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Welcome to the September issue of EPM, which begins with the CPhI Worldwide — and associated shows (ICSE, P-MEC, InnoPack) — 2012 Preview. All featured exhibitors appear in hall and stand order, making them easier to locate, and hopefully helping you to linearly plan your visits to companies of interest. Due to the fact that this is a show preview issue, there has been an influx of high quality news stories and the EPM team has worked hard to cram as much as possible into the ensuing pages. Particularly worthy of attention — appearing on page 18, in the Containment 5 Showcase of the Manufacturing Equipment & Products section — is a case study provided by Powder Systems Ltd, on the company’s supply of several high containment filter dryers to Mumbai-based drug manufacturer Cipla Ltd’s new oncology plant in Bangalore. The filter dryers are used for the small- and large-scale manufacture of HPAPIs in 15 anti-cancer products, having passed the fundamental Site Acceptance 25 Test, which ensures designated OEL levels are met, last month. In addition, the Ingredients & Contract Services section features an advisory piece on page 28, written by Anthony Recupero, Ph.D., Senior Director, Licensing, at Aptalis Pharmaceutical Technologies, outlining the benefits of partnering with a drug delivery firm early on in the drug development process. Recupero refers to the high occurrence of poorly water soluble NCEs that can be formulated and in effect rescued through the application of drug delivery technologies. He also cites evidence of improved patient adherence that is attributable to taste-masking and controlled-release technologies, which in turn has led to strengthened 32 market adoption. Finally, in his Regulatory Affairs column on page 33, Dr. Biffignandi explores the true meaning of ‘technology transfer’, providing an overview of its various roles in serving industry, academia and the regulatory authorities to ensure the successful and timely delivery of blockbuster, generic and new drugs worldwide. And that is all from me on this issue, as I sign off and begin to prepare for our annual trip to CPhI Worldwide in Spain’s vibrant capital. If you are attending and would like to share your views on a new development, product or service in the next issue, please email me: ellie@rapidnews.com.
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eab members
from the editor
Henrik Broholm, Senior Specialist, H. Lundbeck A/S Henrik has been working in the pharmaceutical industry for the last 15 years, mainly in connection with finished goods packaging (blisters, ampoules and containers). At H. Lundbeck, he has gained valuable experience of working at both vendor and customer sites, further extending his pharmaceutical packaging expertise. Henrik is for the most part involved with user requirement specifications, machinery and process qualification and validation, the introduction of new products on packaging lines, and incorporating new features as required by authorities, e.g., 2D matrix coding with track and trace and child resistant blisters and packs. James Cartwright, Global Granulation Leader, Particle Generation, Control & Engineering, GlaxoSmithKline James began working within the pharmaceutical industry in 1996. During this time, he has been instrumental in developing and launching three products for various clinical indications spanning acute Otitis Media, Lymphatic Filiarisis and Type II Diabetes Mellitus. James studied Chemistry and Chemical Engineering and is a Fellow of the Royal Society of Chemistry. Dr. Dimitris Dogramatzis, RPh, PhD Dimitris is a registered pharmacist and pharmacologist, whose industry career encompasses medical affairs, marketing, country and regional management positions. Dimitris has served as Regional VP — Northern Europe for SERONO and authored two textbooks entitled ‘Pharmaceutical Marketing: A Practical Guide’ (2001) and ‘Healthcare Biotechnology — A Practical Guide’ (2010). Dr. Dave Doughty, Director of Process Understanding & Control, GlaxoSmithKline In his 30 plus years in the pharmaceutical industry, Dave has a superb track record in leading teams to develop and commercialise products. This is underpinned by his expert knowledge of the science and mechanistic principles of dosage form design and processing, including PAT, manufacturing operations and GMP. Dave has co-authored product and process patents. Product innovations include oral and transdermal dosage forms. Process innovations include compression and coating of tablets and continuous manufacturing methods and associated PAT. Continuous processes include feeding, mixing, granulation, drying, coating and a novel method of manufacturing low-dose, high-potency drugs. John Gamble, Senior Research Scientist, Bristol-Myers Squibb After graduating from the University of Salford in 1998 with a degree in Chemistry with Industrial Experience, John began his career in quality control analysis of parental vaccines, later moving on to physical analysis of inhaled drugs, before arriving at his current position as Senior Research Scientist within the Powder Properties Optimisation group at Bristol-Myers Squibb. John has a keen interest in understanding the interrelationships between the physical properties of drugs and excipients and their subsequent behaviour during formulation and manufacturing. Aidan Mc Nabola, Engineering Director, UCB Group, SCHWARZ PHARMA Ltd Aidan is Engineering Director at Schwarz Pharma Ltd, based in Shannon Co. Clare, Ireland, and is responsible for site infrastructure, engineering systems — including capital projects — utilities, IT and automation on site. Aidan holds a B. Eng Degree in Mechanical Engineering and has more than 23 years experience in primary and secondary manufacturing in the pharmachem and medical device industries. Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer, working for the wellknown French pharmaceutical company Sanofi. Grégory started working in one of the group’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment. He later moved to Spain and continues to lead new equipment installation projects at one of the group’s Spanish solid form plants and since 2009 has been in charge of process maintenance and improvements. Grégory has experience of the most well-known providers of solid form equipment. Kostas Saranteas, Senior Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc. Kostas is Senior Director of the Process Chemistry and Engineering Dept. at Sunovion’s R&D Division. He holds BS/MS/PhD degrees in Chemical Engineering and an MS degree in Environmental Engineering. For 15 years, Kostas worked at Polaroid Corp., specialising in batch process equipment modelling, process optimisation and scale-up. For 11 years, Kostas has been employed at Sunovion. He leads cross-functional teams, championing accelerated process development for drug substance and drug product synthesis from laboratory-scale to full-scale manufacturing.
Preview
Scientific Data Documents Condition-Specific Ingredients for Digestive and Immune Health Hall 4, Stand A52 DuPont Nutrition & Health will present new scientific data on digestive and immune health ingredients at the international pharmaceutical event CPhI Worldwide. Clinical documentation on the DuPont Danisco range of HOWARU preformulated probiotics and OsmoAid Lactitol confirms their ability to alleviate specific health conditions. Available in various finished formats, the ingredients are designed to meet the precise application needs of the pharmaceutical and dietary supplement industries. Dedicated probiotic research conducted at DuPont Nutrition & Health
advanced facilities in Finland is behind all HOWARU preformulated probiotics. Condition-specific probiotics include HOWARU Restore and HOWARU Protect. In clinical trials, dietary supplementation with HOWARU Restore has shown a strong aid to relieving gut stress caused by antibiotic treatment. Supplementation with HOWARU Protect in clinical studies appears to reduce the incidence of respiratory illness and associated side effects. A recent addition to the DuPont Danisco portfolio, OsmoAid Lactitol provides gentle relief from constipation. Numerous studies on adults and children
have shown OsmoAid to be a welltolerated laxative with none of the adverse side effects of many other conventional anti-constipation treatments. DuPont will share a stand with Gielleppi — its Italian distributor for DuPont Danisco probiotics for dietary supplements and pharmaceuticals. DuPont Nutrition & Health +44 7788 720124 sarah.jane.jumppanen@dupont.com www.dupont.com
Strong Company Integration Backs Drug Delivery Specialist’s Evolving Brand Hall 4, Stand B76 In 2011, Eurand N.V. was acquired by Axcan Intermediate Holdings, Inc., forming the combined company Aptalis Pharma Inc., a proven specialty pharmaceutical company with a robust portfolio and growing pipeline of gastrointestinal and cystic fibrosis products. Aptalis Pharmaceutical Technologies (formerly Eurand Pharmaceutical Technologies) is the company’s proprietary and synergistic R&D engine. More than a year after the merger, Aptalis Pharma Tech continues its history of proven commercial success by focusing on the drug development process for the Aptalis Pharma pipeline and portfolio of products, as well as for the company’s client partners — most recently with Gilead Sciences, Inc., on the FDA approval for the NDA of Gilead’s Viread (tenofovir disoproxil fumarate). Aptalis Pharma Tech offers expertise in oral drug delivery technologies, one of which is its proprietary Microcaps tastemasking technology, capable of encapsulating an assortment of drug particle shapes and sizes. This marketproven microencapsulation technology uses a proprietary coacervation process to create a complete and uniform physical barrier around individual drug particles for outstanding taste- and odour-masking for high patient acceptability. The formulation team at Aptalis
leveraged its Microcaps technology to develop the formulation for Viread, an oral powder administered in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients aged 2–5. In January 2012, Aptalis Pharma announced the FDA approval of Gilead’s NDA for oral powder formulation of Viread. As codevelopers, Gilead is responsible for Viread’s product commercialisation, while Aptalis will manufacture and supply the oral powder to Gilead. The Aptalis Pharmaceutical Technologies platforms — combined with licensing, manufacturing and R&D capabilities — enable Aptalis Pharmaceutical Technologies to produce customised drug formulation solutions for partners across a range of therapeutic classes, such as GI, cardiovascular, pain, nutrition, respiratory and CNS. To explore codevelopment opportunities, please fill out the ‘Contact Us’ form at the Aptalis Pharma Tech website. Aptalis Pharmaceutical Technologies +1 908 927 9600 www.aptalispharmatech.com
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CPhl Worldwide 2012 Phosphate Products Producer Highlights Benefits of Calcium Range and Debuts Mineral Offerings Hall 4, Stand F56NA Innophos will show its extensive range of calcium phosphate excipients and minerals at this year’s CPhI Worldwide. Providing important nutritional qualities in addition to the functionality of excipients, these ingredients offer added value for both pharmaceutical and supplement manufacturers, as well as consumers. According to Innophos, visitors to its stand will see the industry’s largest selection of calcium phosphates, plus highly bioavailable chelated minerals from Kelatron and AMT Labs, wholly-owned subsidiaries of Innophos. The Innophos portfolio of calcium phosphates is suitable for wet granulation and direct compression tabletting for dietary supplements, OTC medicines and prescription drugs. The ingredients are stable, insoluble, white in colour and compatible with a wide range
of actives. Encompassing dicalcium phosphates and tricalcium phosphates, Innophos’ ingredients meet diverse processing parameters and nutritional requirements in a wide range of applications. Some of the calcium phosphate highlights are: • DI-TAB, a granular dicalcium dihydrate with 23% calcium and 18% phosphorous content, ideally suited to dietary supplements; • TCP-DC, a tasteless and odourless tricalcium phosphate with 35% calcium content for direct compression in chewable tablets, antacids and calcium supplements; • and Calipharm A, a dicalcium anhydrous powder with high phosphorous content for chewable multivitamins and vitamin premixes.
