Front cover: Next generation tabletting technology — Fette Compacting’s FE35 is the next tablet press in the FE Series. Like the FE55, it follows the Tri-Easy design for smooth handling. The FE35 combines all the advantages of the new FE range of models from Fette Compacting with the shortest product changeover times of its class.
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© October 2012. While every attempt has been made to ensure that the information contained within European Pharmaceutical Manufacturer is accurate, the publisher accepts no liability for information published in error, or for views expressed. All rights for European Pharmaceutical Manufacturer are reserved, and reproduction in part or whole without written permission is strictly prohibited.
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I have just returned from CPhI Worldwide 2012, which was as usual an exceptionally busy and immensely informative event. I spoke to key representatives at a number of contract service organisations and the overriding message was clear — due to the rise in blockbuster patent expiries and subsequently emerging generics and biosimilars, the topic of drug delivery, how products can be differentiated and also modified to better meet the needs of patients, had to be high on the agenda for every manufacturer. You can find out exactly what they had to say about their offerings in this area in the next, not to be missed issue. Returning to the content of this issue, there are two timely feature articles that complement the Cleanroom Buyers’ Guide and Particle Analysis Showcase respectively. The first — ‘Cost-Effective Selection of Cleanroom 8 Wipes’ on page 15 — has been written by Karen Rossington, Marketing Consultant to Contec, Inc., who possesses many years’ experience and therefore expert knowledge of the life science contamination control industry. Rossington advises on the various ways in which a cleanroom facility might significantly reduce its consumables spend, specifically in relation to cleanroom wipes — the second biggest consumables purchase according to McIlvaine’s Cleanroom World Markets report. The second article — ‘Particle Analysis — The Development of Instrumentation and Standards’ on pages 23–24 — has been provided by Dr. Graham Rideal, founder of Whitehouse Scientific Ltd, a company that specialises in the provision of particle size standards. Rideal summarises the history of certified reference standards, in terms of both the instrumentation utilised and methods applied, their benefits and their drawbacks, right up to the present day. Finally, in his Regulatory Affairs column on page 33, Dr. Biffignandi focuses on the ‘Draft Regulation for Medical Devices’, the additional resource and cost implications of which were discussed at the recent TOPRA Symposium for Medical Devices. And that just about wraps up the penultimate 2012 issue. If you have any comments on this or any other issue, please email me: ellie@rapidnews.com, as any feedback is highly valued.
EPM 4
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.
MANUFACTURING PRODUCTS & EQUIPMENT OEM Equivalent Dust Filter Cartridges and Air Filters Offer Significant Cost Savings D J N UK supplies dust filter cartridges and air filters from Nottinghamshire, UK, throughout the UK, Ireland and Europe. The company offers the benefits of: • high quality equivalent dust filter cartridges; • high quality equivalent air filter elements; • ISO 9001:2008 accreditation; • and overnight delivery to the UK, Ireland and Europe. D J N UK supplies equivalent filter cartridges and consumables for dust and air filtration equipment; supplied to the manufacturing industry direct or to the servicing engineers and companies who maintain dust extraction equipment on behalf of COSHH regulated companies. Whether the customer is a blue chip company or small, one-man business, whether for the food, pharmaceuticals,
foundries, chemicals, heavy industry or anything else, D J N UK can provide a suitable dust filter cartridge. D J N UK offers equivalent filter cartridges for the following OEM dust extractors from its Nottinghamshire depot — Airmaster, Donaldson, Torit, Dusthog, Nanoweb, Unicell/ Excel, Farr, WAM, Eurofilter, Mahle, Nordic, Conspare, Dustcheck, Mix UK, DCS, Disa Airmaster, DCE, Heaton Green, DEI, plus many more. All equivalent filter cartridges and dust filter cartridges are UK and EU quality tested and 70% are UK manufactured. In addition, D J N UK is able to save its customers thousands of pounds by cleaning their filters for reuse, which in turn reduces the costs associated with dirty filter disposal and means less landfill.
Bi-Layer R&D Tablet Press Provides Exceptional Performance at Reasonable Price Elizabeth has launched a series of semi-automatic tablet presses, engineered for quality, performance and value. Manufactured in the US, this new range of tablet presses offers the following features and advantages: • fully GMP compliant and certified; • claimed by company to offer highest tonnage in class; • proprietary GMP wear coating on product contact parts; • hardened steel wear plate on die table; • 9-station D tooling, 11-station B tooling, and 5 x 5 combo for B and D size on the same turret; • adjustable punch overload system; • adjustable punch overload protection on pre and main load cells; • pre and main load cells as standard; • and simple touchscreen interface. The Elizabeth Companies’ Elizabeth Hata International +1 412 829 7700 sales@eliz.com www.eliz.com EPM 5
D J N UK Ltd +44 1623 559558 www.djnuk.co.uk
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Weighing Platform Allows for Long and Uninterrupted Feeding Cycles of Milling Containment System Mettler Toledo recently supplied a highprecision weighing platform to Hosokawa Alpine for a containment
system to process high-potential chemicals. The system’s design includes a milling device and consists of a product contact area and a separate technical compartment. Processing high-potential ingredients requires operator protection without compromise. This is achieved by installing complete processes in containment systems, such as isolators. But working in contained environments makes ergonomic operation in milling and feeding systems a challenge. For both safety and hygiene, there must be strict separation of the product-contacted
process area and the technical area. This means drives, instruments and valves are installed in an enclosed technical compartment attached to this isolator casing. The Hosokawa Alpine loss-in-weight feeding system has an accuracy of less than one per cent over a dosing range from 2.5 to 600 dm³/h. The process chamber of the isolator contains only the product-contacted parts of the feeder. The feeder drive, gear unit and weighing platform are installed in the technical compartment of the isolator, strictly separated from the product-contacted area inside the process chamber. The loss in weight feeding device is
mounted on top of the Mettler Toledo WMH high-precision weighing platform with electromagnetic force compensation (EMFR) weighing technology. This is an excellent technology to measure output of loss in weight feeders, because it offers high weighing capacity in combination with high resolution and accuracy. These features stand up to heavy feeders and large hoppers to ensure long and uninterrupted feeding cycles. Mettler-Toledo (Schweiz) AG +41 44 944 25 68 eugen.schibli@mt.com www.mt.com/ind-wmh
Catalytic Aeration Drastically Reduces Isolator Decontamination Cycles With the use of catalytic aeration, M+P — part of Optima Pharma (Schwäbisch Hall) — is able to reduce the duration of the aeration phase in isolators by more than 50%. The aeration phase is the most time-consuming process in the decontamination of isolators used for pharmaceutical filling and closing equipment. Decontamination of isolators with vaporous H2O2 takes place in three process steps, which begins with the conditioning of the temperature and humidity. Next follows the sterilisation phase, in which a vaporised H2O2 fog kills off any viable microbes. Even in low concentrations, H2O2 can be detrimental to pharmaceutical products, so the final phase, aeration with fresh air, must be complete. Without the use of catalytic aeration and depending on the allowable residual concentrations (usually <1 ppm–10 ppb; largely dependent on the product), the average time required for aeration is between 3 and 12 hours. Using catalytic aeration, the aeration phase can be shortened by more than 50%. The construction and decontamination process of M+P isolators allows the use of catalytic aeration. The microbial kill-rate of the H2O2 during decontamination is not influenced by the catalytic converter. The time advantage of catalytic aeration is of particular benefit; the smaller the residual concentration to be achieved, the better the efficiency. A further advantage is that the catalytic converters are also effective during the production phase. As experience has shown, H2O2 diffuses into plastic parts such as format parts during the VHP phase and adsorbs over time. Even after the aeration phase and during production, an increase in the residual H2O2 concentration can occur. This increase in concentration is only slowly flushed out with time. The catalytic aeration employed by M+P is effective during the production phase and prevents increases in residual H2O2 concentration because the isolator continuously re-circulates air through the catalytic converter. OPTIMA packaging group GmbH +49 791 506 1410 sabine.gauger@optima-ger.com www.optima-ger.com EPM 6
™
Courtoy - celebrating 100 years of outstanding technology Our customers are smiling. Are you? Keeping one step ahead of your competitors is difficult. To compete in the rapidly evolving pharma market, you need an edge. At GEA Pharma Systems – Courtoy™ that’s what we do: we listen to your needs, develop tablet compression technology that surpasses them, then use our experience to put you ahead – and keep you there, wherever you are in the world. Highest productivity … guaranteed quality … maximum operator safety … assured reliability … true innovation … fastest after-sales service … experienced process support.
GEA Pharma Systems - Courtoy™ GEA Process Engineering nv Bergensesteenweg 186, B-1500 Halle, Belgium Tel: +32 2 363 83 00, courtoy@gea.com
engineering for a better world
www.gea-ps.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Track and Trace Solution Puts Stop to Counterfeiting for Sanofi Subsidiary According to the EU Commission, the rate of counterfeit drugs has risen by around 400% since 2005. The Customs departments of European countries seize up to 2.4 million counterfeit pharmaceutical packages each year. It is therefore more important than ever in the fight against drug counterfeiters to have a clear identification and traceability of the original products. A. Nattermann & Cie. GmbH, a subsidiary of Sanofi Aventis Group, has effectively put a stop to counterfeiting. A Mark & Vision system from Krempien+Petersen Qualitäts-Kontrollsysteme GmbH with a Cognex In-Sight 5613 vision system and DataMan 200 barcode reader subject the Data Matrix codes and printed text labels to thorough inspection. The new labelling system from I.M.A. (Industria Macchine Automatiche S.p.A.) verifies and checks the identification imprints applied to the side flaps of the product packaging. The DataMan 200, developed specifically for the efficient reading of even the most complex Data Matrix and linear barcodes, verifies that the label is applied in the first step. In-Sight 5613 performs quality testing at the next station, where this high-speed system with ID reader has a resolution of 1600 x 1200, and checks the product-specific Data
Matrix code and its associated variable OCR (optical character recognition) data. The required 200–250 packages per minute were exceeded by almost 100%, and with cycle times of up to 400 identified and controlled drug packages, a more than veritable result is guaranteed. Only 40 pieces out of 250,000 during the two-shift operation are scrapped each day, a successful number for any operation. Cognex UK Ltd +44 1327 856 040 sales@cognex.com www.cognex.com
Handheld Instruments Selected by USP for Spectral Library Development Project
The United States Pharmacopeial Convention (USP) has selected the Thermo Scientific TruScan RM and microPHAZIR RX instruments to support its recent initiative to provide USP-approved libraries to pharmaceutical manufacturers. This spectral library project is one of the many USP initiatives designed to set standards that help ensure the quality, safety and benefit of medicines and foods. With an assembled consortium of world class vendors, this project aims to provide manufacturers with a USPapproved library of methods for material identification across the globe. This provides a harmonised approach to ensuring the quality of pharmaceutical ingredients before entering the supply chain. “With increases in supply chain variability, the development and deployment of public standards is critical to ensure the safety and efficacy of medicines,” said Edward Zhao, Vice President, Business Development of USP. “USP relies on advanced analytical capabilities and modern equipment, such as the TruScan RM and microPHAZIR RX, to provide the highest quality of standards for use by global pharmaceutical manufacturers.” TruScan RM, a Raman-based spectrometer, and microPHAXIR RX, based on near-infrared (NIR), will be used to develop all methods included in the USP spectral library. Both instruments are easy to use and enable on-the-spot, actionable pass-fail results within seconds. “We believe it’s important to provide tools to our customers that support their mandates for enhanced product quality and a more secure supply chain,” said Maggie Pax, Senior Director, Pharma-Chem, Thermo Fisher Portable Analytical Instruments. “Our TruScan RM and microPHAZIR RX instruments are perfect complements to the library development project, providing USP with a rapid, easy-to-use way to develop methods that can be quickly deployed to manufacturers around the world.” Thermo Fisher Scientific Inc. +1 978 642 2561 alyssa.knightly@thermofisher.com www.thermoscientific.com/quality EPM 8
Latest Container Inspection Machine Features Higher Resolution Cameras EXACTA is the latest inspection machine designed and built by Optrel Inspection Systems, the brand belonging to Spami. This machine makes notable improvements in terms of process quantity and quality, since a single tower will provide an inspection speed of up to 24,000 containers per hour. The same was previously achieved with the configuration of two towers. The inspection is run via video cameras and a lighting system that is well synchronised with the motor of the tower. The key concept underlying the operation of this new machine is the continuous motion movement, developed in order to reach a higher inspection quality, through more powerful video cameras with a higher resolution compared with the previous ones (2048 x 2048 pixels). This continuous motion facilitates and enhances the control of the ampoules, vials and cartridges, since their transport is made more stable. From a mechanical design point of view, new concepts are introduced, such as: • productivity increase through a compact solution; • improved ergonomics thanks to greater accessibility for the operator; • and modularity, since the machine was designed for modules that are assembled together while at the same time being independent from each other and susceptible to specific configurations based on customers’ needs. Spami - Optrel +39 049 9318111 info@optrelinspection.com www.optrelinspection.com
Tabletting Equipment Specialist Boasts 30 Years’ Industry Experience ADAMUS HT has 30 years of experience in design and production of tablet press tooling, spare parts for tablet presses, capsule fillers and format parts for blister lines. The company’s mission is to deliver high quality products and services at a competitive price, whilst maintaining short delivery times. For tools and spare parts production, the certificated materials are sourced from approved and certified producers only. In the case of tools requiring a special coating, Adamus HT collaborates with proven quality subcontractors. All these offerings, combined with a large sales network, allow Adamus HT to distribute products globally to many of the leading, international pharmaceutical, generic and contract manufacturers. The complete Adamus HT product portfolio consists of compression tooling, spare parts for tablet presses, format parts for blister lines and cartoning machines, allowing the company to offer customers the full package, from tablet design through to packing the blister into cartons. Adamus HT’s vast experience allows it to work with clients to design standard or multitip tooling for tablets, with different shapes, various embossing and logos, taking into account the requirements for maximum lifetime of tools and durability of the tablets during finishing steps (coating, blistering, etc.) Additionally, Adamus HT can now offer the Punch Inspector, a fully automated measuring device for punches, and automatic machines for compression tooling polishing. ADAMUS UK +44 1252 345923 mike.nicol@adamus.co.uk www.adamus.co.uk
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Aseptic BFS Machines Manufacturer Provides Worldwide Coverage
Bottelpack machine type 4010M, with high voltage leak detector.
