, the product family is defined as a group of biocidal products having: (i) Similar uses (ii) Same active substances (iii) Similar composition with specified variations (including all other co-formulants; not just pigments, dyes or perfumes) (iv) Similar levels of risk and efficacy. The text also provides that the assessment of the biocidal product family conducted according to the common principles for the evaluation of dossiers for biocidal products set out in Annex VI of the BPR shall consider the maximum risks to human health, animal health and the environment and the minimum level of efficacy over the whole potential range of products within the biocidal product family.


To summarize, biocidal products within a product family should have similar uses and the same active substances. Variations in the composition or the replacement of non-active substances should be specified, but may not adversely affect the level of risk or significantly reduce the efficacy of the products (Table 1). Frame formulation (BPD)

Biocidal product family (BPR)

Specifications for a group of biocidal products having the same use and user type

Group of biocidal products having similar uses

– must contain the same active substances of the same specifications

– the active substances of which have the same specifications

– and their compositions must present only variations from a previously authorized biocidal product which do not affect the level of risk associated with them and their efficacy

– and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products

– a reduction in the percentage of the active substance and/or

– a reduction in the percentage of one or more active substances may be allowed, and/or

– an alteration in percentage composition of one or more non-active substances and/or

– a variation in percentage of one or more non-active substances, and/or

– the replacement of one or more pigments, dyes, perfumes by others presenting the same or a lower risk, and which do not decrease its efficacy

– the replacement of one or more non-active substances by other specified substances presenting the same or lower risk

– the classification of any product within the frame formulation should normally be the same (Ref Note for Guidance on Frame Formulations Competent Authority meeting; NfG on FF – CA-Feb11-Doc.6.1.a)

– the product family can have different classification and labelling (C&L), but the hazard and precautionary statements must be the same for all products covered by one meta-SPC

– each component is specified with its allowable concentration range (NfG on FF – CA-Feb11-Doc.6.1.a)

– the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0%

Table 1 – Comparison of concepts of ‘frame formulation’ and ‘biocidal product family’3

26 Speciality Chemicals Magazine 36.08 November 2016

JSC International: providing expert support  Biocides  Agrochemicals  REACH/CLP With the ever increasing regulatory burden facing companies, reliable specialist input is essential. At JSC we recognise the complexity of the EU regulatory systems and use our experience and knowledge to support you and your products, ensuring regulatory compliance and continued sales. For further information on how JSC can support your regulatory needs and to meet the team, visit our website.

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B I OC I D E S How to develop a product family

The product family is structured using the concept of a ‘meta-SPC’ (Summary of Product Characteristics). Because it contains products with different classifications and features (e.g. first aid measures), it is important to group products together in a meta-SPC. All products within a meta-SPC have: a) Similar compositions within a specified variation, which fall within the specified variations for components and concentrations ranges of the whole BPF b) Similar uses resulting from the risk and efficacy assessment, which are associated to a common set of risk management measures (RMMs). However, products within a meta-SPC can have different RMMs and instructions for use linked to each authorized use (e.g. to a different user category or application method) c) The same hazard and precautionary statements d) A common set of first aid instructions, disposal, storage and shelf life. A biocidal product family can consist of one or more meta-SPCs, with the number in the product family being carefully considered to allow postauthorization notifications. A biocidal product family can include different user categories, target organisms, application methods, application rates, and frequency and fields of use. It can also include products containing more than one existing active substance or belonging to more than one product type. By definition, products belonging to a product family must have a similar composition within specified variations. Although the co-formulants may be included in the product family composition at 0%, all active substances contained in a biocidal product family have to be present in each product (content ≠ 0). Different formulation types may belong to the same biocidal product family, provided differences in composition do not significantly affect overall conclusions from the risk assessment and efficacy evaluation. The risk assessment would be completed for the worst case product for human health and the environment (usually the most hazardous with maximum risk) and the worst case product for efficacy (usually the lowest active concentration thereby providing the minimum level of efficacy). The risk assessment must

1st level General information: • Proposed family name • Product type(s) • Authorization holder, product manufacturer(s), active substance(s) manufacturer(s) • Formulation type(s) • Product family composition range

cover the range of products and all uses within the product family. However, where the assessment on the basis of an overall ‘worst case’ for the entire biocidal product family is not possible, the assessment may be focused at a meta-SPC level, taking into consideration the composition of the products and the different uses described in each meta-SPC. Chemistry, Toxicology, Ecotoxicology, Fate and Efficacy are data requirements for a biocidal product family authorization. However, careful consideration of the products in the family may allow options to read-across from one product to all others within the family, with only specific individual testing required for certain endpoints. It is necessary to specify if liquid formulations include water-based liquid, solvent liquids or emulsions and both concentrate and ready-to-use products can be incorporated into the same biocidal product family. Products belonging to one family can have different classification and labelling, but the hazard and precautionary statements must be the same for all products covered by one meta-SPC. The products can also have different RMMs but each meta-SPC should have its own set of RMMs in order to facilitate the post-authorization notification of new products belonging to that meta-SPC.4

Options for authorization

The authorization decision will include a ‘Biocidal Product Family SPC’, which will be made available in the R4BP3 system (the central hub through which all biocides applications are made) and disseminated by ECHA, so they can be found by inspectors or the general public when searching by the product authorization number or trade name(s) of the products as they are made available on the market. The information of the biocidal product family is presented in three levels plus details for dissemination (Table 2). Submission of the biocidal product family dossier is via R4BP3 for either Union Authorization or National Authorization followed by Mutual Recognition. In both instances an evaluating Member State should be contacted to confirm they are happy to accept the dossier for evaluation. The evaluation of the biocidal product family shall follow the timings specified in the BPR Article 30.

2nd Level

3rd Level

Meta-SPC containing the description of a group of products within the BPF having: • Product names • Family authorization number, including the suffix identifying the meta-SPC • PT(s) of the meta-SPC • Specific composition range for the meta-SPC • Hazard and precautionary statements • Intended uses, instructions for use, RMM’s and other directions that are use-specific • General directions for use and disposal that are valid for all intended uses • The particulars of likely direct or indirect effects, first aid instructions, emergency measures to protect the environment • Conditions of storage and shelf-life of the product

• List of all product names included in the meta-SPC with authorization number and product specific suffix

Product Specific SPC (for dissemination) • Authorization conditions will be the same as those in the meta-SPC with the exception of the full formulation details • Full formulations will be available on R4BP3

Table 2. – Information presented for a biocidal product family

28 Speciality Chemicals Magazine 36.08 November 2016


New products in the family

Once the biocidal product family is authorized, it is possible to place new products on the market that can belong to the biocidal product family but were not identified in the original authorization. A notification system can be used by the authorization holders to inform competent authorities that they intend to place on the market new products. The notification is completed via R4BP3 and requires the submission of the full formulation of the proposed new product, the trade name, the suffix to add to the authorization number and the meta-SPC to which the new product belongs. The notification is only a 30-day process before a new product can be placed on the market. This should be completed for each member state where the product is authorized if application was through mutual recognition. The notification process is not required when the variation in composition concerns only pigments, perfumes and dyes within the permitted variations of the existing product family range.

Product Family Consortia

The product family concept has benefits that will allow companies to work together as consortia under the BPR. These benefits, which can offer significant cost savings, were not available under the BPD. By applying for Union Authorization (UA) for a Product Family reference dossier, individual consortia members are able to apply for UA or, following the recent

amendment of the Same Biocidal Product Regulation, 5,6 apply for individual member state authorization for their products. However, it is recognised the biocidal product consortia may not be the best option for all companies and products, with individual biocidal product families remaining the route chosen by many companies.


The BPR product family approach offers companies the benefit of reducing regulatory costs through grouping products together into families. The product family can contain products within differing product types and different types of users (e.g. professional and non-professional). It may also contain differing application methods (e.g. wipes, sprays). The ability to vary the concentration of non-active substances (down to 0%) allows for considerable formulation variations to be accommodated. It is highly recommended that pre-submission meetings are held with the chosen evaluating member state well in advance of dossier submission, allowing time to discuss the approach foreseen by the applicant and possible issues. The combination of the Biocidal Product Family, Union Authorization and the Same Biocidal Product Regulation may offer companies lower cost authorizations through working together in consortia, although it is recognised that this approach may not suit all companies and products and may not always result in â&#x20AC;&#x2DC;Happy Familiesâ&#x20AC;&#x2122;.

REFERENCES 1. 2. 3. 4. 5. 6.

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. Council Directive 98/8/EC of 16 February 1998, Official Journal of the European Communities, 24 April 1998, L123/1. Taken from Note for Guidance on handling the transfer from frame formulations to biocidal product families. European Commission CA-Sept13-Doc.6.2.c-Final Note for Guidance on implementing the new concept of biocidal product families. European Commission CA-Nov14-Doc.5.8-Final. Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council. Commission Implementing Regulation (EU) No 2016/1802 of 11 October 2016 amending implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council.

Speciality Chemicals Magazine 36.08 November 2016 29


Ban of Methylisothiazolinone in Consumer Goods and Detergents? Nicolas Gallacier, of LANXESS Deutschland GmbH, explains the new labelling and legal implementations surrounding the EU Commission’s reassessment of the safety of MIT earlier this year.


ethylisothiazolinone (MIT, Figure 1) is one of the most common active ingredients used as a bactericide and antimicrobial substance in industrial applications. It is added to many household detergents, glues, paints and other industrial products in order to prevent microbiological contamination, and consequences such as change of viscosity, gas production, pH shift or even foul odour. Over the past ten years MIT has been one of the essential biocidal actives in all preservation systems, and it has been used to replace, for example, formaldehyde releasers in consumer goods.

Figure 1 – MIT

Consequences for the labelling of preparations and end products

The proposed limit will have severe consequences for the use of MIT as an active ingredient in preservation systems. MIT effective dosages are usually in the range of 50 to 200 ppm. With the proposed specific concentration limit of 15 ppm, products preserved with MIT will have to be labelled with H 317 in the near future. H 317 label Today 2-Methyl-1,2-thiazol-3(2H)-one Methylisothiazolinone (INCI) CAS number: 2682-20-4

≥ 1000 ppm


≥ 15 ppm

MIT effective dosage: 50–200 ppm

Increasing reports of sensitization to MIT in cosmetic products

An increasing number of published reports in recent years show that sensitization to MIT containing products is developing all over Europe. The sensitization cases occur mostly with cosmetics in which the use of MIT as a preservative is permitted up to the maximum allowed concentration of 0.01% (100 ppm).1 In the light of this information, the Scientific Committee on Consumer Safety (SCCS) was appointed by the European Commission to provide a reassessment of the safety of MIT, when used as a preservative in cosmetics products. In December 2015, the SCCS adopted an opinion stating that no safe use can be supported for leave-on cosmetics but, for rinse-off cosmetic products, a concentration below 0.0015% (15 ppm) MIT is considered safe for the consumer from the point of view of induction of contact allergy.

MIT classified as highly potent skin sensitizer for biocidal uses

For industrial uses, MIT had no entry in Annex VI to CLP Regulation (Classification, Labelling and Packaging). A self-classification with a Generic Concentration Limit of 0.1% (1,000 ppm) was applied for skin sensitization. The data submitted in the Biocidal Product Regulation (BPR) dossier supported a specific concentration limit (SCL) ≥ 600 ppm for MIT for skin sensitization. In March 2016, in the frame of the evaluation of MIT under the BPR, the European Chemical Agency (ECHA) published the conclusions of the Risk Assessment Committee (RAC).2 The RAC agreed to classify MIT as a highly potent Skin Sensitizer Category 1A with the Hazard Statement H 317 “May cause an allergic skin reaction” and a specific concentration limit (SCL) ≥ 0.0015% (15 ppm).