Making their CPhI debut, co-exhibitors Kelatron and AMT Labs will present a wide range of fully reacted, highly stable and bioavailable mineral chelates, including the prestigious K-Pure and Chelamax portfolios. Focal points from the mineral range will be a full range of bisglycinates, ascorbates and citrates, available in various forms for diverse end-product applications. Technical and applications experts will be available throughout the exhibition to consult visitors on suitable ingredients for their specific applications or to discuss new projects. Innophos +49 6131 622 1033 gunter.becker@innophos.com www.innophos.com
International API and Excipient Supplier Discusses Product Development Programme Hall 4, Stand H41NA
International Supply Chain Consortium Rx-360 Holds Q&A Session Hall 4, Stand H88
Rochem International, a multifaceted global company with offices in the US, Europe and China, is a leader in the supply and regulatory compliance of generic APIs, excipients, sweeteners and nutraceuticals. Recently ranked #34 on Crain’s New York Business ‘Fast 50’ list, the company is proudly entering into its 18th year of business in the pharmaceutical and nutraceutical markets. Please visit Rochem at CPhI Worldwide to discuss the company’s new product development programme, which will enhance communication between its factories and customers to ensure a speedy regulatory approval ahead of the competition. Learn about
changing pharmaceutical climate. Review the new and expanded development product list and products in the pipeline for both the animal and human markets. Rochem’s experienced team — covering business development, sales, regulatory and technical expertise — looks forward to welcoming visitors to the company’s stand. Rochem is committed to continuous support of its manufacturing partners in China and customers around the globe. Rochem International Inc. +1 631 738 1188 lholm@rochemintl.com www.rochemintl.com
the company and its factories’ commitment to GDUFA and the
Peptide Supplier Outlines Full Scope of API Development and Manufacturing Expertise Hall 5, Stand F16 Bachem is a leading independent supplier of peptidic APIs for the human and veterinary pharmaceutical markets. The company offers over 90 generic APIs, of which more than 60 are peptides. They are produced in annual quantities up to hundreds of kilogrammes. With its high capacity and the outstanding quality of its products, Bachem holds a probably unique position. Bachem GMP facilities are registered with and inspected by the FDA and other national authorities. Fully integrated support for API development is provided, which includes: • development and manufacturing of APIs, including HPAPIs; • production and release of sterile products for use in approved clinical trials (Clinalfa brand); • dedicated project management for customer projects; • efficient production by solid-phase peptide synthesis (SPPS) and solution phase chemistry; • know-how in amino acid chemistry, electrochemistry, enzymatic reactions, chiral synthesis, high pressure reactions and synthesis of peptide conjugates;
Rx-360 has announced its presence at CPhI Worldwide and invites visitors to receive a comprehensive overview of the company’s activities and learn how it is able to enhance the security of the supply chain and to improve the quality of products. An Rx-360 Q&A Session will be held at CPhI, on 10 October, from 3 to 5 pm. Chief Purchasing Officers, Senior VPs of Quality and Rx-360 representatives of member companies will be discussing the organisation’s priorities, recent accomplishments and benefits of membership. “At Amgen we have already seen significant benefits from sharing audit information and conducting joint Rx-360 audits and we fully support the Rx-360 Audit programme such that Amgen will waive the audit of any supplier that has successfully completed an Rx-360 Audit,” said Martin VanTrieste, SVP Quality, Amgen. The Rx-360 Q&A Session is open to members and non-members. Procurement professionals and representatives in supply chain, purchasing, quality and regulatory affairs areas are especially encouraged to attend. “There is no question that this session will do more for your business than you can imagine. By attending this Q&A session, you will be taking the right step towards having a sound and compliant vendor qualification programme in your company,” said Guy Villax, Board Member of Rx-360. Rx-360 +1 202 230 5189 info@rx-360.org www.rx-360.org
• and containment technology (OEL < 0.1 µg/m3/8h). Bachem is currently involved in more than 173 cGMP projects targeting NCEs. Twenty out of twenty-five of the largest pharmaceutical companies worldwide rely on the company’s cGMP and quality assurance system. Currently, Bachem supports its customers in 84 clinical
phase I and II projects, 30 clinical phase III projects and 150 market-approved drugs containing Bachem’s APIs. Bachem AG +41 61 935 2333 sales.ch@bachem.com www.bachem.com
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CPhl Worldwide 2012 Specialty Chemicals Expert Presents Promise to Pharma Industry Hall 5, Stand H23 Clariant’s promise to create added value by appreciating the needs of its pharmaceutical sector customers will take centre stage at CPhI Worldwide. Presented for the first time under the company’s new branding, the specialty chemicals expert’s trusted high purity, high quality, tailored processing solutions can help meet the efficiency and performance requirements of specific pharmaceutical formulations. Clariant is a firm believer in working closely with customers in order to maximise the benefits of its extensive portfolio of building blocks, enhancers and ingredients for the processing of sensitive applications. A highlight for visitors will be Clariant’s broad portfolio of pharmaceutical PEGs/macrogols, a leading product range under the trade name Polyglykol, used as an API in laxatives and as excipients for tablets, suppository masses, organ preservation, protein purification and drug delivery systems. Clariant offers a complete range of different molecular weight, high purity PEGs supported by CEP certification and DMF. “Appreciation is the key to delivering the innovative and competitive processing solutions required by the pharmaceutical sector. This philosophy of listening to our customers is at the heart of Clariant and we are excited to have the opportunity to present this to the pharmaceutical community within the fresh look and feel of our new company branding at the forthcoming CPhI,” commented Boris Segalowitch, Business Line Head Personal Care EMEA, Clariant.
Boutique Service Focuses on Niche and High Potency APIs Hall 5, Stand H47 Icrom specialises in GMP production of niche APIs and related intermediates by applying its proprietary technologies to serve the worldwide generic pharmaceutical market. Icrom is an APIs boutique that exports its products in more than 50 countries, covering all regulated and semiregulated markets, including the US and Japan. Icrom’s operations are based on a broad 40 years of chemical and quality experience with GMP manufacturing facilities comprising several units, from small glove-boxed workshops for GMP productions of high-potency APIs up to
kg scale and to the tonne scale in multipurpose industrial plants. The production facilities are regularly inspected by the Italian AIFA and US FDA agencies, and audited by the main multi-national generic pharmaceutical companies that Icrom proudly counts among its main customers. The company’s efforts in the development of new products have been recently focused on niche and highpotency APIs, particularly those used in ophthalmic and oncology drugs. When it comes to difficult to make, high-value and high-quality APIs, it is advisable to
Clariant International Ltd +41 61 469 6363 kai.rolker@clariant.com www.clariant.com
Specialist in Creation and Commercialisation of APIs Offers to Share Expertise Hall 7, Stand F22 Formil Química is a Brazilian company located in Baruerí - SP. The company produces, through chemical synthesis or extraction, and commercialises APIs on local and external markets focused on pharmaceuticals, veterinary and cosmetic companies. Formil Química’s expertise is derived from constant research, driven by its R&D teams, which work both independently and in co-operation with universities and research centres, as well as in partnership with customers. The company produces under rigorous GMP procedures that can guarantee the quality and reliability of its products, processes and services. Formil Química Ltd +55 11 66330733 ricardo.coelho@formil.com.br www.formil.com.br
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go to an APIs boutique, which is where Icrom differentiates itself. Icrom invites CPhI Worldwide visitors to drop by its stand or arrange a prescheduled appointment by email. Icrom SpA +39 039 604 0836 info@icrom.com www.icrom.com
CPhl Worldwide 2012 Aminoglycoside Antibiotic Microparticles Address Lung and Nose Infection Hall 8, Stand C30 A new nasal spray technology currently under development at LISAPHARMA’s R&D department will be presented at CPhI Worldwide. Tobramycin microparticulate powders containing the hydrophobic adjunct sodium stearate were constructed for their use as pulmonary formulations in dry powder inhalers. Spray-dried powders have been characterised in terms of particle size distribution, morphology, crystallinity, drug dissolution rate,
toxicity on epithelial lung cells and aerosol efficiency. The presence of the sodium stearate had a direct influence on the aerosol performance of tobramycin spray-dried powders. Powders containing 1% w/w sodium stearate had fine particle fraction of 84.3±2.0% compared with 27.1±1.9% for powders without adjunct. This was attributed to the deposition of sodium stearate on the particle surface. Preliminary analysis of the toxicity
Film-Sugar-Coating Solution Accelerates Production Process
antibiotic powder agglomerated in soft pellets can be insufflated for nasal application in prevention of nose infections in surgically treated patients. The fragments of tobramycin agglomerates, obtained by insufflation, are deposited in the nasal cavities. LISAPHARMA SpA +39 031641257 sbizzotto@lisapharma.it www.lisapharma.it
Excipients Producer Demonstrates Versatility of Erythritol Product in ODTs
BENEO-Palatinit GmbH — Hall 9, Stand C29, BIOGRUND GmbH — Hall 9, Stand B11 BENEO-Palatinit and BIOGRUND are presenting SugaPolish FSC at this year’s CPhI Worldwide. The ready-to-use blend, containing galenIQ (Isomalt EP, BP, USP-NF), provides pharmaceutical and nutraceutical oral solid dosage forms with a film-sugar-coating that is comparable to a dragée. The process time, however, is drastically reduced. SugaPolish FSC is a dry-milled,
effect of sodium stearate on A549 cell lines showed that the adjunct, in the concentration used, had no effect on cell viability over a 24-hour period compared with particles of pure tobramycin. Tobramycin pulmonary powders with low level of sodium stearate, presenting high respiration performances and no toxicity on lung cells, could be used to improve therapeutic outcomes of patients with cystic fibrosis. The same
Hall 9, Stand B24
homogeneous, sugar-free blend, accelerating the coating of tablets. Being ready-to-use, the blend is easily handled and less time is required to prepare the coating suspension. For the process, all open and closed coating systems can be used. At a weight gain of only 10%, shiny dragée-like tablets are produced within less than 70 minutes coating time, including the waxing step already. Undesired taste and odour of APIs are successfully masked due to the stable filmsugar-coating. Tests confirmed that moisture absorbance is reduced in comparison with film coating, while stability of the product is improved. Even on very hydrophobic centres SugaPolish FSC leads to an excellent adhesion of the coating. The final product has an appealing appearance with shiny and brilliant colours, as well as a pure and natural taste. BENEO-Palatinit GmbH +49 621 421 150 info@galeniq.com www.galeniq.com BIOGRUND GmbH +49 6126 9526 30 info@biogrund.com www.biogrund.com
At CPhI Worldwide, Cargill Pharma will focus on the versatility, performance and benefits of its Zerose erythritol in orally dispersible, chewable and effervescent tablets. In these applications, Zerose erythritol demonstrates exceptional taste-making properties, whilst still benefitting from being a zero-calorie, non-hygroscopic, non-cariogenic polyol, with a high-level of digestive tolerance. Cargill staff will be on hand to discuss the results of Cargill’s latest pilot study, demonstrating the performance of Zerose erythritol as an ODT excipient for bitter or astringent active ingredients. Children, older people and those on the move are particular growth areas for ODTs. Over the last four years, Cargill Pharma has been developing Zerose erythritol as a pharmaceutical excipient for such tablets, and announced a new
patent application for the use of Zerose erythritol in ODTs at CPhI 2010. The Cargill stand at this year’s CPhI will feature examples of orally dispersible, chewable and effervescent tablet products produced using erythritol in their formulation. Also this year and for the first time at CPhI, Cargill will present its pharmaceutical alcohols, under the banner ‘Making quality alcohol naturally’. Cargill’s alcohol is used by many leading pharmaceutical companies in a variety of applications, including the production of tablets, extracts, tinctures, anaesthetics, antiseptics and liniments and lotions. Cargill Pharma +32 2257 0708 catherine_boghmans@cargill.com www.cargillpharma.com
Analytical Services Provider Announces Expansion and Re-Structuring Hall 10, Stand B90 Butterworth Laboratories is an independent contract analytical services provider to the pharmaceutical, medical device and chemical industries. There has been a significant increase in demand for the company’s services, which has seen its staff compliment grow from 40 to 46, encompassing both laboratory and support staff, and it is anticipated that this expansion will continue next year. To facilitate this increase and anticipated further growth, there has been a re-organisation of the Senior Management team to produce a more efficient management structure. In the restructuring, a new position has been created, COO, between the Directors and Senior Managers. This has been filled by David Hawkins who will still
maintain his role as Head of Quality Assurance and IT. John Welch has become Head of Business Operations, taking on the management of non-analytical departments, whilst David Riches, Head of Analytical Operations, and David Bell, Head of Projects, continue in their previous roles. John Welch and Steve Evans will be exhibiting at ICSE, so please email them to arrange a meeting and find out more about the restructuring and Butterworth Laboratories’ services. Butterworth Laboratories Ltd +44 20 8977 0750 john.welch@butterworth-labs.co.uk / steve.evans@butterworth-labs.co.uk www.butterworth-labs.co.uk
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CPhl Worldwide 2012 Partnering Organisation Offers Comprehensive Services Set for Liquid and Semi-Liquid Forms Hall 10, Stand D84
ASM – Aerosol-Service is a leading company in developing, mixing and filling high quality pharmaceutical and cosmetic products in liquid and semiliquid forms. This includes standard aerosols, bag-on-valve systems, sticks, airless-systems, jars, bottles, etc., depending on the customer’s requirements. ASM is a proactive and innovative partner and provides complementary services such as project management. With its broad know-how, ASM offers the optimal support and also collaborates with external partners like consultants, suppliers, universities, etc. ASM has the ISO 9001:2008/ISO 13485:2003 certificate, as well as the GMP certificate, and is equipped to produce, mix and fill under cleanroom conditions. ASM provides a complete service tailored to the customer’s needs, offering the following services and benefits: • development of customised products for clients; • optimisation of existing products; • purchase of all materials under favourable terms; • mixing; • milling; • packaging; • release of products; • compilation of all the necessary documents; • and organisation of worldwide distribution. Aerosol-Service AG Möhlin +41 61 855 67 67 info@aerosol-service.com www.aerosol-service.com
Chemicals Specialist’s Packaging Division Showcases Moisture and Oxygen Control Solutions Hall 10, Stand F78
The Swiss specialty chemicals group Clariant will have a major presence at CPhI Worldwide. Performance Packaging, a member of Clariant’s Functional Materials business unit, will spotlight its broad portfolio of desiccant canisters for moisture control in pharmaceutical packaging and its Integrated Desiccant
Contract Manufacturing Expert Seeks Challenging Projects Hall 10, Stand E05 The Wockhardt team is interested in talking to all CPhI Worldwide visitors looking for: • a safe pair of hands for their project; • an experienced biotechnology and pharmaceutical CMO; • cGMP facilities with MHRA/FDA and RoW approvals; • excellent technical support on site; • robust and proven firewall security for their Intellectual Property; • fully validated cold chain capability; • and controlled drug licenses. Thanks to Wockhardt’s expert staff, it has become a leading, global contract manufacturer. From development to
high-volume commercial manufacture, the company utilises more than 60 years experience to ensure the client’s product is professionally managed all the way to market. A full turnkey service from product development right through to commercial scale-up is offered. With a network of 11 manufacturing facilities located in the UK, the US, Europe and Asia, Wockhardt aims to provide its high quality, expert and cost-effective services wherever and whenever they are needed. From initial agreement to production, the average time to completion of
technology transfer is just four months. Some programmes have even been completed within two. Wockhardt UK +44 1978 669358 knowhow@wockhardt.com www.wockhardt-knowhow.com
Packaging Expert Highlights Preservative-Free Drug Delivery Devices
Capsule Filler Embodies Total Scalability Philosophy
Hall 10, Stand E84
Hall 10, Stand H09
Rexam Healthcare designs, develops and manufactures packaging — including containers and closures, drug delivery devices, metering pumps and valves and medical components — to improve patients’ health. Visitors to Innopack will have the opportunity to see the company’s full range, including its latest offerings in terms of preservative-free systems. In addition, Marketing Director Patrice Lewko will discuss new solutions in a challenging environment at the Speaker Corner on 10 October. Product highlights are: • The Novelia multidose eyedropper system that, according to the company, represents a major innovation in ophthalmic drug delivery devices by providing patients with a preservativefree alternative for chronic treatments with patient-friendly packaging. The packaging also features a tamperevident ring. The key benefit for patients is that usage is similar to a classic
Closure (IDC), a pharmaceutical cap combining tamper-evident, child-resistant and twist-off functionalities with a built-in desiccant. Furthermore, Valère Logel, Head of Development for Performance Packaging, will give a conference presentation entitled Your Drug Environment Under Control, on 10 October, at 10 am. Performance Packaging is a global leader in the design and manufacture of controlled atmosphere packaging solutions. As well as canisters and the IDC, Clariant will exhibit its Advanced Desiccant Polymer (ADP), which is used to create active healthcare packaging and device components by integrating desiccant directly into thermoplastics. Other featured solutions will include OxyGuard barrier bottles, which effectively block oxygen ingress by a factor of 100 compared with regular bottles, Handy Active Tubes, with a convenient flip-top cap and built-in desiccant, and
multidose eyedropper. For ophthalmic pharmaceutical companies, Novelia offers major advantages — compatibility with existing filling lines, a wider range of drug viscosities and user-friendly criteria for customers. • The Advancia pump combines userindependence and preservative-free properties in a single system. The Advancia pump guarantees a consistent spray regardless of the user. The particle size provided by the pump is also consistent. It is ideal for the distribution of preservative-free drugs as it guarantees non-contamination at the time of spraying. The EU has given its support to this project through the provision of €504,000 from the European Regional Development Fund (ERDF). Rexam Healthcare +33 1 58 47 56 82 laurence.quesdeville@rexam.com www.rexam.com/healthcare
PharmaKeep humidity-neutral oxygen absorbers. Logel’s presentation will explain why standard desiccants may not meet the needs of today’s novel drugs and diagnostic systems for a controlled package atmosphere. He will describe new solutions that ensure an accurate humidity range to avoid extreme changes inside the packaging. Logel has a master degree in polymer engineering and has been the head of development for Performance Packaging since 2005. An expert in product design and engineering, he has lead the market introduction of innovative packaging solutions for moisture control, oxygen adsorption and multi-layer polymer barriers.
