EPM Mar/Apr 2013 by EPM Magazine

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IN THIS ISSUE: TechnoPharm & POWTECH 2013 Preview Tabletting Equipment Maintenance Particle Analysis Drug Delivery

European Pharmaceutical Manufacturer March/April 2013

Volume 13 | Issue 02

Front cover image: The new and the old — Natoli 27-tip micro-tab tooling and an antique pill roller.

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in this issue

michael taylor

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TechnoPharm & POWTECH Preview 2013 5–14

Exhibitor News

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Latest News Roundup Corporate News

Particle Analysis

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SHOWCASE: 40

Drug Delivery

page 42

CLASSIFIEDS EPM 3

Address changes should be made on the original carrier sheet (address label) that came with this issue and then faxed to the publisher at +44 (0) 1244 671074. European Pharmaceutical Manufacturer is published by Controlled Media Limited. European Pharmaceutical Manufacturer is distributed in electronic and print formats to a combined readership of 25,000 pharmaceutical manufacturing professionals. Send address changes to European Pharmaceutical Manufacturer, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE, UK.

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© April 2013. 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. ISSN No.: 2052-4811

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Welcome to the TechnoPharm and POWTECH 2013 Preview issue. Starting on the page opposite is an entire section dedicated to the products and services that exhibitors intend to highlight at these events. All entries are in hall and stand order, with the intention of making it easier for you to navigate your way around. As highlighted in my previous ‘from the editor’, the new EPM website has now launched, so please take a moment to visit www.epmmagazine.com and let us know what you think. We are looking for guest bloggers to contribute on an occasional basis; if you are interested, either email or call me (contact details on page 3). Turning to the content of this issue, there is an interesting story on

page 27 from Evocutis, detailing the company’s successful launch of LabSkin, a 9 full thickness skin model that incorporates living, primary skin cells. According to the company, it is the closest replica of human skin available and can be used to demonstrate the effects of a product on both skin and the micro-organisms that live on it. LabSkin has a fully differentiated edpidermis and dermis. It is mechanically robust, provides a 10–14 day testing window and has a wide 27 range of applications from antimicrobial, anti-ageing, inflammatory response and penetration testing to wound healing and infection modelling. Containment as always being a hot topic, another story worthy of mention on page 19 has been provided by EziDock Systems, announcing the latest version of its 36 established Ezo-Flow CSV transfer system, currently in use at ‘11 of the top 12 pharmaceutical companies’ and said to offer a highly advantageous means of transferring hazardous liquid and powder over the traditional split butterfly valve. Responding to customer feedback, EziDock Systems has ensured that the Mk 3 model is easier to operate and completely liquid tight for easy flushing and the uncomplicated addition of liquids. Finally, Dr. Biffignandi’s Regulatory Affairs instalment on page 41 provides an overview of the EU and US biosimilars markets. He examines and compares the latest regulatory clinical and nonclinical development pathways for both, concluding that the EMA and FDA have worked successfully together towards the ‘harmonised’ global development of biosimilars. The EPM team will be attending the TechnoPharm and POWTECH shows and will keep you posted on any developments via the website. 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 Pharmaceutics, 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. He started working in one of Sanofi’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment. In 2009, Grégory moved to one of the group’s solid form plants in Spain to lead new equipment installation projects as well as take charge of process maintenance and improvements. He returned to France in 2013 and continues with projects at one of Sanofi’s API production plants. Grégory has experience of the most well-known providers of solid form equipment. Kostas Saranteas, Senior Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc. Kostas is Senior Director of the Process Chemistry and Engineering Dept. at Sunovion’s R&D Division. He holds BS/MS/PhD degrees in Chemical Engineering and an MS degree in Environmental Engineering. For 15 years, Kostas worked at Polaroid Corp., specialising in batch process equipment modelling, process optimisation and scale-up. For 11 years, Kostas has been employed at Sunovion. He leads cross-functional teams, championing accelerated process development for drug substance and drug product synthesis from laboratory-scale to full-scale manufacturing.

& PREVIEW 2013 NürnbergMesse, Nürnberg, Germany • 23–25 April 2013

Efficient and Cost-Effective Dosing Solution for Difficult Flowing Products Dec, headquartered in Lausanne, Switzerland, has announced its forthcoming attendance at POWTECH, Hall 1, Stand 213. Founded in 1987, Dec is a leading global provider of powder handling systems to the pharmaceutical, chemical, food and cosmetic industries. Visitors to the trade fair can look forward to a wide range developments in the powder handling and containment

systems field. Among this year’s product highlights is the DosiValve, a simple and cost-effective solution for the dosing of powders and granules. Designed to avoid typical flow and accuracy problems when using standard rotating or vibration valves, the DosiValve allows for precise dosing, even when handling difficult products. The system works either through gravity charging for normal charging and discharging

applications (such as drums, big bags, containers, silos, hoppers, etc.) or active powder charging, in combination with the PTS powder transfer system for longer conveying

distances in a safe and contained manner. Dec staff look forward to welcoming visitors to the company’s stand and discussing their powder handling needs and challenges. Dec Group +41 21 694 20 40 g.mikhaiel@dec-group.ch www.dec-group.net

Solution for Complete Discharge of Mixers If creating the ideal mixed product is the sole objective, almost all kinds of mixers on the market are able to achieve this. However, if complete discharge of the mixed product is also required, the choice of mixers is a lot more limited. amixon has developed a patented solution known as ComDisc, an abbreviation of ‘complete discharge’. It is a new system applied to flat bottom mixers, providing up to 99.997% carry out of the mixed product. The lower mixing arm is fitted with ComDisc tools. During the mixing process, the tools float through the

mixing goods. They move in the shadow of the product flow and therefore do not touch the bottom of the mixer. As the filling level decreases, the ComDisc tools move down and wipe out the residues of the mixing goods towards the outlet. This process takes place without de-mixing. ComDisc patented tools are made of very durable, FDA approved plastic that is largely non-adhesive and suffers minimal wear. They are installed in such a way that they will not get lost. The design of the tools is approved for dry and wet cleaning.

OEB Level 5 Containment Valve and Ultra-Clean Drum Müller’s focus at POWTECH, Hall 1, Stand 345, will be on the new generation Müller Containment Valve MCV, designed for handling toxic or highly potent products. The MCV series is suitable for up to OEB Level 5 (OEL <1 µg/m³) and not only safeguards the health of employees but maintains product purity and protects the environment. The locking device of the valve is improved, which offers great advantages for the operator. Also new is an explosion pressure shock resistant version, providing safety against flames breaking through for gases of explosion group IIB up to +6 bar. Out of the many drum types in various sizes for solids and liquids produced by Müller, the ultra-clean drum is to be the one highlighted at the event. According to the company, since its launch, this drum’s quality has set the new standard for the pharmaceutical industry. The edging is welded, which ensures that no cleaning liquids can hide or accumulate,

amixon GmbH +49 5251 688888 0 info@amixon.de www.amixon.com

Latest Material Characterisation Products and Expert Advice

even in automated washing procedures or in washing machines. All products meet FDA and cGMP standards and Müller customers benefit from an extensive service package, with individual consulting delivered by qualified staff as well as on-site visits attended by competent sales representatives. More than 35 years of experience makes Müller an expert partner in fulfilling the requirements of the pharmaceutical manufacturing sector. Müller GmbH +49 7623 969 155 fred.lonzer@mueller-gmbh.com www.mueller-gmbh.com

Together with the SinConvex helical mixing tool, ComDisc is able to achieve a nearly complete discharge of the mixed goods. This way, cleaning times can be reduced and raw material is saved. The whole mixing process is more hygienic and almost without cross contamination. The advantages that ComDisc can provide are not only available for new amixon mixers, as these tools can also be retrofitted to existing flat bottom mixing machines. amixon will be exhibiting at POWTECH, Hall 1, Stand 304.

Malvern Instruments will be presenting at POWTECH, Hall 1, Stand 357. Dr. Alan Rawle, a highly-respected figure in the field of light scattering, will present ‘Attrition of FCC catalysts studied by pressure size titration (PST) in laser diffraction dry dispersion’ while Dr. Debbie Huck, an authority on imaging, will present ‘Component specific particle characterization of particulate-based products’. Look out too for live instrument demos around Partec. Dr. Rawle’s presentation is part of the Partec conference schedule for Tuesday and will take place at 15.20. He will examine how the latest, highly controllable dry dispersion engines for laser diffraction analysis can be used to quantify the strength of particulates and their propensity to undergo attrition, for example, when fluidised. Dr. Huck’s Partec presentation is planned for Wednesday at 14.40 and will focus on the capabilities of the Morphologi G3-ID, an instrument that combines automated imaging technology

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with Raman spectroscopy to provide size, shape and chemical identity measurement in a single system. Her focus will be what can be achieved with the new technology and the applications where this brings real value. Displayed on the Malvern stand will be the new Zetasizer Nano ZSP system for particle size, zeta potential, molecular weight and protein mobility measurement and the application of microrheology. Laser diffraction particle sizing instrumentation will be represented by the Mastersizer 3000, the latest generation of the world-renowned Mastersizer range, and the Insitec, a process analyser for real-time monitoring. Lastly, visitors will learn how the Morphologi G3 is being combined with Raman spectroscopy to extend analytical capabilities (Morphologi G3-ID). Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com

NürnbergMesse, Nürnberg, Germany 23–25 April 2013

TechnoPharm & POWTECH Preview 2013 Weigh Module Made for Automated Vial Handling Mettler Toledo will exhibit a very compact robot cell for replacing tedious, low added-value manual operations at POWTECH, Hall 1, Stand 413. It is used whenever a large amount of samples need to be weighted or automated pipettes have to be calibrated. The robot, made by Asyril SA, has an incorporated high-precision weigh module made by Mettler Toledo. The robot cell, with a dimension of 700 x 700 x 700 mm, is configured as an automatic vial weighing device. It hosts

several racks for vials to check more than one batch without the intervention of an operator. It has a drawer mechanism for in-feed and out-feed of racks into the robot cell. This allows convenient and safe handling of batches. The incorporated WXS weigh module is very compact and saves valuable space inside the robot cell to leave room for allocating other measuring devices or more palettes. It has a weighing range of 220 g, with a readability of 0.01 mg. This

allows for the mounting of an additional preload for a holding device whilst maintaining weighing accuracy. It benefits from mechanical protection against overload and against lateral shear forces resulting from automatic loading or in the event of handling equipment malfunction. Mettler Toledo GmbH +41 44 944 25 68 eugen.schibli@mt.com www.mt.com

Controlled Metering of Solid Materials with Rotary Feeder Although rotary feeders have become firmly established in process engineering for feeding and metering powders and granulars, this does not mean that the possibilities of this technology have been exhausted. For Frewitt, the rationale behind the development of a new rotary feeder lay not only in the continuous feeding of products but also in the capability of fulfilling several other criteria. Hence, increased service life, GMP compliance, process reliability and versatility in use became the stated objectives. Product trials demonstrated that the straight design of the blades was not leading to the desired outcomes. A series of test results were ultimately instrumental in the decision to bend the six blades mounted on the rotor axle

slightly, in the lengthwise direction of the axle. The advantage being that greater resistance and torque could be achieved. A special grinding process was used to achieve the Ra 0.4 fineness of the stainless steel (AISI 316L) surfaces contacting the product, thus ensuring a frictionless, residue-free product flow. The ProFi-Valve, as Frewitt’s new universal rotary feeder is called, can be easily mounted on the infeed hopper of the sieve mill by means of a Tri-Clamp DN 150 (ISO 2852). The delivery volume is as high as 400 kg per hour at a maximum speed of 20 rpm. Moreover, the operation is exceptionally quiet. The rotor can be dismantled quickly without any special tools. This, plus the modular design, makes cleaning easier. It should

Multi Capability Milling Station

Nanonisation of APIs

F.P.S. Food and Pharma Systems develops, manufactures and installs fine size reduction machines and containment solutions for sterile and highly toxic APIs worldwide. At POWTECH, Hall 1, Stand 542, the company will present an interchangeable milling station for the execution of milling operations in research and pilot plant departments, with different technologies integrated on a single system. The platform incorporates: • spiral jet mill type PILOTMILL-5 or PILOTMILL-6 • 100 mm pin mill 100 • loop mill type QMILL-6 • cone mill. A minimum footprint is given for use in existing rooms. The milling system can be operated in conjunction with a cryogenic exchanger, which allows the reduction of process temperature down to -100˚C. The system can be designed for installation in electric rated areas and with processing of OEB4/5 products if combined with the F.P.S. barrier isolator system. F.P.S. Food and Pharma Systems Srl +39 031 543429 sales@foodpharmasystems.com www.foodpharmasystems.com

The comminution or deagglomeration of APIs is called micronisation. Nanonisation is a term for reducing particle size to the nanometer range and brings about several advantages. It further increases the surface area of APIs that could result in enhanced solubility and drug bioavailability. The NETZSCH Grinding & Dispersing business unit offers equipment for all process engineering tasks in the fields mixing, dispersing, deaeration, wet and dry grinding and classifying. Besides the machine design, there are other essential conditions for the successful comminution or dispersion of solids. This is the right formulation of the product suspension as well as the selection of the best grinding media and the optimal operating parameters of the mill. The development of the formulation and the optimisation of the operating parameters can be conducted in laboratory mills. In particular, when it comes to the selection of the operating parameters of the mill, NETZSCHFeinmahltechnik can revert to a pool of experience of more than six decades. Illustration 1 shows the development of the particles size distribution of APIs during a grinding test on a laboratory bead mill. The customer aimed at a close particle size distribution with x99.3 <400 nm. Moreover, the parameters had to be optimised to ensure that the product suspension would not exceed a defined maximal temperature during the comminution process. Once the operating parameters have been optimised, the results can be transferred to production-size mills. An essential parameter for the scale-up is the specific energy input, which states the energy input with reference to the product

also be pointed out that the ProFi-Valve is designed for WIP, CIP or SIP. A mechanical drive, a gear motor with a frequency converter or a pneumatic drive can serve as a drive unit. The rotary feeder ensures that the product is gently processed and prevents the mill inlet from becoming stopped up, making the formation of

product columns and bridges a thing of the past. The ProFi-Valve effortlessly processes products with very diverse properties (highly adhesive, poorly flowing, abrasive). Customers that process potentially explosive products were also considered and the ProFiValve can be equipped for operation in ATEX zones 1/21. The ProFi-Valve passed every endurance test in the laboratory and in operation, thus fulfilling the criteria for market success. Frewitt will present the ProFi-Valve at POWTECH, Hall 1, Stand 442. Frewitt SA +41 26 460 74 00 info@frewitt.com www.frewitt.com

Illustration 1: Development of the particle size distribution obtained during a grinding test in a laboratory bead.

Illustration 2: Results of the scale-up from a laboratory agitator bead mill to a production-size mill. quantity produced. Illustration 2 shows the results of the scale-up from a laboratory agitator bead mill to a production-size mill. The illustration clearly shows that the results of the laboratory test can be exactly transferred to the production-size plant.

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NETZSCH will be exhibiting at POWTECH, Hall 4a, Stand 223. NETZSCH-Feinmahltechnik GmbH NETZSCH Grinding & Dispersing www.netzsch-grinding.com/pharma

TechnoPharm & POWTECH Preview 2013 Latest Containment Solutions from Powder Processing Equipment Group The global Hosokawa Micron group of companies come together at POWTECH, Hall 4a, Stand 231, to demonstrate their comprehensive, new technology in all aspects of powder and particle processing. With a wide range of equipment for the powder and bulk materials market, the Hosokawa Micron group of companies will showcase both new developments and proven technology that delivers genuine engineering solutions suited to current and future commercial projects. The UK member of the group, Hosokawa Micron Ltd, based in Runcorn, will be displaying and demonstrating a range of containment equipment designed to meet operator exposure levels down to <1µg/m3 — from small, flexible, compact isolator and glove box systems designed to meet the demands for a cost-effective, flexible, barrier containment solution to larger hybrid isolators for the containment of larger pieces of equipment and processes and providing the operator with a larger working area whilst offering the workplace mobility associated with smaller barrier containment units. Also demonstrated will be Hosokawa Micron’s latest, energy saving downflow booth, which features energy conservation mode of operation, 5D high-containment screens, automatic filtration monitoring and a temperature cooling pack for safe operation combined with optimum operator working environment options. Hosokawa

Award-Winning Vacuum Pump

Micron’s containment specialists will be available to meet with companies wishing to investigate further individual projects and how incorporation of Hosokawa Micron equipment can enable them to meet production objectives. With significant new developments on show across a range of online diagnostics, online process particle sizing equipment and systems for performance improvement available groupwide, visitors to the Hosokawa Micron stand will be able to see first hand how Hosokawa’s investment in R&D can help them achieve processing benefits that deliver competitive advantages. Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk

NürnbergMesse, Nürnberg, Germany 23–25 April 2013

Edwards will provide live demonstrations of its increasingly popular CXS dry pump for chemical and pharmaceutical applications at POWTECH, Hall 4a, Stand 526. Process engineers from around the world will meet at POWTECH to discuss leading edge developments in mechanical processing technologies. Edwards will launch its ‘Challenge Us’ campaign at the show, offering customers the chance to meet with experts in chemical and pharmaceutical applications. Throughout the event, Edwards is making a dedicated team of technology experts available and inviting customers to bring their current vacuum application challenges to the POWTECH stand for discussion. Edwards’ CXS dry pump is sure to cause some excitement after winning a ‘Gold Stevie Award’ at the prestigious 9th Annual International Business Awards in the ‘Best New Product or Service of the Year’ category. According to the company, two elements of the CXS set it apart from competitor pumps: the tapered screw technology facilitates excellent liquid and solids handling, leading to high operational reliability while providing deep vacuum down to 1.5 x 10–2 mbar; and the range of builtin control and safety features makes the CXS easier and cheaper to install when compared with other pumps currently available on the market. “We’re looking forward to attending POWTECH 2013 with our CXS dry pump, which demonstrates why

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Edwards is a clear leader in vacuum technology,” said Marinella Varallo, Global Market Sector Manager, Edwards. “Our knowledgeable team has decades of experience in the chemical and pharmaceutical industries, which when combined with leading edge product ranges means we are able to offer customers choice and flexibility, tailoring the most appropriate vacuum solution to meet their individual needs. “We look forward to customers coming to our stand, sharing their experiences and allowing us to demonstrate our expertise in the vacuum field. Edwards’ success has not only been down to the innovative products we are able to supply but our partnering with customers and providing solutions for today’s challenges.” Edwards Group Ltd +44 1293 603507 debbie.thompson@edwardsvacuum.com www.edwardsvacuum.com

TechnoPharm & POWTECH Preview 2013 Tablet Coater Boasts High Efficiency at Attractive Price The new Lödige LC is a highly efficient tablet coater. It provides: • a 20% reduction in costs owing to development of essential machine parts • a 30–100 % filling degree through optimised drum geometry and optimised mixing elements • and a 40% increase in speed thanks to high-performance air technology, nozzle distances and number of nozzles. Optimal process control, easy handling and easy cleaning were the top-priority criteria for development of the coater. The coating process can be divided into three sub-processes — spraying of lacquer, drying of the tablets and mixing of the tablets. The LC coater series reportedly optimises all three subprocesses. The totally perforated drum, with a free surface of more than 40%, allows a high air flow. The mixing elements ensure uniform and gentle mixing, even with variable filling degrees between 30% and 100%, which is the