Full Range of Spare Parts and Comprehensive Servicing for Kek-Gardner Machines Process Components is the OEM of spare parts for the Kek-Gardner range of mixers, centrifugal sifters and milling and blending machines. Consequently, the company can provide everything needed to maintain the correct function of the Kek-Gardner range of machines, from a complete replacement agitator through to gland packing for shaft seals. Spare parts supplied by Process Components are all manufactured to original standards and supplied with a full manufacturer’s warranty. In addition to its ability to produce spare parts, Process Components offers customers expert process knowledge and manufacturing techniques needed
to meet the demanding process requirements synonymous with these machines. The company’s experienced service engineers can assist in providing preventative maintenance, machine inspection and repairs for all Kek-Gardner mixer, blender, sifter and milling machines. As Process Components has extensive records for Kek and Gardner machines going back many years, customers have come to recognise that this high level of traceability will ensure that they receive the genuine replacement parts, resulting in minimal downtime and maximum machine reliability and longevity.
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
Process Components Ltd +44 1625 412000 sales@pro-components.com www.pro-components.com
Cleanroom Cleaning Service
Cleanrooms (Design and Construction)
Garments
Hand Tools, e.g., Clamps, Pliers, Forceps and Knives
Isolator Technologies, e.g., Gloveboxes and Ports
Lighting
6
9
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Clean Room Construction Ltd, UK +44 1634 295111 slawton@crc-ltd.co.uk www.crc-ltd.co.uk Connect 2 Cleanrooms, UK +44 15242 74170 info@connect2cleanrooms.com www.connect2cleanrooms.com
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Powder Systems Ltd (PSL), UK +44 151 4487700 sales@powdersystems.com www.powdersystems.com Precision Cleanrooms Ltd, UK +44 845 3013110 wbeard@precisioncleanrooms.co.uk www.precisioncleanrooms.co.uk Shield Medicare — a division of Ecolab, UK +44 2920 854390 info@shieldmedicare.com www.shieldmedicare.com
OTHER
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Contec Inc., France +33 2 97 4376 98 fcostanzo@contecinc.com www.contecinc.com Helapet Ltd, UK +44 800 0328 428 sales@helapet.co.uk www.helapet.com
Workstations and Workbenches
Ceiling, Floor and Wall Panels
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Wipes and Sponges
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Transport Carts/Trolleys
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Sterile Packaging, e.g., for Ready-to-Use Components
7
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Sterile Components, e.g., Stoppers, Syringes, Caps and Plungers
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Cabinets
Clean Modules Ltd, UK +44 1332 696970 enquiries@cleanmodules.co.uk www.cleanmodules.co.uk
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Restricted Access Barrier Systems, e.g., for Filling of Pre-Sterilised Syringes
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Mops/Mop Heads
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Building Projects (UK), UK +44 1457 861702 ajbell@buildingprojectsuk.com www.buildingprojectsuk.com
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Mixing and Storing Vessels
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Air Handling Equipment
cleanrooms
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Air Monitoring Equipment
buyers’ guide
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Sterile disinfectants 7
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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Biomanufacturing Platform Facilitates Fast and Low-Cost Drug Development Xcellerex FlexFactory Suite, Marlborough, Massachusetts, US.
Xcellerex’s FlexFactory is a fully modularised and integrated biomanufacturing platform. It enables the deployment of new production facilities for vaccines, biotherapeutics, monoclonals and biosimilars in as little as nine months — versus three to five years for present technology — at half the total cost of traditional stainless steel plants. FlexFactory is designed for quick start-up and easy expansion at a fraction of standard costs. Now, companies can advance new drugs from R&D to commercial manufacturing. The system provides easy scale-up to bioreactors as large as 2,000 l — with full purification downstream through final bulk product — all on the same, integrated, single-use flow path. Xcellerex, Inc. +1 508 480 9235 webinquiry@xcellerex.com www.gelifesciences/xcellerex
Detectable Bellows and Drip Cups Further Reduce Risk of Tablet Contamination Granule contamination during the tabletting process can cause costly manufacturing problems: black spots on tablets, resulting in high numbers of rejected tablets; and increased wear on punch guides and the tightening of upper punches, which can result in excessive machine downtime and high maintenance costs. Punch bellows and drip cups help to prevent tablet and punch guide contamination during the tablet compression process. However, there is a small risk that the close proximity of these to the die table may lead to the inclusion of small fragments of silicone material in the finished tablet. All silicone bellows and drip cups supplied by I Holland are 100% FDA compliant, but to reduce the possibility that small fragments may reach the end user, I Holland has now developed bellows and drip cups that are identifiable by standard metal detection equipment. The new solutions from I Holland have been independently tested by metal detection expert Lock Inspection Systems Ltd. In these tests, samples of I Holland’s metalised bellows, which are also manufactured to FDA standards, proved to be 100% detectable at a size of 2 x 2 mm using an INSIGHT PH EPM 12
metal detector. These new designs mean that even tiny fragments of the material should never reach the consumer. I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk
EPM 13
ARTICLE In today’s current economic climate, pressure to minimise costs, increase bottom line profits or meet budget targets is more acute than ever. Even the smallest cleanroom facility will spend tens of thousands of pounds on cleanroom consumables in a year, in a large facility the consumable spend will run into hundreds of thousands of pounds. McIlvaine’s Cleanroom World Market report put the revenue for cleanroom consumables at $10.3 billion dollars in 2011. This spend is steadily increasing year on year. Gloves are the single biggest consumable purchase, closely followed by wipes. Wipes are used at all stages of the production process through all classes or grade of cleanroom, including support areas, so it is easy to see why the global spend on cleanroom wipes is currently estimated at $776 million.
COST-EFFECTIVE SELECTION OF CLEANROOM WIPES
Cost reduction strategies As consumables form such a significant part of the running costs of a facility, it is an area that many facilities look at with a view to reduce costs. However, careful consideration needs to be given as to where these cuts should happen. A reduction in consumable quality that leads to contamination of a final product could end up being dramatically more costly than any immediate savings, therefore the challenge is reducing consumable costs whilst upholding environmental standards that maintain yield levels and do not create final product issues. One cost reduction strategy is to utilise alternative suppliers that promote themselves as either manufacturers selling direct or as distributors handling large amounts of product at lower selling prices. This strategy can be appealing based on the initial purchase price of the product, however there are often hidden costs in this approach that are not obvious at first glance. Global supply In today’s global age, products can be easily sourced worldwide at the click of a button. The Far East is recognised as a hot spot for all kinds of fabric manufacture, including wipe fabrics. A Google search returns results for 182 suppliers in the medical/healthcare sector within minutes. It is very tempting to cut out the middle man and buy a cheaper wipe directly from a convertor. However, some factors to consider are: • Does the vendor really manufacture these products? If not, how do they control the quality of the products and how robust are their quality systems? • Do the downstream raw material suppliers have quality control processes in place?
• What are the minimum purchase requirements and how much inventory will you need to maintain? • What happens when there is a problem; will the vendor stand behind their product? • What are the freight and duty costs? • How will you audit these suppliers? • Will they still be in business a year or two from now? When purchasing from a specialised cleanroom wipes supplier, the customer is also investing in companies with a high degree of technical support and research and development skill. Consider how much testing has been done on the product both through the process and on the final product before it reaches the market. Wipes that are manufactured in facilities without these controls in place, and with variable sources for the raw material, are unlikely to always meet the expected specification. Product reviews One of the most effective ways of reducing consumable spend without compromising on contamination control is to carry out an in-depth product application review. There are contamination control specialists that support customers with expert advice on whether they are using the most suitable product in each area of the cleanroom. A product application review takes place on site, allowing observation of the cleanroom operations, the environmental classification required and the consumable products used. The scope should include all process consumables in the cleanroom and supporting areas. The goal is to identify product suitability for specific cleaning processes. Recommendations can then be made as to product suitability and cost-cutting
opportunities that do not affect the overall levels of contamination. The table shows some real cost saving examples from product application reviews carried out at biotechnology, pharmaceutical and semi-conductor facilities. This may seem a simplistic approach to cost saving, but it is surprising how many products have potentially been over specified over time. In addition, advances in product development could lead to alternative substrates or packaging formats becoming available that better suit an application at a lower cost. There are numerous life science facilities where sterile wipes purchased for Grade A and B zones as required by GMP1 are used in Grade C and D cleanrooms, because it is easier not to have another type of wipe on site and thus avoid potential mix ups with where it is used. There are substantial savings to be made by not using sterile wipes where they are not needed. Verification that the correct wipe is being used in the correct area can be easily achieved by using different shaped or coloured wipes. This gives a quick visual indicator as to whether an operator has the correct wipe for the grade of room. Considerations for cost cutting include: • Can smaller size wipes be used? • Will a lighter weight version of the same substrate suffice? • Can single-ply be used instead of twoply? • Can a non-sterile product be used? • How are the wipes packaged; is there wastage? • Can packs with more wipes per pack be used? • Can presaturated wipes be used instead of wipes and spray bottles? • Can bulk product be ordered in place of stacked?