MG2, a specialist for over 40 years in the design and manufacture of automatic dosing and packaging machines for pharmaceutical and cosmetic products, will be showcasing a FlexaLAB capsule filler, a top model in the field of machines for R&D laboratories, clinical trials, small batch outputs and special production. FlexaLAB embodies perfectly the MG2 capsule filling total scalability philosophy — customers will always find the right answer to their specific need, choosing between different and scalable solutions for different requirements in dosage capability, production capacity, weight control and containment. FlexaLAB is based on the same functioning principles as MG2 highspeed machines. For the production of up to 3,000 capsules per hour, it can work either in continuous or intermittent motion, depending on the type of dosing unit installed. Thanks to the possibility of installing two dosing units at the same time, product combinations inside the same capsule are possible, thus guaranteeing the maximum flexibility required by R&D laboratories. The machine on show will be fitted for low powder dosages without compression. MG2 is a world leading supplier of these systems, which are particularly suitable for inhalation products.
Clariant International Ltd +41 61 469 6363 kai.rolker@clariant.com www.clariant.com
MG2 S.r.l. +39 051 4694128 marketing@mg2.it www.mg2.it
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MANUFACTURING PRODUCTS & EQUIPMENT Aseptic BFS Machines Manufacturer Provides Worldwide Coverage According to rommelag, it is the inventor of Blow-Fill-Seal (BFS) technology and the leading worldwide manufacturer and supplier of bottelpack advanced aseptic BFS machines. bottelpack machines have been supplied for packaging sterile liquids, creams and ointments. rommelag also supplies complete finishing lines, as well as leak detectors and cap welding machines. The rommelag organisation consists of several factories and commercial offices. Today, there are two sales companies for the marketing of bottelpack systems, rommelag ag, located in Buchs, Switzerland, and rommelag KunststoffMaschinen Vertriebsgesellschaft GmbH, headquartered in Waiblingen, near Stuttgart, Germany. They are supported by two contact offices located in Evergreen, US, and Shanghai, P.R. China. In total, more than 1,000 employees are at the customer’s service. bottelpack aseptic machines have a modular design, an integrated cleanroom class A (US-class 100) and an optional dark/white machine separation. The fully automatic machines work on either an intermittent cycle with one and two moulds or continuously with rotating moulds. All are automated CIP/SIP capable. The machine capacities vary according to the container characteristics. From 0.1 to more than 1,000 ml size containers are filled at rates of up to 30,000 containers per hour. The filling is done by an extremely accurate time-pressure dosing system. The rommelag companies are represented in many countries and utilise outstanding specialists to advise customers all over the world regarding pharmaceutical container selection and design, product compatibility of plastics, closures design and requirements. They also provide competent advice on environmental matters. rommelag works closely with plastics manufacturers’ technical application departments and other related institutions. Last year, sister company maropack in Zell, Switzerland, opened a Biosafety Level 2 production site for contract packaging of biological products, e.g., vaccines, with BFS technology. This year, sister company Holopack in Sulzbach, Germany, has opened the new Pharma 2020 factory, a modern liquid packaging plant for contract manufacturing with BFS technology. rommelag ag +41 62 834 5555 mail@rommelag.ch www.rommelag.com EPM 11
Bottelpack machine type 4010M, with high voltage leak detector.
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Vision System Helps Increase Efficiency by 200% on Pharma Packaging Line A major pharmaceutical manufacturer’s packaging line presents a challenging vision system application because of the need to select exactly the right label among dozens of possible alternatives needed to meet differing languages and regulatory requirements around the world. The vision system used in the past rejected 25% of good packages. When the pharmaceutical manufacturer installed a new packaging line, in consultation with WJ Automation, the company upgraded the vision system to Cognex In-Sight 5100 and 5600 vision systems, which use optical character recognition/optical character verification
(OCR/OCV) to read characters on the label and compare them with the correct sequence. Depending on the specific label that is used, information can appear on the right side, left side or on both sides of the label. The left side of the label normally has a maximum of three lines of text, with a maximum of 15 characters on each line. The right side of the label normally contains the Pharmacode, a 1D barcode standard used in the pharmaceutical industry as a packing control system. Some labels also have 2D barcodes, which could be on either side of the label. A 1D barcode that defines the lot also
appears across the bottom of each label. This means that a relatively larger field of view must be read to fully verify the label. The labels are also very glossy so they have a tendency to create reflections that can detract from image quality. Using the Cognex vision systems has reduced the false reject rate to 0.5%, improving the first pass yield (quality) and consequently the overall equipment effectiveness by 200%. Cognex UK Ltd +44 1327 856 040 sales@cognex.com www.cognex.com
White Paper Confirms Accuracy of Blister Leak Detection Machine
A new white paper by Dr. Dorian Dixon of the University of Ulster has revealed that Sepha’s VisionScan leak detection machine has a 100% success rate in detecting defects in a variety of blister packs. The findings of the study showed that the VisionScan system enables the accurate non-destructive detection of faulty pockets in a range of pack designs and material types. In repeat testing of 190 packs, each containing a pocket with a laser drilled hole, the VisionScan system correctly identified 100% of the defective pockets. None of the good packs were incorrectly identified as defective. Additionally, the ability to adjust test parameters, in line with different material, enables the sensitivity of the system to be controlled to ensure the most accurate test for each individual blister pack type. VisionScan is a tool-less, nondestructive leak detection machine for blister packs. It uses high-resolution camera imaging technology to detect defects down to 15 µm in individual blister pockets and weak seals in less than 60 seconds. VisionScan has been developed to meet growing demand from pharmaceutical blister pack manufacturers for a low-cost yet accurate and modern leak detection alternative to the blue dye test that can be integrated into their quality control system. Since its launch in 2011, VisionScan has been the technology of choice for a wide range of customers throughout the world, including some of the largest pharmaceutical manufacturers, as well as generic manufacturers and contract packers. Sepha Ltd +44 28 9048 4848 marketing@sepha.com www.sepha.com EPM 12
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Dosator Filling Unit Allows Powders to be Developed for Any Production Equipment
A dosator powder filling system has been developed by Dott Bonapace for its fully automatic, benchtop capsule filling machine In-Cap, to compliment the existing dosing disc filling system currently available. As a research and development machine, the In-Cap is frequently used to formulate and refine products that are to be transferred to production units. This new system will enable powders to be developed for all types of production equipment, as well as allowing different types of product to be handled in the way best suited to their characteristics. The new unit has been designed so that it can not only be fitted to new machines, but also installed on all existing Bonapace In-Cap units without any modifications to the machine or to the controls. The system consists of a ring of dosator tubes, each with an internal pin that forms the chamber. The length of this chamber is centrally adjustable to suit the filling requirements. The dosators are raised and lowered each cycle, while being rotated as the machine indexes. The tubes are lowered into the powder bed of the hopper, with an adjustable tamping facility if required for forming a slug of product. They continue to rotate until located over the open body of the capsule when the dosator pin is used to push the powder out of the chamber and into the capsule. The hopper consists of an annular ring, minimising the amount of product needed to allow the unit to run. The depth of the powder bed is adjustable, while the residual product is agitated after the dosing station. A bulk hopper feeds powder to this device and has been designed to minimise the problems of bridging experienced with some products. This new system marks a major step forward for the In-Cap machine, which has so far proved successful in many locations throughout the world.
Biopharma Processing System Supports Production of Multiple Products Over Range of Scales Merck Millipore, the Life Science division of Merck, has launched the Mobius FlexReady Solution with Smart Flexware Assemblies for Chromatography. As the newest addition to the company’s family of integrated single-use processing solutions, it is a fully-automated system designed to achieve optimum performance during the purification of biopharmaceutical products quickly, reliably and safely. The Mobius FlexReady Solution with Smart Flexware Assemblies for Chromatography delivers exceptional performance, operational flexibility and scalability. Unlike traditional single-use processing systems, this modular system is quick and easy to set up, providing the ability to switch from one scale to another with a minimum number of component changes, making it ideal for pilot plants and CMOs that have rapidly changing demands. Comprehensive services, including IQ/OQ, process qualification consultancy and first run support, ensure rapid implementation and optimised performance. The Smart Flexware single-use flow path delivers equivalent or better performance to that of traditional stainless steel systems, while maximising system flexibility. Smart Flexware assemblies are clearly labelled, making them easy to install, while significantly reducing the risk of operator error and challenges typically associated with installing single-use flow paths. Additionally, the flow path significantly
reduces dead-legs and moving parts, decreasing the risk of contamination to virtually zero. According to Merck Millipore, its Mobius FlexReady Solutions provide the industry’s only complete single-use process train, offering both upstream and downstream solutions that reduce the time and resources required for commercial protein manufacturing. The company recently launched a state-ofthe-art GMP bioproduction facility in Martillac, France, where Merck Millipore experts help drug manufacturers leverage Mobius single-use technologies to speed a therapeutic molecule’s journey to the clinic. Merck Millipore +1 781 533 5197 janice.paquette@merckgroup.com www.millipore.com/mobius
Dott. Bonapace & C. S.r.l. +39 02 33122 1 r.colombo@dottbonapace.com www.dottbonapace.com
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Data-Loggers Guarantee Exceptional Value for Money LogTag products are specifically designed to meet the growing demand for cost-effective data logging solutions. LogTag data loggers are a perfect match for all applications where temperature and humidity must be recorded reliably and independently over any time frame. Typical applications include transport/warehousing (cold chain) and room monitoring in numerous industry sectors, including foodstuffs, hospitals, pharmacy and biotechnology. The temperature logger TRIX-8 is accompanied by a comprehensive and intuitive software package for analysis, operating in 16 languages. The temperature measurement range of -40˚C to +85˚C covers a variety of applications with an accuracy better than ±0.5˚C. In addition to the temperature data loggers, combined temperature/humidity models also exist, as well as loggers with remote sensor probes. Lowtemperature loggers down to 80˚C are also available. CiK Solutions GmbH +49 721 62 69 085 0 info@cik-solutions.com www.cik-solutions.com / www.logtag-recorders.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Anti-Slip Tray Drain Cover Made to Match Floor Surface
manufacturer of all ASPEN stainless products, Canal Engineering is able to offer complete drainage systems, bespoke stainless steel equipment and can customise any standard product to suit its environment. View Canal Engineering’s full range of industrial stainless steel products online or contact the company’s specialist engineers to discuss bespoke requirements.