Latest Research into Impact of Humidity on Powders

most important condition for achieving best uniformity of coating. The nozzle arm guarantees the perfect adjustment to the tablet bed, therefore it is always possible to set the best spraying distance and angle. Directly under the spraying zone, the heated inlet air is led to the tablet bed and ensures the quick drying of the wet surfaces. The air exhausts through the tablet bed. Due to work safety reasons, the whole product inside the coater is kept below atmospheric pressure. Complete discharge is still guaranteed without any additional equipment and the required discharge time has even been reduced. A new solution has been found for the cleaning process. An integrated ultrasonic generator reduces the necessary cleaning time considerably, especially in cases of hardly soluble substances. The coater is intended for through-thewall assembly and therefore provides optimal separation between process area and technical area. Furthermore, it is always accessible by the maintenance staff. Last but not least, the new control system is very easy to operate and fulfills all the latest GMP requirements. The Lödige LC will be displayed at POWTECH, Hall 5, Stand 222. Gebrüder Lödige Maschinenbau GmbH +49 5251 309 371 lemperle@loedige.de www.loedige.de

NürnbergMesse, Nürnberg, Germany 23–25 April 2013

At POWTECH, Hall 5, Stand 425, the Freeman Technology team will present new research on the impact of humidity on powders, a topic of significant interest to many powder processors. The presentation, entitled ‘The influence of ambient moisture on powder flow’, will be the first opportunity to learn about the company’s latest study highlighting how the FT4 Powder Rheometer can be used to quantify the impact of humidity in a process relevant way. The team will also present two posters entitled ‘Investigation of the influence of atomic layer deposition coatings on powder rheology’ and ‘Quantifying the effect of caking by powder rheometry’. While it is recognised that moisture impacts powder behaviour, the effects can be challenging to quantify in ways that directly relate to performance, either in a process or in the end-use application. Previous research by powder characterisation specialist Freeman Technology has already demonstrated the role of the FT4 Powder Rheometer in tackling this issue. The latest data, from the study of powders common in the food and

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pharmaceutical industries, provides further illustration of the diverse effects that moisture can induce and the value of multi-faceted powder characterisation within this context. Experts from Freeman Technology will be on hand throughout the event to discuss any aspect of powder characterisation. With a strong and coherent strategy for solving powder processing challenges, the team looks forward to meeting all those involved in optimising manufacturing performance. Freeman Technology Ltd +44 1684 851 551 pr@freemantech.co.uk www.freemantech.co.uk

TechnoPharm & POWTECH Preview 2013 Range of Processing Machines and Complete Lines At TechnoPharm, Hall 6, Stand 129, IMA Active division will exhibit the PERFIMA LAB perforated pan and the ROTO CUBE LAB high-shear granulator and single-pot processor. Both PERFIMA LAB and ROTO CUBE LAB are laboratory systems making use of the same highly advanced technology as those developed for the production range, enabling the processing of all kinds of product, giving exceptional flexibility and easy scale-up. PERFIMA LAB can be considered not only as a laboratory coater but also a machine for small production batches. Thanks to its interchangeable drum (three drums available), it is possible to work a wide range of capacities from 3 to 60 l. The high degree of automation allows easy operation and maintenance procedures to be applied. The ROTO CUBE LAB is a high-shear granulator and single-pot processor for the complete wet granulation and drying process, from the loading of raw materials to the discharge of dry granules. Process is carried out in a single, contained bowl,

NürnbergMesse, Nürnberg, Germany 23–25 April 2013

Formulation Vessel Takes Centre Stage

thus reducing risk of contamination and increasing protection for the operators, an optimal solution in case of high containment process. IMA Active staff will be available to illustrate the features of these new solutions on show as well as a wide range of machines and complete lines to meet all the requirements of the pharmaceutical industry. IMA S.p.A IMA Active Division +39 051 6514111 mktg.soliddose@ima.it www.ima-pharma.com

Deionised Water Requires Special Sealing Solutions

Elastomers comprise a large number of different ingredients. Low-molecular weight organic compounds in particular can be dissolved out of the matrix by certain solvents and sometimes even by water. This effect, also known as leaching, is even more marked in applications involving deionised water. The material 70 EPDM 291 from Freudenberg is a reliable choice for sealing challenges in deionised water plants. The extraction of elastomer ingredients always goes hand-in-hand with a measureable shrinkage of volume, which in turn affects the sealing effect of the product. At the same time, the various solvents can — depending on their polarity — diffuse into the elastomer matrix, resulting in a measurable increase in volume. If both effects occur simultaneously as a result of superimposition, the composition of the sealing material and, consequently, its properties undergo a fundamental change despite the fact that there is no noticeable change in volume. In addition to purely physical processes, chemical processes such as post-curing, the breaking of crosslinks and even chain degradation can occur, resulting in striking consequences for the properties of the seal. Such reactions generally lead to changes in the seal’s mechanical properties. In order to be able to register these changes in a reliable manner, it is important that not only changes in mass and volume but also changes in mechanical properties are closely and accurately measured and analysed. The key parameters in this context are hardness, elongation at break, tension at 100% elongation and tensile strength. Depending on the application in question, a variety of threshold values for changes in properties have proven useful for the assessment of suitability. The threshold values for changes in mass and volume are +/-5% and +/-10% respectively; for changes in mechanical values, they are +/-15% for dynamic applications and +/-30% for static applications. The elastomer compound 70 EPDM 291 boasts very good properties in contact with both water and deionised water. The most significant property of 70 EPM 10

GEA Diessel will be showcasing its fermentation and formulation technology at TechnoPharm, Hall 6, Stand 229. The main exhibit will be the 100 l formulation vessel as an example of the company’s quality and design excellence for the control of liquid pharmaceutical processing. GEA Diessel fermentation systems have a customised design, free from dead legs that can harbour contamination, making them suitable for sterile operations. They are also notable for their ability to accurately control process parameters such as temperature, agitation and pO2. GEA Diessel fermentation systems are ideal for use in microbial and/or cell fermentation, where the highest levels of quality and performance are required. Pharmaceutical manufacturers demand the highest standards with regard to their fermentation systems. Every function, every component and every detail has to comply 100% with the relevant quality standards. The use of a high-performance and reliable fermentation system will in itself ensure that many of these conditions, which are essential to safe and high-quality production, are fulfilled. The company will share the stand with its fellow GEA Pharma Systems companies that together provide everything that is needed for a complete pharmaceutical processing plant. Experienced GEA Diessel engineers and sales staff will be on hand to answer questions. GEA Diessel GmbH +49 5121 7420 dirk.hetzel@gea.com www.diessel.com

EPDM 291 in this context is the fact that there are no significant increases in mass and volume even when the material is submerged in water at 200˚C over long periods. Nor were any significant effects noted after a prolonged period in deionised water at 100˚C. O-rings, O-ring type seals in special shapes, or seals for valves and fittings made of 70 EPDM 291 remain reliably resistant in water up to 180 °C, deionised water up to 160˚C and air up to 150˚C. 70 EPDM 291 meets the specifications of the European standard DIN EN 681–1 WB and the American standard NSF 61, the requirements of the drinking water regulations in Germany, Great Britain and France without restrictions and the strict requirements of the FDA for both food and pharmaceutical products. The high purity of this material is also further emphasised by its USP Class VI approval. Freudenberg experts will be on hand to discuss the benefits of 70 EPDM 291 at TechnoPharm, Hall 6, Stand 227. Freudenberg Sealing Technologies GmbH & Co. KG +49 6201 80 3631 michael.scheuer@fst.com www.fst.com

TechnoPharm & POWTECH Preview 2013

NürnbergMesse, Nürnberg, Germany 23–25 April 2013

Solid and Liquid Dose Equipment At TechnoPharm, Hall 6, Stand 235, Bosch Packaging Technology presents highlights from its comprehensive pharmaceutical portfolio: the laboratory devices Solidlab 1 and 2; the Manesty tablet press Xpress 100; the company’s smallest high-shear mixer granulator Hüttlin Mycromix; the KKX 3900 inspection unit for filled capsules; the tabletop device ETAC Easy View for visual inspection of containers filled with liquid pharmaceuticals; and the Fast Air Lock ISS 1000 for quick transfer of pharmaceutical equipment into and out of isolators. Since 2011, the product brands Hüttlin and Manesty have been part of Bosch Packaging Technology’s portfolio. The two process technology specialists have

The laboratory devices Solidlab 1 and 2 combine three process modules in one single machine: powder mixing, granulating and coating of pharmaceutical pellets and tablets.

jointly developed the laboratory machines Solidlab 1 and 2 for the manufacture of tablets and pellets. By using a common base assembly, the three process modules — powder mixing, granulating and coating — are combined in one single machine, enabling cost and space optimisation. Solidlab 1 handles batches from 0.05 to 2 kg. Based on the same construction principle, Solidlab 2 processes volumes from 0.5 to 12 kg. Hüttlin Mycromix is the smallest highshear mixer granulator in the laboratory equipment range. It handles batches from 0.05 to 1 kg. The bottom drive unit Hüttlin Gentlewing ensures highly homogenous mixing qualities for granulates. All processes can be easily transferred to production equipment via scale-up. The tablet press Manesty Xpress 100 is equally suited for R&D purposes. Its data acquisition system provides an ideal platform for evaluation of new tabletting formulations. With a range of flexible turret options, clinical trial batches can also be produced. On the Xpress 100, the same mpowersoftware is used as on production machines, enabling easier comparison of test results. The inspection unit KKX 3900 is used for weight and quality control of filled hard capsules. It can be installed after any capsule filling machine and achieves an output of up to 220,000 capsules per hour. The system is based on soft x-ray technology and inspects quality parameters such as weight and length of

capsules with high accuracy. Apart from the 100% inline weight control, the digital image evaluation gathers further process-relevant information. The inspection technology portfolio from Eisai Machinery includes manual, semiand fully-automated systems. The computerbound visual inspection unit ETAC Easy View, for instance, examines vials, ampoules, syringes and cartridges for particle The KKX 3900 operates on the basis of soft X-ray technology contamination and and inspects process quality parameters such as weight, cosmetic container length and condition of filled capsules. defects and is designed for containers with diameters from 8 to 50 mm. A camera transmits the results The computerdirectly to the all-in-one computer, which bound visual allows for an especially fast evaluation. inspection unit Due to its compact design, the examines vials, user-independent and fully validatable ampoules, tabletop device is flexibly applicable. syringes and The Fast Air Lock ISS 1000 was cartridges for developed for transferring particle pharmaceutical equipment into and out contamination of isolators. An efficient evaporation and cosmetic process and an optimised loading unit container result in very fast cycle times of only defects. approximately 20 minutes. The ISS 1000 is available as an integrated or standalone module and operates Bosch Packaging Technology independently from the main filling +49 7951 402 648 isolator. www.boschpackaging.com

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TechnoPharm & POWTECH Preview 2013

NürnbergMesse, Nürnberg, Germany 23–25 April 2013

Inspection Companies Join Forces Visitors are invited to view the latest inspection systems from Lock Inspection Systems & Loma Systems at POWTECH, Hall 6, Stand 237. Lock will be showing its Insight PH pharmaceutical metal detector for the inspection of tablets and capsules, Insight PH VF pharmaceutical vertical fall metal detector for pharmaceutical powders and granules and Insight VF vertical fall metal detector for the inspection of powders and granules with a high throughput rate. From Loma, an IQ3 Pipeline metal detector for the inspection of liquids and pastes will be on display. The Insight PH is more than capable of

accepting high output rates of tablet presses and dedusting equipment processing up to 30,000 tablets or capsules per minute, rejecting any minute metal contaminations with high efficiency. The Insight PH is well-known for easy validation using the IQ, OQ and PQ documentation. The Insight PH VF can be installed to inspect powders and granules prior to the encapsulation or compacting process. Early detection of contaminants can avoid damage to expensive tooling and will keep downtime to a minimum. The Insight PH VF can be supplied with several reject mechanisms. Lock will show visitors the Insight VF

vertical fall metal detector for the inspection of powders and granules at high throughput rates. The Insight VF inspects free-falling powders or granules at capacities of up to 50 tonnes per hour. The Loma IQ3+ Pipeline metal detector series has been designed to provide highly sensitive in-line metal detection for all types of pumped liquid and semi-liquid products, including creams and pastes. The Lock & Loma Sales team will be more than happy to explain the benefits that these machines will bring to production processes.

Insight PH VF. Lock Inspection Systems & Loma Systems +31 765030212 marketing@lockbv.nl www.lockinspection.com / www.loma.com

Single-Source Filtration Solutions

BECO INTEGRA PLATE enclosed depth filtration system. Eaton has announced its participation at TechnoPharm, Hall 6, Stand 240. The company will be presenting its extensive range of single-source filtration products for chemical, fine and specialty chemical and pharmaceutical applications, including products from the Begerow line. Visitors will be able to obtain comprehensive information on the expanded range of filtration technologies, including depth filtration, bag filtration and cartridge filtration. Eaton rounds off its programme with a wide range of laboratory filters, which facilitate laboratory and pre-production trials and transfer the results with the same filter medium to production scale. Products on display from the Begerow line include: • BECO depth filter sheets are used in enclosed plate and frame filters. • The BECO INTEGRA PLATE enclosed depth filtration system is an alternative to classic filtration systems when the protection of operating personnel and product is a priority. • Mineral-free BECOPAD depth filter medium provides impressive throughput, high dirt holding capacity and chemical resistance. • The combination BECODISC stacked disc cartridges and enclosed BECO INTEGRA DISC filter housing in sanitary design offers excellent reliability. • Prefilter and membrane cartridges used in the BECO INTEGRA CART filter cartridge housing deliver a compact filtration environment and the risk of bypass is virtually eliminated. Eaton’s filtration business team is looking forward to interesting technical discussions with show attendees. Eaton Corporation +49 6704 204 204 utahilgers@eaton.com www.eaton.com/filtration EPM 12

TechnoPharm & POWTECH Preview 2013

NürnbergMesse, Nürnberg, Germany 23–25 April 2013

Live Demonstrations of Leak Detection Machines Sepha — a manufacturer of nondestructive, leak detection and deblistering machines for the global blister packaging market — will be showcasing its VisionScan and MediScan machines at TechnoPharm, Hall 6, Stand 248. VisionScan is reportedly the world’s first tool-less, vision-based leak detection machine for blister-packs and was developed to meet growing demand from pharmaceutical blister pack manufacturers for a low-cost yet accurate and modern leak detection alternative to the destructive blue dye test. VisionScan uses high-resolution camera imaging technology to detect defects in individual blister pockets and

VisionScan. weak seals down to 15 µm and can be easily integrated into existing quality control systems. VisionScan is simple to

operate and has a rapid test time of less than 60 seconds per test. With the ability to test multiple packs per test cycle and an operating system that can store up to 30,000 product types, VisionScan is an ideal solution for high-volume pharmaceutical manufacturers and packagers. Sepha will also showcase its MediScan machine, a tool-less, non-destructive detection device, suitable for testing the integrity of larger, single, non-porous pouches, sachets and medical device packaging. Live demonstrations of both machines will take place throughout the show on Sepha’s stand.

High-Potency Powder Handling Equipment

Powder Systems Ltd (PSL) will be exhibiting its filtration, drying and high-containment solutions at POWTECH, Hall 6, Stand 439. “PSL couldn’t miss the chance to be part of this international trade fair,” explained Rémy Wattiaux, Managing Director of PSL. “We have been supporting pharmaceutical and laboratory industries worldwide for 24 years but also other industries such as specialty chemical and battery. PSL is expanding its mechanical processing offering and POWTECH is the place to be to meet with key decision makers.” PSL provides small-scale to bulk production powder handling solutions, including contained charging, dispensing, sampling, vessel offloading and drum filling. The company’s range of glovebox and isolators enables users to perform many synthesis and formulation processes safely with high containment down to the nanogramme level for the handling of highly potent powder. PSL is also a centre of excellence in the design and manufacture of filtration and drying technologies. Its filtration solutions include the laboratory glass filter dryer (GFD), the pressured filter plate simplefilter and a large range of filter dryers that are designed to perform efficient filtration and drying of any type of cake. Powder Systems Ltd Europe +33 9534 04448 saleseu@powdersystems.com www.powdersystems.com EPM 13

MediScan.

Sepha Ltd +44 2890 484848 info@sepha.com www.sepha.com

TechnoPharm & POWTECH Preview 2013

NürnbergMesse, Nürnberg, Germany 23–25 April 2013

Milling Systems for Products of Almost Any Viscosity At POWTECH, Hall 6, Stand 452, FrymaKoruma will highlight its CoBall annular gap bead mill and MZ toothed colloid mill, which assist with achieving efficient processes and exceptional product quality. FrymaKoruma’s CoBall annular gap bead mill is an in-line milling system, ideal for superfine grinding of APIs for ophthalmic medications and sterile ointments as well as numerous cosmetics and chemical applications. The CoBall mill’s unusually narrow milling chamber is filled between 50 and 80% with beads. Its milling power is high in relation to the very small chamber and the grinding energy input can be as much as 8 kW/dm3, therefore extremely homogeneous results and particle sizes on the nanoscale are possible. Thanks to the conical geometry of the rotor-stator tool, the CoBall mill inputs

the milling forces directly into the product. The residence time in the milling chamber is therefore significantly reduced. Despite the high energy input, the process temperature can be precisely controlled because the CoBall mill has a very efficient heat exchange surface. Cooling ducts in the rotor, stator and mill cover prevent the product from overheating. The annular gap bead mill is also remarkably easy to clean owing to the small volume of the milling chamber. Practically no residues adhere to the interior if the product is changed. The gentle acceleration of the beads and the wear resistant coating of the process tool guarantee excellent results and high product quality. The toothed colloid mills in the FrymaKoruma MZ series make sure every product is always milled to the correct size. The technology is

especially suited for wet grinding liquid to highly viscous products for the pharmaceutical, cosmetic and chemical industries. With a choice of coarse, standard and cross-toothed tools, the process can be precisely adapted to the product in question. The milling gap can moreover be individually adjusted. The mill is available in several different versions with product throughputs of between 100 and 40,000 l per hour. The engineers responsible for designing the mill paid particular attention to eliminating all dead spaces such as gaps, corners or slots from the interior. Residues are thus prevented from accumulating and the risk of contaminating subsequent batches can be ruled out. Finally, owing to the integration of CIP and SIP, MZ mills reportedly redefine the benchmarks for hygiene management.