Real life examples of product reviews leading to cost reduction (provided by Contec, Inc.) Cleanroom Class
ISO 6 or 7
ISO 7 or 8
ISO 5
Application
Current Product
Recommendation
Discussion The PNHS-99 is the same wipe currently in use, except it is 9” x 9”. This ensures the Heat sealed, laundered, Heat sealed, laundered, same performance with the cost savings Wiping fused quartz. 100% polyester knit 12 x 12” 100% polyester knit 9 x 9” associated with a smaller wipe. The wipe wipe. wipe. can be folded in half and used four times, similar to the current protocol. This is a lower cost alternative to the wipes 100% knitted, laundered Meltblown polypropylene, currently in use. They provide an adequate Work surface cleaning. polyester with thermal presaturated with 70% level of IPA with a clean wipe substrate to sealed edges 9 x 9” wipe. IPA 9 x 11” wipe. keep work surfaces clean. This substrate is clean enough for the grade of room. A unique combination of cleanliness and performance, the Goldsorb wipe contains 30% round microfibre yarn, providing 100% sealed edge, single exceptional surface cleaning performance, 100% sealed-edge, two-ply, Cleaning product contact ply, laundered, knitted high sorbency and excellent durability, laundered, knitted polyester surfaces. polyester/microfibre without the added bulk and expense of a 9 x 9” wipe. 9 x 9” wipe. two-ply wipe. The Goldsorb wipe would be a very suitable alternative to the two-ply wipe, offering improved performance, cost reduction and SKU consolidation.
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• Can knife cut be used in place of laser or ultrasonic cut? • Can nonwoven be used instead of knit? Summary Cleanroom consumable costs are a significant part of a cleanroom facility’s running costs, which must be controlled if budgets and profit targets are to be met. Support from specialist cleanroom consumable manufacturers can help identify cost cutting measures with no loss of quality or increased risk of contamination. Any cost saving measure should be carefully considered with a long-term view to ensure it is not false economy or likely to compromise the consistency and repeatability of a product that in turn could impact the production process or yield. Reference EudraLex. The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use. Annexe 1.
Author: Karen Rossington is a freelance marketing consultant, specialising in the life science contamination control industry. With a BSc in Business Studies and Engineering, she has spent 17 years in the industry in both sales/marketing and R&D roles. Rossington has presented at ISPE, PDA, R3, PHSS and Pharmig 3C on the subject of disinfectant testing and contamination control. This article has been written in collaboration with contamination control specialist Contec Inc., www.contec.com.
Alexanderwerk GmbH, Germany +49 2191 795 0 mark.driessen@alexanderwerk.com www.alexanderwerk.com
Gebrüder Lödige Maschinenbau GmbH, Germany +49 5251 309 0 lemperle@loedige.de www.loedige.de
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IMA S.p.A. - IMA Active Division, Italy +39 051 6514111 tenorec@ima.it www.ima.it Kek-Gardner Ltd, UK +44 1625 665 999 sales@kekgardner.com www.kekgardner.com Quadro Engineering Corp., US +1 519 884 9660 mibrahim@idexcorp.com www.quadrocomil.com
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Size Reduction — Parts & Accessories
Size Reduction Equipment
Crushers
Containment Solutions
Compactors
Mills — Sanitary
Mills — Pelletising
Mills — Homogenising
Mills — High-Shear
Mills — Hammer
Mills — Granulating
Mills — Fluid Energy
Mills — Fine Grinding
Mills — Dispersion
Mills — Continuous
Mills — Cone
Mills — Colloid
Mills — Attrition
Kneading Mills
Grinders
Comminutors
Pelletisers
Granulators — High-Shear
Granulators — Vacuum Dryers
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Hanningfield, UK +44 1702 549777 sales@hanningfield.com www.hanningfield.com Hosokawa Micron Ltd, UK +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk
Granulators — Size Reduction 5
Frewitt SA, Switzerland +41 26 460 74 00 r.herzog@frewitt.com www.frewitt.com GEA Pharma Systems - Collette, Belgium +32 3 350 12 11 collette@geagroup.com www.gea-ps.com
Granulators — Centrifugal
Granulators — Fluid Bed
Granulators — Rotary
grinding, granulation and milling
Granulators — Particle Enlargers
buyers’ guide
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SHOWCASE MIXING & BLENDING Next Generation Vertical Mixers Offer Complete Discharge An overview of the technology for the mixing of solids may create the impression that all the principles of mixing were devised long ago. However, these processing machines are subject to continuous further development. One of the aims is to simplify the manufacturing of the apparatus. Beyond that, further development is intended to extend the user’s benefits and to improve production processes. Engineers also focus on the optimisation of hygiene and mixing quality. A new development offered by amixon’s vertical mixers allows for the removal of the mixture from the mixing chamber almost without residues. amixon’s vertical mixers feature a patented SinConvex mixing device that rotates around a vertical axis. In so doing, the mixed products in the periphery of the mixing chamber are screwed upwards. Once at the top and obeying the laws of gravity at the centre of the mixing chamber, they flow downwards. The vertical mixing tool usually rotates slowly, its peripheral speed mostly being of the order of 0.8 m/s to 2.5 m/s. Therefore, amixon mixers mix gently and do not change the granulometry of the mixture. The fact that the mixing device is only mounted and driven from the top is a major benefit. As such, amixon mixers meet the highest possible hygienic requirements and require practically no maintenance.
In some areas of application, the users of vertical mixers have had to accept the disadvantage that a poorly flowing mixture (particularly finely dispersed or moistened/greased) can result in mixing product residue clinging to the helix of the mixing device following discharge. What is needed is either spinning or manual cleaning. However, bearing in mind the ATEX rules, spinning is permissible only if the mixing products are not combustible/do not generate explosive dusts. As a solution, amixon has introduced a device called ComDisc, a short form for complete discharge. It provides a carry out of the mixing good up to 99.997% and more. The working principle is that lower mixer arm is fitted with one or more wings. During mixing, the system moves into the shadow of the flow and turns to the rear. As the filling level decreases, the ComDisc elements turn in the direction of rotation and gently scrape the mixture residues towards the outlet. Together with the SinConvex Technology, it is possible to reach a nearly complete discharge of the mixer. The carry out of the mixing good happens without segregation, cleaning times can be reduced and raw material is saved. amixon GmbH +49 5251 688888 0 info@amixon.de www.amixon.com
Lab Blenders Provide Key Capabilities for Product Testing and Development
Versatility of Blender Range Allows for Variety of Load Bearing Capacities
Natoli Engineering offers two laboratory blenders — a pilot plant system and a self-contained tumble blender. These blenders are ideal for research and design, primarily product testing and new product developments. The pilot plant system has eight attachments, while the tumble blender has five conventional attachments. The tabletop tumble blender mimics the results produced by a large production blender, with the difference being batch
Bohle blenders feature standard arm connection and clamps, round forks on the lift arm, lift arm with eccentric clamps, lift arm with power clamps and lift arm with hydraulic clamps. The fact that the customer can also order a blender that swivels about its vertical axis to function as a post-hoist provides a large number of variations. The blender can be designed to precisely meet the customer’s requirements for everyday production. Other advantages of Bohle blenders are long service lifetime and extremely low maintenance. The range of Bohle blending systems demonstrates the flexibility of the company’s engineering and manufacturing departments. Bohle blenders can be adjusted and used in any imaginable pharmaceutical production situation. No matter what kind of containers used — round or square — Bohle blenders can handle them with excellent blending results.
size. The pilot plant system is suitable for pharmacy teaching departments and for the manufacture of low volume, specialty products. Each blender offers solutions for different needs, but both can be easily integrated into a laboratory environment. Natoli Engineering Company, Inc. +1 636 926 8900 info@natoli.com www.natoli.com
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L.B. Bohle Maschinen + Verfahren GmbH +49 2524 9323 150 t.borgers@lbbohle.de www.lbbohle.de
SHOWCASE TABLETTING EQUIPMENT MAINTENANCE & STORAGE Storage Solutions and Maintenance Poster Help Prolong Lifespan of Tablet Tooling
Proper maintenance and storage can significantly extend the life of tablet compression tooling. Therefore, Natoli Engineering has taken great pride in compiling a large selection of storage solutions. With products capable of storing individual to complete sets of tooling, Natoli offers a solution for nearly every requirement. The latest addition to Natoli’s lineup is a mobile die segment cabinet. This cabinet was designed to decrease stress on die segments and the technician transporting them. One feature of this cabinet is the ability to adjust drawer length, allowing the cabinet to store any size die segment. In addition, this cabinet is able to accommodate up to 408 kg of weight, thanks to its distinctive weight bearing casters. An integrated tool drawer and shock absorbent mat add to the exceptional quality of this cabinet. Another exceptional storage product in the Tablet Compression Accessories Catalog is a complete punch and die storage system. This system’s key feature is a customisable tool holder, which can be effortlessly transferred from a storage cabinet to a tooling transporter and even to an inspection bench. This seamless integration decreases the amount of time tooling is subjected to the stress of handling. In addition to the free Tablet Compression Accessories Catalog and for greater maintenance of tablet compression tooling, Natoli Engineering offers the free Tooling Maintenance Poster. From cleaning to storage and everything in between, this poster lists the proper steps in the maintenance process. Those who wish to protect their tooling investment would benefit from these two resources. Natoli Engineering Company, Inc. +1 636 926 8900 info@natoli.com www.natoli.com
Seven Simple Steps to Protecting Tablet Tooling It makes good business sense — maintain and store punches and dies correctly and expect to produce a better product for longer, reduce costs and enhance profitability. Eighty-five per cent of punch and die problems and damage can be conclusively traced back to an unsuitable aftercare procedure and inappropriate handling. I Holland’s PharmaCare range of equipment has been designed to allow users to follow the 7-Step Process and meet all of their maintenance and storage requirements. It is a planned, professional aftercare programme that will contribute more than it costs to a company’s turnover. The PharmaCare 7-Step Process: 1. Clean — tooling should be cleaned and dried to remove any oil or product residue. 2. Assess — visually inspect tooling for signs of obvious damage and establish if maintenance is required. 3. Repair — light surface corrosion and damage can be polished out and repaired. 4. Measure — measuring is essential
after repair to ensure that critical tooling dimensions have stayed within tolerance. 5. Polish — polishing should result in a smooth mirror finish. 6. Lubricate — lubrication is important to protect, preserve and aid the smooth operation of tooling. 7. Store — storage cabinets should be specially designed to maximise security and safety and minimise damage to tooling during transportation. I Holland runs regular training seminars on ‘The 7-Step Process’ at its facility in Nottingham, UK, and at various venues around the world.
I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk
Storage Box Provides Safe and Economical Protection for Tablet Tooling Elizabeth Carbide Die Co. provides a pharmaceutical tooling storage box for the safe, convenient and economical storage of pharmaceutical tablet punches and dies. Designed to accommodate both B and D Tooling, the pharmaceutical tooling box offers the following features: • removable tray that holds up to 72 punches and 36 dies (B tooling) and 48 punches and 24 dies (D tooling); • head supports that elevate the punch from the tray for easy removal; • moulded keyways and guides that provide secure storage of individual punches and prevent collisions between tools;
• die storage on top of tray for immediate access; • deeply recessed handles for secure handling; • and stackable and easy to clean design. Dimensions of the pharmaceutical tooling box are 45.7 (l) x 26.7 (w) x 18.4 cm (h). The Elizabeth Companies’ Elizabeth Carbide Die Co., Inc. +1 412 751 3000 ryank@eliz.com www.eliz.com
Ultrasonic Cleaning Machine Preserves Punches and Dies Cleaning of punches and dies has become a critical process in tablet manufacturing due to the stringent FDA norms. Proper cleaning is essential, not only for removal of residue, but also to avoid product contamination. The ultrasonic punch and die cleaning machine ensures effective and consistent cleaning without manual intervention. Even the most delicate part of a punch — the tip — is cleaned of all the deposits without any risk of deterioration. Difficult areas like intricate embossing and the inside of the die are also cleaned with the same efficiency. Additionally, the chances of tooling damage are reduced as manual handling is minimised. Punches and dies are accommodated in specially designed stainless steel tooling trays, which are passed through four stages:
1. First stage ultrasonic cleaning with temperature control. 2. Second stage ultrasonic cleaning with temperature control. 3. Hot air drying. 4. Lubrication for rust prevention during storage. The cleaning time per rotary set of 40 pcs is around 45 minutes. If the punches are to be used after cleaning, the lubrication stage can be avoided.