In specialist environments where appearance is nearly as important as a non-slip, hygienic and safe floor finish, the new ASPEN Resin Filled Tray Drain Cover is ideal. Now available in two standard sizes, the ASPEN Resin Filled Tray Drain Cover can be filled with a resin to match the colour, finish and functionality of the surrounding floor surface. This new product from the forward thinking ASPEN team creates a durable, hardwearing floor finish, with anti-slip protection and looks to match. As the UK-based designer and
Canal Engineering Ltd +44 115 986 6321 aspen@canalengineering.co.uk www.aspen.eu.com
Next-Generation Paper Padding Improves Packaging Speed Storopack has enhanced the operating speed of the new generation paper paddings machine PAPERplus Chevron2 by 50%. With a speed over 30 m/min, the machine unfolds a paper tube and processes the material into a flexible paper padding and packing filler. The patented product fills more volume using less material and the polished and sophisticated aesthetics of the finished protective packaging is typically focused towards the pharmaceutical and cosmetics industries. To even further improve the positive unpacking experience, PAPERplus Chevron is available with white kraft paper. For into-the-box, top-fill applications, containing light products such as medicines where greater cushioning performance may not be necessary, PAPERplus Chevron2 has an additional setting, which simultaneously reduces paper consumption during operation, specifically for this purpose. The machine is available as a tabletop model or on a movable metal stand. PAPERplus Chevron2 offers a variety of options for integration into the packaging station and the packaging process. In a standard packaging system, the paper pads are made available in plastic pipes at an ergonomic working height for clasping. Using a conveyor system, the machine can supply paper padding to several packaging stations. The padding strip is automatically divided into sections. Based on the working comfort principles, Storopack configures the PAPERplus Chevron protective packaging system for maximum effectiveness, efficiency and ergonomics by using the into-the-box protective packaging solution. The PAPERplus Chevron paper padding system was introduced in 2007. According to Paul Deis, Product Manager, PAPERplus Chevron has a unique position in the market for protective packaging made from paper: “The Chevron concept is an innovation and to this day it does not have a successor. The new machine generation once again brings two dimensions to the fore. Higher speed ensures higher productivity and the additional mode for reduced material consumption, when less cushioning performance is required, reduces the risk of oversupply and over packaging.” Storopack UK Ltd +44 114 249 2004 packaging.uk@storopack.com www.storopack.co.uk EPM 14
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Adamus HT +48 91 4599 101 marketing@adamus.com.pl |www.adamus.com.pl
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Bosch Packaging Technology Ltd - Manesty, UK +44 151 547 8000 sales.packaging-kny@bosch.com | www.manesty.com
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Fette Compacing GmbH, Germany +49 4151 12 0 tablet@fette-compacing.com | www.fette-compacing.com I Holland Ltd, UK +44 115 972 6153 sales@iholland.co.uk | www.iholland.co.uk
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IMA SpA, Italy +39 051 651 4111 mktg.soliddose@ima.it | www.ima-pharma.com
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Natoli Engineering Company, Inc., US +1 636 926 8900 sales@natoli.com | www.natoli.com
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Tablet design, tooling design, lab services, technical training, laser tool inspection system and accessories.
SHOWCASE CONTAINMENT & OPERATOR PROTECTION Containment at Source with Rotary Tablet Press Range’s Exchangeable Module Today, the pharmaceutical markets are increasingly involved in the development and production of highly potent active ingredients. One of the main concerns is to control the operator exposure during the manufacturing and processing of these hazardous substances. GEA Pharma Systems - Courtoy has positioned itself as a specialist in the field of high containment tabletting for OEB 3–4 and 5 products. The Courtoy MODUL tablet press is based on a demonstrably successful concept — the Exchangeable Compression Module or simply ECM. The ECM is a small isolated section within the machine that can be removed in a contained manner in just 15 minutes. The ECM, including the punches and cams, is then brought to a washing area where it can be automatically washed offline. Meanwhile, a second prepared ECM can be installed in the machine and production can be resumed within one hour. Companies that have invested in the Courtoy technology did so for the following reasons:
• manufacturing can be done in a standard production room (no drain or water connections inside the room); • small compartment, less contamination — the ECM represents 30% of the entire press; • higher productivity compared with WIP machines; • only 30 l/min water consumption compared with 80 l/min and more on a WIP tablet press, meaning less waste water treatment; • no corrosion of rollers and other parts, since the inside of the press need not be washed; • no risk of seals leaking water inside the press, contaminating the mechanical compartment; • no second wash cycle required after removing the feeder, tooling, etc.; • and very high containment level, yet practical in daily use. With more and more companies engaged in the manufacture of more
The online selector tool features fully dimensional product images with information hotspots. If the visitor hovers over these triangles, the key features of the product are explained. particles, as well as anti-static properties and limited flame resistance through a specialist fabric coating. For comfort and ease of movement, the designs incorporate extra material in the arms and legs, and some models feature knitted cuffs and an elasticated waist and ankles. 3M protective coveralls have been subjected to rigorous material and seam tests, and performance classes are demonstrated on the data sheets available for each model. To access the selector tool and to view the full range of protective coveralls from 3M, please visit www.3M.co.uk/coveralls. 3M +44 870 60 800 60 ohesuk@mmm.com www.3m.co.uk/ohes
GEA Pharma Systems - Courtoy +32 2 363 83 26 veerle.chiau@gea.com www.gea.com
Flexible Isolator Provides Maximum Safety with <1 µg/m³ OEL
Online Product Selector Makes Finding Right PPE Easier Diversified technology company 3M has launched an online product selector tool showcasing an extended range of coveralls, laboratory coats and accessories. The selector tool has been designed to help customers access useful product information quickly and easily to help them identify the most appropriate Personal Protective Equipment (PPE) against skin hazards in the workplace. Louisa Perry, Product Manager for 3M’s Safety Solutions Division, explained: “We offer a wide range of protective coveralls, laboratory coats and accessories that cover a broad spectrum of robustness and protection, from general purpose designs for light duty work to more advanced models with specialist features for more hazardous conditions. The new online selector tool provides summary information on each product, including certification, features and benefits, applications, suitability and material information — everything the customer needs to help them make an informed decision.” The coveralls available from 3M offer a range of features, from breathable panels for increased comfort, to specialist fabric treatments for increased alcohol and oil resistance. Most models feature a threepanel hood designed for enhanced compatibility with additional PPE, plus two-way zips for added on/off convenience. Storm flaps provide additional protection, while seamless shoulder and sleeve tops provide comfort and fewer entry points for contaminants. Further options include protection against certain biohazards and nuclear
potent products, GEA Pharma Systems Courtoy not only offers the right technology, but also the experience coming from a large installed base.
Weiss GWE develops and produces technically sophisticated containment systems for the protection of staff, product and environment. The WIBO Flexible Isolator is the perfect addition to and expansion of all WIBO systems to form a closed system offering maximum safety. Weiss GWE flexible isolators with glove ports are ideal for the filling, weighing or sampling of active substances and highly toxic materials. Design is customised in every case and governed by the process to be realised. The systems can be used in applications where there are negative pressure atmospheres and achieve an OEL of <1 µg/m3. Interfaces for infeeding and outfeeding can be realised with a continuous liner. Fibre drums and vessels are docked using a double O-ring. The continuous liners used achieve a high containment level and the simplest of handling characteristics. The setup kit consists of a clamping and holding fixture, an air connection to the WIBO air system and a workplate for covering the scale (weighing workplace). This enables simple and rapid installation of the flexible isolator. Following clamping, a leak test (vacuum test) can be conducted using the WIBO system control. Existing WIBO systems can also be retrofitted in this manner. Where a WIBO system is not available, the flexible isolator can be designed with a separate frame. As well as low investment costs and
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exceptional safety, the flexible isolator offers the added benefit of being especially suitable for frequent product changes, as complicated cleaning procedures and cleaning validations are not required. Weiss GWE GmbH +49 4484 189 0 contact@gwe.de www.gwe.de
SHOWCASE CONTAINMENT & OPERATOR PROTECTION Powder Systems Ltd (PSL) has supplied a full suite of contained filtration and drying solutions to a leading drug manufacturer in India, Cipla Ltd, for its new oncology plant in Bangalore. The new plant includes several production lines and PSL has provided a suite of filter dryers for both small- and large-scale production of potent APIs. The suite provided incorporates contained discharge to achieve a proven OEL of less than 1 µg/m-3 during the sampling period. The high containment filtration and drying suite consists of four filter dryers with integrated high containment discharge isolators for assured operator and product protection. One of the small-scale agitated nutsche filter dryers for kilo lab production is in PSL’s GFD
PRODUCTION UNDERWAY AFTER HIGH CONTAINMENT FILTER DRYER SUITE PASSES CIPLA ONCOLOGY PLANT’S SITE ACCEPTANCE TEST
FilterBox. This stainless steel isolator comprises a glass filter dryer, both designed and integrated by PSL. Cipla opted for a full, high containment scaleup solution to repeat its process while handling small to large quantities of highly potent compounds. The contained product offloading can be done either inside the FilterBox or through the discharge isolators mounted on the side of the 0.125, 0.3 or 0.6 m2 filter dryers. Scale-up from chemical development in small-scale batches to industrial volume is a complex and time-intensive process, requiring considered technology risks and equipment design and process constraints. The commercial application of a technology developed at an early stage requires scalability of the equipment used throughout the whole process. “The new oncology plant needed to transfer from the kilo-lab scale for oncologic chemical development to obtain larger volumes of highly potent APIs. The contained filtration suite provided by PSL is an ideal solution. The highly active batch production will be carried over to the scaled-up
industrial yield and they will obtain kilogrammes of dry and homogeneous HPAPIs in a shorter time-tocommercialisation,” explained Rémy Wattiaux, MD of PSL. Cipla and PSL proceeded to the Site Acceptance Test last month. It was essential that all the containment systems complied with the targeted OEL level prior to commencing with production of the 15 different anti-cancer products. Independent OEL tests were carried out during surrogate (lactose) handling trials in PSL’s filter dryer discharge isolators and the Kilo-Lab GFD FilterBox. The target containment limits for personal exposures of less than 1 µg/m-3 averaged over the task duration and less than 0.3 µg/m-3 as an eight-hour time weighted average (8h TWA) were achieved. It was also desirable to prove control personal exposures to less than 25% of these values, i.e., < 0.25 µg/m-3 over the task duration and < 0.075 µg/m-3 as an 8h TWA.
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CASE STUDY
Vaibhav Dalvi, Sales and Service Manager of PSL India, on-site at Cipla Ltd, Bangalore.
Powder Systems Ltd +44 151 448 7700 info@powdersystems.com www.powdersystems.com
SHOWCASE TABLET INSPECTION & TESTING Inspection Systems Provide Dependable Checking for Tablet and Punch Defects I Holland’s PharmaCare range provides high quality visual and physical tablet inspection systems, from the simple, portable Holland MiniCam to the robust C53 tablet hardness tester. The Holland MiniCam and iNSPECT vision systems have been developed for the close inspection of tablets and punch tips. The magnifications vary from 17 to 200x with LED illumination, which gives a clear, precise, high quality image and allows for quick and easy identification of defects and wear, thereby saving time and money in production. The image is viewed on a PC with easy to use software*, which can be saved for reference or emailed directly to I Holland for consultation. The visual systems provide both live and still images for close up inspection and photography. The C53 tablet hardness tester is simple and flexible to use. It can be
connected to a digital calliper and micro balance that enables tablet weight, thickness and hardness to be printed from the integral printer, all on one information sheet. It is a small and lightweight model, allowing the unit to be easily moved within the production environment. Other features include: • automatic sizing of tablet; • 20 column x four–line LCD display; • ‘Standard’ setting for easy operation; • compact Qwerty keyboard available; • test results printed and/or sent to a PC; • USB ports incorporated for data transfer; • and software can be easily customised to bespoke output requirements. I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk
Tablet Analysis Equipment Now Available in Latest Edition of Tablet Compression Accessories Catalog Natoli Engineering Company has revealed a new, affordable selection of tablet analysis equipment. From balances to laboratory blenders and everything in between, there is a variety of analytical equipment to suit a variety of needs. Available analysis equipment includes tap density, dissolution, friability, powder flow and tablet hardness testers. A sieve shaker and a granule friability tester are two of the newest pieces to be introduced with the new catalogue. In addition to the wide selection of analysis equipment, other products include laboratory blenders, precision balances and moisture analysers.
*Software included compatible with Windows 2000/XP/7.
Fully Automated System Monitors Tablet Hardness for Multiple Press Rooms
The SOTAX HT 100 tablet hardness tester is ideal for high throughput production settings because of the ability to separate different batches
regardless of tablet shape and size. This unit uses a multi-chamber carousel in order to hold hundreds of tablets for automatic processing. The HT 100 is a fully automated system that incorporates a built-in balance to measure tablet weights in addition to tablet thickness, diameter/width and hardness. It is fully supported by IQ and OQ documentation and user training. QDoc software is fully validated software for collection of data that can be configured for autoexport into Excel or into one’s data tracking system. The measurement principle of tablet hardness can be changed from Constant Speed to Constant Force. This feature is easily selected per product method to compare with and reproduce results of all common hardness testers available.