Romaco Group, FrymaKoruma +49 721 4804 0 susanne.silva@romaco.com www.frymakoruma.com

Aseptic Filling Machines and Contract Service rommelag manufactures and supplies bottelpack blow-fill-seal (BFS) machines for the aseptic filling of sterile liquids, gels and pastes as well as offers a spare parts service, stability tests and contract filling. bottelpack aseptic filling machines have an included class A (US class 100) cleanroom with dark/white separation. The machines are fully automatic and incorporate CIP and SIP capabilities. The machine capacities vary depending on the product filled and the container design used but can handle up to 35,000

containers per hour, from 0.1 to more than 1,000 ml in size. Commonly used plastics are PE, PP, PET and others. Using bottelpack CoEx machines, rommelag manufactures multi-layer containers with barrier layers for the packaging of supersensitive products. rommelag will be exhibiting at TechnoPharm, Hall 9, Stand 433.

bottelpack machine type 4010M, with external punch and high-voltage leak detector.

rommelag ag +41 62 834 55 55 mail@rommelag.ch www.rommelag.com

Rapid Change Line Laboratory/Pilot Mixer Granulator At TechnoPharm, Hall 9, Stand 468, DIOSNA will present its laboratory/pilot mixer granulator P/VAC 10-60 RC, one of the two key machines in the new DIOSNA granulation rapid change line (RCL). This granulation line combines the through the wall technique, which is usual for production lines, with the exchange bowl technique, which prevails in laboratories and pilot plants. The handling during exchange of the process units is considerably simplified and the time requirement reduced to a minimum, hence the name RCL. A mixer/granulator in rapid change design consists of two (or more) units. The basic unit is installed in the wall to a technical zone and includes the control, both drives and the WIP equipment. It can be upgraded with, for example, a vacuum system for drying the granules. Then there is/are the moveable process unit(s). A moveable process unit consists of a mixing bowl with the bearings and seals for the tools. During docking, the process unit is EPM 14

moved to the basic unit then the locking is effected automatically. DIOSNA Dierks & Söhne GmbH +49 541 33 104 0 info@diosna.de www.diosna.com

MANUFACTURING PRODUCTS & EQUIPMENT Compact Sieve Meets 3-A Sanitary Standards Russell Finex continually ensures its separation and filtration equipment effectively complies with industry standards and guarantees outstanding product quality. Therefore, in order to meet the requirements of the 3-A standards, the company has made modifications to one of its most popular vibratory screeners, the Russell Compact Sieve. Introduced over two decades ago, the Russell Compact Sieve was reportedly the first straight-through vibratory screener on the market and since then has been installed within a wide range of food and pharmaceutical applications across the world. Renowned for its compact and easy-clean design, this unit is used throughout the process industry. With its hygienic design — including fully stainless steel construction, FDA approved materials and gap-free mesh screens — and a few refinements, the Russell Compact Sieve range now meets the requirements of the 3-A sanitary standards. Having the Russell Compact Sieve meeting requirements of the 3-A sanitary standards not only reduces validation

time but also provides numerous functional benefits. A low-profile straight-through design enables these screeners to fit neatly into production lines, boosting productivity of the screening processes without requiring excessive headroom. The most important feature of the Russell Compact Sieve is its quick-release clamping system. Band-clamp arrangements used on conventional screeners can be more difficult to dismantle and often require tools, whereas the Russell Finex quick-release toggle clamps offer the ability to perform screen changes without tools, reducing operator involvement and increasing productivity. Key benefits of the Russell Compact Sieve are: • Quick-release clamping system allows for fast screen changes without tools.

• Quiet operation (typically less than 70dBA) is achieved with a solid rubber suspension system. • Easy to clean crevice-free design meets the requirements of the 3-A sanitary standards. Russell Finex Ltd +44 208 818 2000 enquiries@russellfinex.com www.russellfinex.com

Life Sciences Equipment Provider Announces QbD Consultation and Deployment Services Telstar has reinforced its pharmaceutical consulting area by driving two new business lines that will offer consulting services for quality systems in GXP environments. Specifically, Telstar has incorporated a new Quality by Design (QbD) deployment service and has expanded its R&D quality systems service for the preclinical (GLP) and clinical (GCP) phases in the development of active ingredients and drugs as well as for pharmacovigilance in the marketing phase. The expansion of Telstar’s consulting services portfolio took place on 1 February 2013, when the Catalonian company acquired dTC Development Team Consulting’s business. dTC Development Team Consulting, which has been in business since 2000, is highly specialised in executing projects that deal with GXP regulatory compliance and with the improvement of manufacturing processes based on QbD concepts. With the integration of dTC’s know-how into its business, Telstar now claims it stands strengthened as the only Spanish company capable of offering a global pharmaceutical consulting service that encompasses the entire drug lifecycle. The integration of this specialised service enables Telstar to position itself

as a leading provider of GLP services for nonclinical development, GCP services for clinical development, QbD services for process development and redesign, PAT/NIR services for process monitoring and control and GMP services for GMP production and operational excellence. The full range of Telstar’s consultation services has now been consummated by

EPM 15

the incorporation of these two business lines, with services related to regulatory affairs and compliance in the life sciences sector. Telstar, S.A. +34 93 736 16 00 marketing@telstar.eu www.telstar.eu

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CIP Sanitary Two-Deck Screener Scalps and Dedusts A new Vibroscreen double-deck screener from Kason removes oversize and undersize particles from on-size chemicals, minerals, plastics, foods, dairy products, pharmaceuticals and other bulk materials. The 1016 mm diameter unit contains two horizontally-mounted screens in a cylindrical housing supported on a circular base by rugged springs. An imbalanced weight gyratory motor affixed to the housing imparts vibration, causing oversize particles to travel across the coarse upper screen and exit through an upper discharge spout at the screen’s periphery. On-size particles falling onto the lower screen

are discharged through a centre discharge spout, as undersize material flows through the screen, onto a chute and through a lower discharge spout. The screener is equipped with quickdisconnect clamps between each screen frame, providing rapid interior access for inspection and screen changes. An integral CIP spray wash system employs spray nozzles strategically placed to emit cleaning solutions, rinsing solutions and/or steam for sanitising the interior of the screening chambers without the need to open or otherwise disassemble the unit. Constructed of stainless steel with

ground and polished welds, it meets 3-A, FDA and BISSC sanitary standards as well as UL, ATEX, CSA and CE electrical standards. An Air-Lift device is available to pneumatically raise any of the screen frames, enabling one operator to rapidly perform what was previously a two-person task. The unit is also offered in diameters from 460 to 2540 mm and can operate on a batch or continuous basis, screening several kilogrammes to 70 tonnes per hour.

Contamination Control Specialist Develops Audit Compliance Technology Dycem has developed technology that can reverse print its contamination control, polymeric floor edging system with full audit details. Using a bespoke QR code, the edging can be scanned to offer full audit details, including installation and recommended replacement dates on all Dycem installed areas. Dycem’s floor edging has been designed to offer a system that is fully audit compliant, effective in removing 99.9% of foot and wheel contamination and reducing 75% of airborne contamination. In addition, clear demarcation and zone guidance signage is also printed on the edging so that decontamination zones are visible to staff and offer full health and safety compliance. Slip resistant and DDA compliant, the edging also ensures optimal compliance with standard operating procedures. Where colour-coded zones are required, the edging can be printed in any colour and it can also be fully branded with company logos/details. Additional floor signage can be manufactured to the client’s specification to act as warning signs for decontamination areas. With auditing an important commercial factor in critical environments, the edging (also available as a label) promotes best practice and quality control through effective documentation and audit programming. Each year, regulatory non-compliance costs the life sciences industry billions of pounds in fines, recalls, audits and more. Without an effective audit programme, a company is at higher risk for non-conformances, regulatory actions, security breaches, poor product quality, loss of certification and registration, increased product liability risk and a suboptimal process improvement system. To avoid these missteps, companies should rely heavily on experienced audit compliance teams to implement best practices and successful processes to meet the internal and external challenges of auditing compliance. Dycem Ltd +44 117 9559921 contact-cc@dycem.com www.dycem-cc.com EPM 17

Kason Corporation, Europe +44 1782 597540 sales@kasoneurope.co.uk www.kasoneurope.co.uk

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Whitepaper Demonstrates 100% Identification of Defective Blister Packs Using Leak Testing Device A new whitepaper published by Dr. Dorian Dixon, a leading packaging expert at the University of Ulster in Northern Ireland, has shown that VisionScan, a non-destructive seal and leak detection device for pharmaceutical blister packs, developed by the engineering firm Sepha, can identify 100% of defective pockets across a range of blister pack types. In contrast with traditional, destructive manual tests such as blue-dye, the VisionScan system uses camera and projection technology, combined with vacuum pressure, allowing for the accurate, nondestructive detection of defects down to 15 µm. In this latest whitepaper, four blister pack types of various designs and materials were evaluated. Laser drilled holes of 15 or 50 µm were drilled into the foil or paper laminate of 25 of each of the four pack types, creating a total of 200 initial test packs. Only one pocket per pack was laser drilled, leaving the remaining pockets undamaged as control pockets. Scanning electron microscopy (SEM) was used to confirm the dimensions of the laser drilled holes. On SEM inspection of the initial 200 test packs, it was shown in a number of blister packs that the laser drilled holes were not drilled correctly or were

Correctly identified Faulty Pockets Pack Type/Hole Size Good Pockets/Good Identified by Gross µm Pockets Failure (G)

* **

Faulty Pockets Number of Defective Identified by Decay Pockets Identified % Failure (D)

Total pockets

1/15

180/180

100

196/200**

1/50

180/180

100

198/200**

2/15

100/100

100

119/200**

2/50

94/95*

100

112/115**

3/15

120/120

100

139/140**

3/50

120/120

100

140/140

4/15

99/100

100

120/125**

4/50

100/100

100

119/125**

SEM inspection of two nominally defective-free pack pockets found pre-existing defects. On SEM inspection, those laser drilled pockets not identified as faulty were found to have either missing holes or incompletely drilled holes.

missing. Data from the pockets identified as having defective holes was not included in subsequent analysis, resulting in a total of 170 test packs for final analysis. Once all such incorrectly drilled pockets were removed from the data, the study showed that the VisionScan correctly identified 100% of both the 15 and 50 µm sized defects in a total of 170 test packs across all four of the blister pack types. Commenting on the results, Dr. Dixon

said: “As the VisionScan is a tool-less, non-destructive test using state-of-the-art vision technology, it removes the possibility of human error and subjectivity, whilst allowing valuable product within defective packs to be recovered. This represents a significant improvement over traditional blue-dye testing, which is both subjective and destructive.” Sepha CEO John Haran commented: “Dr. Dixon’s study and findings

demonstrate the VisionScan’s ability to offer a technologically advanced, nondestructive alternative for the integrity testing of blister packs, whilst delivering quality improvements and cost savings during production for global pharmaceutical manufacturers.”

be flexible with the ability to add lyophilisation modules and a second line without interruption to existing operations. The line speed is to be from 200 (20 ml) to 400 vials (2 ml) per minute, with either manual or, if required, automatic loading systems. The modular concept is an innovative trend in the construction of critical facilities for the pharmaceutical/biopharmaceutical industry, offering fast track, costefficient alternatives to conventional design. Furthermore, the modular design provides standardisation and

repeatability, which further simplifies pre-fabrication and enhances the cost certainty of the project. The modular concept significantly reduces time to market for lifesaving products such as pandemic vaccines and new cytostatics. This new modular facility will be presented at INTERPHEX 2013, the Jacob K. Javits Convention Center, New York, US, 23–25 April, Booth 2964.

Sepha Ltd +44 2890 484848 paul.kelly@sepha.com www.sepha.com

Pre-Engineered Modular Aseptic Facility to Launch at INTERPHEX Telstar, in association with its sister company KeyPlants, has developed a pre-engineered modular aseptic facility for manufacturing of small-volume parenterals (SVP). This installation is

designed to be adapted to pharmaceutical/biopharmaceutical processes requiring operation both in aseptic conditions for product protection and/or under contained conditions for operator protection. The facility, which is designed for either lyophilised powder or solutions, allows handling of either vials or pre-filled syringes with a range from 2 to 20 ml. Furthermore, this installation is conceived to

EPM 18

Telstar, S.A. +34 93 736 16 00 marketing@telstar.eu www.telstar.eu

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Latest Version of High Containment Transfer System Offers Simpler Liquid-Tight Operation Originally launched in 2009, the EziFlow CSV transfer system offered a number of desirable benefits over traditional split butterfly valves or other commonly used contained transfer systems. Three years on, more then 500 systems have been deployed worldwide and 11 of the top 12 pharmaceutical companies are using Ezi-Flow CSV within their operations. Now a new model offers further performance enhancements based on operators’ hands-on experience. The original Ezi-Flow CSV was developed by UK-based pharmaceutical packaging specialist Ezi-Dock Systems to provide a range of much-needed improvements in the transfer of sensitive or hazardous powders, solids, steriles, tablets and wet cake. The system the company developed is now in use within the operations of almost all of the world’s major pharmaceutical manufacturers throughout Europe and in North America, Japan, Singapore, Thailand, Taiwan and India. Ezi-Dock Systems’ MD Steve McAleavy explained: “We were well aware that existing contained transfer systems were far from satisfactory. Manufacturers either used outmoded split butterfly valves, which required lengthy, cumbersome and potentially hazardous cleaning, or newer singleuse systems, which often delivered inadequate levels of containment, high cost and long lead times for systems and consumables. “Given the ever-increasing potency of active ingredients, it was clear that an improved system, offering much higher levels of containment, lower cost and trouble-free supply, would find a ready market.” Key features of the Ezi-Flow system proved popular from the outset. EziFlow offers a full-bore for faster and easier discharge and is available in both 4 and 6” formats. Both the passive connection and the chargebag are disposable, drastically reducing or removing the need for cleaning and revalidation. Attractively, the Ezi-Flow system is at least four to five times less expensive than equivalent split valve equipment. The cost of consumables, which use anti-static materials as standard, is around 40% less than is common in the industry. Ezi-Dock’s Mike Brimson said: “EziFlow CSV was developed specifically to provide class-leading performance and ease-of-use alongside a welcome cost advantage. The original product did just that and our Mk 2 version brought further benefits. Now that we have so many units in use throughout the world, we have been able to channel feedback from users to develop the CSV Mk 3, which is even simpler to operate and is totally liquid tight, allowing safe and easy flushing or the trouble-free addition of liquids. “We have poured thousands of hours and significant development budget into this system and have worked handin-hand with our customers to develop the products they need, rather than the ones it is convenient for us to produce. We believe the result is the finest and best-specified contained transfer system available and it’s all been done here in Nottinghamshire, in the heart of the UK.”

Ezi-Dock Systems Ltd +44 870 041 0326 sales@ezidock.com www.ezidock.com

Gearbox Ensures Lower Maintenance When Mixing Mixing specialist Chemineer has introduced a robust new gearbox — designed specifically for agitator duties — that provides lower maintenance costs and greater productivity for pharmaceutical manufacturing. The enhanced longer bearing and gear life of the Model 20 HT/GT Gearbox benefits from an oversized output shaft that reduces gear deflection and noise. It also has a true dry well seal to eliminate the risk of lubricant leaking down the shaft. Available in right angle (HT) or parallel shaft (GT) configurations, Chemineer’s Model 20 gearbox also has a recessed, low-speed coupling

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half that greatly simplifies installation by removing the need to install the extension shaft up through the gearbox. With its tapered bearings, the Model 20 ensures cool operation and has a high capacity to handle bending and thrust loads while providing long life. Chemineer +44 1332 363175 sales.chemineeruk@robn.com www.chemineer.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Tilt-Down Flexible Screw Conveyor Collects Dust and Sanitises Easily

Compact Condenser Achieves Low Operating Costs and Long Working Life

New from Flexicon is a sanitary, tilt-down flexible screw conveyor on a castor-mounted frame that can be manoeuvred through narrow aisles and around corners. With the hopper, support boom and conveyor assembly tilted down, the unit fits through standard doorways and orients the conveyor tube horizontally, allowing the flexible screw to be removed easily for thorough cleaning and inspection. The conveyorâ&#x20AC;&#x2122;s surge hopper, which is configured for dust-tight connection to the outlet of upstream equipment, includes an air displacement vent with cartridge filter that is equipped with a reverse pulse cleaning system that dislodges accumulated dust with short bursts of compressed air, returning the dust to the hopper on a timed cycle, thus maintaining operating efficiency. Material flows through the hopper into an adapter that charges the conveyor. The flexible screw is driven only at the discharge end and does not require any bearings or seals within the product contact area. As the flexible screw rotates in the material, it self-centres within the tube, providing ample clearance between the screw and tube wall to eliminate or minimise grinding. The conveyor transports bulk ingredients ranging from sub-micron powders to large pellets, while the gentle rolling action of material being conveyed prevents the separation of blends. The enclosed tube prevents product

Compabloc FreeFlow is a highly efficient, fully welded plate heat exchanger, especially developed for use in pharmaceutical applications. Its benefits include compact size, easy cleaning, hygienic properties, exceptional performance and corrosion resistance. The result is better product quality and lower operating costs. According to the company, superior heat transfer efficiency in a Compabloc FreeFlow makes it possible to reduce the required heat transfer area dramatically compared with an equivalent shell-and-tube or graphite block. This means it can be as small as one-fifth in size compared with a shell-andtube and still offer outstanding heat transfer. The Compabloc FreeFlowâ&#x20AC;&#x2122;s small size is especially valuable if the customer is planning to increase production but there is a lack of space. It fits anywhere and is easily integrated into their process. Also attributable to its compact size, investment and installation costs for a Compabloc FreeFlow are low, even when the unit is manufactured in highly resistant materials such as Hastelloy. The robust, fully welded design makes Compabloc FreeFlow insensitive to thermal shock and vibrations. It is built for maximum reliability, offers a long working life and good return on investment.

and plant contamination and permits thorough wash-down. Removing a clean-out cap at the intake end of the conveyor tube allows rapid emptying and flushing of the tube as well as disassembly and wash-down of components. The rugged inner screw is the only moving part contacting material, resulting in reduced maintenance and increased reliability. A broad range of specialised screws is available to handle free- and non-free-flowing bulk materials, including products that pack, cake, smear, seize, plug or fluidise. The mobile conveyor frame is made of stainless steel (shown) or carbon steel with durable industrial coatings and can be finished to sanitary or industrial standards. Flexicon (Europe) Ltd +44 1227 374710 sales@flexicon.co.uk www.flexicon.co.uk

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The high thermal efficiency reportedly allows a Compabloc FreeFlow to work with a closer temperature approach than a shell-and-tube or graphite block. This makes it possible to use less cooling medium and in some cases, a warmer, less costly cooling medium.

Compabloc FreeFlow has excellent hygienic characteristics. It has no contact points on the product side, is fully drainable and is easy to clean and inspect. It fully meets the requirements for installation in stringent cGMP processes. The risk of cross contamination between batches is minimal thanks to the absence of contact points and the crevice-free design, which facilitates fast and thorough cleaning. Alfa Laval +44 1276 633833 rebecca.halpin@alfalaval.com www.alfalaval.com

Diosna Dierks & Söhne GmbH, Germany +49 541 33104 0 info@diosna.de www.diosna.com

Ovens — Vacuum

Ovens — Sterilising

Ovens — Microwave

Ovens — Drying

Dryers — Vertical

Dryers — Spiral

Dryers — Spray

Dryers — Shovel

Dryers — Shelf, Truck, Vacuum

Dryers — Rotary

Dryers — Microvawe

Dryers — Paddle

Dryers — Ribbon

10 11 12 13 14 15 16 17 18 19 20 21 22

Dryers — Pan

Dryers — Liquid

Dryers — Flash

OTHER

Vacuum dryers. 10

14 15 16

Vacuum dryers. 1

Hosokawa Micron BV, The Netherlands +31 314 37 33 33 info@hmbv.hosokawa.com www.hosokawamicron.nl

Lödige Maschinenbau GmbH, Germany +49 5251 309 0 lemperle@loedige.de www.loedige.de

GEA Pharma Systems, Belgium +32 3 350 1293 pharma@gea.com www.gea-ps.com

IMA S.p.A. - IMA Active Division, Italy +39 051 6514111 tenorec@ima.it www.ima.it

Dryers — Gas Assisted

Dryers — Conical

amixon GmbH, Germany +49 5251 688888 0 info@amixon.com www.amixon.com

Dryers — Fluid Bed

Dryers — Freeze/Lyophilisers

Dryers — Continuous

drying & moisture control

Dryers — Air

buyers’ guide

Collette, Aeromatic-Fielder, Lyophil & GEA Niro.