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Concept Engineering Co. +91 22 2685 8479 info@adeptexport.com www.adeptexport.com
Corporate News & Events
Pharmintech Organiser Forecasts Record Attendancy for 2013 Event Pharmintech is one of Europe’s most prominent trade events dedicated to technology for the pharmaceutical, nutraceutical and personal care industries. The next show will be the fourth and takes place on 17–19 April 2013, at Bolognafiere, Italy. A key event for the business community, the 2010 Pharmintech show reported as many as 350 exhibitors, 35% of which were from outside of Italy, and was visited by 4,000 highly qualified industry professionals with strong decision-making power from 60 countries. It is a crucial source of new profitable contacts for exhibitors and a not-to-be-missed source of valuable, up-to-the-minute information on technology and processes for visitors. According to organiser Ipack-Ima, Pharmintech offers comprehensive product and service coverage of all sectors — from subcontracting to pharmaceutical end products — and is an event of international standing,
heralded and supported by a wideranging, targeted communication campaign, capable of ensuring the participation of big names the world over. Pharmintech and Cosmofarma Exhibition (a leading event dedicated to beauty care, healthcare and pharmaceutical related services), will be held jointly for the first time on 19 April 2013. Co-located for one day, the two shows will boost one another’s visitor count — a partnership that is capable of generating additional synergies and therefore cross-show contacts. For one week, Pharmintech, together with Cosmofarma for one day, will play host to the cream of the pharmaceutical industry. Ipack-Ima Spa +39 02 3191091 ipackima@ipackima.it www.ipackima.it
Stainless Steel Hygiene Furniture and Equipment Manufacturer Expands Team to Aid Growth Plans
Bioreactor Specialist Officially Opens Production Facility in Guxhagen
Teknomek has welcomed four new members of staff who have the know-how to push Teknomek’s 25 years of excellence to the next level. With a wealth of experience spanning the globe, new Managing Director Steve Mallett has From left to right, John Clark, Steve Mallett and Rebecca Baker. worked in various managing accounts, especially within director roles for major brands such as companies of a similar size. Pirelli, Waxoyl, Ford, Honda and In order to improve customer service, Mazda. Mallett’s expertise has focused a new role has been created for Sandra predominantly on change Jones, Teknomek’s Telesales Executive, management, while beginning to who will work with the existing sales introduce a culture of continuous team. Having begun her sales career in improvement throughout the business. 1998, Jones has experience in selling Putting this experience into action at to both businesses and consumers. Teknomek, Mallett plans to further Finally, new Marketing Executive John develop the strong brand by recruiting Clark will provide valuable data and developing specialist personnel. analysis and insight into trends, An apprenticeship scheme is performance and pricing. With a underway, with plans in place to background primarily within the expand, develop and train Teknomek’s financial services industry and experienced and skilled workforce. manufacturing, Clark has gained Working closely with Mallett is valuable experience in utilising Financial Controller Rebecca Baker, databases for use within direct who is to head up the accounts team. marketing. He is particularly keen to Despite a qualification in physiotherapy, use his expertise to improve customer Rebecca began her career as a trainee relationships and encourage new accountant with BP, qualifying with the business. CIMA (Chartered Institute of Management Accountants) in 1987. Teknomek Ltd Joining Teknomek in June, Baker +44 1603 788833 possesses extensive experience in www.teknomek.co.uk developing accounting systems and
Sartorius formally opened its new plant in Guxhagen, northern Hesse, Germany, for the manufacture of bioreactors. After approximately one year of construction, the new building was officially dedicated in the presence of the Prime Minister of the state government of Hesse, Volker Bouffier, the Mayor of the community of Guxhagen, Edgar Slawik, and numerous guests from the local political and business community. Approximately €18 million were invested in the plant at which Sartorius now manufactures bioreactors and further production equipment for customers in the biopharmaceutical industry. Covering a total area of approximately 929 m2, the new building complex provides space for a high-tech manufacturing hall and offices for around 240 employees. The building owner is Robos GmbH, from which Sartorius has rented the premises in a long-term lease. Sartorius had reached maximum capacity limits at its former bioreactor production facility in Melsungen, Germany. Bouffier stated: “By deciding to build a new production facility just a few kilometers away from Melsungen, Sartorius has reinforced its close ties
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with northern Hesse. At the same time, this decision also underscores the advantages of the business location of the State of Hesse. We offer companies an excellent infrastructure and intentionally promote the regional economy so that innovative mediumsized companies will invest in and stay with us.” Joachim Kreuzburg, the Chief Executive Officer and Executive Board Chairman of Sartorius, said: “The new plant enables us to substantially enhance our manufacturing processes and creates additional capacity for us in view of the rising demand for biopharmaceutical production equipment. As a result, we are optimally prepared for further expansion, especially for single-use bioreactors.” Sartorius AG +49 551 308 1686 petra.kirchhoff@sartorius.com www.sartorius.com
LABORATORY PRODUCTS & EQUIPMENT
Microgramme Weighing in Aggressive and Temperature Extreme Environments Conventional balances cannot be used in extreme temperature, high gas pressure or aggressive environments. The instrument manufacturer Rubotherm has developed a magnetic suspension balance for these applications. The incorporated micro balance from Mettler Toledo provides precise and reliable weight values over a long time period. The scientific investigation of chemical reactions and production processes takes place in isolated measurement atmospheres that are often also of a corrosive and/or explosive nature. High gas pressure and extreme temperatures often prevail in these atmospheres. In investigations of this kind, the change in mass over time is an important measured variable. However, a conventional analytical balance cannot be used in these extreme conditions. The instrument manufacturer Rubotherm has developed a balance for measurements in a pressure up to 1,000 bar and temperatures ranging from 77 to 1,800 K. The balance uses a suspended magnetic coupling to transfer the weight force of the sample to the exterior weigh module without any physical contact. The weighing chamber and measurement chamber are therefore completely isolated from each other. The incorporated Mettler Toledo weigh module has an underfloor weighing device with integrated overload protection. The function and precision of the balance can be checked and, if necessary, adjusted at any time using the incorporated calibration weights. The engineers at Rubotherm appreciate the rugged design of the WXS weigh module and the readability of 1 µg over the entire weighing range of 22 g.
Small Yet Versatile Autoclaves to be On Show at Medica
A selection of smaller-capacity steam sterilisers, including models equipped with the new Tactrol Touch, will be exhibited by Priorclave on Stand 1E02, at Medica, Messe Dusseldorf, Germany, on 14–17 November. Developed by Priorclave, Tactrol Touch, a compact touchscreen control centre, guides autoclave users easily through set-up procedures for achieving optimum sterilisation performance as well as providing real-time monitoring of process status. The EH150 Priorclave, the company’s first steam steriliser to be released with the new touchscreen control, is a 150 l, front-loading autoclave, providing 20% more load area than conventional models of similar size. It will be joined on the stand by one of the company’s most popular top-loading autoclaves, the EV100, a 100 l, electrically heated autoclave, and the compact, top-loading C60 Priorclave, equipped with advanced cooling and automatic timed freesteaming to aid faster throughput. Models presented by Priorclave will give an insight to the versatility and build-quality of the smaller autoclave ranges that cater for low-volume, periodic sterilising requirements, as well as have the flexibility for higher volume and more frequent applications. An extensive range of options, not often found in smaller machines, enables Priorclave to tailor, when required, a machine built to satisfy virtually any laboratory sterilising requirement.
Mettler-Toledo (Schweiz) AG +41 44 944 25 68 eugen.schibli@mt.com www.mt.com/wx
Priorclave Ltd +44 20 8316 6620 sales@priorclave.co.uk www.priorclave.co.uk EPM 21
LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Universal Device Provides Enhanced Mechanical Calibration of Dissolution Testers More and more people in the pharmaceutical industry are adopting the new regulatory guidelines for enhanced mechanical calibration of dissolution systems. In order to improve and simplify the implementation of the enhanced mechanical calibration, SOTAX has announced the SOTAX MQD, a new universal tool for qualification of all brands of USP 1 and 2 dissolution testers. The SOTAX MQD serves to simplify data capture and reporting while meeting industry compliance requirements. It wirelessly communicates with the intuitive software and guides the user through a simple, step-by-step protocol to complete the qualification. By reducing user interpretation of manual readings
along with the automated PDF report, the MQD allows for efficient calibrations with reliably precise data. The fully NIST traceable MQD also simplifies the overall qualification
workflow, as the user only needs this one tool for calibration of any dissolution tester, regardless of brand (USP 1 and 2), and therefore eliminates the need for complex tool sets.
SOTAX AG +41 61 487 54 20 petra.silbereisen@sotax.com www.sotax.com
Open All Hours Reference Standards Webshop Receives Positive Feedback LGC Standards’ webshop is enjoying considerable success, providing customers around the world with the convenience and flexibility of ordering in 16 languages, 24 hours a day, seven days a week. Featuring over 30,000 products, it reportedly represents the most comprehensive source of online reference materials and can be searched quickly and easily using the intuitive search engine. The Center for Nuclear Technologies at the Technical University of Denmark (DTU), Roskilde, has taken advantage of
this online facility to order certified melting point standards to ensure correct calibration of its equipment. Dr. Sorin Aburel, Head of Production at DTU’s Hevesy Laboratory, explained: “We are a radiochemical and radiopharmaceutical facility involved in the development of new diagnostic and therapeutic radiopharmaceuticals. The raw materials that are used for radiopharmaceutical production must undergo identification tests according to Ph. Eur., including melting point determination, and correct calibration of
our instruments is essential. We use the webshop to buy certified melting point standards and really appreciate the convenience of being able to order at any time, not just in office hours. It is easy to access and placing an order is simple; you just pick the things you need, transfer to the webshop and with one click you have everything you require.” To start using the online ordering service or to learn more, visit www.lgcstandards.com.
LGC Standards +44 20 8943 7412 amanda.russell@lgcstandards.com www.lgcstandards.com
Astellas Pharma Adopts Terahertz Spectroscopic Imaging System
Latest Version of Informatics Suite Extends Capabilities of Scientific Drawing and 3D Modelling Modules
Advantest has announced that its terahertz spectroscopic imaging system TAS7500, which utilises Advantest’s THz wave technology, is being put to use by Astellas Pharma Inc. in Japan. The TAS7500 system enables non-destructive, contact-free spectroscopic analysis and imaging of the inner structures of pharmaceutical products. The system can analyse pharmaceuticals in liquid, powder or solid form, and evaluate crystalline forms, chemical constituents, density and other characteristics. The system can also produce 2D and 3D images of tablet coating layer thickness and density distribution, as well as cross-sections of multi-layer tablets. Pharmaceutical firms are developing increasingly complex products, including the recent development of multi-layer tablets that deliver active ingredients more effectively. Manufacturers face a serious challenge in the speedy analysis of the crystalline forms and chemical constituents of promising pharmaceutical materials. The spectroscopic analysis and imaging functions offered by the TAS7500 enable fast, simple, high-throughput drug analysis that contributes to speedier R&D and scale-up. Wataru Momose, Senior Researcher at Astellas’s Pharmaceutical Research and Technology Labs, said: “The TAS7500 is compact and fits on a desktop. It offers a good selection of spectroscopic analysis
PerkinElmer Inc. has introduced the newest edition of ChemBioOffice Informatics Suite. Available from Adept Scientific, ChemBioOffice version 13.0 increases the productivity of scientists with improvements to the ChemBioDraw and ChemBio3D programs, while providing secure cloud storage for improved data sharing. The ChemBioOffice suite helps chemists and biologists to efficiently track their work, giving them more time to focus on their research, visualise and gain a deeper understanding of their results and correlate biological activity and other properties with chemical structures. The new informatics product provides individual scientists in an organisation with the tools they need to create publication-ready drawings of compounds, reactions, materials and their properties for use in ELNs and databases, as well as to query chemical databases. The improved biopolymer toolbar of the ChemBioDraw program, a leading scientific drawing program, enables fast and easy modifications to larger therapeutic agents and molecular structures such as amino acids, peptides, RNA, DNA and nucleotides. In addition, users can now copy and paste any sequence into the program to manipulate part of, or the entire section of, a sequence in the search for modifications to gain a deeper understanding of their results and
— transmission, reflection, ATR (Attenuated Total Reflection) — and imaging functions, and has stable, highspeed measurement capabilities. At present, the most widely used PAT tools are near-infrared spectroscopy and Raman spectroscopy, but the TAS7500, based on THz wave technology, is very useful in further improving drug R&D efficiency.” Kazuhiro Sako, Ph.D., Vice President, Pharmaceutical Research and Technology Labs, also expressed high hopes for the improved drug R&D efficiency offered by the TAS7500, saying: “Astellas has an increasingly important role in developing and rapidly delivering high-quality pharmaceuticals to patients. Making full use of new analytical devices like this, we aim to contribute even more to people’s health around the world via highly effective and reliable pharmaceutical products.” Advantest Corporation www.advantest.co.jp
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correlate biological activity with chemical structures. To assess the shape and properties of small molecules and biochemical compounds, the ChemBio3D program enables synthetic chemists and biologists to generate 3D models. The ChemBio3D program can evaluate data input and provide valuable information such as the degree of fit of compounds into a receptor. In addition, the program acts as a hub for other 3D modelling programmes, providing easy and consistent access to other computational and molecular modelling programs. The addition of a sharable cloud location to ChemBioOffice makes it easier for scientists to collaborate by securely sharing and importing ChemBioDraw and ChemBio3D structures, reactions and drawings with other scientists around the world. Adept Scientific plc +44 1462 480055 leads@adeptscience.co.uk www.adeptscience.co.uk
ARTICLE Although sieving has been used since the ancient Egyptian times in the manufacture of beer, one of the earliest automated instruments for particle size analysis was based on the Electrical Sensing Zone method, more commonly called the Coulter Counter, and first appeared in the 1950s. In this high resolution method, still used today, particles in saline solution are pumped through an orifice where the electrical pulses produced can be converted to particle size, Figure 1. The area under each pulse is directly proportional to the particle volume and is assigned to a number of channels. To convert the area of the pulse to a particle size, the channels are calibrated using single size or monosized microspheres, usually a polymer latex. However, one criticism levelled against the mono-disperse standards was that they were too idealistic and did not represent real materials encountered in particle metrology.