H 317: “May cause an allergic skin reaction” 30 Speciality Chemicals Magazine 36.08 November 2016

B I OC I D E S Hazard Statement

Hazard statements are part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) A hazard statement is a phrase that describes the nature of the hazard in the substance or mixture. H 317 is a hazard statement related to potential skin sensitizers. The product has to be labelled with the GHS 07 symbol (exclamation mark) plus the H 317 phrase: “May cause an allergic skin reaction” This new classification and specific limit will have also consequences for the authorization of MIT containing products for non-professional users. According to the Note for Guidance3 issued by the Commission, services responsible for biocidal products, products containing sub-category 1A substances at a concentration triggering classification as a skin sensitizer are expected to be restricted to professional users only, unless exposure can be avoided by means other than the wearing of personal protective equipment (PPE). In practice, this would mean that MIT can no longer be used in consumer products. This will have a major business impact for the preservation of consumer goods, and even professional detergents for which MIT is an essential active ingredient for effective in-can preservation.

Legal implementation end of 2018 earliest

The publication of the 10 th ATP (Adoption of Technical Process) with the new MIT labelling limits by the EU Commission is expected between mid and end of 2017. As the new legislation will be implemented 12-18 months later, the new limits are expected to come into force by the end of 2018 at the earliest.

Adaptation of the preservation strategy with MIT-free formulations

LANXESS is carefully following the implementation of this new classification and will provide customers with the necessary support to understand the consequences, and assistance in adapting preservation strategies accordingly. MIT-free formulations containing combinations of Isothiazolinones (BIT, CMIT/MIT, OIT) and Bronopol are already available, allowing the shift to complete MIT-free preservation systems. Looking ahead to the next step with non-sensitizing preservatives, it will be possible to use active ingredients or formulations with biocides that have little or no sensitizing potential (Table 1). These active ingredients are viewed as very good possible alternatives for detergent and cleaning products in the future. They can be tested alone or in combination to provide optimal preservation systems. Active ingredient


Dibromodicyanobutane (DBDCB)

Showed excellent results for dishwashing liquids Effective dosage below 1000 ppm (limit for EUH 208 label)

Dodecylguanidine hydrochloride (DGH)

Not a sensitizer Recommended for use in cationic systems such as fabric conditioners

Orthophenylphenol (OPP)

Not a sensitizer Long history in laundry detergents

Zinc pyrithione (ZPT)


Not a sensitizer Recommended for use in opaque fluids

Table 1 – Active ingredients that might replace MIT in the future, and which have little or no sensitizing potential


The increase in reported allergies to MIT is probably mainly driven by its use in cosmetics nevertheless its use as a preservative in products such as household detergents, glues or paints has been identified as an additional cause of sensitization. As a consequence, it was necessary to inform sensitized consumers about the presence of MIT with a proper labelling. However, the new drastic MIT classification and resulting restrictions of use will represent a challenge for industry because this is a key preservative for in-can preservation. Only a good understanding of the new labelling and legal implementations should allow the industry to overcome the H 317 challenge, and even to move forward with sensitizer-free combinations.

Regulation (EC) No 1223/2009 – Annex V/57. Committee for Risk Assessment – RAC Opinion proposing harmonised classification and labelling at EU level of 2-methylisothiazol-3(2H)-one (ISO) – CLH-O-0000001412-86-105/ F – adopted 10 March 2016. Note for Guidance: Authorization of biocidal products classified as skin sensitizers requiring PPE for non-professional users CA-Sept13-Doc.6.2.a – Final.Rev1 (Amended by CA-May14-Doc.5.2.a).

CONTACT Nicolas Gallacier Global Marketing Director Industrial Preservation & Coatings Business Line Biocides LANXESS Deutschland GmbH Material Protection Products Business Unit Cologne, Germany t: +49 221 88850 e:

Speciality Chemicals Magazine 36.08 November 2016 31


SiC Advanced-Flow Reactors for Highly Corrosive Media Olivier Lobet and Alessandra Vizza of Corning Reactor Technologies review how companies are at last taking a new approach to manufacturing, building facilities to make chemicals in a different way.


ntil recently, all pharmaceutical companies made drugs by mixing ingredients in large vessels, in separate steps, with no way of checking quality until each step was completed. As the industry has become more competitive, many companies have started looking at their operations and expenses.1 In addition, the FDA seems to be encouraging changes in processes to ensure high quality by design.2 Continuous flow reactors are recognized as one of the most effective process intensification solutions to improve chemical synthesis. The method introduces raw materials into a single, continuously running process. With the continuous flow approach, customers run the production processes ‘non-stop’ and they are able to make adjustments during the processing.

Advanced-Flow reactors

Corning started its continuous flow reactor technology development in 2002 at the Corning European Technology Center (CETC) in France, when flow chemistry was emerging as an active R&D subject.3 Corning’s Advanced-Flow reactors are designed for the seamless transition from lab feasibility to process optimization, and to commercial-scale production of chemicals for the pharmaceutical, fine and specialty chemical industries. These reactors comprise highly engineered fluidic modules that integrate heat-transfer and mass-transfer in a single piece of equipment. These scalable reactors enable seamless, cost-effective solutions for fast scale-up and the time to market. This increases the efficiency, scalability, yields and quality of chemical processing.4 Shorter processing times may help companies be first to market in industries where time is critical to success.5 Furthermore, the Advanced-Flow reactor is designed to use materials that allow chemical synthesis without corrosion. The use of specialty glass and silicon carbide (SiC) contribute to the manufacturing of corrosive synthesis that is not possible with other materials or technologies.

Why is SiC an attractive material for chemical reactors?

SiC exists in about 250 crystalline forms. Alpha SiC (α-SiC) is the most common polymorph formed at temperatures greater than 1,700ºC, and it has a hexagonal crystal structure. This is the SiC structure used in Corning reactors. SiC is suited to use in continuous flow reactors in a corrosive environment, typically at high temperatures, for a number of reasons. 1. Low thermal expansion (typically 4x10 -6/ºC), close to Corning Pyrex glass, provides SiC with excellent resistance to thermal shocks, at least enough to handle typical exothermic chemical reactions or thermal quenches that might occur in continuous flow reactors. 2. High thermal conductivity (110 to 180 W/m.K at 20ºC), typically a hundred times higher than glass, and ten times higher than Hastelloy, leads to the possibility of designing chemical reactors with high surface heat transfer coefficients. This is especially valuable for high volume production reactors, which can keep a high volumetric heat transfer coefficient despite higher channels. 3. SiC is a brittle material, but its biaxial flexure strength measured from a ring on ring testing is 450 MPa, with no impact of operating temperature (up to 1,400ºC). This is typically four times the biaxial flexure strength seen with glass. SiC is therefore able to handle high mechanical stresses, and it can do this continuously, considering its additional characteristics: high static fatigue coefficient, practically no cycling fatigue, and low creep, especially when temperatures are kept below 1,000ºC. SiC is a suitable

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material for designing fluidic channels that need to withstand very high internal pressures. Corning Advanced-Flow reactors can be operated up to 18 barg pressure and 200ºC. 4. High and broad chemical durability, especially for strong bases such as NaOH or KOH (even at high temperatures), for strong acids such as H2SO4, HNO3 and HCl, and even for hydrofluoric acids (HF) and fluorine gas, which are typically the limitations of glass materials (Table 1). These properties make SiC one of best material candidates for multipurpose chemical process development reactors and production reactors. SiC reactors enable access to conditions that cannot be achieved with glass and metal based reactors. Weight loss (mg/cm2.year)

SS 316 L



H2SO4 -96%




HNO3 -65%




NaOH -10% Low Tº




NaOH -30% High Tº







HCl -32%

Table 1 – Glass material can handle most chemical corrosions except for hydrofluoric acids (HF), F2 and highly caustic solution (NaOH) at 220ºC

Seamless scalable process development and production continuous flow reactors

Scaling up chemical reactions is always a challenging task. With conventional batch technology, the scale up is basically a process of increasing the batch size to address the need of larger production volume, trying to replicate results obtained in the lab and maintaining a high level of safety. When using a flow reactor, two variables are critical to maintain during scale-up: volumetric heat and mass transfer coefficients.6 To increase reactor throughput, the size and internal volume of the fluidic modules have to be increased while keeping the same performance characteristics such as residence time distribution, mixing quality, heat transfer and pressure drop for the same residence time. Corning has already demonstrated seamless scale-up from process development lab reactors made of glass or SiC (reactor G1) to production reactors made of glass (G3) and SiC (G4)7 (Figure 1).

When using a flow reactor, two variables are critical to maintain during scale-up: volumetric heat and mass transfer coefficients.


key performance characteristics are identical in G1 glass and G1 SiC reactors.

Figure 1 – Process development G1 SiC reactor and G4 SiC production reactor (courtesy of Angelini)

A major issue is heat transfer, which must be consistent when going from lab to production. A patented engineering solution developed by Corning has been able to generate the same volumetric heat transfer coefficient for the G1 SiC module as the G1 glass module and, therefore, the same volumetric heat transfer coefficient as G4 SiC reactor (Figure 3). This kind of equipment is offering a new perspective for process chemists, who are now able to develop flow chemistry processes based on high corrosive media, even with high pH chemicals, at high temperatures or with F2, and HF involved systems. With these SiC reactors, chemical throughput increases should be possible under the same conditions, with similar production reactor performances. The G4 SiC production reactor has been developed with increased channel dimensions, leading to a lower surface to volume ratio. However, in terms of heat transfer, this has been compensated by the significantly higher thermal conductivity of the SiC material (as explained previously). The volumetric heat transfer coefficient of about 1 MW/m3K has been retained. As disclosed in US patent US20140115871A1,8 making a seamless scale-up between small glass reactors and larger SiC reactors is achievable, following some design rules. However, scale-up from a small to a larger SiC reactor is different. In terms of fluidic design and channel sizes, the ones already used in G1 glass fluidic modules were used, one of them being the unique patented heart-shape design that offers optimal mixing, especially for multi-phases systems such as immiscible liquids and gas-liquid reactions. Consequently, key performance characteristics (e.g. residence time, residence time distribution, pressure drop and mixing quality) are identical in G1 glass and G1 SiC reactors. In terms of scale up, these characteristics are comparable between G1 SiC and G4 SiC production reactors, especially mass transfer (Figure 2).9

Different mechanical designs for different purposes

Despite the consistency of scale-up performances, Corning’s SiC flow reactors have different mechanical designs (Figure 4). The open mechanical architecture of the G1 SiC reactor offers chemist the possibility ‘to do it himself’. This offers an element of flexibility, for example to add more residence time, define different temperature zones, add injection points, or even to add a glass fluidic module somewhere inside the reactor configuration, making a SiC / glass hybrid reactor. This is the aim of the multipurpose G1 SiC reactor, providing ease of re-configurability, without referring back to the equipment supplier. The G4 SiC production reactor is a dedicated reactor, with process and utilities plate stacking mechanical configuration, but that can be fully customized, especially that can replicate the flow process defined at the lab level into G1 SiC. Despite the potentially large number of plates, the reactor is compact. Its integration into the production environment is aided by a flanges type of connection to, for example, the plant’s existing utility pipe system.








40 50 60 Residence time (s)

Volumetric mass transfer coefficient 3(W/m3/K) Volumetric heat transfer coefficient (W/m /K)

Volumetric mass transfer coefficient (l/s)

Exp. a ∙ τb 1.5E+06

G1 glass G1 SiC G4 1.0E+06



Operating window 0




Residence Dme (s)





Residence time (s)

Figure 3 – seamless scale up of heat transfer coefficient

Speciality Chemicals Magazine 36.08 November 2016 33

R E AC T OR T E C HN OL OGY Enabling and enhancing chemistries at severe conditions

SiC reactors enable access to harsh conditions not possible with glass and metal based reactors, leading most of the time to increased productivity.10 Two examples from the literature, the Wolff–Kishner reduction11 and the biphasic reaction of C alkylation,12 were performed using the Corning G1 SiC reactor. In the first example, the Corning G1 SiC reactor increased productivity 80-fold, by increasing internal volume. Due to seamless scale up of Corning Advanced-Flow reactor portfolios, this result can be readily achieved on an industrial scale using the G4 SiC production reactor. For the C alkylation, due to the high chemical durability of SiC, it was possible to demonstrate higher productivity, first by increasing reaction temperature and then increasing NaOH concentration. Ultimately, 100% conversion was achieved in 30 seconds.