Vacuum dryers. 1

Powder Systems Ltd (PSL), UK +44 151 4487700 sales@powdersystems.com www.powdersystems.com

Filter dryers. 14

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Dewaterers

Distillation Equipment

Filter Presses — Automatic

Filtration Systems — Ion Exchange

Filtration Systems — MF

Filtration Systems — RO

Filtration Systems — UF

Ion Exchange Systems — Continuous Process

Pasteurisers

Steam Generating Systems

Stills

Superheaters

Ultrafiltration Equipment

Water Purification Systems

3M Purification Division, UK +44 1344 858437 ccahir@mmm.com www.3m.co.uk/purification

Depyrogenation Systems

purification & filtration

Bacteria Control Systems

buyers’ guide

Axium Process Ltd, UK +44 1792 883 882 gale.rudd@axiumprocess.com www.axiumprocess.com

GEA Process Engineering Ltd, UK +44 1925 855702 david.dubbin@geagroup.com www.geaprocess.co.uk Filter Devices, UK +44 1582 501980 filters@helapet.co.uk www.filterdevices.co.uk

Vacuum mixer dryer. 2

Powder Systems Ltd (PSL), UK +44 151 4487700 sales@powdersystems.com www.powdersystems.com

OEM filters and hydrophobic PTFE instrument protection.

Filter dryer (liquid/solid separation), lab glass filter dryer, vacuum/pressure filter — the simplefilter.

Russell Finex Ltd, UK +44 208 818 2058 marketing@russellfinex.com www.russellfinex.com Wychwood Water Systems, UK +44 1993 892 211 sales@wychwood-water.com www.wychwood-water.com

Additional

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SHOWCASE CLEANROOMS

Low Endotoxin Polyester Wipe Launches in Response to Customer Demand Contec is a leading manufacturer of contamination control products for critical cleaning and disinfection in manufacturing environments worldwide — pharmaceuticals, microelectronics, optics, semiconductor, biotechnology and healthcare. Celebrating its 25th anniversary this year, the company has years of experience in helping customers in these very different markets find or create the Contec product that best meets their critical environment cleaning requirements. In response to customer requests,

Contec has added PROSAT Sterile low endotoxin wipes, with 70% IPA and 30% WFI (EP), to its range of presaturated wipes. Manufactured with the highest grade distilled WFI (EP), each batch of wipes has a guaranteed endotoxin level of less than 1EU per wipe. Manufactured from Polynit Heatseal, which is a 100% knitted polyester wipe with sealed edges, the wipe produces a very low level of particles and fibres. Laundered in a cleanroom environment and treated for additional sorbency, the

wipe is ideal for use in product contact areas. The product is now available in two sizes; 230 x 230 mm or 300 x 300 mm. Both sizes are provided folded in a resealable pouch, which takes up a very small amount of space if it needs to be used in an isolator or RABS. Each pouch only contains 10 wipes, eliminating any wastage at the end of a session. Triple bagged, the pouches are validated sterile so are suitable for use in the highest grade of pharmaceutical cleanroom.

Contec, Inc. +33 2 97 43 77 51 infoeu@contecinc.com www.contecinc.com

Touchscreen Photometer Delivers Improved Compliance and Decreased Testing Time DOP Solutions has launched the dop touch aerosol photometer for integrity testing of HEPA and ULPA filters. The touchscreen user interface delivers some exceptional benefits such as auto calibration, min/max/average challenge and %penetration results and pdf test report printable to paper or USB flash and includes some new features such as user data input, language options, auto DNS, chamber health and vibration alarming. It is claimed to be the most stable optical system available and measures down to just 1 mg/m3 upstream concentrations, supporting the use of lower test challenges. The optical chamber and sample pathway are also capable of hazardous environment sampling as a standard feature. According to the company, it is the only

touchscreen photometer in the world and delivers improved compliance, increased quality or safety and decreased testing time. It will support testing compliance to GMP, ISO and all other industry-specific guides for HEPA filter testing. DOP Solutions has been a leader in the cleanroom testing and monitoring industry for more than 20 years and provides Lighthouse particle counters, integrated facility monitoring systems and KIMO airflow instruments. Training courses in all clean air and containment testing practices are available through the company’s Academy for Cleanroom Testing. DOP Solutions Ltd +44 1462 676446 sales@dopsolutions.com www.dopsolutions.com

Pass Boxes Allow for Safer and Cleaner Transfer of Materials

Stainless Steel System Ensures Hygienic Environment at Pharma Facility In specialist environments where hygiene and practicality is highly important, ASPEN Stainless is a logical choice. Recently, ASPEN Stainless has manufactured and installed drainage channels and gullies on behalf of a company asked to re-design a pharmaceutical manufacturing facility. In addition to the drainage system, sections of ASPEN bump rail has been manufactured and installed to provide edge protection around the facility. Working together, the ASPEN stainless steel products will create a hygienic and anti-corrosion environment for the pharmaceutical facility to maintain an efficient cleanroom for the manufacture of their products on a daily basis. ASPEN Stainless is a UK-based designer and manufacturer of all stainless steel standard and bespoke products. The company is able to offer complete drainage systems and bespoke stainless steel equipment and can customise any standard product to suit its environment with a lifetime guarantee stamp of approval.

Kambic stainless steel material hatches benefit from the company’s years of experience in development and production of laboratory equipment, already used by many medical and pharmaceutical institutions, development laboratories and manufacturing companies around the world. Pass boxes are most commonly used to allow safe transfer of material, equipment, documents or samples between cleanrooms or rooms of different grades and pressures. Available from CiK Solutions, Kambic’s standard pass box range benefits from add-on options such as air circulation and filtration, UV lights and many others, ensuring material transfer is safer and cleaner. More information is available at www.cik-solutions.com/pass-boxes.html.

Canal Engineering Ltd +44 115 9866321 aspen@canalengineering.co.uk www.aspen.eu.com

CiK Solutions GmbH +49 721 62 69 08 50 info@cik-solutions.com www.cik-solutions.com

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SHOWCASE TABLETTING EQUIPMENT MAINTENANCE Tablet Tooling Expert Showcases Latest Products at INTERPHEX I Holland will be using INTERPHEX 2013 — the Jacob K. Javits Convention Center, New York, US, 23–25 April — to present its extensive punch and die portfolio, including multi-tips, coatings and designer shapes, along with its latest addition to the PharmaCare range, the MF40 automated punch and die polishing machine. MF40 has a 40 l media drum and increased capacity holders, giving a maximum of 51 B or 36 D punches per polishing cycle. The machine uses single-phase power and fits in the same compact footprint as the MF35, making it a space and cost-effective machine. Andy Dumelow, I Holland’s PharmaCare Product Manager, said: “The MF40 polishing machine was developed to be used as part of I

Holland’s recommended PharmaCare 7Step Process, a professional punch and die maintenance and storage programme. “Automated polishing is an integral part of this 7-Step Process and will maximise trouble-free tablet production by helping to keep tooling in perfect condition. By following this process and correct maintenance, costly tablet press downtime and compression problems associated with capping, tablet weight and thickness variation can also be reduced. “INTERPHEX is the perfect event to introduce a number of I Holland’s newest PharmaCare products and tool coating products to the market, giving us the opportunity to meet with decision makers within the industry and explain

the innovative and unique processes and research that the company has developed to help our customers achieve effective manufacturing.” Other products to be exhibited on the I Holland stand include the HNC Laser and the Holland Die Condition Monitor, a piece of precision equipment designed to monitor the condition of the bore for any die type, including multitips. To find out more about I Holland’s product portfolio and speak with the team of experts, visit Booth 3164 at INTERPHEX. I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk

Tabletting Equipment Specialist Provides Comprehensive Training and Support Natoli Engineering Company offers training and support for tablet production equipment and tooling. With options ranging from technical training seminars to on-site training, Natoli Engineering provides its customers with many opportunities to gain valuable knowledge. In 2009, Natoli Engineering reportedly introduced the first, non-commercial technical training centre dedicated to educating the tablet compression industry. Seminars at the Technical Training Center include a well-balanced combination of presentations, group

discussions and hands-on experience. These seasonal seminars are always evolving to satisfy the ever-changing processes within the tablet production industry. In addition to the Technical Training Center, Natoli Engineering offers customised on-site training programmes, specific for the customer. For example, polishing and repair work should be performed by a trained professional in order to achieve enhanced tablet quality and extended tool life. Natoli Engineering offers its customers the ability to have this

specialised skill taught onlocation so that learning can be completed in a familiar environment. For advanced troubleshooting or for quick answers, Natoli Engineering offers the convenience of speaking with a skilled technician over the phone or through email. First class customer service, coupled with training and support, is one more reason why Natoli is a leading manufacturer and supplier of tablet compression tooling.

Natoli Engineering Company, Inc. +1 636 926 8900 training@natoli.com www.natoli.com

‘Process Technology’ and ‘Tableting Tools’ Seminars to be Held in April

Training Sessions Deliver Lab to Production Tabletting Expertise

Fette Compacting is to hold two seminars, one entitled ‘Process Technology’, on 23–24 April 2013, and the other ‘Tableting Tools’, on 25–26 April 2013, both taking place at the company’s Competence Center Germany in Schwarzenbek, Hamburg. Products and production processes are always changing and both technical and commercial knowledge need constant updating. In pharmaceutical production in particular, employees’ qualifications are of exceptional importance, as such a lot depends on the expertise of the workers. This starts with the selection of the right pressing tools and continues with professional tool management and the use of optimum production parameters. The well-established Fette Compacting training programme makes an important contribution to long-term protection for customers’ and employees’ futures. These services are supplemented by technology seminars on a wide range of applications, seminars that emphasise

Manesty has been part of the pharmaceutical process portfolio of Bosch Packaging Technology since 2011. From laboratory to production scale, customised Manesty tablet presses and coaters offer high quality and flexibility to the pharmaceutical industry. Manesty’s training courses and seminars are specially designed to educate delegates on tablet compression and coating technology and how to obtain the best results from their Manesty equipment. Following these courses, delegates should gain a greater understanding on a variety of topics, including a detailed knowledge of the science of tablet compression and coating, troubleshooting and maintenance. With Manesty’s newly equipped GMP laboratory trials area and training centre, the company now offers the following training at its Knowsley site in the UK: • 14–16 May 2013, Tablet Coating Techniques

the value of communicating comprehensive theory and practical application knowledge. This understanding is communicated by the company’s own specialists and by external experts from the industry and from technical education. More information about the seminars and the registration process can be found on Fette Compacting’s website. Fette Compacting GmbH +49 4151 12569 training@fette-compacting.com www.fette-compacting.com

EPM 25

• 11–13 June 2013, Tableting Compression Technology • 11 July 2013, Tablet Coating Techniques • 17–19 September 2013, Tableting Compression Technology • 15–17 October 2013, Tableting Compression Technology To book a place on a Manesty training course, contact Peter Bradley, peter.bradley@bosch.com, +44 151 547 8056. Bosch Packaging Technology www.boschpackaging.com

Corporate News

Tablet Tooling Manufacturer Wins Regional Award in HSBC Global Connections Initiative Nottingham-based I Holland has won the prestigious HSBC Global Connections initiative, winning the regional final against six other Midland based companies out of a total of 400 entrants. The HSBC Global Connections initiative supports and celebrates innovative, globally-minded UK businesses and looks for companies that are forward-thinking and ambitious, helping to further their growth agendas overseas. I Holland’s Finance Director, David Hinds, commented: “We were honoured to be named the regional winner of the HSBC Global Connections competition. We have worked hard to expand the company and we now sell to 85 countries globally and have a network of 40 agents worldwide. Six decades of research, development and investment have helped us get to this stage.” Recognised for its global reach, ongoing innovation and progressive

ideas, I Holland is eligible for up to £6m of funding, plus a cash reward of up to £120,000. “I Holland has a track record for innovation and we have to continue doing that to keep ahead of our competitors,” continued Hinds. “The funding will help us to develop projects that will keep the businesses moving forward and will give us the opportunity to build on existing developments, like the company’s Asia subsidiary in South Korea.” Established in 2011, I Holland’s Asia subsidiary was created to give the company greater control of the company’s near-net-shape supply chain in the region. In its first year of trading, it achieved profits of £220,000 on sales of £2.2m and is going from strength to strength. Another initiative that will benefit from the HSBC Global Connections win is the TSAR (Tabletting Science Anti-Stick

Research) project. With the assistance of Nottingham University’s School of Pharmacy, a research programme is being undertaken to investigate the cause of tablet formulation sticking. Hinds concluded: “We have a track record for innovation and we have to maintain that to keep ahead of our competitors. TSAR is just one of those projects that will propel the company forward and the award is a welcome boost to help us achieve this.” I Holland will now be entered into the national finals of the HSBC Global Connections competition, where a financial reward of up to £240,000 is available.

Partnership to Advance Knowledge in Solid Dosage Engineering Operations and Instrumentation Natoli Engineering and the Arnold and Marie Schwartz College of Pharmacy and Health Sciences at Long Island University (LIU) have announced a partnership to establish The Natoli Engineering Institute for Industrial Pharmacy Development and Research. The Natoli Institute will be located at the Brooklyn campus of LIU and will be dedicated to advancing knowledge in the field of pharmaceutical solid oral dosage engineering operations and instrumentation. Work will focus on understanding many of the long time problems of sticking and picking associated with the compression of tablets, the development of formulations for new and existing molecules and the measurements required to ensure proper delivery of formulations to the

tablet press and the control of the tablet press. An existing laboratory at the university will be renovated to hold the Natoli Institute with the opening date targeted for September. The opening of this institute is yet another example of Natoli’s dedication to helping its customers. Natoli is a premier manufacturer and supplier of tablet compression tooling, accessories, presses, parts and services for the pharmaceutical, nutraceutical, veterinary, industrial, confectionary and chemical industries. Natoli’s dedication to excellence and commitment to providing outstanding customer service has propelled the company to the forefront of the tablet compression industry.

Natoli Engineering Company, Inc. +1 636 926 8900 c.kettler@natoli.com www.natoli.com

Solid Dosage Machine Builder Expands Production in Ennigerloh In October 2012, L.B. Bohle started to build new production facilities in Ennigerloh, Germany. In the first phase, a new plant with 3.700 m2 has been constructed. The production space covers 2,600 m2 and the other 1,100 m2 is divided into factory and offices. With the new facilities, owner Lorenz B. Bohle said: “We are looking to achieve strong sales growth and more efficient production with a continuous flow of work.” Sixty new jobs will be created at the Ennigerloh facilities and for the county Warendorf. L.B. Bohle has so far invested €5 million in the new plant and has a further €1 million planned for the next phase of updating the old plant. Bohle added: “The target of this investment is to accommodate a year-

T. Remmert (Sales Manager), A. Bohle (Head of Engineering), Dr. O. Gericke (District Administrator), L. Bohle (Managing Director), B. Lülf (Major of Ennigerloh), W. Pieper (IHK Westphalia), P. MichalczkHülsmann (gfw), R. Pawloski (Architect), W. Tillmann (former Major of Ennigerloh) and T. Borgers (Head of Marketing). on-year increase in sales of 20%.” The main driving factor for this significant expansion is the success of the company’s coating machines, which are being produced at the plant.

L.B. Bohle Maschinen + Verfahren GmbH +49 2524 9323 150 t.borgers@lbbohle.de www.lbbohle.de

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S. Deakin (Sales & Business Development Director), C. Prideaux (Managing Director) and D. Hinds (Finance Director).

I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk

Powder Handling Systems Provider Expands Presence in German Market Dec Group, with headquarters in Switzerland, is further expanding its presence in the German market and opened a new sales office in Buchen, Germany, at the beginning of the year. The company found proven specialist Bernhard Strebel to lead the new sales office. With extensive experience and indepth technical and market knowledge in the field of material handling, he will aim to enhance the Dec Group’s position in the German market. Strebel supports sales out of the Dec West office in Buchen, Germany, and will likewise rely on support from the head office in Ingolstadt. Dec Germany GmbH, specialising in process engineering, including project management from planning to commissioning in the field of bulk material handling, has been successful for several years in Germany and Austria. Serving the chemical, pharmaceutical and food industries, Dec Group provides systems for transferring, dosing, filling, emptying, blending and micronising as well as containment solutions for difficult bulk handling material. Dietrich Engineering Consultants sa +41 21 694 20 40 info@dec-group.ch www.dec-group.net

LABORATORY PRODUCTS & EQUIPMENT

Cosmetic and Pharma Sectors Show Confidence in Living Skin Equivalent Evocutis is helping to reduce animal testing and provide alternatives to live human skin testing after securing sales with leading cosmetic and pharmaceutical companies using its living skin equivalent LabSkin. The sales, included in contracts worth £280,000, will see the advanced living skin equivalent model being used to support the research of several wellknown consumer healthcare and pharmaceutical companies in multiple territories including the US, UK and Europe. As a first step in product development or claims support, LabSkin offers an alternative to ethically sensitive and expensive animal and human volunteer testing. Comparative studies indicate that LabSkin acts very like human skin and can play a vital role in helping to validate product marketing claims. The reportedly unique construction of the LabSkin dermal and epidermal layers allows creams and lotions to be applied over time in a similar manner as they would be on real human skin. Focusing on the future evolution of LabSkin model systems, Evocutis has also entered into research collaborations with leading university groups. At the University of Bradford’s Centre for Skin Sciences, LabSkin is being used to develop a pigmented living skin equivalent, which can be used for substantially improved testing of sun

protection products. Collaboration with the research group at Bradford could lead to LabSkin being developed for different skin types and colours. Recent research with the London School of Pharmacy on dermal penetration has also demonstrated that LabSkin, as a living skin model, offers distinct advantages over laboratory standard non-living tissue. Gwyn Humphreys, Chief Executive Officer of Evocutis, commented: “We have seen a positive response to LabSkin from the pharmaceutical and cosmetics markets, demonstrating the need for ethical and cost-effective alternatives to tests on living skin in leading laboratories. With continued success, we think LabSkin’s innovative technology for modelling real skin could bring significant changes to product development and testing.” LabSkin is a highly versatile skin research tool. Originally developed as a device for skin microbiology testing and research, it is now finding uses in all areas of skincare. Unlike other living skin

equivalent models, it is robust enough for skincare products to be repeatedly applied directly to the surface by hand and, with barrier properties similar to human skin, it can be used to more accurately predict the response of skin to test products. Its ease of use is helped by the large surface area — roughly the size of a 10p coin. Because its window of use extends between 10 and 14 days, researchers can see the effect of skin products over a period of time, as in normal use. Evocutis plc +44 1937 547470 info@evocutis.com www.evocutis.com

User-Friendly Chromatography and Spectroscopy Catalogue Available to Order Agilent Technologies has introduced the 2013 Essential Chromatography and Spectroscopy Catalog. The new catalogue is divided into five sections to help the reader easily navigate Agilent’s growing portfolio, which includes general chromatography, sample preparation, GC and GCMS, LC and LCMS and spectroscopy. This edition of the catalogue contains CrossLab products for use with other manufacturers’ instruments. It also includes details about electrochemistry meters and supplies, Captiva syringe filters, Ultra Inert and application-specific GC columns, LC biomolecule and Poroshell 120 columns and OneNeb nebuliser for inductively coupled plasma

optical emission spectrometry (ICP-OES) and microwave plasma-atomic emission spectrometry (MP-AES). The 2013 catalogue lists thousands of products with part numbers, descriptions and configurations as well as hundreds of applications. Method descriptions, selection guides, compatibility charts, maintenance schedules and tips for how to get the most out of Agilent consumables provide the customer with additional value. The catalogue is available in English, French, German, Spanish, Chinese and Japanese. The 2013 Agilent Essential Chromatography and Spectroscopy Agilent Technologies UK Ltd Catalog can be ordered at +44 131 452 0200 bit.ly/agilentcatalog2013. www.agilent.com