PARTICLE SIZE ANALYSIS — THE DEVELOPMENT OF INSTRUMENTATION AND STANDARDS
The first polydisperse standards In response to this criticism, the National Institute of Standards and Technology from the US brought out a series of wide distribution or polydisperse glass microspheres. Ten thousand particles were measured by microscope, which provided data most suitable for the Coulter counter. To support the automated sedimentation techniques, the standard was also certified by sedimentation using the Andreasen Pipette, Figure 2. The success of the Coulter Counter unveiled a hitherto unforeseen difficulty — obtaining a representative sample from a polydisperse reference standard. Early methods of size analysis such as sieving required tens of grammes of sample. Even the Andreasen Pipette could use up to 10 grammes. By contrast, the Coulter only required about
30 mg of a standard for an analysis, microscopy required even less, so very careful procedures had to be adopted to ensure that the sample taken for analysis was representative of the bulk sample. BCR quartz standards In 1980, the European Community Bureau of Reference (BCR) brought out a range of standards based on crushed quartz. Quartz was selected because of its cheapness and more random shape than the idealised glass microspheres. The primary method of analysis was sedimentation using the Andreasen Pipette method, although sieving was also used for the largest size. Five standards were produced from 0.3 to 650 µm. About the same time, laser diffraction was being developed as a new powerful tool for particle size analysis. However,
Figure 3. Primary methods of particle analysis give very comparable results for glass microspheres.
Figure 4. Highly repeatable results for single shot bottles from a 100 stage spinning riffler (courtesy of Malvern Instruments Ltd).
Figure 2. Sedimentation analysis — the Andreasen Pipette.
Figure 1. The principle of the Electrical Sensing Zone particle counter (Coulter). for a number of reasons, some of the early laser instruments produced equivocal results. These included not only the non-representative sampling from the large 10 g sample bottles, but also the inhomogeneous optical and shape properties of the quartz. It was also suggested that the comparatively crude Andreasen Pipette sedimentation method may not have been the ideal benchmark on which to base a reference size. Removing the shape factor issue By the early 1990s, laser diffraction was becoming a predominant method of size analysis and the quartz standards were seen as increasingly unsuitable for the technique. The BCR then decided to introduce a duplicate series of spherical references designed to overcome the ambiguities associated with the crushed quartz standards. The standards were to be certified by primary or absolute methods only, i.e., methods where size could be linked directly to international standards and did not rely on secondary effects of the particles such as diffraction patterns, turbidity, Brownian motion, elutriation or computer modelling. The methods specified were: sedimentation (both gravimetric and centrifugal), microscopy and image analysis, precision sieve analysis and the Coulter method. However, the rapid development of the laser technique and the consequential requirement for improved quality assurance meant that by the time the new spherical references were produced, the demand far exceeded all
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expectations. Indeed, Malvern Instruments predicted that it alone would use all the standards in less than a year. Whitehouse Scientific was therefore commissioned to produce a duplicate set of standards in much larger weights, which became known as Mirror standards. The purpose was not only to dilute the demand for the new standards, thereby extending their lifespan, but also to shortlist over 40 particle sizing laboratories that applied to certify the official BCR standards. As the new standards were spherical and strict sub-sampling and analytical guidelines were prescribed, much improved reproducibilities were observed compared with the quartz analysis, both within a given primary method and when the results of several methods were compared, Figure 3. Avoiding the cardinal sin The cardinal sin in particle size analysis is to take a spatula sample of powder from a bottle. Due to particle segregation in filling or transit being quite common in dry powders, a single spatula sample is rarely representative of the distribution of particles in the bulk sample. Once taken, not only is the sample for analysis unlikely to be representative, but the remaining portion in the bottle is, by definition, also no longer representative of the initial bulk sample. The best way of minimising sampling errors is to supply the standards in single-shot weights designed specifically for the particle sizing instrument being used. This minimises sampling errors by the analyst. One of the biggest sub-dividers used today has 100 stages capable of producing sub-samples as low as 10 mg. Figure 4 shows that the single shot sub Continued on page 24
LABORATORY PRODUCTS & EQUIPMENT ARTICLE Figure 5. NanoSight particle tracking results for a mixture of gold sols and a polymer latex.
samples, all 320, when analysed by laser diffraction, have virtually identical particle size distributions. Instruments of the future The development of laser diffraction particle size analysis has been without question the most significant development in particle metrology in a generation. Exceptional accuracy and reproducibility is now possible in ultrafast analysis times. However, the equivalent spherical diameter produced is only a partial description of a particle, particularly when the particle in question deviates from a sphere. Particle shape can have a profound effect on the handling of the powders and in the subsequent physical and chemical use of the particles. Microscopy, now over 300 years old, is once again the new kid on the block. This is because, with the addition of high-speed cameras and computers, image analysis combined with microscopy can now be used to analyse millions of particles in a matter of seconds, producing not just the equivalent spherical diameter of the particles, but individual dimensions of every particle. As nano-particle applications accelerate, especially in the medical field, there has been an increased focus on instrumentation in this region, i.e., below 0.1 Âľm. Traditionally, electron microscopy has dominated the field, but the disc centrifuge, developed over 50 years ago, is making a dramatic comeback with high-speed and ultra-high resolutions down to 5 nm. The most radical new development in recent years however, is the latest nanotracking instruments, which follow the EPM 24
bombardment of nano particles by temperature excited molecules in a liquid dispersant. Laser light is used to track the velocity of the moving particles; smaller particles being deflected at much higher velocities than the larger ones, Figure 5. Conclusion Particle size analysis has come a long way in the last 40 years, but it is no longer sufficient just to get an answer. The answer must be proved to be correct by using traceable particle size reference standards. It is comparatively easy to calibrate with idealised monodisperse spherical standards, but the real challenge is to calibrate instruments with polydisperse standards, where the competence of both the instrument and the analyst is tested. The leading manufacturers of all particle sizing instruments now supply single shot reference standards usually produced by an independent laboratory and very good agreement with the primary methods of analysis is regularly achieved, irrespective of the instrument being used for the analysis.
Author: After graduating from Lancaster University, Dr. Graham Rideal joined multinational company ICI, where he pioneered and patented revolutionary nano-platelets. This led to the foundation of Whitehouse Scientific Ltd in 1983, a company specialising in the production of glass microspheres used as reference standards in particle size analysis and filter testing. Whitehouse Scientific Ltd, www.whitehousescientific.com.
SHOWCASE PARTICLE ANALYSIS Nanoparticle Characterisation Systems Provider Introduces Syringe Pump Capabilities Always looking for ways to enhance the capabilities of its Nanoparticle Tracking Analysis (NTA) systems, NanoSight has announced the addition of a syringe pump to its range of accessories. This is available for use with all models of NTA systems, meaning even the oldest users may enjoy the benefits of upgrading. Enhancing reproducibility of sizing and counting data and combating photobleaching when using fluorophore labels underscores the reliability of NTA as one of the most used nanoparticle characterisation systems today. Improving measurement repeatability is always most important to analysts. The syringe pump allows an increased number of sample particles that are detected and tracked during an analysis. This gives a more representative sample population and increases the repeatability of the size distribution results, especially for polydisperse samples. It also improves
the repeatability of concentration measurements by continually introducing fresh sample volumes during analysis. This, in combination with the SCRIPT batch analysis procedure, ensures consistent standard operation procedures for outstandingly accurate and reproducible concentration measurements, especially for counting larger particles and aggregates. Furthermore, increasing the sampling population allows for more accurate analysis of extremely dilute systems, which would otherwise require extremely long capture durations to detect and track sufficient particles for statistically robust measurements. Using the syringe pump reduces the photobleaching effect seen by fluorescent nanoparticles illuminated by the laser beam under static flow conditions. Flowing fluorescently labelled samples through the beam
reduces the time each particle is being illuminated by the laser and is therefore highly recommended for fluorescent labelling studies. A fresh population of unbleached nanoparticles is continually introduced into the instrument field of view, giving improved statistics for fluorescence measurements. Speaking about the new capability for NTA, NanoSight Head of Development Dr. Patrick Hole said: “The syringe pump has greatly increased the performance of our NTA systems and meets the requests from our users worldwide who have been asking for better reproducibility as they have come to rely upon NTA as their ‘go to’ test method when sizing and counting their nanoparticles.” NanoSight Ltd +44 1980 676060 jeremy.warren@nanosight.com www.nanosight.com
Presentation Advises on Moving Laser Diffraction from Lab to Production
Static Laser Scattering Allows for Particle Size Measurements Up to 2000 µm
In a new presentation from Malvern Instruments entitled ‘Moving laser diffraction from the laboratory into the production process’, Product Group Manager Dr. Paul Kippax discusses the benefits and challenges of taking laboratory-based particle sizing out into the production process. The presentation is particularly tailored to the pharmaceutical industry, but is generally relevant to all manufacturers considering an investment in on-plant real-time particle size measurement. It can be freely downloaded at www.malvern.com/laboratory-toproduction. Particle size information is used in the development and manufacture of a significant number of products, with laser diffraction now the analytical technique of choice across many industries. A key attraction of the method is the availability of process systems for real-time measurement that complement highly productive laboratory instruments. However, some still perceive the transition from laboratory to line as potentially problematic and consequently fail to fully exploit the potential of this powerful analytical method. In the presentation, Dr. Kippax looks at how particle size information is used to understand and control product performance, and examines the application and benefits of both off- and
The FRITSCH ANALYSETTE 22 laser particle sizers are used around the world in production and quality control, as well as in R&D for precise determination of particle sizes. Advantages of the ANALYSETTE 22 models are a 0.01–2000 µm measuring range, short measuring time, high measurement precision, consistent reproducibility, reliable comparability and user-friendly operation. There are two models to cover all applications: the ANALYSETTE 22 MicroTec plus — an all-round-laser with a measuring range of 0.08–2000 µm for all typical measurement tasks, and the ANALYSETTE 22 NanoTec plus — a high end instrument for measurements down to the nano range, providing high precision and sensitivity for the smallest particles through the measurement of the backward scattering in a third laser beam. Each ANALYSETTE 22 consists of a