Customer experience moving from lab to industrial production

Since 2015, when the G1 SiC reactor was included in the Corning reactors portfolio, the number of applications requiring such materials has increased. Seamless scale-up has been proven by numerous applications and it is currently used by several customers in Europe and Asia, especially in FDA compliant sites. The Italian pharmaceutical company, Angelini, recently stated, “Continuous Flow reactors allow us to perform new syntheses not possible before, increasing yields, product quality, scalability and efficiency of chemical processing, reducing at the same time the performance variability and cost.” The introduction of such technology in their FDA compliant plant in Aprilia opens new opportunities for API production.

Concluding Remarks

It is clear that continuous flow reactors are now a reality for the industrial application and production of chemicals. The seamless scale up between the lab and the production unit offers proof that Corning Advanced-Flow SiC reactors offer an efficient, scalable approach that may increase yield and the quality of chemical processing, while simultaneously reducing costs. The process allows the use of highly corrosive media, and this is important in a market that needs to perform chemical synthesis without being limited by its equipment. The robustness of the product, and the engineering capabilities of the company, continue to be criteria that attract customers looking for market leadership and high quality.


Figure 4 – G1 SiC and G4 SiC mechanical architecture, open and stacked

Continuous Flow reactors allow us to perform new syntheses not possible before.. 34 Speciality Chemicals Magazine 36.08 November 2016

1. J D Rockoff. The wall Street Journal, Feb. 8, 2015 “Drug making breaks away from its old ways”. 2. P Poeschlauer, R Guidat. Specialty Chemical Magazine 2015;35:32-34. 3. W Ehrfeld, V Hessel, H Löwe. Microreactors: new Technology for modern chemistry – Wiley –VCH 2000. 4. G Calabrese, S Pissavini. Aiche Journal 2011;54:828-834. 5. F Schimdt, B Chevalier. Chemistry Today 2009;27:4-5. 6. J Jorda, A Vizza. Specialty Chemical Magazine 2012;33:19-21. 7. R Guidat, A Vizza. Specialty Chemical Magazine 2015;35:30-32 . 8. R Guidat, et al. US20140115871A1 Systems and method for scale up of continuous flow reactors. 9. D Lavric, C Cerato-Noyerie, P Woehl, F Zhang. Multiphase systems: Enhanced Mass Fluxes in Corning Advanced Flow Reactors, IMRET 12, Lyon, France (2012). 10. C Horn , A scalable metal free pilot size flow reactor for highly corrosive media IMRET 2016, Beijing, China. 11. K Jensen et al. Green Chemistry 2014;16:176. 12. M Ueno, et al. Chem Comm 2003,936-937.

ACKNOWLEDGEMENT To the Corning AFR team and particularly to the R&D team for the experimental work.

CONTACT Contact Alessandra Vizza Abrial Regional Commercial Manager EMEA & NSA Corning Reactor Technologies | Corning SAS | Avon Cedex France t: +33 (0) 1 64 69 76 82 e:


Industry 4.0 Delivers Significantly Increased Competitiveness As Industry 4.0 leads to the creation of more ‘smart factories’, Dr Dirk Kirschneck, Managing Director of Microinnova Engineering GmbH, considers its impact on the fine chemicals industry.


he term ‘Industry 4.0’ is said to originate from a project emerging from the high-tech strategy of the German government, which promotes the computerization of manufacturing. The term allegedly refers to the fourth industrial revolution whereby, in context, the first industrial revolution used water and steam power, the second introduced mass production, the third electric power, and now – the fourth – relates to the digital revolution and the use of electronics and IT to further automate production. The name was first proposed only in 2011 at the Hanover Fair, but plans and a report soon followed in 2013, leading fairly rapidly to formal adoption of the term by the German government, and widespread adoption of the movement across the world. Under Industry 4.0, within modular-structured ‘smart factories’, cyberphysical systems monitor physical processes, create a virtual copy of the physical world and make decentralized decisions. Cyber-physical systems communicate and cooperate with each other and with humans in real time, leading to increased speed, efficiency and numerous advantages over conventional manufacturing plants.

Drivers for Industry 4.0

The main driver for Industry 4.0 is increased pressure towards competitiveness and manufacturing productivity. The rapid increase in cross-border movement of goods, services, technology and capital leads to the emergence of a global market. The challenge is to push the main parameters for competitiveness to a new global level. Industry 4.0 for chemistry will enable manufacturers to apply innovative tools, which will increase speed to market and boost productivity for improved competitiveness on a global level. Time Time is one of the most important success factors. Lead times, development times and stock change-over times all contribute to overall business performance. Innovations of Industry 4.0 enhance the ability to minimize development time for new products, keep production times low, or make rapid system changes in order to generate higher profits. Smart manufacturing in the chemical industry needs to address the challenges of start-up and change-over times. Non-value generating steps need to be removed. Optimization of mass and heat transfer will reduce operating times significantly, while on-line analytics and good process understanding will permit rapid response to failures and increase manufacturing performance. Quality Manufacturing excellence requires a high level of process capability to maximize the potential for getting it ‘right first time’, and to minimize the need for rework procedures or corrective actions. For example, powders and polymers often have particle-size-distributions or molecular mass distributions of two magnitudes, while a tighter specification would have a better product performance. Smaller lots with specific characteristics will enable tighter specifications and more complex products.

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Resources Cheap labour has been one of the fundamental success factors for business models in medium developed countries in the past. This will change in the future, as it will become possible to run automated chemical manufacturing plants with a minimum of staff. Another success factor will be the availability of cost-effective educt materials. Industry 4.0 will have a significant impact with the same strategies as described here. Advanced manufacturing strategies generate new options to act on raw materials as well. Another strategy could be a backward integration. Costs A lot of the parameters associated with time, quality and resources can be translated into costs. Building up a cost function may lead to key drivers for cost optimization. Typical drivers for cost optimization are increased yield, selectivity, safety and space-timeyield, and reduced workup and staffing demands. However, since every molecule is different, their cost functions will be different, too. For example, linking different chemical steps together could lead to less workup and reduced working capital. Intensified reactions reduce the plant size with an impact on, for example, the safety level, ATEX concept and a reduced infrastructure demand. Furthermore, intensified processes achieve higher yields and can be performed in fully automated plants, subsequently reducing the number of operators needed for manufacturing.

The toolbox for future processing

Cross-Linking New options in automation and communication technologies offer a wide range of cross-linking options. For example, the manufacturer can link with the plant construction company for preventive maintenance, ensuring maximum plant utilization and minimizing unplanned downtime. This interaction may lead to a shift of responsibilities for plant availability towards the construction company. In another example, a link between the raw material supplier and the manufacturer could enable on-demand supply. A detailed quality feedback loop would enable the supplier to continuously improve on a deeper level. Knowledge-based processing Unlike other industries, the fine chemical industry still executes a lot of traditional processes, based on previous trial-and-error methods. Most processes are transferred to manufacturing by means of their adjustment to existing batch plants. The continuous processing approach transformed the petroleum industry in the 1960s and, due to cost and performance factors, almost all transformations in that industry are now operated in a continuous way. Continuous processing enables two fundamental things: first, a much better control of parameters, allowing the same conditions for all molecules; and second, new


strategies can be applied, which are not possible in batch processes. Furthermore, mass and heat transfer distances can often be reduced, along with processing times. Other industries describe their process capability by means of the six sigma approach. This enables an evaluation of the process capability for a certain applications based on the relationship of parameter fluctuations in comparison to the specified limits. Implementing such methodologies to manufacturing processes clearly increase performance levels. Process Excellence by deep Process Understanding Process excellence is an indication of how product quality may be influenced by the process and its execution. The key to success is to build a model that describes the connection of the quality parameter to the processing parameters on a cause-effect base. The quality of a product is typically described by means of a quality parameter list in a specification. These quality parameters are sometimes considered to be critical quality attributes (CQA) of a product, and they are influenced by critical process parameters (CPP) identified in the manufacturing processes. The fundamental idea is visualized in Figure 1 for the CQA Crema, the gold brown foamy layer on an espresso. The figure shows that four quality issues can occur to the crema: it can be too dark, too light, too less or not stable. Too dark can be caused by the roast grade of the beans, the particle size distribution in the milling step or by the extraction temperature. An unstable crema is caused by the age of the beans or by the extraction pressure.

Figure 2 â&#x20AC;&#x201C; Microinnovaâ&#x20AC;&#x2122;s systematic way of identifying CPP, by analysing the process from six different perspectives Smart Manufacturing A right-first-time philosophy pushes focus to the chemical reaction and reduces workup effort. On-line analytical tools enable a model predictive control of manufacturing plants. One step further would be the implementation of self-optimizing systems for production. It is expected that modular and flexible continuous operating manufacturing plants with a high automation level will be the backbone in chemical manufacturing in the future. A minimum of labour demand will enable European and American companies to compete with the Far East. Small reaction volumes and precise control will increase safety levels of chemical manufacturing.

Conclusion: Business Game-changer Industry 4.0

Figure 1 â&#x20AC;&#x201C; Critical quality attributes (CQA) of a product are influenced by critical process parameters (CPP) in the manufacturing processes At Microinnova we have a systematic way to identify this processing knowledge. To CPPs, the process is analysed from 6 different perspectives, as shown in Figure 2. First, reaction and interaction, where consecutive or side reactions might compete with the main reaction (and degradation could occur in some cases). CPPs can occur in mass transfer and in heat transfer. The processing system could be influenced by the environment of the molecule like complexes or pH effects. Conditions refer to concentrations, pressures and temperatures and their impact on the system. The source represents all effects coming from the raw materials. Based on the CPP analysis, a technology selection can be made. This selection uses CPP data on the one hand, and on the other hand other important parameters such as application scale or media viscosity. In some cases, it makes sense to use sophisticated process intensification technologies to finally operate as efficiently as possible.

Industry 4.0 delivers a significant new impact for the future competitiveness of companies. Classical issues like cost advantage on lower plant operator wages in emerging markets will become less important, as new success factors rise. The ability to innovate will be the most important success factor for the future. The choice of business model will be a constantly dynamic procedure, contrasting with the past, when business models lasted for decades. Industry 4.0 will be a game changer for the chemical business. Every company that is able to adapt to new strategies quickly will likely generate a significant advantage with respect to competitiveness.