EPM 27

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP 13 Millimetre Syringe Filter Improves Testing Accuracy for Low LCMS Extractables in Small Samples

Project to Optimise Freeze Dried Drug Dosage Form for Treating Muscle Atrophy

Pall Corporation has introduced a 13 mm Acrodisc MS syringe filter certified for low extractables in highperformance LCMS applications. The new 13 mm size, which is designed specifically for small sample analysis using LCMS, complements Pall’s current Acrodisc MS syringe filter offering of a 25 mm filter. The 13 mm Acrodisc MS syringe filter improves the accuracy of testing, enhances LCMS performance and extends the longevity of testing instrumentation. The low extractable levels of the new 13 mm Acrodisc MS syringe filter minimise interference with the ionisation process and reduce the need for retesting. This lowers costs while minimising downtime due to unexpected contamination. To ensure high performance, product tubes are packaged individually so that filters not in use remain sealed and protected from external contamination. Constructed with Pall’s new water wettable polytetrafluoroethylene (WWPTFE) membrane in a high density polyethylene housing, the Acrodisc MS syringe filter can be used with both organic and aqueous solvents. It offers excellent chemical resistance and good particulate retention with minimal

Using an SP Scientific LyoStar freeze drying system, pharmaceutical process development expert GILYOS GmbH in Wuerzburg, Germany, will participate in a research programme called FORMOsA, which was recently funded with about €2 million by the German Bavarian Research Foundation. The project focuses on age-related muscle atrophy (sarcopenia). In this project, GILYOS will be actively involved in the formulation development and freeze drying process design and optimisation of follistatin for subcutaneous application. Follistatin is a messenger substance that is present in almost all types of tissue. The protein effectively inhibits myostatin, which, in turn, plays a key role in skeletal muscle atrophy. Follistatin might therefore be a promising substance for treating sarcopenia. To optimise the freeze dried dosage form, GILYOS will use the Lyostar freeze drying system to investigate partially crystalline formulations as such mixtures allow short process times that are of great economical interest. The SP Scientific LyoStar3 freeze dryer provides outstanding process accuracy, reliability and ease-of-use features. For applications ranging from process development for scale-up to product processing for stability studies to formulations work, the LyoStar delivers consistent results. The LyoStar features RTD-controlled shelf temperature accuracy of +/–0.5˚C or better and

protein adsorption. This protects instrument columns from particulate build-up and reduces the frequency and cost of replacement. It also enables more consistent LCMS testing performance. “Pall’s 13 mm Acrodisc MS syringe filter is the newest innovation in our comprehensive line of syringe filters and is suitable for samples as small as 25 µl,” said Larry O’Connell, Senior Vice President, Pall Laboratory Products. “Our new size will continue to improve the accuracy, cost and reliability of high performance LCMS testing. The applications for this advancement are extensive and growing rapidly as testing technology advances.” Pall Corporation +1 734 913 6488 laura_zaborski@pall.com www.pall.com/lab

EPM 28

vacuum control within 0.1% of set-point. Its robust 5.5 hp cascade refrigeration system enables shelf pull down from ambient to –40°C in less than 25 minutes and the ultra-reliable scroll compressors feature just three moving parts. Available with ControLyo nucleation on-demand technology, the LyoStar 3 provides R&D and process development scientists with precise control over their freeze drying processes. Genevac Ltd +44 1473 240000 salesinfo@genevac.co.uk www.spscientific.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Gas Addition Module Enhances Gas Dependent Reactions of Continuous Flow Reactors

100% Single-Use TFF Skid Eliminates Cross Contamination and Increases Market Reach

Uniqsis has announced a new gas addition module for its FlowSyn continuous flow reactor range. The new module enables fast, controllable pre-saturation of liquid reagents with a wide range of gases, thereby promoting efficient gas dependent reactions in flow, such as carbonylation, hydrogenation, ozonolysis and direct synthesis of carboxylic acids. Mixing gas and liquids in a controllable and reliable manner has always posed a particular challenge for flow chemists, in particular the prevention of undissolved gas bubbles that have an adverse effect on the control of pressure and residence time in flow chemistry. The pressurised tube-in-tube design of the gas addition module overcomes this problem by ensuring continuous interaction between the gas and liquid at every point along its length. The tube-in-tube design is based on semi-permeable membrane technology, whereby the semi-permeable inner tube containing the liquid (typically a solvent) is bathed by a stream of pressurised gas that is enclosed within a thick-walled impermeable outer tube. The pressurised gas is able to cross the semi-permeable membrane of the inner tube and dissolve into the liquid carried within. However, because of the semipermeable nature of the inner tube material, the liquid is unable to cross in the opposite direction. The gas addition module is compatible with a wide range of reactive gases (e.g., CO, CO2, H2, ethene, ethyne and SO2) and organic solvents (e.g., THF, Acetonitrile, Methanol and Propanol).

Novasep has launched the Sius singleuse tangential flow filtration (TFF) skid. The TFF skid completes the Novasep proprietary, single-use TFF solution for pre-clinical to clinical cGMP biomanufacturing. The new skid is reportedly the first on the market to offer a 100% single-use TFF solution. The Sius TFF skid is comprised of an automated benchtop unit with a fully disposable flowpath and is extremely compact. It is capable of laboratory- to pilot-scale TFF operations. Eliminating the risk of cross contamination, the unit widens the market for disposable TFF solutions, accommodating surface areas from 0.1 m2 to 2 m2 for microfiltration and ultrafiltration/diafiltration (UF/DF) applications. Novasep has achieved a 73–80% reduction in consumable price to USD 800/m2 by designing the TangenX(R) Sius single-use TFF cassettes to be more cost effective. This compares with $3,000/m2 to $4,000/m2 for competing products. The long-term drive by the biopharmaceutical industry to reduce costs, including the costly effort of cleaning equipment and validation, makes it increasingly reliant on disposable technologies. These offer numerous benefits over traditional reusable technologies. One of the most important of these is a time saving of 50–70% using Sius technology over traditional reusable TFF technologies. The Novasep Sius TFF skid’s flowpath can be combined with TangenX Sius TFF

Capable of generating a continuous gassaturated solvent stream in typically less than 10 seconds, it enables flow chemists to carry out a wide variety of applications with minimum effort, including heterogeneous and homogeneous gas-liquid reactions such as hydrogenation, ozonolysis, carbonylation and direct synthesis of carboxylic acids. A particularly convenient feature of the Uniqsis gas addition module is the availability of an optional portable gas reservoir. This handy space-saving device is easy and safe to charge with gas from a larger reservoir and obviates the need to bring bulky pressurised gas cylinders into the immediate experimental area. The gas addition module can be added in-line to any FlowSyn system and other continuous flow reactors to provide a solvent feed stream pre-saturated with gas, although it can also be used as a reactor in its own right. Uniqsis Ltd +44 845 864 7747 info@uniqsis.com www.uniqsis.com

Easy to Operate Tube Decapper Significantly Improves Productivity Targeting the ever-growing requirement for higher sample throughput, the new generation Univo Electric Decapper DC480 from Micronic enables laboratories tasked with opening multiple sample storage tubes to achieve outstanding productivity gains. The Univo Electric Decapper DC480 is the latest addition to Micronic’s redesigned ‘blue-white’ line of productive sample handling equipment that is not only compatible with all Micronic tubes up to 1.40 ml but also with tubes and caps of other brands. Through an improved user interface, the operator is able to select any rack to decap without using different adapters for different tube sizes/brands. Easy to install and operate, the compact Univo Electric Decapper DC480 removes and disposes of the push caps from a full, 96-tube, storage rack in eight seconds. Operation is safe and user friendly; simply place a rack of capped tubes onto the access tray, push the start button and the Univo Electric

Decapper DC480 will gently remove all the caps in one action. The integrated cap disposal device ensures that caps cannot be reused. Designed to improve productivity, the Univo Electric Decapper DC480 can be used as a standalone instrument or be simply integrated into a fully automated laboratory environment. Micronic Europe BV +31 320 277070 sales@micronic.com www.micronic.com EPM 29

cassettes and filter plate inserts with the option of a feed bag to provide a complete single-use TFF solution from a single supplier for pre-clinical to clinical cGMP biomanufacturing. It is also one of the only solutions to enable cGMP validated integrity tests. “As the biopharmaceutical market continues to evolve, demand continues to rise for more cost-effective and comprehensive solutions,” said Alain Lamproye, President of Novasep’s Biopharma business unit. “Novasep has reacted to this by concentrating on continuing to increase its product and service portfolio in the downstream processing marketplace and we will continue to do so. By launching Sius TFF Skid, Novasep now offers the first 100% single-use TFF solution on the market whilst remaining very cost effective. We are also developing a larger scale Sius TFF skid to cover commercial-scale applications.” Novasep www.novasep.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Lab Balance Fulfills Particularly High Reliability Requirements The new Secura laboratory balance, developed by Sartorius for applications in regulated areas, monitors its ambient conditions automatically, thereby preventing handling errors. This increases the reliability of weighing procedures in pharmaceutical laboratories and helps users to achieve even better measurement results. The balance is also equipped with various assistance systems designed to prevent further processing of uncertain weighing results, which frequently occur through operating errors during weighing. If errors occur, the balance identifies the uncertain weighing results in the display and blocks their transmission. Nine different models of the Secura balance are available, covering a range of weighing capacities from 120 to 5,100 g and a readability of 0.1 to 10 mg. Precise leveling of a balance is an essential component of equipment monitoring and a prerequisite for obtaining accurate readings. The electronic Level Control sensor ensures that Secura is perfectly level. Noncompliance is indicated visually in the

display and blocks output of the reading. Clear instructions in the display guide the user through the leveling procedure simply and safely. This means that laboratory staff can easily level Secura laboratory balances located in safety work benches or safety weighing cabinets without having to open the safe work area. Even minor temperature fluctuations in the laboratory have a considerable influence on the reproducibility of weighing results. For this reason, balances have to be calibrated regularly and as soon as the ambient conditions change. Once a specified time or temperature threshold is reached, Secura’s calibration and adjustment function, isoCAL, informs the user and automatically adjusts the balance using internal weights. Every adjustment is documented and can be traced for quality assurance purposes. Every balance used in regulated areas such as pharmaceutical laboratories has to meet the requirements specified by the FDA. Pharmaceutical laboratories therefore have to determine the

minimum sample weight according to the USP on site and measurements may not fall below this limit. On request, Sartorius service staff will determine this value during first operation of the Secura balance and issue a minimum sample weight certificate. The value will then be constantly visible in the display of the balance. If a measurement falls below the specified minimum sample weight, an alert will appear in the display and Secura will block printout and transmission of the reading. The user interface of the Sartorius Secura balance has been developed in collaboration with experienced users. The weighing applications are represented as clearly understandable icons on the touchscreen of the Secura balance. This allows users to launch any of the balance’s programs with the touch of a finger, without first having to read the operating manual.

Sartorius +49 551 308 3615 karin.kleist@sartorius.com www.sartorius.com

Pipette Range Proves Key to Mastering Multiple Applications After nearly a year on the market, the flexible, accurate Rainin E4 XLS family of electronic pipettes from Mettler Toledo continues to prove its worth by helping users master a wide range of life science

applications worldwide and helping manufacturers preserve research budgets and keep experienced operators on the job longer with a robust package of hand-saving, accuracyenhancing features. The E4 XLS, designed to be the most ergonomic electronic pipette available, offers a comfortable grip, precise balance and a large full-colour screen for easy reading and operation. Designed to enhance speed and prevent user fatigue, the E4’s joystick control and logical menus, available in single channel, multichannel and adjustable spacer formats, simplify switching between functions. This easeof-use helps experienced operators accomplish more

with fewer errors for manufacturing costsavings in reduced rework. Less impact to the hand’s delicate musculature can translate to fewer repetitive motion injuries and lowered healthcare and labour training costs. The E4 XLS is also extremely versatile, allowing operators to gain its ergonomic benefits across a wide range of pipetting functions. These include titration, dilution, reverse-mode pipetting and sequential volume programming for complex protocols. A multi-dispense feature automatically calculates how many aliquots can be dispensed from a single pickup so operators quickly ascertain how many samples can be prepared. Autopace simplifies repeat dispensing with one-click dispensing across a plate based on user input, while advanced blowout and automatic dispensing options give users even more control. TrueManual mode is also

available for a manual pipetting experience when desired. Embedded RFID tags enable advanced calibration and inventory management. As part of its robust software package, the E4 XLS can be upgraded and expanded directly from an operator’s PC, easing maintenance and helping to ensure a long operating life. With this range of options and ease of maintenance, E4 XLS meets the requirements of almost any sensitive life science experiment. To see the E4 XLS advanced operation carousel menu in action or learn more about how E4 XLS can extend the application mastery of operators in the laboratory, visit www.mt.com/e4. Rainin Instrument, LLC +1 510 564 1736 terry.peckham@rainin.com www.mt.com/rainin

Versatile Safety Enclosure Provides Controlled Lab Environments

Blowdown Evaporator for Productive Solvent Removal from HPLC Vials

Available from Asynt, the Lab-Bubble is a versatile piece of containment equipment that can be used to provide many different types of safety or controlled environments simply by using additional components to change the function of the enclosure. The Lab-Bubble is designed and tested in various configurations for applications including handling of chemicals and powders, weighing, biological sample handling and PCR preparation. The environment in the Lab-Bubble can be controlled for humidity (20–55% RH) using a dry Nitrogen glovebox and temperature of 15–30°C. The air extraction on Lab-Bubble is provided via a small box section fan filtration system that incorporates a safe change HEPA/carbon combination filter. Affordably priced, Lab-Bubble can be used as a simple storage unit and also as a demonstration/teaching unit. The construction of the main body of LabBubble is from 6 mm clear moulded cast

Porvair Sciences has announced a new version of its MiniVap blowdown evaporator, able to quickly and safely remove solvent from up to 48 vials in parallel. Made from solvent resistant black polypropylene, the new MiniVap vial holder has been designed to accommodate up to 48 vials in a standard SLAS/ANSI format. Incorporating advanced evaporator head technology that directly injects heated nitrogen into 48 HPLC vials simultaneously, the MiniVap removes the traditional laboratory bottleneck of solvent evaporation from vials. The MiniVap blowdown evaporator takes just minutes to remove volatile organic solvents from samples collected in 24- or 96-well microplates and now HPLC vials. Compact in design, the affordably priced MiniVap is simple to install, operate and maintain. Installation just

acrylic that ensures excellent visibility and is easily cleaned. The base section is durably constructed from chemically resistant, 10 mm thick high-density polyethylene. Asynt Ltd +44 1638 781709 sales@asynt.com www.asynt.com

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requires connection to a gas supply and standard mains socket. Safety of operation is ensured as the CE marked compact unit fits into all fume cupboards. Porvair Sciences Ltd +44 1372 824290 int.sales@porvair-sciences.com www.porvair-sciences.com

SHOWCASE PARTICLE ANALYSIS NTA Characterises Drug Carrier Polymer Nanoparticles at Saarland University NanoSight has reported on how nanoparticle tracking analysis (NTA) is used to help with the characterisation of polymeric nanoparticles synthesised as drug carrier systems. This work is being carried out at Saarland University, Saarbrücken, Germany, by Dr. Christian Ruge and his colleagues. In the world of pharmaceutical sciences, a detailed and full characterisation of particles synthesised as drug carrier systems is indispensable. The particle size is a crucial parameter to be monitored as this will affect the stability of formulations. It will also impact with respect to size-dependent effects in biological experiments, such as the uptake of drug systems by cells. NTA is used as a complementary tool

to a Malvern Zetasizer to characterise the nanoparticles prepared by Dr. Ruge, a research scientist in the Department of Biopharmaceutics and Pharmaceutical Technology in the group of Professor Claus-Michael Lehr. The particles are mainly polymer-based and typically in the size range from 100 to 400 µm. Especially when studying samples of moderate polydispersity (i.e. with a polydispersity index of larger than 0.2), the group uses the NanoSight system to measure the preparations to identify particle populations that are not resolved by the Malvern system. Dr. Ruge spoke of the benefits of using NTA rather than techniques such as scanning electron microscopy or dynamic light scattering: “The fact that the system is performing particle-by-

particle-based measurements is a huge advantage, especially in terms of its resolving power. The fact that the instrument gives a concentration value is very useful. I feel that visualisation of the particles based on their scattered light gives more insight as to the sample and its behaviour. I personally find that it is more fun working with the NanoSight instrument compared with the Zetasizer. The interaction with the instrument and being able to visualise the individual particles makes it less of a ‘black box’ instrument and more interesting for me as a scientist to use. Also, I have found that during demonstrations for students, the NanoSight appears to be more transparent and thus better suited for educational purposes.”

NanoSight Ltd +44 1980 676060 sarah.newell@nanosight.com www.nanosight.com

Centrifugal Field-Flow Fractionation Instrument Debuts at Pittcon Postnova Analytics’ newest instrument, the CF2000, reportedly the first commercial centrifugal field-flow fractionation (FFF) system designed for routine use and providing a real alternative to traditional particle characterisation techniques, was seen for the first time by visitors to the company’s stand at Pittcon 2013. The CF2000 offers outstanding flexibility, robustness and performance, allowing high-resolution particle separation and sizing simultaneously. It has a broad separation range, from samples of 8 µm up to several microns, making it ideal for nanoparticles but also working up into the microparticle size category too. Samples are injected directly without preparation, no special sample treatment is necessary, allowing the fractionation of complex particulate.

What makes FFF such an appealing technique is not only its breadth of analysis but its operational simplicity. There are two physical forces that make up the FFF system. Firstly, the laminar flow that carries the sample through the separation chamber, and secondly, the separation field applied perpendicular to the channel, against the sample flow controlling the diffusion of the particles or molecules. Driven by a centrifugal field, the CF2000 separates particles by dynamic diffusion on the basis of particle size and density. The CF2000 is controlled by the flexible NovaFFF software, which can drive many devices and incorporates system control, data collection, data evaluation and reporting. Coupled to detection systems such as multi-angle light scattering (MALS), dynamic light scattering (DLS), different

forms of UV detectors, small angle X-ray scattering (SAXS) or inductively coupled plasma mass spectrometry (ICP-MS) or other detectors, FFF separation technologies enable the fractionation, characterisation and speciation of large complex polymers, biomacromolecules and nanoparticle species. Such separations often cannot be performed using traditional chromatographic methods, predominantly because of the Postnova Analytics’ CF2000 stationary phase in traditional Centrifugal FFF system. chromatographic separations. The CF2000 instrument can be easily Postnova Analytics coupled with existing high-end detection +49 8191 985688 0 technologies as those mentioned above rainer.juenger@postnova.com or the optimised FFF detectors available www.postnova.com from Postnova Analytics.

Automation of Particle Size Measurement Series Made Possible

Morphologically Directed Raman Spectroscopy Supports Identification of Particles in Mixed Populations

FRITSCH ANALYSETTE 22 laser particle sizers are purchased worldwide to ensure precise determination of particle size distribution. Using static laser scattering, they are suitable for production and quality control as well as the R&D environment. Customers benefit from their extremely simple operation and short analysis times for consistently reproducible and reliable results. Automation of measurement series is now possible with the recently introduced AutoSampler, which can be combined with both models of the ANALYSETTE 22 — the MicroTec plus, with an all-round laser offering a measuring range of 0.08–2000 µm for all typical measurement tasks, and the NanoTec plus, a high-end instrument for measurements down to the nano range, providing outstanding precision and sensitivity for the smallest particles through the measurement of backward scattering in a third laser beam.