on-line measurement. He reviews the primary requirements of a process analyser, which are to deliver relevant information, in a relevant timeframe, using an appropriately robust device, and goes on to outline how laser diffraction process systems, as exemplified by Malvern’s Insitec range, meet these challenges, by combining rapid measurement with extremely high reliability. Installed in the process line or on an associated sampling loop, these systems deliver the real-time monitoring that underpins optimised, often automated, control, and can provide substantial economic return. Throughout the presentation, the focus is on how best to apply laser diffraction technology to meet requirements, whether in research, development, manufacture or QC, and how to ensure the successful application of the technique across the product lifecycle. Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com
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compact measuring unit that can be quickly and easily combined with various dispersion units for dry and wet measurements respectively. A practical fast-switch system allows the operator to quickly switch between dispersion units by simply changing the cartridge containing the measuring cell. The ANALYSETTE 22 completes most measurements in less than a minute. The instrument is then immediately ready to be used again. Clearly organised results are directly visible on the screen and a customised report can be saved or printed out. FRITSCH invites readers to send a sample for a free-of-charge measurement and detailed analysis protocol. FRITSCH GmbH Milling and Sizing +49 67 84 70 146 koehler@fritsch.de www.fritsch-sizing.com
Corporate News & Events
LAB INNOVATIONS 2012 Organiser Unveils Details for Royal Society of Chemistry Conference The Royal Society of Chemistry (RSC) is bringing together leading experts in chromatography, biopharmaceuticals and environmental forensics, and laboratory health and safety, plus career development specialists, to speak at a special conference at easyFairs’ LAB INNOVATIONS, at the NEC in Birmingham, UK, on 7–8 November. The two-day conference, carefully devised by the RSC for laboratory managers and scientists working across the chemical industry, life sciences, food and beverage and research institutions, will focus on analytical chemistry — including the latest advances in measurement, life sciences and environmental research — plus continual professional development and health and safety. The industrial researchers, worldrenowned academics, spin-out researchers and technical sales managers addressing the conference include Lee Coney, Chief Scientific Officer — Biologics, at NDA Analytics, who will talk about the application of bioassays for the development of
biopharmaceuticals. In vitro bioassays are used throughout the entire product development lifecycle of biological therapeutics from lead optimisation right through to the clinic. The conference will also feature a talk by David Collins from the Irish Separation Science Cluster (ISSC) based at Dublin City University. David Collins recently received the Royal Society of Chemistry 2012 Ronald Belcher Award for outstanding achievements in the development of analytical instrumentation. The ISSC is an internationally recognised separation science group, which is truly multidisciplinary, with chemists, biologists, engineers and physicists all working together to provide industry with analytical solutions to complex problems. Collins will be talking about some emerging technologies within the group, specifically in instrumentation development. The scientific sessions will also include talks by: Katya Nesterenko, Dublin City University, Irish Separation Science Cluster — Team Leader, Paul Gabbott,
Discovery Tools Company and Peptide Producer Collaborate in Field of Fluorescence
AssayMetrics’ Fluorescence Lifetime is a reportedly groundbreaking assay technology used in the biochemical screening of new drugs in high throughput screening and compound characterisation roles in the pharmaceutical industry. Discovery tools company AssayMetrics has announced a collaboration that involves peptide and antibody company Cambridge Research Biochemicals making key peptide substrates labelled with AssayMetrics’ Fluorescence Lifetime dyes. The peptides are used to screen novel drugs in equipment such as AssayMetrics’ Fluospec FL reader and are employed in assays involving kinases, proteases, protein:protein interactions and other target enzyme systems.
The collaboration brings together two companies to offer solutions to the pharmaceutical industry that enable faster, more efficient and cheaper drug discovery and development, thereby improving the effectiveness of pharmaceutical R&D. Dr. Pierre Graves, MD of AssayMetrics, commented: “This is exciting news as Cambridge Research Biochemicals have considerable expertise in making the type of complex peptides needed for innovative discovery.” Emily Humphrys, Commercial Director of Cambridge Research Biochemicals, was equally positive: “This technology has so much potential that we are really pleased to be collaborating with AssayMetrics at this early stage.” AssayMetrics Ltd +44 29 2002 6269 pierre.graves@assaymetrics.com www.assaymetrics.com Cambridge Research Biochemicals +44 1642 567180 crbsales@crbdiscovery.com www.crbdiscovery.com
Thermal and Elemental Analysis, PETA Solutions and Thermal Instruments Ltd, UK, and Dr. Laura Waters of the University of Huddersfield, UK. In 2011, Dr. Waters was awarded the JPAG Analytical Science Award for her pharmaceutical research, the British Science Association Darwin Award for public engagement and the Intelligent Formulation Award for the promotion of formulation. More recently, she won the Geoffrey Phillips Analytical Science Award 2012. In addition, the two-day programme will address a range of practical issues through workshops and walk-in sessions, ranging from health and safety obligations to information on getting the most out of continual professional development (CPD). For instance Dr. Andrea McGhee, RSC Professional Standards Specialist, will discuss achieving chartered status, while
Charlotte Ashley-Roberts, RSC Careers Specialist, will talk about continuing a career. This will involve a detailed Q&A session, followed by one-to-one advice for RSC members. easyFairs UK Ltd +44 20 8843 8822 richard.thompson@easyfairs.com www.easyfairs.com/labinnovations
Deal Marks Analytical Instrumentation Provider’s Entry to Third Largest Asia-Pacific Biotech Market Avacta Analytical has signed a third distribution agreement with Pall Life Sciences — a global leader in filtration, separation and purification — appointing Pall as the Indian distributor for its marketleading Optim 1000 protein drug development tool. The Optim 1000 is an analytical instrument that provides biopharmaceutical developers with information about the viability of candidate drug molecules and formulations much earlier in the drug development process, avoiding costly end stage product failures. The latest collaboration extends the existing North America and South East Asia agreements, granting Pall exclusive marketing and distribution rights to the Optim 1000, to include India. Alastair Smith, Chief Executive of Avacta Group, commented: “Pall has proved an excellent partner for Avacta, and the success of our existing collaborations in North America and South East Asia was a major factor in
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the decision to appoint the company as the sole distributor for the Optim 1000 in India. The Indian biopharma industry is growing rapidly, offering exciting new opportunities, and we look forward to working with Pall in this new territory.” For more information, visit www.avactaanalytical.com/optim-1000. Avacta Analytical +44 844 414 0452 info@avacta.com www.avactaanalytical.com
INGREDIENTS & CONTRACT SERVICES
CDMO’s Development Service Business Doubles Revenues and Grows Capabilities Vetter has reported that its Development Service has doubled its revenues over the last five years, due to increased customer demand for support on complex biologics. Vetter Development Service (VDS) supports products from preclinical development through Phase III and develops robust processes that enable a seamless transfer to Vetter Commercial Manufacturing. Offering a continuum of service, the global VDS organisation comprises more than 150 scientists, engineers and other personnel. Vetter’s Chicago facility provides early-stage clinical production, featuring equipment optimised for small-batch manufacturing. The Ravensburg facilities support a range of development products through Phase III and feature sophisticated new technologies with enhanced analytical capabilities. Since the full operational launch of VDS Chicago, Vetter’s first US facility, in October 2011, the site has contracted with a number of companies from around the globe, including Belgium, Israel and Korea, in addition to the US. Supporting preclinical through Phase II products, the site has already released customer batches for clinical trials. Over the past few months, the Chicago site has expanded analytical and microbial testing, added approximately 610 m2 of GMP storage and built out its business office to accommodate more than 20 additional work spaces. Future plans include adding a third cleanroom to the two existing ones, which will expand current operations and provide filling of pre-sterilised syringes. As part of its continuous investment in its state-of-the-art facilities, over the last year Vetter acquired sophisticated new technologies at its Ravensburg development laboratories, which enable: better control of syringe and cartridge siliconisation; more-accurate detection of sub-visible particles in drug products; and a greater ability to simulate commercial-level processes in the VDS setting for even smoother product transfer to commercial production. Paul Nelles, Ph.D., Vice President of Vetter Development Service, said: “The growth of VDS demonstrates the increasing need for expert support in the development of complex compounds to address a growing market. This rise in demand confirms our decision to expand Vetter Development Service to North America, as was urged by our USbased customers.” Vetter Pharma International GmbH +49 751 3700 0 info@vetter-pharma.com www.vetter-pharma.com
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Microbiology lab, VDS Chicago.
Process Development, VDS Ravensburg.
INGREDIENTS & CONTRACT SERVICES ROUNDUP Drug Delivery Specialist Enters Commercial Supply Agreement for Once-Daily Combination and Extended-Release Capsules
Contract Analytical Laboratory Provides Comprehensive Microbiology and Toxicology Testing Services
Catalent Pharma Solutions has entered into a supply agreement with VIVUS, Inc. to supply Qsymia capsules, a proprietary combination phentermine and extended-release topiramate. Utilising its drug delivery capabilities, Catalent partnered with VIVUS during the development of Qsymia, including pre-formulation and formulation, clinical supply and validation. Qsymia has recently been approved by the FDA as the first once-daily combination treatment for chronic weight management in adults who are obese or overweight with a weightrelated co-morbidity. Dr. Ian Muir, President of Catalent’s Modified Release Technologies business, commented: “It is extremely exciting for Catalent to see the FDA approval of this significant new therapy for weight management. As a combination therapy with two active ingredients that needed to be formulated and delivered in a
Wickham Laboratories is one of the UK’s leading contract analytical laboratories with an exceptional international reputation, specialising in microbiology and toxicology testing. Significant investment has been made into the company and resources, which saw the successful completion of the relocation and expansion of the business to a new facility in 2012. The company’s staff of 90 plus personnel conducts analysis of pharmaceutical and medical device products for batch release into European and international markets. Wickham Laboratories is inspected by MHRA, audited by FDA and all tests are offered to comply with harmonised methods of PhEur, USP and JP. Wickham Laboratories’ range of microbiology testing services includes routine quality control, method development and validation of products. The company also specialises in disinfectant efficacy and log reduction
testing, whether for cleaning agents or in novel wound dressing applications. The Microbiology team also assists a significant number of pharmaceutical and medical device customers with sterility testing, cytotoxicity and BET. Sterility testing operates within a cleanroom complex finished to the highest standards and boasts accommodation suitable for a number of isolator units complete with ballasted pass-through autoclaves. Wickham Laboratories also offers toxicology safety testing. Designed to bespoke specifications, this unit carries out safety testing based on small animal models, which includes biological testing for quality control of existing products, new formula registration and new medicines research.
can offer our European customers quick and detailed support on all tabletting issues. The lab location in Germany will accelerate and optimise the cooperation with the R&D departments of our European customers.” Additionally, the laboratory will extend its services to host hands-on
applications training and technical seminars for up to 20 people at a time.