Features of the HT 100 are: • automated tablet separation — the SOTAX HT 100 separates even the smallest tablets using the vibration-free Auto Separator; • automated tablet alignment — the SOTAX HT 100 is equipped with the patented Auto Alignment device that automatically aligns the tablet in the correct orientation for hardness testing, which ensures proper positioning of the tablet and therefore reliable, reproducible hardness readings; • and fast tablet testing — according to the company, the SOTAX HT 100 is the fastest hardness tester on the market. For demonstrations, please get in touch with SOTAX. SOTAX AG +41 61 487 54 54 info@sotax.com www.sotax.com
Tablet Checker Guarantees 100% Accuracy with High Throughputs Precise checking of the diameter and thickness of sugar- and film-coated tablets is a challenge if a high throughput is required. The Bohle Tablet Checker KA ensures precise checking for these applications because the tablets will be checked during a nonmoving phase. The process can be validated and 100% checking of all tablets is guaranteed. Transport from the stainless steel feeding hopper to the pairs of sorting discs is effected by oscillating slides. Checking of thickness between the pairs of discs is extremely precise as these can be adjusted in a reproducible
way by a hand operated measuring device with a 0.02 mm scale. At the same time, the slackness of the bearing is compensated. The advantages of the Tablet Checker KA are: • proven technology; • precise calibration; • process can be validated; • precise measurement; • idle position of the pills between the pairs of discs; • and at the diameter check, each pill must have laid in a check hole before it can leave the machine.
L.B. Bohle Maschinen + Verfahren GmbH +49 2524 9323 150 t.borgers@lbbohle.de www.lbbohle.de
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One of the most distinctive products to be introduced is a new portable, handheld hardness tester. Measuring just 25.4 cm long and 7.6 cm wide, this portable unit is suitable for use in both the laboratory and manufacturing areas. Although this device is powered by batteries, adding to its portability, there is an option for printer attachment, when validation is required. “Capable of measuring 2 to 28 mm tablets, with a hardness range up to 500 Newtons, this small device is powerful,” said Rachel Krafft, Marketing Coordinator, Natoli Engineering. Features of the handheld hardness tester include two precision ground platen jaws, sliding guard, collection tray and a convenient handle. The new expanded selection of tablet analysis is just an example of why the Tablet Compression Accessories Catalog serves as a leading resource for tablet compression accessories. Natoli Engineering Company, Inc. +1 636 926 8900 info@natoli.com www.natoli.com
SHOWCASE TABLET INSPECTION & TESTING Single Testing System Measures Five Parameters of Virtually All Tablet Shapes The SmartTest 50 provides outstanding semi-automatic testing of up to five physical parameters — weight, thickness, width, diameter/length and hardness — of practically any tablet shape. In full compliance with current Pharmacopeia requirements, the system offers exceptional precision, flexibility and user-friendliness. Next to fast and efficient operation, the SmartTest 50 provides accurate and highly reliable test data, resulting in increased productivity and ease of regulatory compliance. Tablet samples are placed in a carousel by the operator and all further testing is done automatically. The patented SmartAlign system guarantees reliable orientation of test samples in the integrated measuring stations and can automatically turn oblong and oval shapes for width and length measuring prior to hardness (breakforce) testing. In order to ensure trouble-free alignment at all times, an integrated cleaning function removes debris and broken tablet fragments from all contact
surfaces of the hardness station after each measurement, including platen surfaces. Proven Dr. Schleuniger hardness measuring technology with a precision S-beam load cell complies with all current USP and EP requirements and offers consistently accurate results. Featuring high-performance electronics, an integrated precision weighing module and intuitive touchscreen operation, the SmartTest 50 has been designed to maximise efficiency of physical testing processes. At the same time, it allows for an extremely wide range of tablet shapes to be tested and is very easy to operate and calibrate. From performing simple tests to running large sample sizes using up to 100 programmed products — including nominal values and T1/T2/PL limits — the SmartTest 50 is a true multi-purpose instrument.
View a video of the SmartTest 50 online at: bit.ly/Qcri3Q.
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Dr. Schleuniger Pharmatron AG +41 33 227 50 00 info@pharmatron.ch www.pharmatron.com
Corporate News & Events
Coding and Marking Expert Strengthens Product Identification Team as FMD Draws Closer Domino Printing Sciences has further strengthened its specialist, global pharmaceutical product identifications group with the appointment of Julia Felgate as Marketing Executive. Felgate joins Domino’s team of experts dedicated to helping pharmaceutical manufacturers comply with the pending Falsified Medicines Directive (FMD) 2011/62/EU. In her new role, she will support the team in focussing on the consultation and successful implementation of holistic, best practice solutions to comply with the developing legislative requirements.
Drawing on her international marketing and events management experience, Felgate will manage and implement proactive campaigns to educate and inform Domino’s customers and partners of the implications of all new legislation under the FMD. This will enable stakeholders to prepare themselves to be fully compliant for when the FMD comes into force on 2 January 2013. “It is an extremely exciting time to be taking on this new role within Domino’s international FMD group,” said Felgate. “As we continue to monitor and prepare for the FMD legislative requirements, it is essential that pharmaceutical manufacturers are made fully aware of these requirements and how they can make preparations now to ensure that they are ahead of the competition when compliance becomes compulsory.” Domino’s FMD team, headed up by Life Sciences Manager Craig Stobie, has spent the last 18 months consulting and engaging with key stakeholders to anticipate and prepare for forthcoming EU announcements. “Staying one step ahead and being ready for what the FMD will dictate in terms of product identification and traceability is going to be essential to avoid disruption to business for pharmaceutical manufacturers,” said Stobie. “With the expectation of a number of key EU announcements in the coming
months, Julia’s appointment will ensure that all our partners and customers will be in the best possible position to review all the solutions and options to get themselves fully compliant as quickly and efficiently as possible.” Domino Printing Sciences plc +44 1954 782551 craig.stobie@domino-uk.com www.domino-printing.com
Leading Companies Sign Up for Cleanzone’s Debut in Frankfurt Cleanzone, taking place on 24–25 October, in Frankfurt am Main, is shaping up as numerous leading companies confirm their participation in the new, international cleanroom technology trade fair. “The concept has met with tremendous acceptance both in Germany and abroad, and the industry has been particularly pleased with the international orientation of Cleanzone,” stated Klaus Reinke, Member of the Extended Board of Management of Messe Frankfurt Exhibition. Exhibitors so far include the companies Colandis, Kelvin, Kimberly-Clark, Profi-con and WISAG. In all, Messe Frankfurt is expecting some 50 exhibitors for Cleanzone’s debut, which will be showcasing cleanroom systems, technology, construction components and consumables, as well as selected projects from universities and other higher education institutes. Cleanzone is responding to the growing range of cross-industry applications for cleanroom technology, making it an attractive event for decision-makers from the fields of chemicals, pharmaceuticals, food, nanotechnology, optics, laser technology, microelectronics, automotive and aerospace, fostering a cross-industry exchange of expertise. The trade fair’s hands-on and interactive concept sets the event apart; not only are companies invited to bring cleanrooms to life right on their stands, but trade visitors are also given the opportunity to take part, free of charge, in lectures, presentations and workshops on issues of importance to the cleanroom industry as part of an integrated forum. The Cleanzone Congress will be held alongside the trade fair, offering the latest know-how on key topics in the field of cleanroom technology. The experts, speaking on both days, will include Dr. Udo Gommel (Fraunhofer IPA), Conor Murray (3dimension Cleanroom and Chairman of the Irish Cleanroom Society) and Florian Dittel (Dittel Engineering). EPM 22
In addition to the transfer of highly specialised knowledge, this new industry meeting place will be helping to integrate the worlds of science and business, while promoting networking across industry and national boundaries. As part of three panel discussions focusing on Fundamentals, Technology and Operation, leading international specialists will be offering an in-depth look at the latest research findings, technological trends and the outlook for the industry, as well as practical aspects of operation, including efficiency, cleaning, apparel and training. Messe Frankfurt is organising the congress in collaboration with experienced industry experts, with Reinraum-Akademie GmbH and the partner associations of Messe Frankfurt being responsible for the content of the congress. High standards are guaranteed, as all of the presentations will be based on scientific findings and will be independent of any products or providers. Messe Frankfurt +49 69 7575 6290 anja.dieteatmessefrankfurt.com www.cleanzone.messefrankfurt.com
LABORATORY PRODUCTS & EQUIPMENT
Latest Software Release Speeds Up Custom Analysis Routines of High Content Screening Systems Molecular Devices has launched MetaXpress 5.0 high content image acquisition and analysis software, which has been designed to improve the ease and speed of custom analysis using the company’s ImageXpress Micro and Ultra systems. The new software enables usercreated analysis to be run on MetaXpress PowerCore software, which harnesses the speed of parallel processing and instantly cuts analysis time from hours to minutes. An interactive tool incorporated into the software allows users to create custom analysis easily, without resorting to dedicated programming expertise. The system includes a total of 19 predesigned analysis routines, with the facility to freely add in custom steps to create a tailored analysis. MetaXpress 5.0 also features object click-to-find, allowing scientists to rapidly identify objects of interest within their images. Investigators can easily import data from third party hardware and export measurements to a variety of formats with the new MDCStore Xchange service plug-in. Zheng Yang, a computational biologist in the biotechnology industry, commented: “This unique software solution addresses the specificity required for common image analysis problems, yet offers the flexibility sought after in advanced development for high content screening methods. The MetaXpress software has dramatically increased the speed and throughput of high content and morphometric screening of our neuron cultures. The ability to apply a custom analysis module to all images captured from a single well in batch form saves significant time in our screening workflow.” “With the release of MetaXpress 5.0, our software can now analyse images using custom analysis routines at speeds that will keep up with acquisition,” said Grischa Chandy, Product Manager of Cellular Imaging at Molecular Devices. “ImageXpress systems combined with MetaXpress software offer some of the fastest high content screening solutions available, significantly improving screening
workflow and providing the flexibility needed for the research environment.” For more information on MetaXpress 5.0, please visit www.highthroughputimaging.com. Molecular Devices, LLC +1 408 747 3816 chris.kier@moldev.com www.moleculardevices.com
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SHOWCASE REACTORS Single-Use Bioreactor Handles 4–10 l Volumes for Efficient Benchtop Pilot to Production Scale-Up Xcellerex has introduced its XDR-10 single-use bioreactor designed for benchtop use. The XDR-10 allows smooth scale-up to full production and is ideal for GMP clinical and commercial manufacture of biotherapeutics, vaccines and other biologics. According to Xcellerex, the new system is the industry’s first and only bag-type, single-use bioreactor flexible enough to handle 4–10 l volumes. It is available in single-, twin-, triplet- and quad-vessel configurations. The new bioreactor joins Xcellerex’s existing line of fully-integrated, fullycharacterised systems available with working volumes of 50, 200, 500, 1,000 and 2,000 l — and features the same fluid contact materials, fluid dynamics and control strategies. It also integrates with Xcellerex’s FlexFactory biomanufacturing platform. The XDR-10’s reliable, predictable results greatly reduce risks and times in scaling from benchtop pilot to production. It is said to be perfect for
process development, small-scale production, seed train culture or process troubleshooting and features include: • outstanding sparging flexibility for adaptability to a broad range of cell lines; • a low shear, high input-power impeller that provides gentle, efficient mixing for sensitive cells or media; • an optimised impeller position that maximises volume range and turndown ratio; • and industrial-grade automation, which ensures process performance and consistent data management. The XDR-10 can function as a production vessel in its own right or become a scale-down tool or satellite platform (with multiple-vessel configurations available) for larger projects to be continued in larger bioreactors. The XDR-10 handles the industry’s toughest challenges in process development — to perform as a small-scale production vessel and work as an ideal vehicle for seed-train culture.
Bioreactor Range Provides Maximum Flexibility for Microbial and Cell Culture Applications
Sartorius Stedim Biotech (SSB) is bringing a completely revamped generation of its successful bioreactor series to the market. BIOSTAT B is an autoclavable fermentor/bioreactor that has been specially designed to cover the wide variety of requirements in biotechnological and biopharmaceutical R&D. It can be supplied as a flexible, basic unit for preclinical research, up to a ready-configured, fully qualified bioreactor system that meets the requirements of a validated GMP environment. BIOSTAT B is a modular-designed system. Its control unit is available as a single or twin version and can thus control up to two culture vessels simultaneously and independently. For the vessels, users can opt for 2 l, singleuse polycarbonate bioreactors or reusable stirred glass bioreactors with volumes of 1, 2, 5 or 10 l, depending on their needs. The system is suitable for both microbial fermentation and cell cultivation applications.
Xcellerex, Inc. +1 508 683 2200 webinquiry@xcellerex.com www.xcellerex.com
100 ml Pressure Reactors Expand Versatility of Synthesis Workstation
New functions and an especially userfriendly design make working with the bioreactor even easier. The colour 12” touchscreen display guides users easily and intuitively through the menu. Among the new functions, a gravimetric controller that uses a high-capacity balance as well as an rpm-controlled pump helps ensure that substrates are accurately dispensed. Laboratory staff can adjust the feed rate directly on the control unit display, which eliminates the need for external software. Quick-connect couplings make it fast and simple to connect the culture vessels to the control unit. A potentialfree alarm contact shields the BIOSTAT B from electromagnetic currents, ensuring interference-free measurements during cultivation processes. Sartorius Stedim Biotech +49 551 308 3324 dominic.grone@sartorius.com www.sartorius.com
In any application, the XDR10’s power and flexibility minimise the number of required runs — to save time, work and costs. As are all XDR single-use bioreactors, the XDR-10 is an integral component of the Xcellerex FlexFactory modular biomanufacturing platform that leverages single-use technology and advanced process automation. The flexible platform enables biomanufacturers to accelerate their deployment of new manufacturing capacity while lowering risk, decreasing time-to-market and reducing capital costs. The approach enables the deployment of new production facilities in 9–18 months (versus three to five years for current technology) at a total cost of less than 50% of conventional plants.