The new AutoSampler has 26 positions for 40 ml containers and provides complete sample feeding, automatic dispersion, measurement and cleaning. Further benefits include: • complete sample feeding via the tilt function • programmable rinsing function for each container • automatic standard operating procedure control of all processes • retrofittable for the FRITSCH Wet Dispersion Unit. Regularly updated information on FRITSCH particle sizing technology, from dynamic image analysis to dynamic light scattering and static laser scattering, and descriptive videos can be found on FRITSCH’s website. FRITSCH GmbH • Milling and Sizing +49 67 84 70 146 koehler@fritsch.de www.fritsch-sizing.com

With the introduction of the Morphologi G3-ID system last year, Malvern Instruments is providing researchers with the ability to apply morphologically directed Raman spectroscopy to a range of different sample types. Such advanced particle analysis is proving valuable and highly effective in applications that include inhaled product characterisation and pharmaceutical bioequivalence studies, bioequivalence for nasal sprays having been referenced specifically in a talk given by the FDA at this year’s IFPAC Annual Meeting in Baltimore, Maryland, US. The use of morphologically targeted Raman spectroscopy has also been described in the independent article ‘Advanced Particle Analysis Integrated Into Performance-directed Characterization’, Justin Pritchard and Martin Warman, American Pharmaceutical Review, July 2012, as part of granulation studies, to provide the

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physical and chemical identities of particles in mixed populations. By combining automated particle imaging with Raman spectroscopy, the Morphologi G3-ID offers a single platform for the measurement of particle size, shape and chemical identity. The technology involved enables independent characterisation of individual components present within a blend or mixture, while the instrument itself is designed for automation and ease of use. Standard operating procedures control all aspects of the measurement from sample dispersion through to size, shape and chemical analyses, enabling automatic selection, targeting and chemical classification of thousands of individual particles. Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com

Corporate News

Analytical Instrumentation Specialist Grows Sales Orders by 30% Despite challenging economic conditions and in the face of fierce competition, Shimadzu UK has achieved sales order growth of 30% in the last two years. This growth has been achieved across many products in the Shimadzu range, including GC, GCMS, LC, LCMS, spectroscopy, TOC and material testing solutions. A long-established company, Shimadzu is a global presence in mass spectrometry, chromatography, atomic spectroscopy and thermal analysis and is known for its high-quality engineering and robust, technically advanced scientific instrumentation. Darin Enefer, Shimadzu UK’s Sales & Marketing Director, believes that the company is now really making its mark in the highly competitive UK market: “We have a committed and extremely knowledgeable team of people in Shimadzu UK, ensuring that our customers get the highest levels of support and continuity of service as well as state-of-the-art analytical solutions. Our reputation is growing in the best possible way, through having satisfied

customers who pass on that confidence to others.” Having undertaken a survey of laboratory personnel and those in purchasing roles, Shimadzu UK identified three areas of opportunity on which to build and which Enefer believes are proving crucial to the company’s current success. “It seemed that a gap existed in the market for a scientific instrumentation provider to do three things — listen, provide insight and focus on relationships,” he said. “Taking the time to listen and fully understand what a customer wants is absolutely essential. We recruit and retain people who are both scientifically competent and possess the interpersonal skills needed to build lasting, trust-based relationships. “When it comes to providing insight, we focus intensively on becoming a ‘technical ally’ for the customer, cocreating solutions that really help them towards more effective ways to implement method development and obtain the most accurate and definitive analysis. Many companies in tough

economic times cut back on staff. We did the opposite and have in fact recruited more and more technical specialists who work with the customer, helping them achieve their objectives “Finally, our focus on the relationships means that we don’t stop at the sale, but always look to the longer term, working as a team with our customers and supporting them in mapping their short, medium and long term requirements. Our team approach means that customers often build relationships with sales, service, management and operational staff, all of whom are UK-based and readily available. An implementation manager assigned to every installation makes sure the customer is fully informed so that the installation itself is successful, training is delivered effectively and the user can quickly apply the solution they

have bought to maximise the return on their investment.” The rapidly growing customer base is testament to Shimadzu UK’s commitment to delivering class leading support in all areas. Summing up, Enefer said: “We are proud of our company, our people and most importantly how we work. It’s about principles and pride and making sure we deliver on our promises.” Shimadzu UK +44 1908 552209 sales@shimadzu.co.uk www.shimadzu.co.uk

UK Researchers to Benefit from Highly Sensitive Lanthanide Labelling Reagents Range Cambridge Research Biochemicals (CRB) has signed an exclusive deal with Bio-Nobile (BN) Products and Services in Finland to promote and sell QuickAllAssay labelling reagents in the UK. The ready-to-use reagents are used for labelling of proteins, antibodies and small molecules with a europium chelate and are reportedly unique in that only one kit is required for labelling all assay formats, including time-resolved fluorescence resonance energy transfer (TR-FRET) and quenched resonance energy transfer assays (QRET), and for separation based enhanced timeresolved fluorescence assays. The QuickAllAssay kit offers researchers looking to quantify biochemical markers a number of significant advantages over traditional assay technology. According to the companies, separation based TRF assays, also known as dissociationenhanced lanthanide fluorescent immunoassays (DELFIA), offer a

superior alternative to traditional ELISA technology as they are significantly more sensitive, have a broader dynamic range and are more robust than enzyme-based assays. The QuickAllAssay kit can offer dual and triple label separation based (coated plate) assays, which are now routinely being used by screening laboratories. Lanthanides are now the perfect choice of label with which to build such assays as they offer the possibility of building multi-label measurements within the same well. “We are delighted to be able to offer QuickAllAssa to our UK customers,” commented Emily Humphrys, Commercial Director from CRB. “We believe having a unique kit for both homogeneous and separation assays, which is significantly more sensitive and has a broader dynamic range in one easy-to-use kit, will be of significant benefit to researchers. We are also able to offer custom europium labelling of

peptides, proteins and antibodies, which further broadens our labelled product offering.” CRB is a leading manufacturer and supplier of specialist custom peptides and antibodies and works with some of the largest pharmaceutical companies

and research organisations in the world. DELFIA and LANCE are registered trademarks of Perkin-Elmer. Cambridge Research Biochemicals +44 1642 567180 crbsales@crbdiscovery.com www.crbdiscovery.com

Strategic Alliance Extends Possibilities in Lab and Process Analysis Metrohm and FOSS have entered into a strategic alliance, strengthening the two companies’ positions in their respective key markets. Metrohm will become the sole global distributor of FOSS NIR instruments for the chemical, petrochemical, pharmaceutical and environmental sectors. “Metrohm will extend its product offering beyond the company’s traditional focus on solutions for wet-chemistry analytical techniques, thereby benefiting our

customers with new possibilities both in laboratory and process analysis,” said Dr. Christoph Fässler, CEO of Metrohm. FOSS will continue its strong R&D programme within NIR technology and manufacturing for both companies. “The strategic alliance allows FOSS to focus its NIR business on the food and agricultural industries that we have served for more than 50 years while continuing our leading position within NIR technology and making this

technology available to a broader customer base,” said Torben Ladegaard, CEO of FOSS. Under the deal, FOSS NIRSystems, Inc., based in Laurel, Maryland, US, will become a division of Metrohm USA, to be named Metrohm NIRSystems. “With Metrohm’s strong worldwide presence, commitment to the pharmaceutical and chemical industries and with this investment in NIR, the alliance allows us to further grow our business within these sectors

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and provide our customers with a steady stream of new, innovative NIR products and the highest level of support”, said Dr. Philip Irving, President of FOSS NIRSystems. The global NIR instrument business for these sectors will continue to be run by the Metrohm NIRSystems division of Metrohm USA. Metrohm UK Ltd +44 1928 579600 info@metrohm.co.uk www.metrohm.co.uk

INGREDIENTS & CONTRACT SERVICES

Contract Manufacturing Facility in Halle Expands to Cater for Growing Cytoxics Market Baxter International’s BioPharma Solutions business has begun an approximately 1,750 m2 capacity expansion at the company’s fill/finish cytotoxic contract manufacturing facility in Halle, Westfalen, Germany. The facility continues to grow and has been expanding to meet clients’ growing needs for cytotoxic manufacturing, further enhancing Halle’s complete range of resources to support early phase drug formulation through commercial scale-up, product launch and lifecycle management. This latest effort follows previous capacity expansions in Halle in 2007 and 2011. “Cancer incidence is on the rise and cytotoxic therapies continue to be at the centre of oncology treatment programmes,” said Dr. Burkhard Wichert, Vice President of Manufacturing for Baxter’s BioPharma Solutions business. “Through this expansion in Halle, Baxter will continue to support pharmaceutical companies’ efforts to address patient needs worldwide.” To support the needs of clients globally, the expansion includes the installation of a new commercial filling line with two freeze dryers as well as a clinical filling line with an additional freeze dryer. Both the new commercial and clinical lines will be equipped with an automated loading/unloading,

capping and inspection infrastructure. This expansion is expected to be complete in 2015 and has been designed to support international manufacturing and regulatory requirements. Baxter’s Halle facility has a wide range of capabilities, including commercial-scale production of cytotoxic emulsions, liposomes and suspensions as well as a nanoparticle suite equipped with a high pressure homogeniser. The site is equipped with barrier isolator technology and is one of the most advanced facilities for cytotoxic contract manufacturing in the world. With more than 50 years of experience, the facility’s capabilities include: lyophilisation; process development; aseptic filling of cytotoxic, non-cytotoxic and highly potent liquid and sterile powder vials in clinical and commercial batch sizes; sterile crystallisation of cytotoxic APIs; and expertise in the manufacturing of antibody-drug conjugates. “We believe in our customers and the patients they serve, which is why we continue to invest in the Halle, facility,” said Dr. Wichert. “This expansion and

our advanced technologies allow Baxter to stay at the forefront of parenteral cytotoxic manufacturing while increasing the current Halle workforce by approximately 10%.” The Halle facility is part of Baxter’s BioPharma Solutions business, which supports leading pharmaceutical companies in meeting their commercialisation objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customised support services needed to meet the unique challenges that parental products face. Baxter International Inc. +1 224 948 1812 www.baxter.com / www.baxterbiopharmasolutions.com

Solubilsation Technologies Expert to Expand Pharma Center of Excellence in Delaware Ashland has announced plans to expand its pharmaceutical research and development Center of Excellence at the Ashland Research Center in Wilmington, Delaware, US. Ashland will be expanding its existing capabilities to include formulation development and GMP contract manufacturing services for solid dispersions and oral solid dosages. To support early-stage clinical trials, the expansion will include spray drying and extrusion processes previously located in Columbia, Maryland, US. Approximately 20 positions will be relocated from Columbia to Wilmington in connection with the expansion. The company expects the new facility to be operational by summer 2014, enabling the company to further support the evolving needs of its pharmaceutical customers. Ashland has additional pharmaceutical technology centres in: Buenos Aires, Argentina; São Paulo, Brazil; Shanghai, China; Düsseldorf, Germany; Hyderabad, India; Istanbul, Turkey; and Mexico City, Mexico. “This relocation and expansion supports Ashland’s commitment to ongoing investment in drug solubilisation to help our customers

capitalise on future growth opportunities,” said John Panichella, President, Ashland Specialty Ingredients. “Delaware’s recent decision to provide incentives to encourage Ashland’s growth demonstrates the state’s positive outlook and its commitment to business expansion in Delaware. I am extremely excited Main entrance area at the Ashland Research Center in Wilmington, about the growth Delaware, featuring the Regulated Industries building. opportunities for our pharmaceutical product line and recognise that the multiple technical support labs around state’s actions were integral to our the world, will enable Ashland to deepen decision.” our relationship with customers and “This expansion highlights our ability to allow us to quickly solve customer provide high-value ingredients backed problems.” with superior technical support,” added May Shana’a, Vice President, Ashland Specialty Ingredients Technology and Growth Strategy, +1 302 594 6850 Ashland Specialty Ingredients. “This rrruberti@ashland.com Center of Excellence, combined with our www.ashland.com

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INGREDIENTS & CONTRACT SERVICES ROUNDUP Emulsion Technology for Micro Encapsulation to be Used in GMP Pharma Production Aesica and EmulTech have jointly announced the commercial development of emulsion technology for micro encapsulation (ET4ME) for product formulation. ET4ME, developed by the EmulTech group (a spin out of Eindhoven University of Technology), utilises an elegant micro fluidic process to create a measurable micro particulate suspension where particle size is uniform and reproducible. The technology can be used for a multitude of APIs from small molecules to complex biomolecules, with high levels of batch consistency and reproducibility upon scale up. By utilising a closed system, sterile formulations can be achieved, coupled with resistance to oxidative degradation. The product is already being actively used by an Aesica client to help develop a new dosage form in an acid resistant non-sterile suspension. However, the partners envisage huge growth in the use of this technology for

Drug Delivery CRO and Wet Milling Equipment Provider Enter Collaboration Particle Sciences has teamed up with NETZSCH Premier Technologies to provide drug developers with improved access to state-of-the-art pharmaceutical nanomilling equipment and full pharmaceutical development capabilities. According to Robert Lee, PhD, Vice President Pharmaceutical Development, “Particle Sciences has been using particle size reduction — in both dry and liquid-dispersed states — for decades. With this collaboration, we acquired a NETZSCH DELTAVITA Mill, which is one of the premier systems for pharmaceutical applications. There is a growing demand for wet-milled products, particularly with respect to sterile products. In fact, we are currently working on approximately 20 milling projects; the majority being sterile products. The additional capability allows our clients to get into the clinic faster with a commercially representative manufacturing process.” Particle Sciences focuses on commercially-ready, advanced drug delivery technologies and is FDA registered and licensed for all schedules of controlled substances. Randall Smith, President of NETZSCH Premier Technologies, added: “Particle Sciences provides customers that are interested in wet milling access to full development capabilities, including being able to take their products from feasibility into preclinical testing, then ultimately human clinical trials and commercialisation. They will be a valuable partner to fully demonstrate the utility of our equipment and we will work with them as they continue to expand.” Particle Sciences +1 610 861 4701 mmattera@particlesciences.com www.particlesciences.com

sterile products following an externally validated process simulation trial (PST). Over three years in development, and thanks to the creation of an aseptic protocol by Aesica, the technology has applications in the formulation of injectables — in particular, depot injections for sustained release due to the uniform droplet size, loading and morphology. Formulations have demonstrated improved aqueous stability that will enable customers to revisit previously abandoned products such as injectables, poor solubility compounds and new formulations of existing products. Ian Lafferty, Site Director at Aesica Formulation Development, commented: “We first came across the technology at a conference a few years ago and realised that if we could develop an aseptic process — it’s a tremendous credit to our development team that we could achieve this — it would provide an elegant solution to many compounds. Already, we have started

working with several clients to commercialise this technology and there is a tremendous growth opportunity for sterile products and injectables.” Fränk de Jong, CEO at EmulTech, added: “We knew we had a very innovative proprietary technology and by working with Aesica we now have access to their GMP approved facilities in Nottingham. This, coupled with their ability to develop an aseptic process for the technology, has enabled us to offer a commercialised solution that has the potential to develop formulations that would previously have been unachievable. Thanks to Aesica, the process has been PST validated for steriles and there is a clear emerging demand to develop formulations using this approach.” Aesica Pharmaceuticals Ltd +44 191 218 1960 info@aesica-pharma.com www.aesica-pharma.com

Biopharma CMO Appoints Chief Business Officer Rentschler Biotechnologie has announced the appointment of Frank Ternes to the position of Chief Business Officer. In this position, Ternes will contribute to the success of the organisation by leading the planning, development and execution of all business development, sales and marketing and project management activities. “Mr. Ternes is an excellent addition to Rentschler's management board,” said Dr. Nikolaus F. Rentschler, CEO and owner of Rentschler. “With his broad

experience in the contract manufacturing business, he has a keen understanding of technology, a strong customer focus and a proven track record for achieving success.” Ternes brings more than 25 years of experience from Operations and Technology at Boehringer Ingelheim where he last served as Senior Vice President of Biopharmaceutical Contract Manufacturing. Ternes holds a degree equivalent to a master’s degree in economics from the University of Bonn, Germany.

Rentschler Biotechnologie GmbH +49 7392 701 478 friederike.braun@rentschler.de www.rentschler.de/en.

Packaging Expert Extends Extractables and Leachables Range of Analyses SCHOTT has experienced a strong demand for laboratory services related to extractables and leachables (E&L) and therefore continued to expand this range of analyses offered to its customers. At international trade fair Pharmapack Europe, the German group of companies announced this extension of its services. Extractables and leachables are substances, which can be dissolved and released from the constituent parts — glass, metals, rubber, lubricants, adhesives, etc. — of the packaging materials that form the container system. To determine any possible interactions with the drugs and exclude them, pharmacists are obliged to perform extensive studies. This procedure is mainly intended for the protection of patients. “Through our extended service offering, we are able to support pharmaceutical customers even more efficiently in the assessment of risks,” said Dr. Uwe Rothhaar, Director of SCHOTT Pharma Services division. By strengthening the E&L range of analyses, SCHOTT Pharma Services underlines its position as an experienced partner for pharmacists who benefit not only from SCHOTT’s decades of expertise but also from a combination of laboratory services. Since, as early as in 1911, the SCHOTT group started to produce pharmaceutical containers made of

glass and, at a later date, also commenced to manufacture pharmaceutical packagings such as ampoules, vials, cartridges and syringes, the company has built up comprehensive product and process know-how. Furthermore, SCHOTT maintains a basic research centre for glass by itself. This know-how and these professional skills have been pooled in the SCHOTT pharma services division and since 2009 have also been available to enterprises outside the group. “An increasing number of drug manufacturers ask us to test their outer packages. The spectrum ranges from the analysis of interactions between drug and packaging materials to fracture and strength tests,” stated Rothhaar. His team offers a wide range of analytical services based on the modern instruments of a laboratory that benefits from continuous investment. In addition,

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the resources of the central Research and Technology Development division of SCHOTT — located in the same building in Mainz, Germany, as well as in Duryea, US — can be called on as well. The entire laboratory as well as its operations and processes are accredited to DIN EN ISO 17025. SCHOTT AG +49 6131 66 7339 pharma.services@schott.com www.schott.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP Regulatory Affairs Specialist Launches Clinical Trials Services

Biocatalysis Agreement Continues with Success

ELC Group has launched a new Clinical Trials service for pharmaceutical customers worldwide. The new end-toend service offering spans bioavailability/bioequivalence (BA/BE) and phase I studies, phase II to phase IV and post-marketing surveillance (PMS) studies, medical writing, biostatistics and statistical programming services, clinical data management (CDM), good clinical practice (GCP) audits and training. The new portfolio has been developed specifically to help customers expedite the regulatory submission process and speed time to market. For phase I studies, ELC Group is providing its pharmaceutical customers with full regulatory consulting support, protocol design, assistance with ethics committee submissions, plus access to a Clinical Pharmacology unit and bioanalytical testing — delivered from a centre that is approved by all major regulatory agencies. Additional services include clinical study management, method development and validation, data management, pharmacokinetic (PK) analysis, statistical analysis and report writing. For phase II to phase IV and PMS studies, ELC Group now offers a full range of services, including study feasibility, site and investigator selection, site monitoring, project management, clinical trial supply management and vendor management. As part of its Clinical Trials portfolio, ELC Group is also providing expert biostatistics and statistical programming services — covering all major therapeutic areas — and delivering insights into trial design as