CONTACT Dr Dirk Kirschneck Managing Director Microinnova Engineering GmbH Allerheiligen bei Wildon Austria e: t: +43 3182 62 62 61 10

Speciality Chemicals Magazine 36.08 November 2016 37


Next Generation Solar Power: Building Integrated Photovoltaics Solar energy has the potential to account for as much as 50% of the world’s total energy consumption. We take a look at the emerging market for building-integrated photovoltaics, which offer the opportunity “to turn buildings into power stations”.


urrently, the main share of the photovoltaic market comprises first-generation cell technologies based on wafer-based semiconductors of single crystalline and multi-crystalline silicon (c-Si). In addition, there are wafer products with the more expensive and more energy efficient gallium arsenide. The remainder of the market consists of the second-generation technologies of thin film cells based on materials like cadmium telluride, copper indium gallium selenide and amorphous thin-film silicon (a-Si, TF-Si). These technologies have their limitations, mainly in terms of costs, capacity for being manufactured on a mass scale and potential to raise their energy efficiency. The enormous predicted increase in solar power, from a current global share of less than 1% to up to 50%, will depend on the development of technologies that can manufacture solar cells for the conversion of light to energy on a mass scale, at low cost and with a highenergy efficiency from materials with a long-life cycle. As a result, much funding has been poured into finding the next generation of solar power technology, in the hope of discovering a breakthrough that would help photovoltaics gain a much bigger share of total energy consumption. In particular, research is focussed on materials that could expand segments of huge potential such as building-integrated photovoltaics (BIPV). This offers the opportunity for solar cells to be embedded in glass, facades, and even interiors, effectively turning buildings themselves into power stations. “The big challenge is the creation of an international BIPV market,” says an executive at one European solar cell manufacturer. “It will generate demand for solar cells in such large volume that it will become the future cash cow of the photovoltaics industry.” However, this search for a dominant third generation technology suffered a setback when the average prices of solar modules started to slide around 6 years ago. The price of a c-Si module dropped from an average $2.75 per watt (W) to around $1 by the end of 2012. The decline slowed in the wake of a revival in worldwide demand for solar panels in 2014, but the fall has continued, with average prices dropping to around $0.60/W for c-Si modules in late 2015. By the end of decade, average prices are expected to be below $0.50/W. The main impetus behind the decline in prices has been China, which has been investing large sums in solar power, to boost its renewable energy resources. Chinese-installed solar energy capacity soared from around 500 MW in 2010 to 43,000 MW by the end of 2015. Due to China’s strategy of being as self-sufficient in the energy sector, most of its solar cells are made in the country. Therefore, there has been a massive rise in subsidized production capacity, the majority based on polysilicon. This drove down Chinese module costs from $1.30/W in 2011 to $0.50/W by 2014. Over the past two years, Chinese costs have stabilized, allowing Western competitors to catch up. First Solar Inc., a leading US thin-film manufacturer, was making modules at $0.40/W earlier this year with analysts predicting that it would be achieving costs of $0.25/W by 2019. Cost is a priority in the development of new technologies, whose production processes not only have to be cheap, but whose applications through the supply chain have to be inexpensive as well. Great hopes had been pinned on dye sensitized solar cells (DSSCs) because at the laboratory stage they were registering relatively high energy levels and looked cost competitive. However, they have proved to be more complex to scale up

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for mass production, although certain DSSC products are already establishing themselves in niche markets. Instead, the prospects of DSSC have been downgraded in favour of perovskite, an abundant and cheap mineral whose crystals can be structured into layers suitable for absorbing light for conversion into energy. Since the early 2000s, researchers have increased its energy efficiency in the laboratory from 4 percent to over 20 percent. On the other hand, perovskite solar cells require the use of lead and other toxic substances. Also, they degrade when exposed to moisture. Some of their component materials are expensive. Nonetheless, many of the problems with DSSCs, perovskite and other new technologies are considered solvable. They have attracted substantial research funds, a large proportion of which has been going into academia. As universities and other research institutes – headed by the Swiss Federal Institute of Technology in Lausanne (EPFL) and Oxford University’s physics department – became the leaders in solar energy R&D, manufacturers in the sector have had to rely on partnerships with academia for the scientific knowledge to support the commercialization of new technologies. Most of these manufacturers are start-up companies because many multinational chemical players which have a lot of scale-up expertise have pulled out of the sector due to the squeeze on profitability from tumbling solar module prices. BASF, for example, has virtually given up research in DSSC materials, and also in printable organic photovoltaics (OPV). It has, however, remained a participant in a big BIPV/DSSC research project, called SPECIFIC, in Wales in the UK, led by Swansea University’s department of engineering, a specialist in DSSCs, and the Indian-owned Tata Steel. Research projects like SPECIFIC, which initially focused on DSSCs especially for integration with building structures, have been switching more attention to perovskite cells. This has accelerated progress in the commercialization of perovskite-based solar technologies which can be used in large-scale applications. “The commercialization of perovskite cells should start in around three years, provided some of the problems like durability and environmental issues can be resolved,” says Barry Jenkins, marketing manager for the GCell business of G24 Power, Newport, Wales. The intensification of perovskite research has led to ways of dealing with its major difficulties as a solar energy material. For example, EPFL, which like other DSSC-orientated institutes has transferred resources to perovskite research, has helped lower perovskite cell costs by developing a cheaper material for transporting particles to cell electrodes. In addition, Dyesol, an

The BIPV market will make solar cells the future cash cow of the photovoltaics industry.


The commercialization of perovskite cells should start in around three years. Australian-based DSSC specialist manufacturer that has moved quickly into perovskite, is working with EPFL to tackle the problems around the life-times of perovskite cells. “(We) are focusing intensely on long-life materials and architectures, and long-life Performance, testing at 85°C heat for 1000 hours and light soaking at one sun for 1000 hours,” the company says. “Dyesol is developing technology to achieve this on larger, commercial devices as part of a rigorous riskmitigation strategy as it scales towards mass manufacture.” Scientists at Oxford University’s physics department, where a team led by Professor Henry Snaith have been making big advances with perovskite, have developed a low-toxicity solvent system for the manufacture of perovskite solar cells, removing one of the major barriers to their commercialization. Furthermore, it opens the way to solution-processing of the cells for their industrial upscaling and large-area printing. “We have now developed the first clean, low-boiling-point, low-viscosity solvent (for solution processing),” says Nakita Noel, a leading researcher at the department. “What is really exciting about this breakthrough is that largely reducing the toxicity of the solvent hasn’t led to a reduction in the efficiency of the material in harnessing solar energy.”

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After being pushed into second position in the race to become the leading third generation solar technology, DSSC has started to compete more strongly with perovskite by cutting costs and improving its versatility. In some cases, this has been done by combining dye-sensitized and perovskite materials in single cells. EPFL, where Professor Michael Graetzel and Brian O’Regan first developed DSSCs by working with particles on the mesoscopic level, has been opening new and extended avenues for application of dye-sensitized products. These include broader use of DSSCs in electronic portable devices and in glass panels in buildings, two sectors in which the cells are already been applied commercially. The institute believes it can respond to a strong demand for DSSC glass panels in buildings, particularly for specific colours like green and blue. “We shall develop new routes for preparing an intensely blue organic dye whose synthesis can be up-scaled to the 100 kg quantities,” EPFL says in a statement on its research plans. “We shall also endow the currently used green porphyrin dye with stronger anchoring groups and simplify their synthesis. Furthermore, we shall design and synthesize highly stable novel organic sensitizers, which respond in the visible and near IR regions.” G24, which has a close development partnership with EPFL with Professor Graetzel being one of its advisory board members, is working on processes for commercializing the institute’s newly developed DSSC materials. “There’s plenty of potential still in dye sensitizers,” says Mr Jenkins. OPVs are also still considered to have a big future, while emerging technologies like quantum dots which use nano-metal particles to absorb light are demonstrating prospects for the high-speed printing of solar cells. The factors favouring the long-term future of the new technologies is not only their low cost and flexibility in contrast to the rigidity of silicon but also their wide range of possible application. This versatility is essential if solar cells are to become an ubiquitous source of energy.

MAY 16 - 18, 2017 16Center - 18,• Philadelphia, 2017 PA, USA Pennsylvania MAY Convention Pennsylvania Convention Center • Philadelphia, PA, USA

Not just a new location, a new approach. InformEx, the dynamic event held to build partnerships among buyers and sellers of fine and specialty chemicals, is coming to Philadelphia next May! The home of chemistry innovation, this leading fine chemical show will share exhibition space with the inaugural edition of CPhI North America. Take advantage of unprecedented access to the complete specialty chemical and pharmaceutical industries— all under one roof! Register today at!

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© Ivan Muñoz


The 27th meeting of CPhI Worldwide in Barcelona last month brought together more than 42,000 attendees. They travelled from 158 countries to see 2,582 exhibitors.

Five events in one

CPhI Worldwide gathers not only the entire supply chain together, but also centralizes vital information, analysis, and thought leadership – broken down by industry segments and services to fill separate parts of the exhibition. The three-day exhibition included P-MEC (Pharmaceutical Machinery and Equipment Convention), ICSE (International Contract Services Expo), Innopack and FDF (Finished Dosage Formulations), effectively making CPhI Worldwide five events in one. The FDF show represented a new launch, which will become a brand in its own right as of 2016 due to its size (it was the third-largest segment in 2015), and is even seen as evolving into its own show, going forward.

Expertise and impact

The quality of many of the stands on display, and the expertise available on-site, was astounding. This event, which offers the opportunity to meet with customers and contacts in person, is integral to the businesses and partnerships that drive pharma. We doubt that anyone attending CPhI will quickly forget its scale and scope. A number of companies used the CPhI event to showcase their perspectives on key products, innovations and services. More than 70 presentations were offered, covering topics as diverse as ‘increasing speed to clinical trials of potent molecules’ (David O’Connell,

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PCI Pharma Services) to ‘plant cell culture as a controllable and scalable supply solution’ (Gilbert Gorr, Phyton Biotech), or ‘enzymatic synthesis of chiral intermediates and APIs’ (Hiroshi Kawabata, API Corporation). Presentations covered product research, development and manufacture, finished dosage formulations and packaging. Also interesting was the ‘5 minutes with’ series of videos, constantly playing around the exhibition centre as top executives from a great range of exhibiting companies were interviewed live at CPhI.


A dedicated CPhI Innovation Gallery brought together three platforms spanning CPhI/FDF, ICSE and InnoPack. The CPhI/FDF Innovation Gallery showcased the most exciting pharmaceutical manufacturers taking part in this year’s show, including: Endoca’s industrial scale processes to produce up to 99% pure cannabinoids from hemp; Rontis’s infant and baby nutrition range of products with an advanced blend of pre and probiotics; Cafosa’s functional chewing gum aimed at supporting oral health; Aker BioMarine’s kril oil concentrate, which contains significantly higher amounts of phospholipids, omega-3s and choline; Cerbios Pharma’s new cGMP manufacturing unit for particle engineering based on super critical fluid technology; Ashland’s cellulosic polymer carrier used for bioavailability enhancement of poorly soluble drugs; Ambah/PSI’s ibuprofen intravenous (IV) infusion; and Laboratorios Beta’s development of innovative formulations. The ICSE innovation Gallery showcased contract service providers: Sirio Pharma’s softgel technology designed for the needs of the healthy lifestyle market; Vetter’s ready-to-use closure system for pre-filled syringes; Bespak’s contributions to the design, development and industrialization of some of the world’s leading medical devices; Patheon’s position as a leading global provider of pharmaceutical development and manufacturing services. The InnoPack Innovation Gallery showcased packaging manufacturers: Neopac and GEKA’s precise, hygienic single topical application of oral fluids or dermatological lotions, and Nipro PharmaPackaging’s new technology that strengthens the surface of the primary glass container.

IND U S T RY E V EN T S Pharma Awards Show

Another highlight was the annual CPhI Pharma Awards Show. Established in 2004, the Awards are designed to honour companies and individuals driving the pharmaceutical industry forward through innovations, new approaches, technologies and strategies. This year, four new categories were added: Drug Delivery Devices, Regulatory Procedures and Compliance, Analysis, Testing and Quality Control, and Corporate Social Responsibility. With these additions, the whole pharma supply chain was covered. Congratulations to the 13 prestigious pharma leaders, who were picked from 100 entries (see table below). Excellence in Pharma category


API Development

Novel Synthesis of dronedarone intermediate, Cambrex

Formulation and Excipients

Parteck SRP 80 Excipient, Merck* (Excipients) Using intrinsically enteric capsule technology to deliver enteric protection and delayed release achieved without functional coating, Capsugel (Formulation)


Pyclear Protection: patient protection and cost-efficiency, Pylote

Drug Delivery Devices

3M Intelligent Control Inhaler: the new future for addressing patient adherence and competence in Asthma and COPD patients, 3M

Contract Services & Regulatory Procedures and Compliance Outsourcing

OptiForm Solution Suite and OptiForm Solution Suite Bio, Catalent Pharma Solutions

Regulatory Procedures and Compliance

Emprove Program, Merck*

Supply Chain, Logistics & Distribution

MENA region, raising star with new challenges, Pharma Venture Mena – FZC

Analysis, Testing, and Quality Control

NanoLIBS, B&W Tek


BioSC Lab: DSP purification breakthrough for the biopharma industry, Novasep

Manufacturing Technology and Equipment

The future of continuous pharmaceutical manufacturing: ConsiGma, GEA Group

Corporate Social Responsibility

Centella asiatica project in Madagascar, Indena

CEO of the Year

Udit Batra, PhD, Member of the Executive Board of Merck and CEO, the life science business of Merck* [Udit Batra is CEO of MilliporeSigma]

*the life science business of Merck operates as MilliporeSigma in the United States and Canada

Andreas Mavrommatis, Global Marketing Director at UBM EMEA, added: “The CPhI Pharma Awards celebrates the entire pharma industry, its unique achievements, key people and technological innovations – it’s a celebration of everything that is best in our industry. In the last few years, we have seen an impressive increase in the number of entries, a growing appreciation of the overall value and prestige that winning an Award confers on a company, and, of course, a tremendous increase in the quality of emerging technologies submitted for consideration.” He continued, “Feedback from our judges is that they have been simply blown away by the consistent quality of submissions – which makes their job of choosing a winner all the more difficult. On behalf of CPhI Worldwide and UBM EMEA, I would like to commend all of the finalists and offer my warmest congratulations to this year’s worthy winners.”