Mettler Toledo has announced the launch of 100 ml Hastelloy pressure reactors EM20-100-HC and EM60-100-HC, designed for use with the EasyMax, the synthesis workstation that enables the development of robust chemical processes at laboratory scale. These reactors expand the use of EasyMax to both organic chemists who seek an autoclavelike experience and chemical engineers who desire highpressure process characterisation. Accurate, repeatable high-pressure experiments are facilitated by its data collection capabilities. The 100 ml pressure reactor’s design expands the use of EasyMax in two ways. First, in its basic configuration, organic chemists gain quick set-up and fast results from low- and midpressure reactions using the inbuilt touchscreen/reactor combination like an autoclave. This simplifies mixing, temperature and pressure control, and allows easy measurement of reaction factors such as mass flow and gas uptake. The second solution involves combining EasyMax and the 100 ml pressure reactor with accessories such as iControl software. Chemical engineers gain the ability to thoroughly evaluate reaction parameters such as gas consumption, mass transfer, kinetic activity and heterogenic catalysis in midand high-pressure reactions. Existing ReactIR probes that provide
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robust in-process reaction characterisation are compatible with the reactor. The 100 ml reactor can also be easily switched for the 50 ml pressure reactor to further enhance EasyMax versatility for those who study both small and litre-scale reactions. Mettler-Toledo AutoChem, Inc. +1 410 910 8486 patricia.hicks@mt.com www.mt.com/easymax
Corporate News & Events
Launches and Innovation at LAB INNOVATIONS 2012 A raft of companies have already confirmed they will be launching new products and debuting latest technologies at easyFairs LAB INNOVATIONS, taking place at the NEC, Birmingham, UK, on 7–8 November. LAB INNOVATIONS will be the first show in the world to feature Sairem’s compact, microwave-assisted instruments MiniFlow200 and MiniLabotron2000, designed for chemical, biochemical and pharmaceutical research. In these instruments, high-performance, solid state and magnetron based microwave generators have been combined with batch and continuous flow reactors, ideal for synthesis from mg-scale up to several kg. 3M will be demonstrating its brand new 3M Molecular Detection System. Based on an innovative combination of two technologies — isothermal DNA amplification and ATP bioluminescence — it delivers highly sensitive results in a simple format. LAB INNOVATIONS will be a crucial opportunity for technicians to see firsthand the groundbreaking newly launched system of instrument, software and kits.
LAB INNOVATONS also offers the first chance to see Incus, MSE (UK) Ltd’s latest addition to its recently launched ProAir range of safety cabinets, isolators and vented animal cabinets. The five original products in the range are the Stratus, Cumulus, Cirrus, Cirrus Plus and Arcus. Like the Cumulus, the Incus is a Class II safety cabinet. However, it is not designed to accommodate robotics, but instead is focused on the comfort of the user, being ergonomically designed to minimise strain and easy to clean. Specac’s Mini-Press and MiniFilm Maker will also be making their UK show debut. The former, a two-tonne load, manual hydraulic press creates 7 mm KBr pellets for transmission spectroscopy. This is complimented by the Mini-Film Maker, a low tonnage press with integrated heated platens for hot pressing polymer films. The show is being supported by The Royal Society of Chemistry (RSC), Gambica, Campden BRI, Institute of
Measurement and Control, Society of Biology, British Pharmacological Society and the UK Science Park Association. It will feature a demo area for latest technologies, a conference programme designed by the RSC and delivered by world-class experts with a key focus on
continual professional development, plus a free-to-attend seminar programme. easyFairs UK Ltd +44 20 8843 8822 richard.thompson@easyfairs.com www.easyfairs.com/labinnovations
Lab Products Specialist Appoints President of US Operations Bibby Scientific has announced that Peter Lucas will take over as the new President of its US operations, which includes all of North, Central and South America. Dr. Jim Hefferman, CEO of Bibby Scientific Worldwide, indicated that Lucas’s experience and proven management track record in the pharmaceutical and biotechnology market sectors will provide the leadership needed to accelerate the anticipated major expansion of the
company’s US-based operation. Lucas’s appointment coincides with major new product line advances with the Techne Prime Series thermal cyclers and the Jenway Genova Nano three in one microvolume spectrophotometer. Lucas holds an MBA from DeSales University and brings over 14 years of proven experience in the pharmaceutical and biotechnology sectors. Lucas’s most recent position was North American Director of
Marketing — Laboratory Solutions at Sartorius, where he also previously worked as North American Director of Sales and Marketing. Prior to this, Lucas also led extremely productive teams as Regional/District Manager at Merck KGaA Millipore. Bibby Scientific US +1 609 589 2560 labproducts@techneusa.com www.bibby-scientificusa.com
Microbiological Diagnostic Products Supplier Adds Six Distribution Partners to Growing Network Around World
In line with product and market expansion plans signalled during the recent move to larger headquarters, Lab M has added a further six distribution partners to its global network. These appointments enable the delivery of
increasingly localised support to users of Lab M culture media and associated products in Western Europe, Eastern Europe and the Middle East. In Switzerland, Lab M has appointed Foodtech AG, a company that offers a wide range of microbiology and environmental testing products, and in Poland, Sterbios, a specialist microbiology company that provides tools and solutions to food testing laboratories. For Romania, Bivaria Grup brings experienced distribution of high-tech products serving clinical laboratories,
and in Russia the well-established Simas provides laboratory equipment, with a specialisation in microbiology products. Expansion in the Middle East sees the appointment of Arcomex, a specialist distributor of laboratory equipment in Jordan, and MEATO, a scientific product distribution specialist in Lebanon. “Our new UK-based headquarters are specifically designed to accommodate Lab M’s continued growth and to provide the R&D and manufacturing capacity needed to support it,” said Sales and Marketing Manager Phil Large. “Extending our distribution channels, especially in fast-growing areas, is part of the overall expansion process. I’m delighted to welcome our new colleagues on board and look forward to forging the type of lasting
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relationships that help us all round the world to provide the service excellence that our customers expect.” As part of the rigorously specified fitout of Lab M’s new premises in the Greater Manchester area of the UK, a key requirement was the installation of a state-of-the-art, self-contained, clean manufacturing suite. This high-level facility is already enabling the company to produce a wider range of culture media, supplements and microbiology products, the manufacture of which demands the most stringently controlled environment. Lab M Ltd +44 161 820 3833 info@labm.com www.labm.com
INGREDIENTS & CONTRACT SERVICES
GMP Certified Petroleum Jellies Boast Exceptional Purity and Variety of Textures Established in 1901, Aiglon is reportedly the only producer of petroleum jellies in France. Unlike other petroleum jelly manufacturers with varied fields of application, this family-run French company has chosen to focus on the pharmaceutical and cosmetic markets. Today, it serves the world’s leading cosmetic and pharmaceutical players in France and abroad.
Aiglon petroleum jellies are manufactured according to stringent French Pharmacopoeia Codex guidelines that set the purity bar much higher than other pharmacopoeias in Europe and all over the world. According to Aiglon, in addition to exceptional purity, it is able to offer an unbeatable variety of tailor made textures, from classic petroleum jellies to
easy spreading, beautifully glossy and pearly products that provide a pleasant feeling on the skin. Aiglon petroleum jellies are proven non-comedogenic (according to a recent clinical study carried out by an independent laboratory on 21 female volunteers during 28 days). Petroleum jelly is a special case in the family of pharmaceutical raw materials. It can play the role of neutral excipient in creams and ointments, but also that of active ingredient with protective, healing and hydrating characteristics. For active ingredient purposes, suppliers of petroleum jellies are obliged to conform to GMPs for pharmaceutical active principles — European GMP Part II. Aiglon is reportedly the only petroleum jelly manufacturer certified according to European GMP Part II. This certification, along with the most stringent French Pharmacopoiea purity requirements, allows the company to guarantee its clients maximum security and to anticipate the tightening of regulation for excipients in the future. Aiglon S.A.S. +33 3 44 27 66 93 elena.valesyan@aiglon.eu www.aiglon.eu
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FEATURE OPTIMISING DRUG DELIVERY TECHNOLOGY PARTNERSHIPS
Anthony Recupero, Ph.D., Senior Director, Licensing, at Aptalis Pharmaceutical Technologies — an organisation providing a broad portfolio of oral drug delivery technology platforms and capabilities in licensing, manufacturing and R&D — reviews and highlights the advantages of using an early partnership model in the drug development process.
Pharmaceutical companies have long utilised and benefitted greatly from the expertise of drug delivery technology firms in their mission to create improved product formulations and extend product lifecycles. Due to today’s pipeline attrition challenges however, they are now intensifying their searches for external innovative solutions that will overcome complications in R&D, fill pipeline gaps and strengthen their product portfolios. As such, pharmaceutical manufacturers are seeking the assistance of drug delivery technology specialists much earlier in the product development cycle to augment internal development efforts, particularly when new product profiles delivered by formulation technologies can address unmet patient needs. Outsourcing cost savings Contracting specialised formulation projects to an external specialty provider during early development can offer an improved risk/reward profile in a research-intensive environment: reduced investment spend exposure if the development programme is terminated; longer-term cost-savings from leveraging technology expertise and enabling the reduction of development timelines, thereby increasing speed to market and potentially lengthening the period of market patent protection. Pipeline candidate rescue It is estimated that 40% of active NCEs identified in combinatorial screening programmes employed by many pharmaceutical companies are poorly water soluble, i.e., these compounds have an aqueous solubility less than 10 µm (5 µg/ml for a compound with a molecular weight of 500) (Lipinski, 2002, 2004). In the preclinical and Phase I clinical trial settings, the application of novel drug delivery technology can rescue promising but difficult to formulate R&D pipeline candidates, addressing the pressing issue of R&D productivity. In the US alone, the sale of poorly water soluble drugs that are formulated using ‘enabling’ technologies to improve the dissolution characteristics of the active ingredient (e.g., soft gelatin capsules, nanoparticulate systems) account for roughly $3.5 billion annually, according to data from IMS Health. Patent and brand protection Early application of drug technologies can strengthen market adoption by creating a more differentiated, attractive product upon market entry, potentially allowing for faster in-market uptake and improved market share versus competition. This approach enhances market protection of a brand by establishing a broader IP estate to challenge competitive entry through the addition of new patentable material and extended patent expiry dating. End-user benefits Often, drug technology solutions can be applied to improve the clinical benefits of the drug, as well as increase patient acceptance and adherence to a drug regimen, by improving side-effect profiles, providing taste masking of bitter ingredients or offering dosing convenience. As demonstrated by Saini et al in a study published in the Am erican JournalofM anaged Care in 2009, patients are much more likely to adhere to their drug regimen if they use less frequently dosed medications. This literature review revealed that patients taking chronic medications once daily have been observed to have 2–44% more adherent days of therapy than those taking medication twice daily and 22–41% more adherent days than those taking medications three times a day. Improved patient compliance is beneficial for all stakeholders involved, with better disease management for patients, potential cost-savings for the insurance provider related to ancillary treatment costs for failed drug utilisation, more refills for the pharmacy (e.g., for chronic medications), more units sold for the manufacturer and additional revenues for the marketer and technology licensor. Pharmaceutical companies continue to adapt their approach to external drug technology partnerships by incorporating these formulations and technologies earlier. This approach can maximise brand value by extending product lifecycles, adding extra IP protection and providing benefits for patients treated with these drug products. This
is a different way to approach the market, but it is also an increasingly important element of a pipeline strategy. By moving away from the traditional business model that has shaped the pharmaceutical industry in the past, pharmaceutical companies can look to drug delivery companies as full strategic partners. These partnerships can provide increased R&D productivity, improved drugs, extension of product lifecycles and strengthened offerings resulting in clinical relevance that reshapes healthcare.
Anthony Recupero, Ph.D., is currently Senior Director, Licensing, at Aptalis Pharmaceutical Technologies, where he is responsible for securing and executing drug development and licencing agreements with partnering companies requiring delivery technologies for application to oral drugs in development, and/or NCEs for inclusion into a product portfolio. Prior to joining Aptalis Pharmaceutical Technologies, Dr. Recupero was VP, Business Development, at MaxCyte Inc., a cell therapeutics company, where he led all business development and licencing activities. Dr. Recupero previously served as Senior Director, Business Development, at Gene Logic, and has held several other business development and marketing positions in the biotechnology, bioinformatics and biochemical industries. He earned his Ph.D. in Cell & Molecular Biology from the University of Cincinnati and undertook his postdoctoral work in molecular oncology at the Cleveland Clinic.