In October 2012, Almac announced a collaboration agreement with DSM Pharmaceutical Products — the custom manufacturing and technology business of Royal DSM N.V. — in the field of biocatalysis to provide sustainable manufacturing services to the pharmaceutical industry and has reported the continuing success of the relationship, including the successful transfer of enzymes for enzyme screening, process development and scale-up manufacture. The agreement grants both parties access to their enzyme platform technologies, services and expertise for the manufacturing of APIs. Almac’s expertise in rapid enzyme identification, scale-up and implementation into early phase projects complements DSM’s experience and track record of over 30 commercial manufacturing bioprocesses run on a multi-tonne scale. This gives customers of either party access to enzyme expertise and assets, resulting in cost-effective, green processing at all phases of development from preclinical to commercial manufacturing scale. The collaboration also enables Almac to offer its customers a preferred partner for large-scale production. Since then, Almac and DSM have initiated and completed multiple projects together in the fields of ketoreductase, transaminase, biooixdation and hydrolase. According to the companies, having access to the largest portfolio of off-the-shelf enzymes has really aided in moving projects from conception to reality for customers. Dr. Tom Moody, Head of Almac Biocatalysis, stated: “The success of the projects undertaken between Almac and DSM already demonstrates there is a market for scalable green technologies to access difficult-to-make chiral chemicals. Cost remains a prevalent issue within the industry and the

well as developing complex statistical analysis plans. In addition, ELC Group now offers CDM services for early clinical development and late phase clinical development programmes, including managing data for pharmacovigilance and pharmacokinetic/pharmacodynamic (PK/PD) services. The new service portfolio is rounded off with ELC Group’s GCP auditing, quality assessment and risk analysis services, plus GCP training and workshops for the Institutional Review Board/Independent Ethics Committee (IEC/IRB). All services are complemented by ELC Group’s expert medical writing capability for regulatory submissions, scientific communications and medico-marketing material. Commenting on the Clinical Trials service launch, Marco Rubinstein, CEO of ELC Group, said: “With our new Clinical Trials portfolio, we are delivering a fullservice solution to help ease the regulatory approval process and shorten key timelines for our customers. Our Clinical Trials services are fully customisable and can be offered on a standalone basis or as part of our integrated full-service package, offering ultimate flexibility to our pharmaceutical customers looking to expedite product delivery and create a competitive advantage in the market.” ELC Group +42 22 491 00 00 ajain@elc-group.com www.elc-group.com

introduction of enzymes into processes earlier in the drug discovery pipeline helps to drive cost down as projects move forward. Our collaboration is delivering real rewards to clients from both a technical and financial perspective.” Almac’s success in the biocatalysis field was further endorsed recently by the completion of the Knowledge Transfer Partnership (KTP) with Queens University Belfast to develop, improve and embed bioprocesses in order to facilitate the delivery of novel products for its biocatalysis business. The project was awarded the highest grade of ‘Outstanding’ by the KTP Grading Panel for it’s achievement in meeting KTP’s objectives. Almac Group +44 2838 363363 tania.davis@almacgroup.com www.almacgroup.com

Top 10 Pharma Company Signs Deal for Therapeutic Antibody Platform Another global pharmaceutical company has licensed ProBioGen’s GlymaxX ADCCenhancement technology. The license covers the modification of the pharmaceutical company’s antibody production platform for the generation of antibodies with enhanced potency. The continued licensing success demonstrates the industry’s endorsement of GlymaxX. The GlymaxX technology is highly versatile since it can be applied to any starter or production cell line. It allows both the robust, permanent modification of established antibody expression platforms as well as the rapid conversion of existing antibody producer clones to produce ADCC-enhanced molecules. The GlymaxX technology is based on the stable expression of a heterologous enzyme in the antibody producing cells. GlymaxX prevents antibody fucosylation almost completely but moreover allows the exact adjustment of any desired fucosylation level through the controlled addition of fucose into the culture medium. EPM 36

The license with an option for a commercial license covers the modification of the company’s antibody production platform and the generation of multiple antibodies with enhanced ADCC potency. The technology can be licensed royaltyfree, based on milestone-dependent license fees only. ProBioGen AG +49 30 924 006 0 cmo@probiogen.de www.probiogen.de / www.glymaxx.de

INGREDIENTS & CONTRACT SERVICES ROUNDUP Acquisition Expands Lipid Expertise and Adds FDA Inspected Commercial Manufacturing Facility Capsugel has acquired Encap Drug Delivery. Based in Scotland, Encap’s focus on liquid and semi-solid encapsulation-based product development and clinical and commercial manufacturing for the pharmaceutical industry complements Capsugel’s recently-established Dosage Form Solutions (DFS) business unit. “Encap’s capabilities and offerings align seamlessly with our DFS business unit, which is focused on lipid-based formulations and targeted release capsules,” said Guido Driesen, President & CEO of Capsugel. “This acquisition will accelerate the growth of DFS and further strengthen our leadership position in

liquid-filled formulations in hard capsules.” Amit Patel, President of Capsugel DFS, added: “The combination of DFS and Encap creates greater depth and breadth of our technology platforms, product development capabilities and manufacturing infrastructure, which will collectively enhance our ability to improve our healthcare customers’ products in areas such as bioavailability, stability, dosing and delivery and overall time to market.” Encap operates an FDA and MHRA inspected pharmaceutical product development and manufacturing site, is equipped to handle high potency active

ingredients and has established a clinical fast-track programme that can speed the process from laboratory to clinic. Additionally, Encap’s proprietary targeted release technologies (DuoCap and ENCODE) and abuse deterrence technologies (Abusolve) will add to Capsugel’s growing suite of offerings in these areas. Capsugel DFS’s lipid-based technology platform currently includes proprietary Licaps liquid-filled capsules, softgels, solid-lipid pellets and a lipid formulation software system aimed at accelerating lipid-based product development for customers. The business unit’s emerging targeted release technology platform

Uppsala University’s Professor of Biopharmaceutics Joins CDMO’s Operating Board Recipharm Pharmaceutical Development has appointed Dr. Hans Lennernäs to its Operating Board. Dr. Lennernäs is a Professor of Biopharmaceutics at Uppsala University, Sweden. He currently manages an IMI project entitled OrBiTo, which aims to improve oral drug delivery, controlling a budget of €24.5 million. His research responsibilities and remit are focused on membrane transport and metabolism of drugs/metabolites in the gastrointestinal tract, hepatobiliary system and cancer tissues. Dr. Lennernäs has served as the Principal Investigator in an extensive collaboration with the FDA, University of Michigan, US, and Medical Product Agency, Sweden, over the course of several years, in which he developed a new guideline for the Biopharmaceutics Classification System. He has established an extensive and widely used human permeability database. In addition to his academic achievements, Dr. Lennernäs has built an entrepreneurial reputation by cofounding several companies, including DuoCort Pharma AB and LIDDS AB, whilst investing in a number of patents. “I am very much looking forward to serving on the Board of Directors at Recipharm Pharmaceutical Development,” commented Lennernäs. “This is a company with an excellent track record and an impressive longterm strategy in place.” “We are very pleased to welcome a Board Member of Hans Lennernäs’s calibre,” remarked General Manager Maria Lundberg. “His track record of successfully inventing and developing several novel drug delivery systems that are currently in pre-clinical phase and in preparation for phase I, II and III clinical trials, makes him an excellent addition. I look forward to Recipharm benefiting from his contribution and insights that will help the company perpetuate its track record of commercial success.” Recipharm AB +46 8 602 52 00 info@recipharm.com www.recipharm.com

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includes specialised capsules that enable different types and levels of controlled release delivery. Dr. Stephen Brown, CEO of Encap Drug Delivery, stated: “The acquisition by Capsugel will globalise the reach of our products and services. Encap’s focus on liquid-filled technologies has allowed us to develop depth in bioavailability enhancement and drug delivery and we are pleased to join Capsugel.” Capsugel +1 860 389 0868 www.capsugel.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP GMP Facilities in Germany Ensure Secure and Specialist Supply Chain Solutions Azelis is one of the leading distributors in the pharmaceutical, personal care, food and animal feed industries that increasingly need to accommodate the latest standards in product handling in terms of purity, storage and filling. As a result, exciting changes have taken place at Azelis in Germany, leveraging supply chain to premier levels. Michael Thomson, Regional Managing Director, Azelis DACH, stated: “After successful completion of the ESAD (European Single Assessment Document) in 2006, we are now going one step further. Our sites in Germany are fully compliant to the GMP standard for cleanroom filling in 2013 and we are now pleased to be able to contract this and other value adding services to chemical manufacturers looking for safe, efficient, high quality routes to market.” Azelis’ German operation has two sites conveniently located near the chemical heartland of Europe, in Krefeld and St Augustin, near Bonn. Krefeld is a specialist site for pharmaceuticals and

has been certified GMP and GDP since 2008. The qualified, temperature controlled ambient and cold store pharmaceutical warehouse has a capacity of 1,500 m2 with more than 1,000 European pallet spaces. Oliver Pohlmann, Supply Chain Manager, Azelis DACH, commented: “As one of the few sites with a narcotics license, manufacturing authorisation license and Known Consignor (an exclusive airfreight clearance of actives for export), a whole range of business possibilities is opened for the perfect combination of authorised routes to market. Additionally, a laminar flow bench allows state-of-the-art filling for APIs and excipients in solid form. “Our centre for liquids is located at St. Augustin. This site is an efficient drumming (from bulk to IBCs to cans) and storage facility, with separate units for temperature controlled ambient and cold store. “There are two main areas, one for industrial chemicals and one ESAD/GMP

qualified cleanroom for food, nutrition and personal care products as well as for liquid pharmaceutical excipients. From 2013, premier cleanroom drumming can be undertaken to comply with the following standards: GMP, HACCP, Kosher and Halal.”

Through semi-automatic filling lines to the manual filling of small units, quality control, storage and dispatch, St. Augustin offers the flexibility to open up new business opportunities for chemical manufacturers looking to consolidate efficient, secure supply routes to market. These specialist facilities are lead by a team of fully qualified experts covering all aspects of the business. Thomson concluded: “Azelis guarantees quality and security and we do everything we can to ensure product safety. From 2013, as a result of completing the ESAD and now gaining the GMP standard at all sites, we are now in a position to offer these rarely available value added services and supply chain solutions to external partners. We welcome audits at any stage.” Azelis +44 1992 825555 gillian.berry@azelis.com www.azelis.com

Chemistry Specialist Boosts US Commercial Team Onyx Scientific has further strengthened its US team with the appointment of another business development professional. Adam Moorhouse joins the contract research and manufacturing organisation as a Director of Business Development and will be responsible for developing new prospects for the UK-based company in Western US. Thirty-year-old Moorhouse is the latest high-profile appointment for Onyx Scientific after the company recruited Chicago-based Commercial Executive Dan Brisard to oversee its business development activities across the eastern half of the US in November. With a first class degree in Chemistry

from the University of Oxford, UK, and a PhD in Organic Medicinal Chemistry from the University of Nottingham, UK, Moorhouse brings impressive technical knowledge to his new role. Vineet Luhariwala, Business Unit Head at Onyx Scientific, said: “Adam demonstrates a very high level of energy and enthusiasm that will no doubt make him a major asset to our business development team. “His superb chemistry knowledge will equip him well to identify and pursue business opportunities with existing pharmaceutical and biotechnology clients and prospects on the West Coast.” With MHRA and FDA facilities in the

UK and India, Onyx Scientific assists companies from medicinal chemistry and preclinical through Phase I–III, scaling up to large-scale, commercial API production. Moorhouse joins the CRO following two years working in international business development and account management for a UK-based laboratory instrument manufacturer. He said: “Given my qualifications in chemistry and recent commercial experience, joining a well-established company like Onyx Scientific is a great opportunity. The backing and strategic alliance of a large, successful Indian company like Ipca Laboratories also proved a very attractive proposition.

“I am looking forward to representing Onyx Scientific in the US, with the confidence in the knowledge that the contract service we provide is strong enough to generate 96% customer return business.” Onyx Scientific’s UK-based laboratories deal with complex chemistry to deliver early-stage programmes and are then able to scaleup, tech transfer and increase project efficiency using its commercial manufacturing sites in India.

and focus on late phase clinical development projects. Our clients can be further assured that our systems and procedures are robust and their products will be delivered to the highest quality.” Alan Chambers, Head of Quality Assurance, added: “This success confirms Almac’s dedication to delivering the highest quality standards. To complete this inspection with no findings is testament to the knowledge and expertise of the entire Almac workforce. We are committed to building on these strong foundations

with continual investment within our quality systems.” Almac has also announced the expansion of its manufacturing and support facilities at its Craigavon plant. These include an extended API facility, which doubles the current GMP APIs manufacturing capacity and expansion of its stability storage chambers also with a doubled capacity increase.

Onyx Scientific Ltd +1 908 412 6561 www.onyxipca.com / www.twitter.com/onyxscientific1

CDMO Receives FDA Inspection Approval Following successful MHRA audits in 2011, Almac’s Sciences Business unit has completed a successful inspection of its analytical facilities at its Craigavon headquarters, Northern Ireland, from the FDA. The inspection concluded with no objectionable conditions (483 observations) nor recommendations for improvements. The inspection of the control testing laboratory was in support of preapproval inspections for products for which Almac Sciences is named as the contract test laboratory. The three-day inspection covered the quality and

laboratory control systems and included tours of all test laboratories and specialist analytical facilities, including mass spectroscopy laboratories. Commenting on the approval, President and Managing Director Stephen Barr said: “We are delighted with the outcome of this inspection. We have now established a track record with both authorities that highlights our strong focus on compliance and regard for regulatory standards. This outcome is even more significant with the completion of our expanded API facility

Almac Group +44 2838 363363 tania.davis@almacgroup.com www.almacgroup.com

European Pharma Logistics Provider Extends Warehouse Movianto has expanded its warehouse capacity in Neunkirchen, Germany. With an additional 10,000 m2, the site in the Saarland region now offers capacity for over 32,000 pallets for temperature controlled storage (15 to 25 ˚C), 2,400 spaces for cold storage (2 to 8 ˚C) and 600 spaces for controlled drugs. The warehouse sets high technical standards; the hall is equipped with WLAN, ensuring that picking can be undertaken via wireless barcode

scanners. Since the authorisation given by the local authorities on 4 December 2012, Movianto Germany’s new 1,000 m2 limited manufacturing area, with its nine manufacturing lines, is operational. Here, enough space for country-specific repackaging and relabelling is available as well as a separate area for the storage and handling of medical products. The new facility has been optimised with direct access to the high bay area.

“We are delighted to be able to offer our clients an even better service,” stated Thomas Creuzberger, Managing Director of Movianto Germany. “The expansion of our warehouse capacity by 6,000 pallet spaces and the extension of the export area means that export processes can be accelerated further.” A total of 10 dispatch gates in the new hall guarantees the continual and speedy handling of goods. Movianto is in an ideal position to offer

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its customers a comprehensive service portfolio. The specialist has, for example, taken on all logistics tasks in the centralised warehouse for one of its clients. The services offered range from goods receipt, storage and pick and pack to dispatch and end control for export items. Movianto Deutschland GmbH +49 6821 5016 419 astrid.grahn@movianto.com www.movianto.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP UK Facility Investment to Expand Early Development Capabilities in Europe

Patheon has announced plans for additional investment in its Milton Park facility. Located in Oxfordshire, UK, Milton Park is a dedicated pharmaceutical development services facility focused on early development projects. As part of its early stage offerings, Milton Park currently provides proof-ofconcept and first-in-man development programmes for oral dose forms. It also offers Quick to Clinic, which provides clinical trial materials as fast as four months from receipt of API. This service has been structured to provide support to emerging pharmaceutical companies with promising molecules. With the first phase of additional investment to Patheon’s Milton Park facility, the company will be able to expand upon the early development capabilities currently being offered, including the introduction of the SoluPath programme. SoluPath is reportedly the first, fixed-price, multiplatform solution to improve bioavailability that allows parallel formulation screening using multiple, leading edge technologies to review aqueous, lipid-based and solid state formulations. The result is a bespoke formulation development programme for low solubility/bioavailability molecules, which should facilitate a faster route to the clinic. The purchase of a new HME screening tool and spray dryer will supplement existing technologies at Milton Park to provide the SoluPath service to emerging pharmaceutical companies with poorly soluble molecules. “The introduction of Solupath into Milton Park’s existing capabilities is an exciting addition to Patheon’s service offering in Europe,” said Robin Platt, Senior Director, Operations for Milton Park. “Poorly soluble compounds are increasingly common in pharmaceutical development and we believe Solupath provides a mechanism for identifying the most effective way of improving bioavailability of molecule in these cases.” Paul Garofolo, Executive Vice President, Global PDS Operations, added: “Solupath has been operating successfully in Patheon’s North American facilities. Establishing this capability in Europe is part of Patheon’s global strategy to expand early pharmaceutical development services for our customers.” Patheon Inc. +1 919 226 3200 doingbusiness@patheon.com www.patheon.com

Collaboration to Focus on Improved API Process Development Albany Molecular Research, Inc. (AMRI) and Codexis have entered into a SMARTSOURCING partnership. The collaboration will provide opportunities to combine the two companies’ capabilities and technologies for specific customer projects, yielding increased value to customers in the form of potentially lower costs, greater yields, cleaner processes and/or faster turnaround times. Under this non-exclusive, two-year agreement, the companies will align their respective strengths to identify and implement new and improved manufacturing routes for selected APIs. Combining Codexis’ directed evolution technology that enables rapid enzyme discovery and optimisation with AMRI’s process development and manufacturing capabilities, including utilising AMRI’s proprietary microbial strains, creates synergies that will broaden both companies’ ability to offer customers cost-effective, efficient and sustainable manufacturing processes. “We are pleased to announce this partnership with Codexis, a company that shares our philosophy of prioritising

scientific problem solving, innovation and customer service,” said AMRI’s Chairman, President and CEO Thomas E. D’Ambra, Ph.D. “Combining AMRI’s expertise in chemistry, biocatalysis, quality assurance and manufacturing with Codexis’ cutting edge biocatalysis technology and services creates a proprietary advantage to our customers’ development projects. This is another example of the AMRI SMARTSOURCING strategy of creating partnerships to deliver better outcomes to our customers.” “Codexis selected AMRI for this collaboration because AMRI understands the opportunity to use biocatalysis for effective and comprehensive route assessment and manufacturing,” said Dr. Peter Seufer-Wasserthal, SVP Pharmaceuticals, Codexis. “Both companies have established strong reputations in the pharmaceutical manufacturing industry. By working

together, AMRI and Codexis should identify more opportunities, which will benefit both companies and their customers by developing innovative, cost-effective and practical chemical processes.” Albany Molecular Research, Inc. +1 518 512 2261 www.amriglobal.com Codexis, Inc. +1 212 362 1200 www.codexis.com