Sustainable Stand Award

This year’s winner of CPhI’s Sustainable Stand Award was Bachem. The Swiss firm took great efforts to design their stand to ensure maximum customer experience while greatly reducing their environmental impact by choosing to use a stand comprised of 100% recyclable materials.

Cambrex won the ‘Innovation in API Development’ category for the development of a novel synthesis of an intermediate for Dronedarone. The original route involved a linear, five step process, including a Friedel-crafts addition, and large quantities of chlorinated solvent which was unsuitable for scale up if demand reached the projected peak. Key improvements included: A four step, convergent process which has been covered by three process patents (the route eliminates the Friedel-Crafts addition and a nitration step). Elimination of metal halide catalysts and chlorinated solvents for a more environmentally beneficial process. Minimised waste with the recycling of the major solvents (tetrahydrofuran and acetic acid). Reduction of the cost of goods by up to 40% against the identified ‘next-best route’. Efficient scale up on plant using a 6,000L reactor to manufacture 1MT batches. The new route is also beneficial as it removes all sulfur-containing reagents incompatible with down-stream catalytic hydrogenation. The route was shown to be safe and robust, producing high quality product with only one single impurity, less than 0.05%.

CPhI Annual Industry Report

While many exhibitors took this opportunity to launch their new products, CPhI themselves launched their new Annual Industry Report on the first day of the show. The report, entitled ‘Prospects, Analysis and Trends in Global Pharma’, can be freely downloaded from europe/cphi-annual-report A group of experts, some of whom contributed to the report, discussed the highlights and key takeaways. The generic market was worth an estimated $193 billion in 2015, and the report projects a growth at 6.9% (CAGR) through 2020. Alan Sheppard, of IMS Health, called for more education and trust regarding generics. Many countries could realise big savings by making more use of available generics, he explained. Kate Kuhrt, of Thomson Reuters, noted that North America is still the key opportunity for generics companies, but there is still great interest in Europe and Asia markets. Generic companies in China and Japan have similar aspirations, and they are facing challenges as they look at expanding. Hurdles for generic companies include regulatory scrutiny, explained Kuhrt, and she stressed that companies should think more about adherence to good current GMP rather than “blind compliance”. Vivek Sharma, of Piramal Enterprises, discussed the growing importance of HPAPIs. This is currently a $12.5 billion market, growing at 7.8%. About 25% of drugs in development at HPAPIs, which supply better results and longer duration. There is a big trend in out-sourcing, Sharma explained. Finally, Ravi Limaye, of Biocon, summarized the report’s findings on biosimilars. The market was worth only $1.7 billion in 2015, but is predicted to grow 20-fold by 2020 to $35 billion. Limaye predicted some 350 biosimilar launches by 2020, as a large biologics market opens due to patent expirations.

"Generics are not just there to save money, they’re there to save lives." Alan Sheppard

"The cost of noncompliance is greater than the cost of compliance.” Kate Kuhrt "Companies look for CDMOs with a good track record in regulatory practices and launches." Vivek Sharma

Speciality Chemicals Magazine 36.08 November 2016 43


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egulators, authorities and biocides businesses are continuing to get to grips with the intricacies of the EU Biocidal Product Regulation (BPR). Stakeholders are continually having to develop a better understanding of this complex piece of legislation and its applications. As implementation progresses, an increasing number of companies, across a range of industrial sectors, are feeling the effects. There is a growing need to know their obligations, if they are going to remain within the law. Companies also need to understand the likely impacts of BPR on the supply of ingredients required for the production and performance of their products. Biocides Europe 2016 promises attendees the opportunity to listen to, and gain valuable insights from, senior representatives from European institutions, regulators from Member States, and industry representatives from across the EU. Attendees should be able to bring themselves up-to-date with the complex and changeable regulatory landscape concerning biocides by attending two conference days and a choice of two workshops. Presentations include latest developments from the European Commission and ECHA. As well as discussing details of BPR, speakers will address topics such as efficacy testing of disinfectants, risk assessment, enforcement, EDCs and other borderline topics including MRLs, cosmetics and medical devices. The programme also includes some insights into the regulatory scene for biocides in the US, South Korea and Vietnam.





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44 Speciality Chemicals Magazine 36.08 November 2016

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START SPREADIN’ THE NEWS… SOCMA will play host next month to hundreds of specialty chemical industry decision-makers at their 95th Annual Dinner in New York, New York. EVENT DATE LOCATION

SOCMA's 95th Annual Dinner 5th December 2016 Crowne Plaza Times Square Manhattan, New York, NY, USA




Member Table (for 10 individuals): $3,750 Non-member Table (for 10 individuals): $4,750 SOCMA Member Individual: $380 Non-member Individual: $480 Walk-In: $550


Caron Turner (for registration questions) Email: Tel: +1 (202) 721 4166


PROGRAM OVERVIEW (5th December) 3 PM

SOCMA Annual Business Meeting (members only)

4 PM

Educational speak showcase

5 PM

Speed networking reception

6 PM

Cocktail reception

7 PM

Dinner, awards, entertainment

10 PM

Cordials reception

46 Speciality Chemicals Magazine 36.08 November 2016


ince 1921, the Society of Chemical Manufacturers and Affiliates (SOCMA) has represented a diverse membership of small, medium and large chemical companies from around the world. The association is dedicated to specialty chemical manufacturers, distributors and affiliated service providers, and it is the only US-based trade association dedicated solely to the specialty chemical industry. SOCMA is a recognized voice of that industry. Collectively, SOCMA members are key drivers to a successful economy, contributing $24 billion annually to the US GDP. Their members play an indispensable role in the global chemical supply chain by producing intermediates, specialty chemicals and ingredients used to develop a wide range of industrial, commercial and consumer products. On 5th December, hundreds of those members will gather at the Crowne Plaza Times Square Manhattan. SOCMA’s 2016 Annual Dinner will be preceded by an afternoon of Educational Speakers. Peter Tanous, Founder and Chairman of Lynx Investment Advisory, will provide SOCMA members and guests with an economic update. Christopher Lukach, President of the Anne Klein Communications Group, LLC, will discuss the importance of crisis communications. Attendees will enjoy an evening of networking, fine dining and entertainment. Additionally, highlighting the event will be an awards ceremony honouring winners of SOCMA’s Performance Improvement Awards. The awards recognize their members’ commitment to continuous improvement, outstanding EHS&S performance and educational outreach through the ChemStewards® Program.


Expect EPA Resources to Play Major Role in TSCA Implementation The Environmental Protection Agency (EPA) has begun carrying out mandates just months after the Frank R Lautenberg for Chemical Safety for the 21st Century Act, or what some are calling the new Toxic Substances Control Act (TSCA), was enacted, and agency resources could be one of the biggest factors facing specialty chemical manufacturers. “As EPA continues to implement the new TSCA, much of its success, or failure, will depend on resources and how they are allocated, and some of those resources will come from industry,” said SOCMA Government Relations Senior Manager Dan Newton. According to the new law, 25%, or $25 million of program costs, whichever is the lower, will come from industry. “Industry stakeholders should expect EPA to attempt to recover $25 million since program costs and overhead are expected to exceed $100 million in the years to come,” Newton said. “The fees will be used for section 4, 5, 6 and 14 activities, but there likely will be increased pressure on companies subject to actions under the new chemicals section and risk evaluation section to generate much of the $25 million.” This creates somewhat of a dilemma, Newton said. “If EPA puts too much focus on section 5 new chemicals and attempts to get smaller businesses to foot more of the bill, innovation could be negatively impacted,” he said. “We could see a significant decline in the number of new chemicals introduced, particularly by smaller companies. This is a direction we do not want to go. But, EPA will need adequate resources to review chemicals in commerce expeditiously, which should, over time, enhance public confidence.”

Balancing the fee structure will be no easy task, but SOCMA is confident EPA will pay close attention to small business concerns and consider incentives for innovation and come up with an equitable structure that gets them the resources they need to carry out the law, Newton said. EPA has also started using new criteria prescribed by law on new chemical pre-manufacture notices (PMNs), which now require an affirmative finding of safety. This also included PMNs that were submitted prior to enactment, but pending expiration of the 90-day review period. The new law requires an affirmative review and determination of whether a new chemical presents, may present, or is unlikely to present an unreasonable risk of injury to health or the environment. “Manufacturers can expect increased delays, at least in the short term, and potentially more consent orders and significant new use rules (SNURs),” Newton said. “EPA is also taking a closer look at what constitutes confidential business information (CBI),” Newton said. “The new law requires EPA to review all chemical identity claims, and 25% of most other types of CBI, such as volumes, and then make a determination as to whether the claims are valid. Manufacturers will continue to get default

CBI protection on their new chemical notices until they decide to commence manufacture. But, at that point, EPA will be taking a closer look at the claims. Manufacturers should be prepared to defend them. There are a number of questions companies will have to answer, and they will have to certify their substantiations are accurate.” Furthermore, EPA has already started developing rules on processes for prioritization and risk-evaluation of existing chemicals, a new fee structure and an inventory reset. Proposed rules are expected to come out in mid- to late December with final rules expected in June 2017. TSCA implementation was a key topic of discussion during SOCMA’s Chemical Risk Management Committee meeting on November 1, and will be the focus of an Educational Showcase at SOCMA’s 95th Annual Dinner on December 5, where the afternoon session will include a discussion on TSCA reform for the C-Suite with Jamie Conrad, an attorney with Conrad Law & Policy Counsel, and Beth Bosley, President of Boron Specialties. Also, stay tuned for more on the SOCMA small and medium enterprises (SMEs) track at GlobalChem 2017, the premier chemical regulations conference. This track will focus primarily on how new TSCA could impact specialty chemical manufacturers and SMEs.