controlled release dosage form, Qsymia presented unique formulation and drug delivery challenges. We are very pleased to have partnered with VIVUS in developing Qsymia and look forward to a long and successful relationship.” Peter Tam, President of VIVUS, added: “An extended release formulation of Qsymia was critical to achieving our aim of developing a once-daily treatment. Catalent’s broad range of drug delivery capabilities and extensive experience in controlledrelease technologies helped us to achieve our goal. VIVUS is also pleased to have completed a long-term commercial supply agreement with Catalent to ensure the reliable ongoing supply of Qsymia.” Catalent Pharma Solutions, Inc. +1 732 537 6407 patricia.mcgee@catalent.com www.catalent.com
Wickham Laboratories Ltd +44 1329 226600 mail@wickhamlabs.co.uk www.wickhamlabs.co.uk
Specialty Ingredients Provider to Open Pharma Lab in Dusseldorf Ashland Specialty Ingredients (ASI), a commercial unit of Ashland Inc., plans to open a new pharmaceutical application laboratory in Düsseldorf, Germany, in December. The laboratory will provide high-level technical support to Ashland’s European pharmaceutical and nutraceutical customers. “With a location central to major pharmaceutical and nutraceutical customers in the region, this new lab will enable us to offer sizable value and convenience to global multinational companies as we bring on board research projects,” said Dr. Edmont Stoyanov, Technical Director Pharmaceutical, Europe, the Middle East and Africa, ASI. “In addition, it will ensure our capability to realise novel ideas and developments quickly and sharpen our R&D profile. Ultimately, this will help strengthen our position as a leading innovator and deepen our relationship with originator companies.” The new laboratory will be outfitted with state-of-the-art equipment covering
all the processes required for classical pharmaceutical formulation and research. Staffed with experienced pharmaceutical experts, Ashland’s Düsseldorf laboratory will ensure that Ashland’s customers continue to receive the high level of technical support to which they’ve grown accustomed, and open doors to promising new opportunities. The new laboratory will be part of Ashland’s global pharmaceutical facilities network, which includes numerous laboratories and research centres worldwide, facilitating technical assistance for drug solubilisation, including hot-melt extrusion and spray drying. “Placing Ashland’s experienced pharmaceutical experts in Düsseldorf will provide the highest level of technical support for customers in areas like granulation, coating and tabletting, including direct compression, roller compaction and wet granulation,” added Stoyanov. “We
Contract Services Provider Sells Clinical Packaging Business Patheon has sold its global, secondary clinical packaging and clinical distribution services business to Bellwyck Packaging Solutions, a private company with 20 years’ experience providing clinical trial and contract services for secondary packaging. James C. Mullen, Patheon’s Chief Executive Officer, said: “We are very happy to have reached an agreement with Bellwyck for this business. While we don’t expect the terms of the transaction to have a material impact on our on-going results, this transaction is part of our continued focus on our core competencies of solid-dose and parenteral development and manufacturing. One of Bellwyck’s core competencies is clinical packaging. We are confident that both the customers and our employees, about 20 of whom have joined Bellwyck, are in good hands.” Jeff Sziklai, Bellwyk’s Co-CEO, said: “We look forward to an ongoing
partnership with Patheon as we work together to ensure that Bellwyck continues to provide superior clinical packaging and distribution services to Patheon’s current and future customers. We anticipate a seamless transition for customers and employees.” Patheon’s secondary clinical packaging and clinical distribution services business is globally managed from its Burlington, Ontario, Canada, facility, and includes an operating presence in Cincinnati, Ohio. Terms of the sale have not been disclosed. Patheon Inc. +1 919 226 3313 wendy.wilson@patheon.com www.patheon.com Bellwyck Packaging Solutions +1 866 363 2101 Ext.255 gkeizer@bellwyck.com www.bellwyck.com
Ashland Specialty Ingredients +31 10 497 5529 jknoblach@ashland.com www.ashland.com
PharmaTelevision Interview Spotlights Drug Delivery Specialist’s Year in Review FDA approvals, revenue gain and organic business growth are just a few of the topics that John Fraher, President, Aptalis Pharma, addressed during an on-air interview with Fintan Walton, CEO, PharmaVentures and PharmaTelevision. The interview, conducted during BIO 2012 in Boston, reflects Fraher’s commentary regarding the integration of companies post Axcan Intermediate Holdings’ acquisition of Eurand N.V. in 2011. The interview is available on-demand at PharmaTelevision and at the Aptalis Pharmaceutical Technologies website. Fraher serves a key role in setting strategic direction for Aptalis with specific oversight of the company’s Pharmaceutical Technologies and Global Supply Chain business unit. PharmaTelevision is an online TV channel for the biopharmaceutical industry, offering feature interviews
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with industry leaders, analysis and a television news archive. Approximately one year ago, PharmaTelevison conducted its first interview with Fraher just a few months after Axcan completed its acquisition of Eurand N.V. During the months following the acquisition, the companies completed their integration while realising several major milestones, including FDA approvals, the in-licensing of a number of products and a closing-year revenue of $470 million — a significant increase on the prior year. During his BIO 2012 interview with PharmaTelevision, Fraher discusses these milestones and the company’s strategic direction moving forward. Aptalis Pharmaceutical Technologies +1 908 927 9600 www.aptalispharmatech.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Chemical Company Appoints Replacement Head of Pharma Ingredients and Services Unit As of 1 October, Scott Thomson assumed the role of Senior Vice President in charge of BASF’s Pharma Ingredients & Services business unit. In addition, the company is relocating the global headquarters of the Pharma Ingredients & Services business unit from Evionnaz, Switzerland, to Florham Park, New Jersey. “By moving the headquarters of our global business unit to the US, we are strengthening our presence in one of the world’s largest and most innovative markets for pharma products. This will enable us to even better serve the needs and demands of our international customers in the future,” said Walter
Dissinger, President of BASF’s Nutrition & Health division. BASF produces and markets a broad range of active ingredients and excipients, as well as exclusive synthesis services for the pharmaceutical industry. These products are made to the highest quality standards, using the latest technologies and in compliance with cGMP guidelines. The global head of the unit, as well as three other worldwide management functions, have moved from Switzerland to the US. The relocation will take place in stages over a period of six months and will not affect the regional business
and production units in Europe. That also applies to the production in Evionnaz. Scott Thomson succeeds Martin Widmann, who will now head up the Fuel & Lubricant Solutions unit in Ludwigshafen, Germany. Previously, Thomson was Vice President Market & Customer Development North America at BASF Corporation in Florham Park, New Jersey. BASF +41 27 766 1606 andres-christian.orthofer@basf.com www.basf.com
API and Drug Product Intermediate Specialist Recruits General Manager Hovione has announced the appointment of Dr. Mike Ironside as General Manager, TTC (Technology Transfer Centre) in New Jersey. Dr. Ironside was previously with GSK in the UK, and AMRI and most recently with Anacor Pharmaceuticals, both in the US, where he held the position of Vice President of Chemical Manufacture and Development. “This is a key appointment at an important time for Hovione. We are certain that Dr. Ironside’s leadership qualities, combined with his relevant experience in chemical and analytical process development, scale-up from pilot plant to full commercial scale, will enable us to further strengthen and enlarge our US operations in New Jersey and add new approaches to solve our customers’ most challenging problems,” said Dr. Thomas Eisele, Vice President Corporate Research & Development. “I am excited and honoured about this new opportunity to lead the Hovione team in New Jersey. Throughout my career I have had a great respect for Hovione, a company that is recognised as world leader in pharmaceutical manufacture and particle design. I am looking forward to helping further enhance the TTC’s established reputation for offering our customers integrated solutions for any molecule,” said Dr. Ironside. Dr. Ironside brings over 20 years of experience in the development and scale-up of APIs from lead candidate optimisation through to NDA submission and commercialisation. He also brings extensive experience in the management of scientific and operational teams in biotechnology and CRO environments. Dr. Ironside is a member of the Royal Society of Chemistry in Great Britain and a member of the editorial board of the ACS Journal Organic Process Research and Development. He trained as an organic chemist at Dundee University, Dundee, UK, and holds a PhD in organic chemistry from the same University. Hovione +351 21 982 9362 ipina@hovione.com www.hovione.com
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INGREDIENTS & CONTRACT SERVICES ROUNDUP Drug Delivery Company and API Manufacturer Announce HPAIs Collaboration XSpray Microparticles has announced a partnership with Cerbios-Pharma SA for the joint development of HPAIs (High Potency Active Ingredients). HPAI development will be provided by XSpray in Stockholm, Sweden, while the cGMP production for clinical and commercial use will be carried out at Cerbios in Lugano, Switzerland. “We are very pleased with this partnership. We believe that RightSize technology offers significant advantages in the development of HPAIs, commented XSpray’s CEO Dr. Per Andersson. “This partnership is an important step towards the development of HPAIs with unique characteristics.” The formulation and manufacturing abilities of XSpray’s RightSize technology offer the opportunity to improve drug substances through various strategies, enabling full control over particle design and production —
simplifying drug formulation, extending delivery options and allowing the addition of innovative properties that truly benefit patients. RightSize technology not only provides a superior process to traditional methods, it can also be effectively scaled from discovery scale-up to production volumes, making it an important development in the manufacture of pharmaceutical particles using supercritical fluid technology. One of the advantages of this technology is that the moderate temperatures used make it ideal for particle size reduction of thermolabile compounds. “We are enthusiastic about this partnership with XSpray. Access to RightSize technology will strengthen our API development and manufacturing for third parties,” said Dr. Gabriel Haering, CEO of Cerbios. “Through the use of
this innovative technology for HPAIs, Cerbios will be able to offer a unique capability, enabling the generation not only of particles having narrow particle size distribution, but also different crystal forms and/or polymorphs up to the full control of particle design, including solid state form. In combination with other technologies available at Cerbios, it will generate intellectual property that will definitely help our partners in their success.”
XSpray Microparticles AB +46 8 730 37 00 karen.frost@xspray.com www.xspray.com Cerbios-Pharma SA +41 91 985 63 11 andrea.tam@cerbios.ch www.cerbios.ch
Early Stage Drug Development Services Provider Invests £1.5M in Bioanalytical Facility Quotient Bioresearch has announced the completion of a £1.5m expansion to its Fordham, Cambridgeshire, UK, site. The building work took place over the summer and included a new bioanalytical facility with a capacity for 30 mass spectrometers and new laboratories for immunoassay and cellbased work with biopharmaceuticals and biomarkers. The expansion is in response to an increase in demand for Quotient’s services in this area. Dr. Steve Pleasance, Managing Director of Bioanalytical Sciences at Quotient, commented: “Our new facilities at Fordham will assist the continued growth of our services, supporting our customers in taking new and innovative approaches. I’d like to thank all those involved. This is a big step forward for Quotient and we’re all very excited about how it will expand our offering.”
He added: “The size and scope of this investment shows just how ambitious Quotient is. The laboratories at Fordham are one of the world’s most extensive bioanalytical facilities, with services spanning biomarkers, small molecules, biopharmaceuticals and antimicrobials. Quotient has built a broad and innovative service portfolio, principally targeted at the early stages of drug development. We look forward to showing off this exciting new facility to our clients.” Visitors to Quotient’s Fordham site did not have to wait long to tour the new facility. The company hosted its Autumn seminar on Biomarkers and DecisionMaking in Drug Development there on 4 October. As well as featuring internationally-renowned guest speakers, the seminar showcased recent case studies illustrating how biomarkers are helping make critical
Contract Manufacturer Appoints Three Senior Team Members NextPharma Technologies Holding has announced the appointment of two key additions to its executive team. Andrew Kelley has been appointed Chief Operating Officer and Pierre Delavaud has been appointed Executive Vice President Sales and Marketing. In addition, Matthew Wilder has been appointed Vice President US Sales and Marketing to help drive the company’s business in the US. Kelley brings over 27 years of experience in the pharmaceutical industry, with a strong track record leading manufacturing operations, most recently at Patheon. Delavaud has a strong background in sales and marketing in the pharmaceutical industry and joins the team from SkyePharma, having previously spent 14 years at Catalent, where he held various senior positions. Wilder has over 10 years of sales and marketing experience in the US pharmaceutical industry and joins NextPharma from Sanofi Pharmaceuticals, where he held various senior positions. Franck Latrille, Chief Executive Officer, NextPharma, commented: “We are delighted to welcome our three new colleagues to the growing team at
decisions in the development of both small molecule and biopharmaceutical drugs.
Quotient Bioresearch +44 1638 720500 info@quotientbioresearch.com www.quotientbioresearch.com
CRO Underlines Customer Commitment with Senior Appointments and Continued Investment
Andrew Kelley
Pierre Delavaud
Matthew Wilder NextPharma. This is an exciting time for the company and we are confident that with the injection of their expertise, we can continue to improve our business offerings.” NextPharma Technologies Holding Ltd +44 1483 479 120 info@nextpharma.de www.nextpharma.com
Harlan Laboratories Contract Research Services is continuing to strengthen its service offering across its specialist divisions with a number of senior appointments. Dr. Andrew Hill has joined the company as General Manager, Agrochemicals and Regulatory Affairs to further build Harlan’s expertise and capabilities in the agrochemicals sector. Having been in the industry for over 20 years, with a career that has taken in senior roles in both operations and sales, Hill joins from Covance where he was most recently Director of Early Development Client Services. At the same time, Harlan is expanding its levels of expertise in general toxicology across chemicals, agrochemicals and pharmaceuticals with the arrival of Wendy Henderson as Head of Global Pathology. A veterinary surgeon graduate, Henderson has over 20 years’ experience as a toxicological veterinary pathologist in the CRO and preclinical pharmaceutical industries and takes up her post at Harlan following recent senior management roles at Aptuit and CRL.