Drug Development Facility in Verona Highlights Imaging Brain Studies Offering Stuart Needleman, President and Chief Operating Officer, Aptuit, reported that Aptuit provides scientific expertise to biotech and pharmaceutical companies in need of the design, implementation and analysis of imaging brain studies. Needleman stated: “Since PET (positron emission tomography) brain studies have taken hold as a reliable technology in predicting dosages for human studies, scientists at The Aptuit Center for Drug Discovery & Development in Verona, Italy, have been supporting customers with clinical research services that include highly specialised design implementation and analysis of PET studies and other imaging techniques. Clients can turn to Aptuit with the confidence that we offer well-established knowledge and experience in this groundbreaking nuclear medicine imaging technique.” It was explained that Aptuit can design

and implement PET studies by selecting the PET centre that is best suited to the customer’s specific requirement. Stefano Zancan, Clinical Science Head at The Aptuit Center for Drug Discovery & Development, said: “Our clinical sciences team has ongoing relationships with the most notable and distinguished PET centres around the world. Working alongside scientists at specially selected PET centres, Aptuit advances the study’s implementation and provides our analytical expertise in PK (pharmacokinetic) analysis and PK/PD (pharmacokinetic/pharmacodynamic) correlation to interpret the resulting data. The integration of PET occupancy studies into clinical drug development plans provides a valuable tool for dose selection and optimisation in humans by characterising the relationship between the time course of plasma drug

concentration and target receptor occupancy, while functional imaging, both PET and MRI (magnetic resonance imaging), offers an objective assessment of the effect on a tested compound, thereby increasing the probability of implementing conclusive clinical trials.” As an example of Aptuit’s knowledge and experience in the PET study area, Zancan cited Using Objective Endpoints for POC Studies, a pertinent Aptuit case study. Needleman concluded: “We have successfully employed neuroimaging in a wide range of projects related to predicting dosages for human studies and evaluating dose responses. Aptuit LLC +1 203 660 6600 john.chappell@aptuit.com www.aptuit.com

US Commercial Packaging Operations Launch with Successful FDA inspection CDMO Almac has announced the successful inspection of its new US commercial packaging operations located in Audubon, Pennsylvania, US, by the FDA. The inspection took place on 9–10 January 2013 and the regulatory body concluded that the Pennsylvania-based site is fully compliant with GMPs, with no 483 issued. Commenting on the inspection, Ian Markwell, Vice President of Quality, said: “We are very pleased with the outcome of our inspection as it marks the establishment of our US commercial packaging operations with FDA approval for bottle, blister, wallet and vial labelling/packaging.” Jim McGibbon, US Director of Business Development, explained: “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the US. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”

Almac’s first US commercial packaging client, a US-based diversified healthcare company, is an existing long-term client partner of its UK operations for both formulation development and contract commercial manufacture services. Initially, Almac will supply three commercial products with bulk tablet and capsule manufacture taking place in Almac’s EMA and FDA approved commercial facility in the UK, with final bottle and blister packaging taking place in Audubon. “This is a significant first contract for the Audubon facility filling in excess of

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four million finished packs per annum, so it’s proving a busy start to the year,” added McGibbon. Almac’s new commercial packaging facility offers flexible packaging solutions from primary packaging of solid oral dosage forms to customised secondary labelling and packaging of sterile biopharmaceutical products for both established US products and niche/orphan drug launches alike. Almac Group +44 2838 363363 tania.davis@almacgroup.com www.almacgroup.com

SHOWCASE DRUG DELIVERY Partnership to Supply Sterile Vial Adaptors and Transfer Devices for Needleless Systems Continuing to expand on Helapet’s specialist range of syringe venting, filtration and transfer systems, the company has secured a new partnership with West Pharmaceutical Services based in the US. Recognising the increasing use of needle-free transfer and reconstitution devices in the sterile production of medical solutions in aseptic units, Helapet is offering a quality range of sterile vial adapters and Vial2Bag transfer devices. Helapet’s new range of vial adapters are designed to securely attach to any standard 20 mm vial and facilitate the optimal transfer of medical solutions using a needleless syringe. Using a slim plastic spike for best seal penetration, the vial adapter can be easily applied in confined spaces, including isolators and laminar flow cabinets. Offering a convenient choice between a standard male luer lock connector and a swabable Halkey Roberts valve, Helapet vial adapters can securely maintain the sterile integrity of medicinal contents

Drug Delivery Devices Manufacturer Extends Kontiolahti Site

during repeated use, greatly reducing the risk of cross contamination. A new solution for transferring medical solutions from a vial or syringe into any IV bag, the Vial2Bag is perfect for the accurate application of dosages during sterile production. Using the proven Halkey Roberts drip-free fastening, the Vial2Bag can significantly help reduce cross contamination with its swabable surface, whilst the inclusion of a plastic spike eliminates the risk of sharps injury. Helapet +44 800 0328 428 sales@helapet.co.uk www.helapet.co.uk

Phillips-Medisize has announced a 6,000 m2 expansion to its Kontiolahti, Finland site, which focuses on the production of complex drug delivery devices such as inhalers, injection pens and safety syringes. The facility manufactures various products from multi-component drug delivery devices in prototype form to finished drug delivery devices in a high-speed, automated production environment. The expansion was driven by new opportunities that Phillips-Medisize has been awarded over the past 12 months as well as increased global demand for devices with precise dosage drug delivery requirements that the company currently manufactures at the site. The capacity addition should be online by August of 2013 and will increase moulding and assembly capabilities at the site. Staffing will also be increased by over 15% during the next two years. Today, 336 professionals are focused on meeting the needs of drug delivery device customers around the world. The combination of a stable and experienced medical work force, extensive in-house tool making, cutting edge metrology, modern cleanrooms and high-volume injection moulding and automated assembly capabilities

underlines the company’s mission to provide outstanding support to OEM customers. Commenting on this plant expansion, Matt Jennings, President and CEO of Phillips-Medisize, said: “This plant expansion is in keeping with our global strategy of offering design and development services and associated manufacturing processes for our medical customers. We support this strategy by investing in our people, processes and facilities to assure we can meet the quality, service and performance expectations of our customers. Although a portion of this new capacity will be taken up by recent wins, we did also plan for future customer growth requirements in this expansion.” Phillips-Medisize Corp eu_sales@phillipsmedisize.com www.phillipsmedisize.com

Injectable Systems Specialist Introduces USP Chapter 1 Resource Centre West has announced a new online resource centre to assist pharmaceutical and biopharmaceutical manufacturers as they prepare for the industry’s revised standard regarding labelling for cap overseals and ferrules on injection vials — United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29, 1 November 2010). The revised USP General Chapter <1> Injections standard will go into effect on 1 December 2013. The standard applies to multiple packaging, storage and labelling requirements as well as procedures and methods that provide specifications for individual drug products or substances. Beginning 1 December, printing will be limited to

“The revised standard represents a fundamental shift in the pharmaceutical and biopharmaceutical industry and drug manufacturers need to begin preparing now for implementation,” said Carol Mooney, Global Market Segment Director, West. “West is working side-by-side with customers through the transition to help ensure uninterrupted product supply.” The West Online Resource Center is available at: bitly.com/USP1OnlineResourceCentre.

cautionary statements on the top surface of the ferrule or cap overseal of a vial containing an injectable drug product. A cautionary statement is defined as one intended to prevent an imminent lifethreatening situation if the injectable drug is used inappropriately. The West USP General Chapter <1> Online Resource Center is designed to provide drug manufacturers with information to prepare for implementation of the revised standard. The website includes an informational video and links to USP resources.

West Pharmaceutical Services, Inc. +1 610 594 2900 west.pharmaceutical.services@westp harma.com www.westpharma.com

Oral Drug Delivery Specialist Names Global Development and Licensing Efforts Leader Aptalis Pharmaceutical Technologies, a business unit of Aptalis Pharma that develops differentiated products utilising its oral delivery technologies, has announced that Nigel Ray has been named as the company’s Vice President of Global Licensing. Reporting to John Fraher, President of Aptalis Pharma, Ray will lead the unit’s global licensing efforts as well as the identification and evaluation of strategic

opportunities within the pharmaceutical industry that maximise the value of Aptalis’ technologies. Prior to joining Aptalis, during his twenty-five years in specialty pharmaceuticals, Ray held executivelevel positions with companies including AcelRx Pharmaceuticals, DURECT Corporation and Alza Corporation. Ray holds a Bachelor of Arts in Human Biology from Stanford

University and a Master of Business Administration, Finance and Strategy from the UCLA Anderson School of Management. “Nigel’s rich experience in identifying, structuring and negotiating complex, worldwide product licensing transactions as well as his business leadership skills will serve Aptalis well,” said Fraher. “His leadership and experience in business development

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and marketing will enable the expansion of our technology partnerships while providing pharmaceutical companies with the drug delivery solutions they need to advance and protect product portfolios.” Aptalis Pharmaceutical Technologies +1 908 927 9600 www.aptalispharmatech.com

Events REGULATORY AFFAIRS By Dr. Paolo Biffignandi, Advisory Board Biosimilars member of the pan-European Sector from pharmaceutical regulatory affairs organisation ELC Group and former EU and US President of TOPRA (The Organisation for Professionals in Regulatory Affairs). Perspectives Biosimilar medicines, one of the fastest growing sectors on the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly to the early days of the acceptability of generic medicines. In the same way, the stakeholders of biosimilars are not only the patients but also the pharmaceutical industry, the regulator and the physician. The fact that biosimilars are biological substances mostly endogenous to the human body, or analogues of the same, is perceived positively by the patient (as they are considered to be ‘natural’) and yet cautiously by the regulator and the prescriber; the regulator is driven by concern for unexpected risk (e.g., adverse drug reactions due to immunogenicity) and the prescriber by the best therapeutic outcome of an expensive treatment. The EU Commission and the EMA have established a regulatory framework proving guidance that has permitted 13 European approvals (interestingly, all German, except for one Austrian) for these new medicines. These marketing authorisations were for somatotropin (developed as biosimilars before guidelines), epoetin alfa, epoetin zeta and filgrastrim (for recombinant human interferon alfa-2a, a negative opinion was adopted). In January this year, the EMA launched a six-month public consultation on the revised guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins (LMWHs).This guideline describes the non-clinical and clinical requirements for a LMWH-containing medicinal product claiming to be similar to another one already on the market. The non-clinical section addresses the pharmacotoxicological requirements and the clinical section describes the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects. This new guideline may have a definitive impact on the development of LMWHs and related products, approaching a more relaxed model. In the US, alternatives to huge EU development pathways are possible, such as that exemplified by enoxaparin sodium, a LMWH approved by the FDA through an abbreviated NDA (ANDA) pathway, remarkably, with an AB interchangeable rating (the US term for substitution) with a minimum of pharmacokinetic data to extrapolate to efficacy and safety. Immunogenicity was also resolved based on the decision on ‘sameness’ established by quality data. The overall concept of fingerprinting, using the FDA’s five criteria, is uniquely adopted by the FDA in its pragmatic approach to approval of biosimilars. To better understand the differences and similarities between these two scenarios, one should consider that the FDA divisions can be viewed almost in the same way as Competent Authorities are in Europe, each with its own history, philosophy, review and approval practice. Decisions, therefore, would be on a case-by case basis by product and division but these guidances (e.g., the FDA draft guidance for industry: Quality considerations in demonstrating biosimilarity to a reference protein product, 2012) would provide an overarching perspective as for the European biosimilar framework defined by overarching CHMP/EMA guidelines. Finally, immunogenicity should be recognised but not over-stressed. This is a major concern for the regulator of biologics and is addressed in several EU and FDA guidelines. The EU has a general guideline, covering quality, nonclinical and clinical (plus a class-specific guidance for monoclonal antibodies). The FDA, in its 2012 guidance, emphasises analytical validation methodology, which needs to be robust. The cooperation of the EMA and FDA has been exceptional and covers MAA/NDA/biologics licensee applications reviews, clinical safety, scientific advice, joint GMP inspections and all facets of drug development and approval. Harmonisation will progress and impact global Dr. Paolo Biffignandi development of biosimilars. paolo@elc-group.com

Key Theme of Pharma Integrates is ‘Strategically transforming Pharma business relationships’ Pharma Integrates 2013 will be held on Tuesday 26 and Wednesday 27 November at the Park Plaza Riverbank, London. Following the success of the inaugural Pharma Integrates 2012, the 2013 event will retain the one-and-a-half day conference format. The opening half day will be a series of keynotes and plenary panel discussions. The second day will include two parallel streams, with the majority of the sessions being interactive panel discussions to stimulate information exchange and organic discussion. The overarching theme of Pharma Integrates is ‘Strategically transforming Pharma business relationships’, with presentations and panel discussions addressing key industry issues from both an early and late product lifecycle perspective. Much of the 2012 agenda focused on the development and management of partnerships as one of the key drivers for company success. In 2013, a more strategic approach to building pharma relationships will be taken, examining how strategic relationships are evolving and increasingly becoming a source of mutual competitive advantage. Further, how such collaborations are supporting innovation, productivity, differentiation and profitable growth. What to expect from Pharma Integrates 2013:

• panel discussion format ensuring an outstanding interactive experience • blockbuster topics that straddle a complimentary profile of industry stakeholders • strategically led content dedicated to senior level strategists. Attendee Feedback from Pharma Integrates 2012: “Relevant, good speakers, right size. Made many new contacts — thanks!” Neil Baker, Pfizer. “Nothing similar in the EU. Panel discussion approach very successful.” Laura Walsh, 3M. “The event attracted high level delegates and decision makers and was very informal. Good presentations, very entertaining.” Heather Brunyee, Wockhardt. “Enjoyed the level of attendees, good mix of stakeholders, all with a passion to improve the industry. We now need to deliver!” David Tudbury, Catalent. Life Sciences Index +44 208 667 2121/2122 miranda.zouheir@lsi-uk.com www.lifesciencesindex.com

Shire Director to Present Company’s Outsourcing Strategy at Pharma Outsourcing & Procurement Summit “The US CMO market is the largest for pharmaceutical contract manufacturing, having generated approximately $10.7 billion in revenues in 2011. Expansion of the CMO market is being driven by…increased outsourcing of large pharma companies that are focusing on core competencies to improve profit margins.” (US CMO Market Report: A growth industry in transition by Jesse Sullivan & Jennifer Brice, Frost & Sullivan) WTG (World Trade Group) is pleased to announce that Gordon Ewart, Senior Director, Head of Global Supplier Relationship Management at Shire, will be presenting an exclusive case study on the company’s outsourcing strategy at the Pharma Outsourcing & Procurement Summit 2013. In his presentation, Ewart will cover: • building profitable business relationships • understanding how to manage long, medium and short outsourcing relationships • efficiently managing and dealing with multiple vendors • successfully implementing and sustaining CMO relationships for mutual success • efficiently developing winning working models with CMO partners. This year’s Pharma Outsourcing & Procurement Summit, taking place on EPM 41

5–6 June 2013 at the Maritim Hotel Berlin, Germany, will focus on the latest trends in the pharmaceutical outsourcing industry. The programme is designed to cover three key streams: emerging markets, vendor relationship management and cost reduction in procurement to allow attendees to learn from keynote speakers and debate about current trends and strategies whilst benchmarking against their competition. Some of the other speakers presenting this year include Rajesh Pednekar, Head of Distribution at Pfizer, Chris Low, Director, Global Site Services Procurement, MSD, and Erik Dam, Director Global Supply Strategies at Bayer, to name only a few. World Trade Group +44 207 202 7690 michaela.melcher@wtgevents.com www.outsourcingevent.com

EPM CLASSIFIEDS

To advertise here, please contact Rob Anderton: Tel: +44 (0) 1244 680222 Email: rob@rapidnews.com

CLEANROOMS EQUIPMENT & SERVICES

GRINDING AND GRANULATION EQUIPMENT & SERVICES

CONTAINMENT

DIOSNA Dierks & Söhne GmbH

Telstar Life Sciences

Tel: +49 (0) 541 331 040 Email: info@diosna.de Web: www.diosna.de

Tel: +34 (0)937 361 600 Email: sales.pharma@telstar.eu Web: www.telstar-lifesciences.com

HOSOKAWA ALPINE Aktiengesellschaft

CONTAMINATION CONTROL Helapet are a leading supplier of cleanroom disposables for hospital, pharmaceutical, electronic and laboratory cleanrooms providing solutions for contamination control in critical environments.

Freephone: 0800 0 328 428 Email: sales@helapet.co.uk Web: www.helapet.com

MATERIAL/POWDER HANDLING

Supply of our quality range of SteriClean® sprays, offering an effective mix of alcohols, biocides and neutral detergents aiding disinfection measures in controlled environments.

DESIGN & INSTALLATION

Tel: +49 (0) 821 5906-0 Email: pharma@alpine.hosokawa.com Web: www.alpinehosokawa.com

MIXING & BLENDING EQUIPMENT AND SERVICES

WET GRANULATION EQUIPMENT

Müller GmbH

Russell Finex Ltd

Tel: +49 (0) 76 23 969 0 Email: info@mueller-gmbh.com Web: www.mueller-gmbh.com

Tel: +44 (0)20 8818 2000 Email: enquiries@russellfinex.com Web: www.russellfinex.com

PACKAGING & BOTTLING EQUIPMENT AND SERVICES

INDUSTRIAL SERVICES

Gerhard Schubert GmbH

CHEMICAL CLEANING

Tel: +49 (0) 7951 400-0 Email: info@gerhard-schubert.de Web: www.gerhard-schubert.de

Transflow Industrial Services Limited The Passivation Specialists

Refurbishment, Decontamination, De-rouging, Passivation, Sterilization of your Stainless Steel & Pharmaceutical Plant on or off-site T: +44 (0)20 8591 3875 E: enquiries@transflow-industrial.com W: www.transflow-industrial.com

LABORATORY & R&D PRODUCTS AND SERVICES

FURNITURE

Teknomek Industries Ltd Tel: +44 (0)1603 788833 Email: sales@teknomek.co.uk Web: www.teknomek.co.uk

Fritsch GmbH

Weiler Engineering Inc

Tel: +49 (0) 67 8470146 Email: info@fritsch.de Web: www.fritsch.de

Tel: +1 847 697 4900 Email: solutions@weilerengineering.com Web: www.weilerengineering.com

ENVIRONMENTAL/STABILITY ROOM

PURIFICATION & FILTRATION PRODUCTS AND SERVICES

LTE Scientific Ltd Tel: +44 (0)1457 876221 Email: info@lte-scientific.com Web: www.lte-scientific.com

COATING EQUIPMENT & SERVICES

Bosch Packaging Technology

PARTICLE SIZE ANALYSIS

Tel: +44 (0)151 547 8000 E-mail: info.packaging-kny@Bosch.com Web: boschpackaging.com

Whitehouse Scientific Ltd Tel: +44 (0)1244 33 2626 Email: info@whitehousescientific.co.uk Web: www.whitehousescientific.co.uk

QUALITY AND COMPLIANCE SPECIALISTS

Glatt GmbH WEIGHING

Tel: +49 (0)7621 664 0 Email: info@glatt.com Web: www.glatt.com

Mettler Toledo

L.B. Bohle GmbH

Tel: +44 (0)116 2345074 Email: enquire.mtuk@mt.com Web: www.mt.com/quantos

Tel: +49 (0)25 24 93 230 Email: info@lbbohle.de Web: www.lbbohle.de

TABLET PRESS SUPPLIERS

MANUFACTURING ANCILLARIES ELECTRONIC DRIVE & MOTOR REPAIRS

CONTRACT STERILISATION & TESTING

PUMPS

Fristam Pumpen F. Stamp KG Tel: +49 (0) 40 725 56 0 Email: info@fristam.de Web: www.fristam.de

EXCIPIENTS HPMC FILM COATING

Peristaltic pumps accurately transfer fluid through a sterile and fully validated tube from source to delivery.

BE HERE FOR A YEAR Call Rob on 01244 680222 or email rob@rapidnews.com

Tel: +44 (0) 1326 370370 Email: info@wmpg.co.uk

Web: www.wmpg.co.uk

ADVERTISERS’ INDEX Company Alexanderwerk Amixon Canal Engineering Contec Diosna DRM Elizabeth Carbide

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