Aptalis Pharmaceutical Technologies +1 908 927 9600 www.aptalispharmatech.com
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INGREDIENTS & CONTRACT SERVICES ROUNDUP Minimise Variation of Withdrawn Drug Volume with Vial Adapters Many drugs administered on a regular basis for chronic conditions are now being offered for at-home preparation and administration to aid in patient convenience. Maintaining a consistent dose of drug product to the patient is a critical aspect of patient safety and therapeutic efficacy. With standard needle aspiration, drug makers often provide a significant amount of overfill in a single vial to ensure proper dosing. This can translate into additional expense and greater potential for dosing errors. Advancements in drug delivery technology have provided safety administration systems, such as the vial adapter, which not only provides the opportunity for needle-free transfer of liquid for reconstitution of lyophilised drug products, but also a means for consistent withdrawal of drug product from a vial. A vial adapter is an easy-to-use device that functions by snapping securely over the top of a vial, while utilising a spike to puncture the rubber stopper. It is compatible with Luer lock and Luer slip
subsidiary of West Pharmaceutical Services, manufactures a variety of safety and administration systems, including a vial adapter, that aid in reconstitution, mixing, transfer and delivery of injectable drug products. As the vial adapter can provide more consistent volume withdrawal, its usage may also provide the opportunity to reduce overfill associated with variability of dosing across users. Reducing risk of inadequate or excessive overfill protects both the patient and the pharmaceutical manufacturer. Pharmaceutical manufacturers should consider the value of consistent volume withdrawal offered through the use of a vial adapter during a drug’s clinical phases, where planning and management of overfill may be initiated. syringes for liquid withdrawal. The process of reconstitution and transfer of drug product is accomplished without the use of a needle. In addition, the inclusion of these easy-to-use administration systems with a drug product enables the
drug manufacturer to differentiate its product in the highly competitive pharmaceutical market and offers the potential to improve patient satisfaction and compliance with dosing regimen. Medimop Medical Projects, Ltd, a
West Pharmaceutical Services, Inc. +1 610 594 2900 west.pharmaceutical.services@westph arma.com www.westpharma.com
Formulation Specialist Appoints Group Vice President to Lead Technology and Growth Strategy
Large Scale Excipients Manufacturing Site to Service CEE Region
Dr. May Shana’a has been named Group Vice President, Technology and Growth Strategy, for Ashland Specialty Ingredients, a commercial unit of Ashland Inc. The announcement was made by John E. Panichella, Senior Vice President, Ashland Inc., and President, Ashland Specialty Ingredients, to whom she will report. Shana’a will be responsible for leading Ashland Specialty Ingredients’ global R&D and applications capabilities, with direct operational responsibility for the unit’s global research and technical centres. In addition, Shana’a will be responsible for business development, including leading the strategic growth plan for the business. “With May’s leadership and distinguished qualifications, I am confident we will be able to drive our application expertise even closer to the customer and continue our focus on solving their unique formulation challenges,” said Panichella. “We look forward to the perspective and experience May brings to this role as she leads the aggressive growth strategy for our new product innovations.” Shana’a most recently served as Global Vice President, Skin Care and Portfolio Management, at Johnson & Johnson, where she also held the role of Vice President, R&D, global beauty care. In this role, Shana’a was involved in more than 200 product launches per year targeting the skin, hair and deodorant markets. Prior to Johnson & Johnson, Shana’a spent more than 18 years at Unilever, in skin care, laundry and home care, in the UK, US and Italy, where she was Vice President of R&D home care. In 2002, she received Brandweek’s Marketer of the Year award for the successful launch of Dove Nutrium Bar & Body Wash. Shana’a earned her master’s degree in analytical science and her doctorate in chemistry from the University of Hull in the UK.
UBICHEM Group has announced further growth of its business by adding a new manufacturing site. The new member of the group, UBICHEM Pharma Manufacturing, will be producing starting materials, intermediates and other fine chemical products for pharmaceutical and non-pharmaceutical applications in industrial quantities. This expansion positions the UBICHEM Group as one of the biggest providers in the CEE region. The newly acquired 55,000 m2 facility is located in Budapest, Hungary, and it is able to produce fine chemical products in multi-tonne quantities. The new manufacturing site also expands UBICHEM Group’s presence in the nonpharmaceutical sector. “This new plant represents a milestone in UBICHEM history. From now on, we are able to provide a comprehensive range of
Ashland Specialty Ingredients +1 302 594 6850 rrruberti@ashland.com www.ashland.com EPM 29
services, from process R&D, through pilotscale cGMP API manufacture, to highvolume manufacturing. By applying the rigorous quality control and strict production guidelines we have had in place at UBICHEM Pharma Services since 1996, we will now be able to ensure the high quality of the intermediates and fine chemical products at our new manufacturing site,” said CEO József Répási. “We believe we have a competitive edge over intermediates manufacturers based in Asia by leveraging the highly skilled talent pool of chemists and by meeting high quality expectations and strict deadlines for our customers.” UBICHEM Group +36 1 347 5060 / ext. 132 zszsoter@ubichempharma.com www.ubichempharma.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Chemistry Expert Expands Capabilities Onyx Scientific has announced a collaboration with a purification specialist that will see the company broaden its offering to the global pharmaceutical and biotechnology industry. The CMO has struck-up a strategic alliance with UK-based Reach Separations, which will allow it to deliver more specialist purification and separation services to bolster its early stage development services. As part of the deal, Onyx Scientific will be now able to offer custom separation for companies in drug discovery and intermediate environments. This includes chiral, reverse phase and normal phase chromatography using Supercritical Fluid Chromatography (SFC) and High Performance Liquid Chromatography (HPLC). With MHRA and FDA licensed facilities in the UK and India, Onyx Scientific supports pharmaceutical and biotechnology companies from medicinal chemistry and preclinical through Phase I–III, scaling-up to largescale commercial API production. Denise Bowser, Commercial Director at Onyx Scientific, said: “We were very impressed with the major equipment investment at Reach Separations and the team’s exceptional knowledge in understanding our clients’ challenges in small-scale purification. Given this is an area in which we have limited expertise and one that clients look to outsource, it made perfect sense for us to plug the gap and complement our existing services by working with Reach Separations. We expect this strategic partnership will play an important role in giving our clients quicker access to these types of services, but with the added benefit of knowing it will be managed by us as part of the overall project.” Reach Separations is located in BioCity, Nottingham, which is one of Europe’s largest bioscience incubators that currently hosts over 70 companies and has a rich heritage in drug discovery.
CRO Launches FDA Approved Spray Pattern and Plum Geometry Analysis Service
The company’s technical group is led by purification specialist and Technical Director Phil Abbott. He has worked in the pharmaceutical industry for almost 20 years, including several years at AstraZeneca as a Separation Science Group Leader. He said: “We are delighted to be working alongside Onyx Scientific given the company’s fine reputation in contract medicinal chemistry, scale-up and manufacturing for the world’s drug development industry. We have strong experience in the pharmaceutical outsourcing sector, so understand the challenges and issues clients face. Our role will be to bring our expertise to the table and work as part of the Onyx team to ensure clients’ requirements are always met and timelines never exceeded.” Working as a preferred partner of many of the world’s top pharmaceutical firms, Onyx Scientific’s UK labs in North East England deal with complex chemistry and deliver early stage programmes involving custom synthesis, lead optimisation, process development, solid-state chemistry and GMP API synthesis. It is then able to scale-up, internally tech transfer and provide increased efficiency for clients from its commercial manufacturing sites in India. Onyx Scientific Ltd +44 191 5166516 brian.jolly@onyxipca.com www.onyxipca.com Reach Separations Ltd +44 115 8120009 info@reachseparations.com www.reachseparations.com
Plume analysis will extend existing capability in inhaled product testing at Melbourn Scientific. Melbourn Scientific offers cGMP spray pattern and plume geometry measurement — a regulatory requirement for nasal sprays, oral sprays and metered dose inhalers destined for the US — following investment in the Proveris SprayVIEW and Vereo actuator. Mark Hammond, CEO at Melbourn Scientific, said: “Instrumental spray pattern and plume geometry analysis is already a regulatory requirement for products aimed at the US market and it provides another level of information above particle and droplet size characterisation. “We were the first CRO based in Europe to invest in the Malvern Spraytec for laser diffraction and the product and device development companies we support have found this service highly beneficial. It was following interest from these clients that we decided to extend our portfolio to include spray pattern and plume geometry measurement using SprayVIEW. “When combined with droplet size,
the shape of the plume is highly influential in the bioavailability of the product, particularly in a nasal spray, which has such a specific target area and enables better understanding of device performance.” The 2002 FDA guidance on ‘Nasal Spray and Inhalation Solution, Suspension and Spray Drug Products — Chemistry, Manufacturing and Controls’ lists several tests for characterising nasal spray and inhalation drug products, including instrumental characterisation of the plumes for spray pattern and for plume geometry. Melbourn Scientific has significant experience in analytical and formulation support for the development of Orally Inhaled and Nasal Drug Products (OINDPs). The company selected the Proveris SprayVIEW instrumentation as it helped establish the standards now recommended by the FDA. Zach Pitluk, Chief Commercial Officer at Proveris Scientific Corporation, commented: “It is with pleasure that I announce that Melbourn Scientific is to be the first European CRO to offer a FDA accepted spray pattern and plume geometry analysis service based on the SprayVIEW instrumentation.” The Vereo actuator reliably replicates hand use of nasal and oral spray pumps and metered dose inhalers. It can also be used with Spraytec when using laser diffraction to measure droplet size distribution, or with cascade impactors to perform particle size distribution tests of nasal sprays and metered dose inhalers. Additionally, Vereo actuators are also at the heart of all SprayVIEW spray pattern and plume geometry measurement instrumentation. Melbourn Scientific +44 1763 261648 info@melbournscientific.com www.melbournscientific.com
To advertise in Europe’s leading pharmaceutical publication, call Rob Anderton on +44 (0) 1829 770037 EPM 30
INGREDIENTS & CONTRACT SERVICES ROUNDUP Excipients Specialist Launches Parenteral Portfolio of Polymers and Drug Delivery Services With the push to bring new drugs to market faster, the healthcare industry has made significant advances in utilising lipid-based drug delivery systems to expedite their development. While lipid-based formulations have proven to be capable of improving bioavailability, while also reducing food effect and intra and inter patient variability, many formulation challenges remain. With a very high proportion of the industry’s development pipeline consisting of molecules with poor bioavailability, advances in lipid-based formulation technologies are essential to the future of drug development. To reduce the hurdles to lipid-based product development, the Lipid Formulation Classification System (LFCS) Consortium, a non-profit organisation comprised of researchers from academia and industry, has been created to conduct research into lipidbased drug delivery systems for the oral administration of poorly soluble drugs, with the end goal of developing guidelines that support the development of promising drug candidates. Capsugel is a founding industry member of the LFCS Consortium. The findings are the first of a series of research updates that will be published by the LFCS Consortium over the coming months. These new findings recently published online in the Journal of Pharmaceutical Sciences were presented for the first time by two key members of the Consortium: Professor Colin Pouton of Monash University and Dr. Ross
Blundell, Sanofi R&D. “Given the increase in poorly soluble compounds under investigation that have the potential for real patient and consumer benefit, there is a need to standardise in vitro methods for evaluating lipid-based formulations,” Professor Pouton, Working Group Leader of the LFCS Consortium, shared with attendees. “Our initial findings confirm that using the digestion model is the preferable method for differentiating between formulations.” During his talk, Dr. Ross Blundell emphasised the importance of the LFCS findings for the pharmaceutical industry, stating: “It is difficult to see that an industrial partner working alone could have achieved the same breadth of data in the same time frame as the LFCS. The findings will enable lipid-based formulations to be screened both accurately and rapidly and to move projects more swiftly through the development process.” In the research paper, the LFCS Consortium team describes the test performance of eight different types of lipid-based formulation models and found good differentiation of formulation performance was possible. Digestion experiments were performed in vitro using a pH-stat device and the compound danazol as the model for a poorly water-soluble drug. Lipid-based formulation digestion and drug solubilisation patterns on digestion were examined and experiments were conducted at two sites for consistency to
ensure results could be reproduced. Hassan Benameur, Senior Director of Pharmaceutical Sciences at Capsugel and Elected Chairman of the LFCS Consortium, said: “Researchers at Capsugel have developed lipid-based technologies that are proven to address many of the challenges presented by poorly soluble compounds. We have two world-class centres based in France and the US specialising in the development of lipid-formulations. Findings from the Consortium are important steps toward advancing standardisation methods and helping to facilitate future dialogue between industry and regulatory authorities.” For more information about the LFCS Consortium and its activities, please visit www.lfcsconsortium.org. Capsugel +33 3 89 20 58 46 catherine.lehmann@capsugel.com www.capsugel.com
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Scientists work on the development of lipidbased compounds to help bring new drugs to market faster.