Dan Newton, Senior Manager, Government Relations, SOCMA

Jamie Conrad, Conrad Law & Policy Counsel

Beth Bosley, President, Boron Specialities

Speciality Chemicals Magazine 36.08 November 2016 47


SOCMA Members Seeing Increased Business in Toll Manufacturing More and more chemical companies are outsourcing the manufacture of those chemicals for which they may lack either technical expertise or efficiencies of scale. This practice is commonly known as contract manufacturing, or tolling. When you look at the world of contract manufacturing, there are many trends and factors that impact not only the relationship between the customer and supplier but also the success of the partnership and the company’s bottom line.


n general, SOCMA members have reported increased new business inquiries and expanding opportunities with existing customers, year over year. As a result, some member companies are expanding their operations through infrastructure upgrades. One key factor impacting a tolling relationship is the real cost of commercialization of a new product, which can be quite expensive. “Those customers that understand the costs involved and are prepared to take those risks are the ones that are the most successful,” said Jay Dickson, President of Nation Ford Chemical, Inc., a specialty chemical and toll manufacturer in Fort Mill, SC. To ensure success in the customer-supplier relationship, SOCMA members must set parameters and establish ongoing control mechanisms written into their contractual supply chain agreements. “Besides price and quality, which are obviously included in a supply agreement, volume expectations should be the third most important element,” Dickson said. “Typically, tolling customers are overly optimistic on how quickly their sales will develop with new projects. It is important that both the toller and the customer include minimum and maximum volumes, as appropriate, in a supply agreement.” These agreements tend to vary between different types of customers. For example, “pharmaceutical contracts may include more details relating to acceptable quality of product and product specifications compared to those that involve industrial products,” Dickson said. “Small companies are more interested in the relationship rather than the contract, while the large companies have specific procedural methods prior to hiring a toller. In other words, toll production for a small company can be based on trust rather than attempting to write-in all details into a lengthy contract.” John Foley, CEO of KMCO LLC, has spent 30 years of his career working at large, multi-national specialty and agro chemical companies, and offered the following insight into developing successful tolling relationships. “Now, having the opportunity to head KMCO, one of the largest global customer chemical manufacturers, my advice would be to ensure that you partner with companies that not only have the assets capable of producing the chemistry, but also the strategic, long-term commitment to custom manufacturing, plus a management team with the bandwidth to deliver competitive, operational excellence while ensuring safe and compliant operations.” Dickson also recommended choosing tollers with a proven history of performance. “Some of these tollers will be near their equipment capacity because of a high demand for their services,” he said. “It is always better to invest in equipment at an experienced company than choose a toller that may have immediate availability, but lacks the will and experience to perform effectively.” As a caveat, it is imperative that any toller be able to demonstrate a top-down level commitment to environmental, health, safety and security and demonstrate an exemplary track record in this area. Nobody wants to do business with a company that may run afoul of any government regulations, or worse yet, cause harm to the environment or human life.

48 Speciality Chemicals Magazine 36.08 November 2016

Jay Dickson, President, Nation Ford Chemical Inc

John Foley, CEO, KMCO LLC

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SOCMA Members Reaping Benefits of ChemStewards Management Portal Just 2 years after unveiling the ChemStewards Management Portal, an efficient environmental, health, safety and security (EHS&S) management system, 99% of SOCMA members are submitting their metrics through the portal and have been complimentary of the new tool. “We are extremely pleased with the tremendous response from our membership in using the ChemStewards Management Portal,” said Dr J Holland Jordan, Managing Director of ChemStewards. “The portal allows our members to save time and money by having all of their ChemStewards and related EHS&S documents in a centralized, web-based repository. SOCMA is the only association offering this cloud-based tool for members to manage their EHS&S efforts.”

Dr J Holland Jordan, Managing Director, ChemStewards Not only are 99% of SOCMA member companies submitting metrics through the portal, there are now 279 active portal users. In addition, 90% of audit scheduling is now done through the portal, Jordan said.

50 Speciality Chemicals Magazine 36.08 November 2016

The new portal allows for easy data entry that helps SOCMA members increase productivity for those responsible for managing this important function. It also includes all ChemStewards historical data and allows SOCMA members the option of sharing more EHS&S information with employees and auditors, thereby lowering costs and ensuring a more efficient dissemination of vital EHS&S information. “It was very user friendly, and it actually looked very nice,” said Belinda Adame’ of South Coast Terminals. “I understood everything and felt very comfortable running through the system.” Sheryl Goddard of Ash Stevens also had great things to say about the new portal. “I find it very easy to navigate,” she said. “It has been a good addition to the ChemStewards program.” The new management tool has also been an added benefit for ChemStewards Auditors. “The portal provides ChemStewards auditors with access to a site’s previous audit report and completed audit checklist,” said Kirstin L. Dolan, a ChemStewards Auditor with the WSP Group. “This is especially valuable when a site changes auditors from one audit to the next. It provides the auditor with the ability to follow-up on areas of concern identified by the previous auditor and helps with consistency from auditor to auditor.” Since going live, the ChemStewards staff has provided extensive training for member use, and they are constantly looking for ways to improve the functionality to meet member needs. A few of the new functions include: “Remember me” function – This added feature allows for remembering a username and password previously used to log in to the portal. It lessens the number of wrong attempts made and having their accounts locked. Resources page – This page provides a list of links related to ChemStewards. It will be divided into four sections – Environment, Health and Safety, Security, and Process Safety. Download of SOCMA’s Chemical Operator Training Manual (COT) – Users can easily download the COT and save it to their company repository within the portal for easy access. Q&A Page – This page allows SOCMA members to anonymously post questions with other ChemStewards members to share best practices and discuss issues that impact their EHS&S efforts. “Our mantra for ChemStewards is continuous improvement, and we believe the new portal allows our members to more efficiently store, monitor, track and report their EHS&S efforts,” Jordan said. “We look forward to what the future holds as our members continue to learn more about the nuances of this outstanding new tool.”


Marketing Marketing for for Lasting Lasting Business Business Success Success

For many fine and speciality chemical companies, their For many fine speciality chemical companies, For many lie fine and speciality chemical companies, their their priorities inand quality of research, manufacturing and priorities lie in quality of research, manufacturing priorities liewell in quality of research, manufacturing and product, as as efficient and profitable businessand product, as well as efficient and profitable business product, as well as efficient and profitable business operations. Marketing and brand management are operations. Marketing and brand management are operations. andlist, brand are often not at Marketing the top of the but management Lucy Stone, MChem often not at the top of the list, but Lucy Stone, MChem often not atand the Senior top of the list, but Lucy Stone, MChem Chemistry Account Manager at Notch Chemistry and Account Manager Notch Chemistry and Senior Senior Account Manager at atvalue Notch Communications, explains the enormous that Communications, explains the enormous value Communications, thetoenormous value that that strategic marketingexplains can bring such companies. strategic marketing can bring to such companies. strategic marketing can bring to such companies.

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How do you stand out when everyone is saying thestand same out thing? How do you when everyone How do you stand out when everyone is saying the same thing? The problem many businesses face, is saying thethat same thing? especially in this is that they are The problem thatindustry, many businesses face, The problem that many businesses face, all using the marketing catalyst especially in same this industry, is that they with are especially in this industry, is that they are theusing samethe activation energy and this won’t all same marketing catalyst with all using the same marketing catalyst with get you noticed. the same activation energy and this won’t the same activation energy and this won’t get you noticed. Thisyou is where customer segmentation get noticed. comes in. Don’t just think about the This is where customer segmentation This is where customer segmentation decisionin.maker, comes Don’t but just also thinkabout aboutwho the will comes in. Don’t just think about the help to influence their decision. Drawwill up decision maker, but also about who decision maker, but also about who will personas for eachtheir of these individuals. help to influence decision. Draw up help to influence their decision. Draw up Write a messaging matrix personas for each of thesecontaining individuals. personas for each of these individuals. brandapromises thatmatrix will immediately Write messaging containing Write a messaging matrix containing resonate with each them. Then brand promises thatofwill immediately brand promises that will immediately apply these messages consistently resonate with each of them. Then resonate with each of them. Then in every piece of sales or marketing apply these messages consistently apply these messages consistently communication, in every piece of without sales orexception. marketing in every piece of sales or marketing communication, without exception. In this industry it without is rightlyexception. ingrained in communication, the culture that itcompanies abide byinthe In this industry is rightly ingrained In this industry it is rightly ingrained in rules, especially in terms of abide regulatory the culture that companies by the the culture that companies abide by the and quality issues, so there is a mindset rules, especially in terms of regulatory rules, especially in terms of regulatory that quality things must always be done in this and issues, so there is a mindset and quality issues, so there is a mindset way.things However, the best marketers that must always be done intake this that things must always be done in this the opposite approach; they think outside way. However, the best marketers take way. However, the best marketers take box and bend the rules make you the opposite approach; theytothink outside the opposite approach; they think outside stand out in an industry where everyone the box and bend the rules to make you the box and bend the rules to make you is doing thing. where This iseveryone known as stand outthe in same an industry stand out in an industry where everyone creative and isThis a way of cutting is doing disruption the same thing. is known as is doing the same thing. This is known as through mediocrity. When executed creative the disruption and is a way of cutting creative disruption and is a way of cutting successfully, you will have created a through the mediocrity. When executed through the mediocrity. When executed positive brandyou perception the minds successfully, will havein created a successfully, you will have created a of decision makers and influencers alike. positive brand perception in the minds positive brand perception in the minds Finally, remember marketing of decision makersthat andwhile influencers alike. of decision makers and influencers alike. may consume a lotthat of energy in the short Finally, remember while marketing Finally, remember that while marketing term,consume it will ultimately may a lot ofcatalyse energy ininto thelong short may consume a lot of energy in the short lasting success. term, it business will ultimately catalyse into long term, it will ultimately catalyse into long lasting business success. Our mission at Notch is to offer a unique lasting business success. approach to at science Our mission Notchand is totechnology offer a unique Our mission at Notch is to offer a unique marketing to forscience our portfolio of global approach and technology approach to science and technology corporations. way marketing for We our believe portfoliothe of best global marketing for our portfolio of global corporations. We believe the best way corporations. We believe the best way

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“Our vision is to “Our vision is “Our vision is to to create marketing create marketing create marketing strategies that strategies that strategies thatour differentiate differentiate our differentiate our clients from their clients from their clients from their competitors” competitors” competitors”

or small, are treated with the same acute attention to detail conception or small, are treated withfrom the same or small, are treated with the same to completion. and concise acute attentionConstant to detail from conception acute attention to detail from conception communication is also paramount, to completion. Constant and concise to completion. Constant and concise as is monitoring is and reporting communication also paramount, communication is also paramount, successful outcomes. as is monitoring and reporting as is monitoring and reporting successful outcomes. Our vision isoutcomes. to create marketing successful strategies our clients Our vision that is todifferentiate create marketing Our vision is to create marketing from their competitors. We achieve this strategies that differentiate our clients strategies that differentiate our clients through powerful creativity, innovative from their competitors. We achieve this from their competitors. We achieve this brand strategies, B2B/B2C through powerful pioneering creativity, innovative through powerful creativity, innovative communications dynamic content brand strategies, and pioneering B2B/B2C brand strategies, pioneering B2B/B2C marketing. Aboveand all, dynamic we understand the communications content communications and dynamic content importanceAbove behindall, delivering a real ROI marketing. we understand the marketing. Above all, we understand the for our clients and place greataemphasis importance behind delivering real ROI importance behind delivering a real ROI on two-way feedback across aspects for our clients and place greatall emphasis for our clients and place great emphasis of our relationship. on two-way feedback across all aspects on two-way feedback across all aspects of our relationship. of our relationship.

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Baker Hughes is investing in technology and innovation in the downturn and is looking for ways to help customers improve their operating economics

Depressed Oil Prices Pressuring Specialty Chemical Companies to Reduce Costs, Improve Efficiency Companies investing in technology, innovation during downturn The environment continues to be difficult for specialty chemical companies supporting the oil and gas industry, and some SOCMA members say the depressed oil prices have put unprecedented pressure on their customer base to reduce costs and improve efficiency in all aspects of their business. “Within the specialty chemicals sector, our customers are looking for ways to reduce chemical treatment cost by changing the types of treatments used, or in some cases, optimizing or eliminating some types of treatments all together,” said Melissa Law, Vice President of Chemical and Industrial Services at Baker Hughes. “We definitely see changes in our demand patterns as production declines in some areas and operators shift their chemical treatment focus to reducing cost and improving efficiency,” she said. “At the same time, this change in the operators’ needs increases the need for continued innovation. Investment in technology and innovation continues, even in this downturn, as we constantly look for ways to help our customers improve their operating economics.” John Foley, CEO of KMCO, LLC, said he sees “a confidence that this market will come back. It is just a question of timing – and companies such as KMCO that are positioning capacity to support the recovery are going to strongly benefit from it.” “Our oil and gas segment sales bottomed in Q2 2016,” Foley said. “We are seeing modest growth in Q3 that I fully expect to continue as we align to support key industry partners as they manage through this difficult time.