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These latest arrivals follow a number of high-quality business development hires in the pharmaceutical business unit. Harlan will be announcing further appointments in the near future, covering business development, general toxicology and GMP activities, bolstering its presence on the ground in Switzerland and Germany. Add to this, the company’s significant investment in systems and infrastructure and it is clear that Harlan Laboratories is committed to enhancing the customer experience and speeding up the implementation and delivery of projects and studies. “We are continuing to focus on the needs of our clients in the further development of our services,” explained Harlan CRS President Manuela Leone. “It is vital that we match the necessary levels of experience and expertise with the changing requirements of the markets in which we operate.” Harlan Laboratories Ltd +44 1332 792896 crs.uk@harlan.com www.harlan.com
SHOWCASE PREFILLABLE & PREFILLED SYRINGES
Commercial Launch of Syringe Safety System Technology Platform West has announced the commercial introduction of its B.safe syringe safety system. West acquired the IP and rights to this system in 2011 and has completed the product development and first phase of commercial scale-up at its safety systems manufacturing centre in France. Significant scale-up to highvolume manufacturing will be achieved in the first half of 2013, in order to meet market demands. The system is designed to help protect against needlestick injury when using a prefilled syringe and will complement West’s portfolio of prefilled syringe offerings and technologies. West’s portfolio includes the NovaGuard passive needle system for Luer Lock syringes and the éris system, of which
more than one billion units have been manufactured and used in the market with exceptional performance in the hands of healthcare workers and patients. “We are delighted to reach this significant milestone and be in a position to offer our customers a globally available safety system, leveraging our established expertise around prefilled syringes and needle safety,” said Glenn Thorpe, Vice President, Strategic Market Development, Syringe Systems. “With the completion of the steps necessary to offer this system commercially, we are in position to meet growing market demand in this area, and are pleased to have already signed our first commercial agreement and commenced shipments.”
CDMO Expands Capacities and Services for Prefilled Syringes The demand for prefilled syringes is on the rise and Vetter is prepared. The company is building a state-of-the-art, highperformance filling line for syringes at its Ravensburg Vetter South location. The line can handle batches of up to one million units per day and is particularly well suited for the aseptic filling of Vetter Commercial Manufacturing. high-volume products, like vaccines. The company is also expanding its services for the early clinical phases of new drugs. At its Vetter Development Service (VDS) locations in Chicago, Illinois, US, and Ravensburg, Germany, the company offers a wide range of services, including formulation support and customised packaging development. With another new filling line at the Ravensburg facility and further investments planned in Chicago, Vetter continues to increase its capabilities in clinical manufacturing. Vetter is reinforcing its position as a strategic partner for the development and commercial manufacturing of parenteral drugs. With the expansion in capacity and service portfolio, Vetter is providing efficient answers to the growing demand for prefilled syringes throughout a product lifecycle. VDS Vetter Development Service. supports customers in efficiently the area of prefilled syringes, we provide transferring new drugs from early stage our partners with a full range of services, phase to commercial manufacturing, from small batches manufacturing and including regulatory support. The support in early clinical stages to highcompany’s comprehensive know-how in volume manufacturing for large-scale process and packaging development in commercial production.” aseptic filling is used to support a highprofessional clinical offering. Vetter Pharma International GmbH “Vetter is continuously and strategically +49 751 3700 0 investing in its partnerships with info@vetter-pharma.com international customers,” said Peter www.vetter-pharma.com Soelkner, Vetter Managing Director. “In
West +49 2403 7960 west.pharmaceutical.services@westpharma.com www.westpharma.com
Advanced Drug Delivery Systems Supplier Signs Long-Term Supply Contract for Prefilled Syringe Unilife Corporation has announced the signing of a seven-year commercial supply contract with a pharmaceutical company for the Unifill ready-to-fill (prefilled) syringe. This supply contract relates to the planned launch of a generic equivalent of an approved autoimmune therapy that is currently available in a standard prefilled syringe format for use across several indications. The auto-immune therapeutic space includes disease states such as rheumatoid arthritis, psoriasis, psoriatic arthritis, lupus and Crohn’s disease. The cumulative US patient population affected by auto-immune diseases is greater than seven million people and approximately twice that worldwide. The drug has also been shown to be effective for the treatment of several cancers, including breast, head and neck, leukemia, lymphoma, lung, osteosarcoma, bladder and trophoblastic neoplasms. Currently, the majority of injections within the auto-immune therapeutic class are self-administered by patients using either a standard prefilled syringe or a conventional auto-injector. The release of the generic drug utilising the Unifill syringe will reportedly mark the first time an auto-immune therapy is supplied in a prefilled syringe with safety features that can prevent needlestick injuries and encourage more convenient, safer disposal. An exclusivity fee will be added onto the negotiated unit price of the Unifill syringe when agreed exclusivity conditions are met. Unilife will grant the pharmaceutical customer an exclusivity of supply right for the Unifill syringe for a specific indication and Western European geography. The Unifill syringe was selected by the pharmaceutical customer because of its capacity to differentiate its drug from brand name or generic competitors. The
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implementation next year of a legally binding EU directive mandating the use of needlestick prevention products within European healthcare facilities also played a significant role in the selection of the Unifill syringe. Exclusive access to the Unifill syringe further strengthens the pharmaceutical customer’s competitive strategy. Other international geographies have also been reserved for exclusivity by the pharmaceutical customer and will be added subject to the agreement of terms by both parties. Initial sales of the Unifill syringe to the pharmaceutical customer will commence in July 2012. Sales are expected to progressively increase in anticipation of the scheduled commercial launch of the pharmaceutical customer’s drug within international geographies after regulatory approvals are granted during Fiscal Year 2013. Annual unit volumes for the Unifill syringe within the initial European geography are expected to reach up to 10 million units during the contract period, generating up to $15 million in revenue per year. The unit volumes for the Unifill syringe can increase as other reserved international geographies are added by the pharmaceutical customer. Unilife Corporation +1 717 384 3400 info@unilife.com www.unilife.com
Events
REGULATORY AFFAIRS Less than a week after the draft regulation for medical devices was published, it came under intense scrutiny at the TOPRA Symposium for Medical Devices, held in Dublin on 1–2 October. Amid concerns about the extent of the requirements and additional cost and resource burdens on the medical device sector, Manfred Kohler, from the European Commission, Directorate of General Health and Consumers, was keen to stress to the audience that this is a draft regulation and even if it progresses smoothly through the European Parliament and Council, the changes will take at least five years to come into force. The legislation will expand the scope of medical devices law, clarifying and harmonising requirements on notifying bodies and manufacturers across Europe. It is aimed at increasing the safety of devices through structured and rigorous assessments and ensuring that devices are traceable throughout the supply chain. Although the draft regulation builds on the requirements specified in the medical device directive, it will result in additional mandatory requirements for stakeholders in this sector. This obviously has implications for manufacturers in a sector that is not as well-funded as the pharmaceutical sector, from which many of the proposed changes in practice have been drawn, for example, named sponsors and designated Qualified Persons. Changes will be made to the way notifying bodies operate, clinical investigations are conducted and post-marketing surveillance is performed. These three areas were covered in detail in a later session. Dr. Rainer Edenhauser from ZLG, a notified body (NB) in Germany, and chair of the Notified Bodies Operations Group, supported the move to great mandatory harmonisation of NBs and their processes, as well as moves towards harmonisation of peer review via designated authorities (DAs) and NBs. Dr. Wolfgang Ecker, from the Federal Ministry of Health in Austria and chair of the Clinical Investigation Evaluation EU working group, outlined the impact of the proposed regulation on clinical investigations, which he viewed as an opportunity to overhaul medical device clinical research in Europe. Dr. Reinhard Berger, from the Institute Inspections, Medical Devices & Haemovigilance, AGES Medizinmarktüberwachun, and chair of COEN (Compliance and Enforcement group), covered the impact on post-marketing surveillance of medical device products. The draft legislation includes a definition of marketing surveillance and vigilance and it describes the roles and responsibilities of the economic operators of devices, which include the legal manufacturer, authorised representative, importer and distributor. The introduction of QPs to ensure documentation is complete and conformity is assessed before a batch is released is an improved requirement, as is the proposed centralised adverse event reporting system — referred to as EUDAMED reflecting EudraVigilance, the EU’s portal for reporting medicinal side-effects. It is likely that the final regulation, as outlined by Kohler, will be modified if the reactions at the TOPRA Symposium are anything to go by.
Draft Regulation for Medical Devices
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.
WTG Introduces Early Drug Development Summit With its 15 years of conference production and management experience, World Trade Group (WTG) introduces a leading pharmaceutical event, Early Drug Development Summit, taking place on 3–4 December, in Berlin, Germany. The Early Drug Development Summit brings early drug developers together to discuss maximising drug investments, toxicology, safety and biomarkers. Dr. Lucette Doessegger, Global Head of Translational Safety Medicine at Roche Switzerland, will be sharing her 10 years of industry experience on early drug development at the Early Drug Development Summit on day two at 09:15–10:00, at Hotel Palace Berlin. Dr. Doessegger will discuss Using Translational Medicines in Early Drug Development, which will cover: • designing risk management protocols to understand the mechanism of action and implement safety measurements; • using translational safety medicine to measure signalling before it reaches clinical trials; • and efficiently determining the impact of toxicity effects on specific populations. Confirmed speakers and their presentations include: • Dr. Andy Parsons, VP Preclinical Development, GSK UK — Developing Business Frameworks for the Successful Co-creation of Value; • Peter Theil, Head of Early Development PKPD, UCB Belgium —
Pre-IND PK/PD Characterisation of Small Molecule Drugs and Biotherapeutics to Increase the Probability of Success of Drug Development; • Stefan Proniuk, VP Development, Arno Therapeutics US — Reducing Development Timelines to Bring Products to Market Faster; • Ian Wilson, Senior Principal Scientist, AstraZeneca UK — Successfully Identifying Human Drug Metabolites for Toxicity Testing; • Frederik Deroose, Director, Global Business Office Integrator, Jansenn Belgium — Successfully Using Virtual Outsourcing for Early Drug Development; • and Prof Jürgen Borlack, Head of Toxicology, Hannover University Germany — Utilising Better Animal Models to Improve Safety Studies. Please visit the website to look at the full programme and speaker list. WTG +44 207 202 7690 michaela.melcher@wtgevents.com www.eddsummit.com
Second Coating Workshop to be Held at Université Lille Nord de France The APGI (International Society of Drug Delivery Sciences and Technology) will hold a workshop dedicated to the coating of solid dosage forms for the second time, on 17 April 2013, at the University of Lille Nord de France. The one-day event provides oral and poster presentations from academia and industry, as well as practical demonstrations (in small groups). Topics addressed include engineering aspects during the coating process, the portfolio of commercially available coating polymers, the underlying drug release mechanisms, characterisation methods for thin film coatings, drug release measurement techniques, as well as potential pitfalls and hurdles to be overcome during product development. As practical demonstrations are included, the maximum number of participants is limited to 150. EPM 33
Invited speakers are: Prof. A. Basit, University of London, UK; Prof. R. Bodmeier, University of Berlin, Germany; Prof. A. Gazzaniga, University of Milan, Italy; Prof. T. Rades, University of Copenhagen, Denmark; and Prof. J. Siepmann, University of Lille, France. More information is available at www.apgi.org/coating_WS/. APGI +33 6 29 36 67 39 apgi.asso@u-psud.fr www.apgi.org
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