SHOWCASE DRUG DELIVERY POLYMERS Battery-Free Artificial Pancreas Makes Debut at British Business Embassy Life Science Summit 2012 Bruce Renfrew and Mike Phillips of Renfrew Group International and Professor Joan Taylor from De Montfort University showcased their battery-free articifical pancreas at the prestigious Global Life Science Summit in London, bringing their collaborative, circuitless device closer to reality for millions of people living with Type 1 diabetes. The Summit was hosted by Lord Darzi of Denham, UK Business Ambassador for the Life Sciences and Chair of the Institute of Global Health Innovation at Imperial College London, joined by luminaries of the health sector such as Sir David Nicholson, Head of the NHS, Health Secretary Andrew Lansley and Universities and Science Minister David Willetts. The idea of partnering leading practitioners of design and academia in collaborative projects has resulted in the artificial pancreas, an implantable device that does not rely on electronic controls to regulate glucose levels in the body,
but instead uses a reportedly novel polymeric gel to automatically control the delivery of insulin into the peritoneum. Diabetes affects over 366 million people worldwide and the WHO projects that diabetes deaths will double between 2005 and 2030. The rate of type 1 diabetes incidence among children under the age of 14 is estimated to increase by 3% annually worldwide according to the International Diabetes Federation. Diabetes cannot be cured, but treatment aims to keep blood glucose levels as normal as possible to control the symptoms. The artificial pancreas could herald the end of multiple insulin injections for sufferers of Type 1 diabetes, a large proportion of which are at risk of over or under medicating with current treatment methods. “We have reached a critical point in the development of a fully implantable device, which is one of the essential requirements for the success of an
artificial pancreas and could ultimately improve lives immeasurably for diabetics worldwide,” said Professor Taylor. Funding is required to continue the successful completion of this device’s study and to undertake preclinical trials tests, which would mean a significant step forward in the development of an advanced, first-generation artificial pancreas. Renfrew said: “We are really proud to be working on such a high profile project that could meaningfully aid and improve the lives of Type 1 diabetes sufferers.”
Excipients Specialist Launches Parenteral Portfolio of Polymers and Drug Delivery Services Evonik Industries is proud to announce the expansion of its healthcare business portfolio, now offering solutions for parenteral controlled release and sophisticated pharmaceutical dosage forms, including development of customised drug delivery systems and medical devices up to commercial supply. Already known as a leader in excipients for oral dosage forms through its EUDRAGIT products, Evonik acquired two new businesses in 2011, which made it possible for the company to transition into the area of biodegradable polymers for injected and implanted long-acting formulations and medical devices. In March 2011, Evonik acquired the RESOMER business from Boehringer Ingelheim. RESOMER polymers, based on a combination of lactides and glycolides, are a key ingredient for parenteral time-controlled release of drugs. These polymers are also primary materials in biodegradable medical implants. The introduction of RESOMER into the Evonik Health Care portfolio was a major landmark for the company, but according to Dr. Jean-Luc Herbeaux, Head of Evonik’s Health Care business line: “As a pure product business, it could not sufficiently serve customer needs in formulation development and scale-up support, or manufacturing services.” In November 2011, Evonik acquired the Pharmaceuticals business of SurModics, Inc., which gave the company access to SurModics’ parenteral dosage technology platforms and services, as well as bioresorbable lactide-glycolide polymers, which are marketed as LAKESHORE BIOMATERIALS. It also included the world-class facilities Birmingham
Laboratories for development and manufacturing, in Birmingham, Alabama, US. Both acquisitions have completed the path toward making development and commercial launch of parenteral controlled release drug formulations and biodegradable medical devices a reality for Evonik’s customers. The bioresorbable polymers from Evonik are fully synthetic and degrade over time through hydrolysis. The company offers a variety of drug delivery solutions based on these polymers, such as meshes, fibres, films, micro- and nanoparticles, and insertable implants. They can be used in the human and veterinary pharmaceutical markets for regenerative medicine or as medical devices. Biodegradable implants offer several advantages over metal ones, including lower immunological body reactions and the elimination of subsequent procedures for extraction. Some biodegradable devices include surgical plates and fasteners, orthopaedic fixation devices and also coronary stents. Depending on the exact composition, the materials degrade over a period of a few weeks up to several months. In addition to drug delivery and medical devices, biodegradable polymers can also be used as resorbable scaffolds containing peptides, proteins or other biological macromolecules. After preparation, the scaffold is placed in the desired location of the body to effect activity only in this area. Reabsorption occurs at a predetermined rate. The therapeutic applications of bioresorbable polymers are numerous and include the orthopaedic, cardiovascular, urologic, CNS, pain, oncology and nerve growth areas. They can be used for wound closure, fracture
repair, local delivery of pain medications and much more. In order to ensure a steady supply of products, Evonik has two manufacturing sites for bioresorbable polymers. One is located in Ingelheim, Germany, and mainly produces RESOMER products, while acting as a back-up site for LAKESHORE BIOMATERIALS. The second site, already mentioned, is Birmingham Laboratories, which serves as a back-up site for RESOMER. Birmingham Laboratories is a GMP compliant facility with ISO certification. It employs some 85 experts who work in polymer research and production, quality and regulatory, and development and manufacturing of both drug delivery systems and finished drug products. Here, customised products can be developed, as well as manufactured. Evonik works on a collaborative partnership basis to help develop proprietary solutions for advanced therapies and lifecycle management. This means that the company works with the customer from the early stages of feasibility, all the way through formulation development and process optimisation. But it does not stop there, as Evonik continues to help with license agreements and regulatory support, moving on to manufacturing and full commercial delivery. These services are of course also offered individually, depending on the customer’s needs. For more information, please contact either Art Tipton (+1 205 917 2210, art.tipton@evonik.com), who is responsible for drug delivery services, or Paul Spencer (+1 205 917 2295, paul.spencer@evonik.com), who can help with biodegradable polymers. Evonik Industries www.evonik.com
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If successful, the device would be a simple and low-cost solution to the problem facing all diabetics. Renfrew Group International +44 116 253 1961 mike.phillips@rg3.com www.renfrewgroup.com
Pharma Industry Invite to Participate in Discussion on Topic of EVA Polymers and Drug Delivery Celanese EVA Performance Polymers invites the pharmaceutical industry to participate in dialogue around ethylene vinyl acetate (EVA) polymer technology with the introduction of its new blog at VitalDose.com/blog. Dr. Ken Anderson, a 25+ year veteran of polymer research and technical service, the blog’s author, will be covering topics ranging from technical information and polymer processing to pharmaceutical applications and industry news. “EVA polymers have been utilised for many years in the pharmaceutical world for drug delivery applications. Our new blog will highlight EVA polymers as excipients as we seek to inform the pharmaceutical world about this polymer and its uses,” said Anderson. Celanese invites everyone from students to seasoned research professionals to take part in the discussion. “We look forward to participation from all aspects of the industry, including R&D scientists in contract research and contract manufacturing organisations, small and start-up companies, large pharmaceutical companies, and academia,” Anderton added. Celanese manufactures VitalDose EVA polymers for use in drug delivery. The blog can be found as part of the VitalDose website at www.VitalDose.com/blog. Celanese EVA Performance Polymers Inc. +1 859 525 3737 steve.carpenter@celanese.com www.celanese-eva.com
Events
REGULATORY AFFAIRS According to the WHO, transfer of technology is defined as ‘a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture (horizontal process) or between manufacture sites (vertical process)’. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and/or commercialisation to an appropriate, responsible and authorised party. The development and transfer of knowledge and technology has been — and will continue to be — critical to success in the pharmaceutical industry. Whereas an effective vertical technology transfer is now a standardised regulatory process in the US, in Europe and some Asian countries, other key factors give rise to the horizontal transfer, including lack of manufacturing capacity, lack of resources to launch products commercially, lack of marketing and distribution capability, exploitation in a different field of application, potential for competitive pricing, and opportunities for contingency supplies. In essence, this latter approach helps to facilitate the healthcare system, bringing new, more effective products to market faster. Many pharmaceutical and biotechnology industry players are boosting their inlicensing activities, consolidating manufacturing networks and outsourcing production to less costly third-party manufacturers. All these strategic initiatives require effective technology transfer — smoothly moving technical processes and analytical requirements between the different parties involved. Technology transfer can be considered successful if a receiving unit can routinely reproduce the transferred product, process or method against the theoretical specifications set. In short, it is not a one way street. The sending unit and receiving unit must be equally involved in the process to ensure success. At an early stage, technology transfer is also important in magnifying the basic research performed in academia to commercial-scale production in industry. The Enterprise Europe Network offers thousands of primary research projects for further development by technology transfer, thus facilitating new drug and process development. Technology transfer agreements between developed and developing countries are also valuable in terms of making technologies available to people in developing countries, easily and cost-effectively. One example is Tibotec Pharmaceuticals, an affiliate of Johnson & Johnson, which has granted multiple non-exclusive licenses to Hetero Drugs and Matrix Laboratories of India, and to Aspen Pharmacare of South Africa, to manufacture, market and distribute generic versions of its investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), subject to its approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1 infected adults. The two Indian companies will have rights to market the product in Sub-Saharan Africa (SSA), low income countries and India. Aspen will have rights to market the product in SSA, including South Africa.[1] Thus technology transfer creates a win-win situation for industry, academia and the regulatory authorities. Appropriate and effective technology transfer is vitally important in order to upgrade the quality of design to be the quality of product, and to ensure the ongoing stability and high quality of products via a continuous information exchange.
Laupheimer Zelltage Attracts Top Scientists to Discuss Recent Advances in Biomanufacturing
1. [Source : Technology transfer: a Collaborative Approach to Improve Global Healthcare International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) 2011]
The BioIndustry Association has launched a new UK-based partnering conference. The BIA UK Bioscience Forum, on 4 October, will offer a full conference with informative presentations and discussions on the key issues for the UK bioscience sector, a trade exhibition and networking opportunities alongside the partnering. Steve Bates, BIA CEO, said: “Our UK Bioscience Forum will provide companies with a UK partnering event to help them build relationships, connect with potential partners and to develop their businesses. The Forum fills a gap in the UK bioscience calendar at the beginning of the last quarter of the year. “The conference will provide delegates with the opportunity to hear about the latest thinking in key areas for their businesses, including finance, intellectual property, talent management and manufacturing. I look forward to seeing many companies there on what I am sure will be an interesting and thought-provoking day.”
TECHNOLOGY TRANSFER — ITS DEFINITION AND ITS PURPOSE
Dr. Paolo Biffignandi, MD, PhD, QPPV, FTOPRA, former President of The Organisation for Professionals in Regulatory Affairs (TOPRA), is an advisory board member of the panEuropean pharmaceutical regulatory affairs organisation ELC Group. He is a renowned physician who graduated in Medicine with PhDs in Endocrinology and Pharmacology. Dr. Biffignandi started his highly successful career in the pharmaceutical industry after a period at the University of Torino, Italy, and in 1989 he became an independent consultant in medical and regulatory affairs. He is the author of more than 160 scientific articles and co-author of three books on European Regulatory Affairs and a member of several scientific societies, including DIA, RAPS and TOPRA. From 2003, he was a member of
Dr. Paolo Biffignandi paolo@elc-group.com
the Board of Directors of TOPRA, of which he was President in 2009–10. In 2009, he was appointed Fellow of The Royal Society of Medicine, in the UK.
Rentschler, a leading CMO for the development and production of biopharmaceuticals, hosted its second Laupheimer Zelltage conference with the theme Bioprocess light, on 11–12 June, in Laupheim, Germany. Over 190 leading scientists from industry and academia shared their ideas on strategies to facilitate processes and implement lean biomanufacturing principles aimed at generating superior, economical, robust and competitive processes. The symposium programme consisted of three sessions focusing on New Targets for Animal Cell Technology, The Efficient Process and Cutting-Edge Technologies. The lectures included a wide range of topics such as predicting cell line productivity, the advantage of pre-developed producer cells, key components of chemically defined cell culture media and novel disposable and process intensification technologies. Thus, these presentations helped forge a link between cell line development and production. “Contract manufacturers are pushed
towards continuously improving processes and the two-day event was full of inspiring lectures and discussions on new strategies and technologies to enhance quality, efficiency and process robustness,” said Prof. Roland Wagner, Senior Vice President Development at Rentschler. “Besides process optimisation, there is a clearly visible trend towards flexible multi-product manufacturing facilities to reduce the cost of goods, significantly lower initial capital investments and increase plant capacity.” The Laupheimer Zelltage conferences on industrial cell culture technology are carried out in a biennial rhythm. The next conference in June 2014 will be on Advanced Therapy Medicinal Products and is entitled Processes for ATMPs. Rentschler Biotechnologie GmbH +49 7392 701-857 roland.wagner@rentschler.de www.rentschler.de
BIA Launches Partnering Conference
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The keynote speakers at the UK Bioscience Forum are Keith Thompson, Chief Executive of the recently established Cell Therapy Catapult Centre, who will discuss his vision and plans for the centre and Professor Brian Smith who will offer his views on the future of the pharmaceutical industry. The conference will be followed by the long-established BIA Autumn Reception. Nick Stephens, CEO, RSA, one of the Forum supporters, said: “The BIA UK Bioscience Forum provides a platform for the best and brightest UK companies to come together to exchange information and add value to each other’s businesses. Its format encourages collaboration and its delegates create opportunities for success.” BioIndustry Association +44 20 7630 2191 rwinder@bioindustry.org www.bioindustry.org
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HOSOKAWA ALPINE Aktiengesellschaft
CONTAMINATION CONTROL Helapet are a leading supplier of cleanroom disposables for hospital, pharmaceutical, electronic and laboratory cleanrooms providing solutions for contamination control in critical environments.
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Supply of our quality range of SteriClean® sprays, offering an effective mix of alcohols, biocides and neutral detergents aiding disinfection measures in controlled environments.
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Peristaltic pumps accurately transfer fluid through a sterile and fully validated tube from source to delivery.
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Canal Engineering Cognex CPhI Worldwide Dales Pharmaceuticals GEA Pharma Systems - Courtoy L.B. Bohle Mettler Toledo Müller Natoli EPM 34
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