A recent survey from Deloitte shows that 59% of oil and gas executives see 2017 as a year of recovery for the industry. “Those who responded

Melissa Law, Vice President, Chemical and Industrial Services, Baker Hughes

52 Speciality Chemicals Magazine 36.08 November 2016

pointed to expectations of rising prices, a return to increasing capital expenditures and headcount as drivers of their optimistic outlook,” according to a recent article in World Oil. “This recovery in many ways mimics the pattern of the recovery from the Great Recession,” John England, vice chairman, Deloitte LLP and US and Americas Oil and Gas Leader, commented. “If last year was the year of hard decisions, 2017 will be the slow road back. Companies are generally optimistic that prices will rise to a more sustainable level next year; however, they understand that even if we see an uptick in price, the industry likely won’t fully recover until 2018 or beyond.” Foley said KMCO “will keep a conservative demand outlook but prepare for any positive surprises or opportunities that may develop in 2017.” As for Baker Hughes, “In 2017 and beyond, we expect to see energy demand increasing; however, oil prices could remain depressed for an extended period of time,” Law said. “We will continue to focus on standardization and supply chain efficiencies, as well as technology and innovation, in order to sustain and grow in strategic areas.”

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SOCMA Members Have Positive Outlook for 2017 for Specialty Chemical Manufacturing in US, EU REACH could pose obstacle to introducing new products Despite the impact of the recent presidential election, lackluster global growth and a host of mergers and acquisitions, SOCMA members are optimistic about the specialty chemical market in both the US and EU as they look ahead to 2017. However, at least one company feels the looming 2018 REACH registration deadline could pose a big obstacle for introducing new products in those markets. “We are forecasting a strong 2017 for specialty chemicals in the US and EU,” said Jay Dickson, President of Nation Ford Chemical, a specialty chemical manufacturer in Fort Mill, SC. “Additionally there will be pockets of high growth in China and, of course, some contraction, as Beijing is cracking down on the higher polluting commodity production and companies that do not have proper waste emissions treatment.” Dickson said his company has a positive outlook over a two-year horizon. “Growth is expected in the commercialization of higher value added products in the specialty chemical sector.” KMCO CEO John Foley says he feels that the specialty chemical sector will keep a tight rein on capital investment, which “leaves custom manufacturers such as KMCO in a favorable position to support these companies’ growth or restructuring of existing production via levering his company’s installed capacity.” KMCO, LLC, located in Houston, TX, is a specialty chemical

Jay Dickson, President, Nation Ford Chemical Inc

manufacturer and toll processor to many of the world’s largest chemical companies. “Our growth can be significant by levering ‘blocking and tackling’ productivity improvement and upgrading our utilities,” Foley said. “We have the ability and the strong intent to double our custom manufacturing volumes.” According to Michael Gromacki, President of Dixie Chemical, Inc, a specialty chemical manufacturer located in Pasadena, TX, merger and acquisition is going on both upstream and downstream and is creating some challenges in the specialty chemical sector. “Your customer base is consolidating and your supply chain is consolidating, and it is resetting new relationships,” Gromacki said. “This growth and acquisition is great for the companies involved, but there are a lot of other companies affected by it as well. Consolidation in the next year or so is going to be a factor, not necessarily a bad factor overall, but it’s going to be a factor.”

John Foley, CEO, KMCO LLC

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Dixie Chemical is also seeing commodity swings. “Some materials are long that are benefitting specialty chemicals, and some are getting tighter,” Gromacki said. “So the commodity swings are just things we have to keep track of. These are two issues we will see going forward in the next year or two.”

So what are the growth drivers for these companies?

Nation Ford says its products that improve performance, or the quality of life, will drive much of the growth in this sector. “The US and EU are the leaders in technological advancement in chemical manufacturing, and that will fuel growth in these regions.” The specialty sector is in a stable growth situation, according to Gromacki. “Our fuel and lube market and thermoset market are growth markets, and our paper market is stable and growing at the GDP level.”

Michael Gromacki, President, Dixie Chemical

S OCM A S P E C I AL FE AT UR E Nation Ford Chemical, a specialty chemical manufacturer in Fort Mill, SC, is projecting a strong 2017 for specialty chemicals in the US and EU

The main thing that concerns Dixie Chemical is uncertainty in Asia, Gromacki said. “Some are saying it’s overheated. Others are saying it’s propped up and stabilized, or in an upswing. We are also concerned about the lay of the land with petroleum. You see this Middle Eastern discussion about the possibility of the Saudis and Iranians curtailing oil, so it’s both geopolitical and oil related,” he said. Despite these concerns, Gromacki said his company is “really positive about our markets right now. There are a lot of different megatrends we benefit from, including the electrical energy distribution and smart grid that are driving innovation. Our materials automotive lightweighting is another big trend that benefits us. There is also additive manufacturing and infrastructure investment – all areas we feel are good factors for our chemistries.” Dixie doesn’t see any regulatory issues affecting its business, Gromacki said. “If we adapt to regulatory changes better than our competitors, we win,” he said. “We just need to understand them, to adapt, but we don’t spend a lot of time worrying about regulations but looking at how to grow.” For Nation Ford Chemical, the major concern on the regulatory front is REACH and the pending 2018 deadline that could pose a significant challenge for specialty chemical manufacturers. “The biggest challenge will be registering specialty chemicals in the EU for the 2018 deadlines,” Dickson said. “The high cost of registration may make it prohibitive to introduce new products in those markets.”

KMCO, LLC, is a specialty chemical manufacturer and toll processor in Houston, TX

Speciality Chemicals Magazine 36.08 November 2016 55


Sustainability Culture Runs Deep at Fairmount Santrol’s Alpha Resins SOCMA member Fairmount Santrol’s Alpha Resins, specialty chemical manufacturing facility in Detroit, MI, takes great pride in sustainable development.


recipient of the last four SOCMA Sustainability Awards, sustainability is ingrained in every aspect of Fairmount Santrol’s business model, according to Dana Cooper, former Faimont Santrol, Alpha Resins Director of Business Excellence.

“The sustainable development culture runs deep at our company. Everything we do strives to nourish a stronger, more prosperous future for our company and our communities. When a company commits to contributing to the world’s social, economic and environmental needs, it can realize greater performance in all aspects of business… From Fairmount Santrol’s 2015 Sustainability Award Application So how did this sustainability culture start with Alpha Resins? For founders, Charles Fowler and William Conway, who came from a mining background, reclaiming the earth to its better state

was part of their vision for the company. When Fairmount Santrol acquired Alpha Resins in June 2011, the company immediately took time to focus on safety and sustainability. The entire staff attended a company sponsored event called the Appreciative Inquiry Sustainable Development Summit shortly after the acquisition, where they were welcomed into the company’s sustainable culture. “It was a big shift from where they were and where we wanted them to be,” Cooper said. “We spent the first two months before the summit introducing the concepts of Sustainable Development; we focused on what we dreamed of and what we wanted for the site.” According to Beau Daane, Director of Sustainable Development for Fairmount Santrol, a key piece of the puzzle is this Summit, held every three years. All employees attend the Summit, where the company president might be sitting by the accounting person in Detroit or a loader operator from Illinois.

“They are all in a room together co-creating the future together,” Daane said. “We want our employees to know that their ideas and their voice matters, and everyone is empowered. The theme of our 2014 Summit was ‘United and Empowered.’ Through the Summit, Fairmount Santrol was seeking to co-create something positive for the future.” The company established 13 sustainable development teams (including Communications, Best Practices, Business Innovation, Clean Water, Empower U, Environmentally Response Products and Process, Health and Wellness, etc.) The teams are corporate-wide and evolve with each Summit. For example, some teams may merge into one, or sometimes a new team is created. “It’s really driven by the focus and interest of our employees (family members),” Daane said. The teams set goals each year that have various themes, and the goals are tied to the employee’s yearly bonus. In 2015, the Detroit facility reached 103 percent payout on the Sustainable Development goals.

The Fairmount Santrol family members at the 2014 Sustainability Summit’s Day of Caring

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S OCM A S P E C I AL FE AT UR E While the sustainability efforts at Fairmount Santrol are supported by company leadership, it’s driven by the employees, Daane said. Because the efforts are employee-driven, there is greater employee engagement. They also receive 40 hours of paid volunteer time per year, of which the family members are particularly proud. “The Detroit site has advanced in its level of engagement,” Cooper said. “Participating on a team and working on a project at their site and doing their part, it’s really amazing how it spreads and how everyone’s engaged. Our group is walking the talk.” Another key to the sustainable culture at Alpha Resins is monthly discussions of goals and metrics. And, there is a corporate technology board to highlight where the company is with its goals, Cooper said. Alpha Resins celebrates successes by highlighting individual and team achievements in a newsletter. The company recently adopted the ChemStewards newsletter template as “another way we can highlight our family members,” Cooper said. “It’s also a way to ensure the ChemStewards program is recognized.” So how has employee buy-in impacted the company’s sustainable metrics? It has reduced waste to landfill by 94 percent from 2009 to 2013 and finally reached their goal of zero waste to landfill in 2014. They have maintained that level since that time. On the

energy front, LED technology is used in any new construction. And, 90 percent of the water used in Alpha Resins operations is reused. The company has also decreased energy consumption by 8.25 percent in 2015.

Alpha Resins Nick Hovious accepts SOCMA’s 2015 Sustainability Award during the SOCMA Annual Dinner last December in New York

“Anytime we look at replacing something, we think of ‘People, Planet, Prosperity,’” Cooper said. “It may cost more, but we will get the savings back over time. And we are able to give back to the community in that regard.” Sustainability efforts are shown beyond the company. They are carried on to Fairmount Santrol’s suppliers, customers and communities. “Suppliers complete surveys to tell us where their sustainability efforts are, and we look at those for opportunities where we can complete projects together,” Cooper said. “We really work in great partnership with our suppliers. We will even go as far as working with customers’ customers or suppliers’ suppliers to educate and work towards developing a circular economy (i.e. an industrial economy that is producing no waste and pollution).” With support from the top and real meaningful engagement at every level, allowing everyone’s voice to be heard, Fairmount Santrol has found the key to success in developing a sustainable flourishing culture. “The Alpha Resins facility is a textbook example of how sustainability should be incorporated into every chemical facility in the ChemStewards program,” said SOCMA’s Managing Director of ChemStewards, Dr J Holland Jordan. “We commend them for their efforts and would like to see more of our member companies following their lead.”


Breaking Down TPP and the ‘Brexit’ Impact on TTIP As countries around the world jockey for economic power, global trade and investment has never been more important. Because of that, and the fact that any hope for a comprehensive deal through the World Trade Organization (WTO) is dead, regional free trade agreements with investment protection standards, environment and health provisions, such as the Regional Comprehensive Economic Partnership (RCEP),1 the Comprehensive Economic and Trade Agreement (CETA), 2 Trans-Pacific Partnership (TPP), 3 and the Transatlantic Trade and Investment Partnership (TTIP),4 are more commonly being explored. These agreements seek to increase trade links, improve regulatory coherence and cooperation, and build rules of the game for business and investments.


n the United States, the Obama Administration led negotiations for the TPP and TTIP, which will allow the US to strengthen its global economic power and leadership in the midst of China’s economic growth and dominance, as well as have the potential to greatly benefit specialty chemical manufacturers. The TPP was signed in New Zealand in December 2015 and is still waiting ratification by the US Congress. “There is a very slim chance the TPP will be passed by Congress during the lame duck session after the November elections due to the poisoned political climate and negative rhetoric of the presidential candidates,” said Jim DeLisi, President of Fanwood Chemical and Chair of SOCMA’s International Trade Committee. “Both Democratic nominee Hillary Clinton and Republican nominee Donald Trump have heavily scrutinized and criticized the agreements and said they want to reopen TPP and negotiate stronger terms, deemed to be more Jim DeLisi, President of Fanwood beneficial to the US. This will Chemical, and Chairman of SOCMA be a difficult task since many International Trade Committee of the US’s TPP partners have clearly said they have no interest in reopening the agreement.” The Administration, as well was the EU, had hoped to conclude TTIP negotiations, but by the end of the 15th Round in New York, it was clear a comprehensive agreement would not be finished in 2016. “The US chemical industry stands to gain the most on tariff reduction from TTIP, saving the industry more than $1 billion annually in eliminated tariffs if approved,” DeLisi said. “Both US and European governments identified the promotion of regulatory cooperation and the elimination of related barriers to trade manufacturers as the most critical areas in which to make progress. However, there are still many stumbling blocks on which the EU and US disagree, including public procurement, investor state dispute settlement (ISDS) and other non-tariff barriers. For those of us in the chemical industry, it is agreed that the differences between REACH and the Toxic Substances Control Act (TSCA) will not be bridged by this deal.” “Brexit” also complicated TTIP negotiations and was clearly not the outcome the chemical industry had hoped for, DeLisi said. The US commercial relationship with the UK and EU combined represents about 40% of the global economy, and chemical trade between the EU and UK is enormous – much of it occurs through intercompany transfers, moving without any obstacles. However, “Brexit,” once initiated under the guidelines of Article 50 of the Treaty of the EU could fundamentally change the current ease of trade that exists between the EU, UK and US. This would be detrimental to both the UK as well as the EU, as the UK is said to have a substantial trade deficit in chemicals

58 Speciality Chemicals Magazine 36.08 November 2016

with the rest of the EU. However, until Article 50 is enacted, it is unlikely that anything will change, and once article 50 is triggered, US producers can hope the UK will end up with a trade deal with the EU similar to those which Norway and Switzerland have negotiated, allowing the free movement of goods into the EU and, more or less, maintaining the status quo with the US. The UK will need to decide how to handle regulatory systems, like REACH, that are currently in place. Since the UK’s major market is the EU, and most of the costs associated will have occurred by time “Brexit” is completed, it would make sense to stay with the current system as written. This would also be a very helpful result for the 40% of EU only representatives who have UK addresses. It remains to be seen how the UK will handle international trade agreements. Since the UK is a WTO member (as well as a member of the UN), all commitments to this organization are unaffected by “Brexit.” Under the current regime, the EU signs trade agreements “on behalf of” the EU member country, and then they list the member states that are signatories to the agreement. However, once “Brexit” is complete, it is unlikely the UK will continue to enjoy the benefits of previously negotiated EU free trade agreements (of which there are many) to which they technically are a signatory unless some form of “docking mechanism” is constructed. It is therefore possible, though unlikely, the UK will find a way to remain bound by all of the EU’s existing international commitments. Assuming the US and remaining members of the EU are not prepared to bring the UK into the TTIP negotiations as a separate party, it is likely there will be strong bipartisan support in both the US and UK to begin negotiating a free trade agreement between the US and the UK at the earliest conceivable opportunity. “With the long-standing, special relationship between the US and the UK, it would make sense for two parties to start now on a free trade agreement between the two countries, with or without TTIP,” said Steve Schmidt, Vice President of Procurement – Global Category Leader Intermediates for Sun Chemical, a SOCMA member company. “That agreement should include the safeguards and corrections SOCMA found in the TPP and TTIP.” However, the next US president will likely inherit both the TPP ratification process and the TTIP negotiations, as the US has a long history of continuity from administration to administration in trade negotiations. Even so, it is likely there will be a pause, for at least a year or longer, before the TPP can be ratified by Congress and TTIP negotiations can re-start. It will likely take this long for the new president to reshape both the US Trade Representative (USTR) and senior management at the Department of Commerce to fit into their vision for the future.

REFERENCES 1. 2. 3. 4.

The Regional Comprehensive Economic Partnership (RCEP) is an ASEAN-centered proposal for a regional free trade area, which would initially include the 10 ASEAN member states and those countries which have existing FTAs with ASEAN – Australia, China, India, Japan, Republic of Korea and New Zealand. The Comprehensive Economic and Trade Agreement (CETA) is an EU-Canada treaty that was finished in August 2016. The TPP is a free trade agreement between Brunei, Chile, New Zealand, Singapore, the US, Australia, Canada, Japan, Malaysia, Mexico, Peru and Vietnam. The TPP aims to achieve extensive liberalization of both goods and services, and entails comprehensive coverage of trade in services, investment, government procurement, non-tariff measures and many regulatory topics. The Transatlantic Trade and Investment Partnership (TTIP) is a trade and investment agreement being negotiated between the United States and the European Union (EU).


Cambrex Projects Strong Growth for API Manufacturers As 2017 fast approaches, Cambrex, an innovative life sciences company with more than 35 years of active pharmaceutical ingredient (API) development and manufacturing expertise, is seeing continued worldwide growth in API volumes and increased outsourcing requirements by large innovator companies. This, coupled with increasing use of generics and additional opportunities for increased penetration in developing markets, is a sign that the industry will continue to experience strong growth, according to Simon Edwards, Vice President of Global Sales and Business Development at Cambrex. “This means the situation has arisen where there are periodic shortages of contract manufacturing organization (CMO) capacity, especially in the US and at critical volumes,” Edwards said. Cambrex has invested more than $150 million since 2012 in facility expansions, equipment, technology and environmental, health and safety (EHS) upgrades to ensure that these demands can be met, and standards in quality, customer service, flexibility and reliability are not only maintained but enhanced. Edwards said that, overall, growth in the contract development and manufacturing industry will see a high demand for suppliers with flexible, large and small-scale good manufacturing practice (cGMP) capacity and world-class quality systems that allow efficient API production. The industry has seen an increase in drug approvals in recent years and will continue to see the shift in pharmaceutical companies sourcing back to US and European contract manufacturers. “Many larger pharmaceutical companies continue to divest their own production facilities, and the rise of ‘virtual’ pharma has increased the demand for contract manufacturing organizations such as Cambrex. The industry has a solid pipeline of late-stage drugs, which, in part, will continue to drive the success of the fine chemicals industry,” he said. Cambrex believes the greatest challenge for API manufacturing would be a sudden change in any of the macro-factors driving the current positive growth. “If there was a decline in the number of FDA or EMA approvals, a decrease in global medicine consumption, or the sudden shortfall in venture capital funding for early stage research – all at the same time as CMO capacity increasing significantly, the knock on effect could impact any CMO’s business strategies,” Edwards said. Cambrex remains positive about business growth, especially with the demand for small molecule APIs, in particular, remaining strong. As pharma companies continue their shift towards discovery and marketing, manufacturing of small molecule drugs will increasingly be outsourced to service partners such as Cambrex. Furthermore, a number of companies, including Cambrex, have expanded their US capacity and invested in more challenging areas of the market, such as controlled substances or highly potent API manufacturing, to address the growing demand in this area, Edwards said. “The proactive approach that Cambrex employs in forecasting future market needs and our investment strategy is something that differentiates Cambrex from others in the industry who may simply build large-scale assets somewhat retrospectively,” Edwards said. “Our investment in technology and appropriate vessel sizes, to ensure the economics of projects match the capabilities we offer, has shown its worth. Clients have bought into this philosophy and understand that as a company we are innovative and forward looking, investing in ‘the right’ capacity.” Cambrex has traditionally been very strong in the manufacture and handling of controlled substances. “As a company we routinely manufacture and distribute commercial quantities of Schedule II-V controlled substances and hold Drug Master Files for more than 20 controlled substances,” Edwards said. “Our portfolio is built on more than 15 years of experience and expertise in this highly challenging field.”

60 Speciality Chemicals Magazine 36.08 November 2016

Simon Edwards, Vice President of Global Sales and Business Development at Cambrex

So what are the growth drivers for the fine chemicals industry?

“There is reason for increased optimism due to a rebound in drug product approvals to levels not seen since early 2000,” according to Edwards. “This is due to successful focused R&D programs coming to fruition, as well as increasing numbers of specialty and orphan drugs and fast-tracked review processes. “In light of these recent drug approvals targeting specialized therapies such as oncology or orphan diseases, the effect has been to a rise in demand for small molecule manufacturing capacity in the 10 metric tonne or lower range compared to the larger volumes seen decades before,” he said. “This will ultimately lead to continued or increased outsourcing by large pharmaceutical companies, many with mature, over-sized captive capacity, to select CMO partners with the ‘right’ capacity for their project.” Edwards says this will create significant opportunities for CMOs, in areas from raw materials to starting materials, registered starting materials, intermediates and advanced intermediates, as well as APIs.


Four Decades of Custom and Toll Manufacturing Specializing in Organic Synthesis

Americaâ&#x20AC;&#x2122;s Leader in Toll Manufacturing 8-Time Winner Silver Award


HE AR T OF T HE I N D U S T RY Speciality Chemicals Magazine would like to celebrate some of the positive influences that our industries have had. Big business can be a genuine force for good in society, and in a world at risk of degradation. Please share your corporate social responsibility stories with and we look forward to seeing many of them here.

HOVIONE CLEANS UP! Fonte da Telha in Almada, Portugal, is characterized by an extensive sandy area that can be seen from the fossil cliff, an area of protected landscape and one of the most important examples of its kind in Western Europe. At the end of the tourist season, Hovione organized a beach cleaning activity. The team of 16 volunteers collected cigarette butts, plastics, papers and empty bottles; a total of ~60 kg of trash. Other beachgoers appreciated their efforts, and they even inspired some of the children visiting the beach to clean their own areas, and to tell their parents to do the same. “This was very important,” explains Isabel Pina, Director Corporate Communications at Hovione. “Sixteen people cannot clean the entire beach, but we wanted to send out the message that beaches need to be kept clean by those who use them.”


Being a mentor is a great way to positively influence our youth. Linda M. Hicks, Vice-President Global Technology at Vertellus, is actively engaged in Girls Inc., an organization that works to make a difference in girls’ lives by empowering them to be confident in their own skin and their ability to achieve their goals. Girls Inc. delivers life-changing programs that inspire all girls to be strong, smart and bold. “As a woman engineer in the male dominated STEM field, mentors helped me develop confidence and define my career path,” explains Linda. “I am proud that Vertellus shares my passion around mentoring our youth. High school age girls meet with Vertellus women scientists, engineers and IT staff to learn first-hand how rewarding these careers are and the educational path needed to secure a job in these fields.”

FARMAK’S FOSTER-GRANDCHILDREN In August, Farmak launched a social project, “Foster grandchildren” to mark its 90 th anniversary. Farmak’s efforts help about 300 elderly people by collecting cash contributions, long-life foods, and ‘cures for loneliness’ (such as letters and children’s drawings). Farmak has spent collected funds on acquiring basic personal hygiene items for the people they are helping. These, together with the other collected items, have been delivered with the support of the Ukrainian Red Cross Society. Farmak plans to report annually on the results of the “Foster grandchildren” campaign and plan the next steps of the project to help elderly people living alone.

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Cerbios shares progress in embedding sustainability “in everything they do” Cerbios-Pharma has published their first Sustainability Report. While a number of companies have these, the publication is notable because Cerbios is an API producer, and the nature of the industry can make sustainability particularly challenging. The Report is published according to the guidelines and framework of the Global Reporting Initiative. “We are really pleased to share with all our stakeholders the positive progress we are making towards embedding sustainability principles in everything we do” confirms Gabriel Haering, CEO.

BASF helps disadvantaged children in india In the slums of Turbhe, Navi Mumbai, more than 7000 families live and work for daily wages of less than 180 rupees. In the absence of crèches and day care centres for children under 5 years, infants are often left in the care of older siblings. This, along with the unaffordability of tuition fees, frequently ends older children’s educational prospects. BASF has pledged to support Aarambh, a local non-profit organization, in setting up two day-care centres in the region. Children will be provided with midday meals and regular health check- ups. Moreover, once the children reach 5 years of age, they are enrolled in regular schools and provided with uniforms and books. To keep children at school for longer, free study classes offer older children extra coaching in subjects like mathematics, science and English. So far, the effort has benefited nearly 200 children.

| Active ingredients Dynamic people What do you need from your API partner? Custom development and manufacturing or generic expertise? Safety, quality and reliability? Excellent. Youâ&#x20AC;&#x2122;ll enjoy working with Cambrex.

Erena Sawyer-Wagner Analytical Chemist Analytical Development

Speciality Chemicals Magazine November 2016  

Volume 36 Issue 08

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