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IN THIS ISSUE: ACHEMA 2012 Preview Solid Dose Inspection Labware Drug Delivery
European Pharmaceutical Manufacturer May 2012
Volume 12 | Issue 03
Front cover: Natoli will be exhibiting its tablet compression tooling, accessories catalogue, replacement parts, singlestation laboratory tablet press, laser vision punch inspection system and more at ACHEMA 2012 — Hall 3.1, Stand J9.
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in this issue
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production art adrian price production jonny jones
advertising
page 5–20
ACHEMA 2012 5–20
Exhibitor News
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MANUFACTURING PRODUCTS & EQUIPMENT
pages 21–30
subscriptions subscriptions tracey nicholls,
Equipment, IT solutions and supplies for all aspects of pilot- and full-scale pharmaceuticals manufacturing through to their packaging and anti-counterfeiting.
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LABORATORY PRODUCTS & EQUIPMENT
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Equipment, IT solutions and supplies for preparation, analysis and storage of samples through to formulation and lab-scale manufacture of pre-clinical/early clinical phase pharmaceuticals.
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SHOWCASE: 33
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INGREDIENTS & CONTRACT SERVICES
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APIs, excipients and intermediates supply and drug development and manufacturing services — from clinical research and formulation through to commercial manufacturing, packaging and logistics.
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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, Unit 2, Chowley Court, Chowley Oak Lane, Tattenhall, Cheshire, CH3 9GA, UK. © May 2012. While every attempt has been made to ensure that the information contained within European Pharmaceutical Manufacturer is accurate, the publisher accepts no liability for information published in error, or for views expressed. All rights for European Pharmaceutical Manufacturer are reserved, and reproduction in part or whole without written permission is strictly prohibited.
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You may have noticed that this issue feels a little more substantial than usual — this is due to an extra eight pages needed to accommodate our ACHEMA 2012 Preview. EPM invited exhibitors to submit a description of the product/s they intended to highlight and received an overwhelming response; I have collated the majority of entries and produced a hopefully useful guide for those of you attending. All featured exhibitors are in hall and stand number order to make locating them easier. Following the ACHEMA 2012 Preview, which is located at the front of the magazine, you will find the usual three sections. Especially worthy of mention in this issue is a Q&A with Aptalis Pharma Inc.'s Chief Research Officer Robert Becker, giving an overview of Aptalis Pharmaceutical Technologies, an Aptalis Pharma division that offers its clients a raft of oral drug delivery technologies for customising drug formulations to be used in the treatment of gastrointestinal and cystic fibrosis. Part of the drug delivery feature, Aptalis Pharma’s Q&A can be found in the Ingredients & Contract Services section, on page 39. In his Regulatory Affairs column on page 38, Paolo outlines the importance of the EXCiPACT certification scheme. Launched in January, the programme ensures that excipient suppliers meet the quality requirements of 39 pharmaceutical manufacturers, therefore ultimately guaranteeing patient safety.
eab members
from the editor
Company
Page
Dr. Dave Doughty, Director of Process Understanding & Control, GlaxoSmithKline In his 30 plus years in the pharmaceutical industry, Dave has a superb track record in leading teams to develop and commercialise products. This is underpinned by his expert knowledge of the science and mechanistic principles of dosage form design and processing, including PAT, manufacturing operations and GMP. Dave has co-authored product and process patents. Product innovations include oral and transdermal dosage forms. Process innovations include compression and coating of tablets and continuous manufacturing methods and associated PAT. Continuous processes include feeding, mixing, granulation, drying, coating and a novel method of manufacturing low-dose, high-potency drugs. John Gamble, Senior Research Scientist, Bristol-Myers Squibb After graduating from the University of Salford in 1998 with a degree in Chemistry with Industrial Experience, John began his career in quality control analysis of parental vaccines, later moving on to physical analysis of inhaled drugs, before arriving at his current position as Senior Research Scientist within the Powder Properties Optimisation group at Bristol-Myers Squibb. John has a keen interest in understanding the interrelationships between the physical properties of drugs and excipients and their subsequent behaviour during formulation and manufacturing. Aidan Mc Nabola, Engineering Director, UCB Group, SCHWARZ PHARMA Ltd Aidan is Engineering Director at Schwarz Pharma Ltd, based in Shannon Co. Clare, Ireland, and is responsible for site infrastructure, engineering systems — including capital projects — utilities, IT and automation on site. Aidan holds a B. Eng Degree in Mechanical Engineering and has more than 23 years experience in primary and secondary manufacturing in the pharmachem and medical device industries.
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Frewitt
6
Printing International
29
GEA Pharma Systems - Courtoy
7
Rommelag
14
26-27
Russell Finex
20
Adamus
22
Gerhard Schubert
Alexanderwerk
19
Getinge
9
Sejong
Amixon
11
I Holland
10
Sepha
Aptalis
41
Korsch
17
Servolift
CPhI
24
L.B. Bohle
12
SOTAX
Diosna
44
MM Live 2012
32
SVIAC
Elizabeth Europe
43
Müller GmbH
5
Thomas Engineering
18
Emerson
8
Netzsch
25
Weiss
20
Fette
2
Pharmatron AG
21
Xcellerex EPM 4
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).
And before I sign off, EPM will be celebrating the Queen’s jubilee with a not to be missed ‘Best of British’ feature in the next issue, containing news on Queen’s Award for Enterprise winners and special jubilee offers on products and equipment.
ADVERTISERS’ INDEX
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.
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Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer, working for the wellknown French pharmaceutical company Sanofi. Grégory started working in one of the group’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment. He later moved to Spain and continues to lead new equipment installation projects at one of the group’s Spanish solid form plants and since 2009 has been in charge of process maintenance and improvements. Grégory has experience of the most well-known providers of solid form equipment. Kostas Saranteas, Senior Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc. Kostas is Senior Director of the Process Chemistry and Engineering Dept. at Sunovion’s R&D Division. He holds BS/MS/PhD degrees in Chemical Engineering and an MS degree in Environmental Engineering. For 15 years, Kostas worked at Polaroid Corp., specialising in batch process equipment modelling, process optimisation and scale-up. For 11 years, Kostas has been employed at Sunovion. He leads cross-functional teams, championing accelerated process development for drug substance and drug product synthesis from laboratory-scale to full-scale manufacturing.
ACHEMA 2012
Just Launched Tablet Press Range Hall 3.0, Stand A50 Elizabeth-Europe’s technical and sales teams will be showing the company’s brand new Eliza press range, reportedly the perfect tools for carrying out galenic experimentation and manufacturing first clinical batches. Visitors are also invited to find out about: • Elizabeth-Europe’s latest innovations in compression tooling — a full range of punches and dies to suite all requirements;
• blister tooling and tailor made special feeders, in particular, the company’s patented, famous Combo feeder and patented high-speed feeder to increase OEE; • spare parts for presses available from Elizabeth-Europe’s warehouse, which allow customers to minimise their stock, and a complete range of compression accessories. Whatever a customer’s requirements might be, Elizabeth-Europe claims it can provide the solution — covering galenic
experimentation, tablet design, blister packaging design, compression and blister tooling, and maintenance — and has the ability to respond to urgent demand anywhere thanks to the company’s worldwide commercial organisation and product centre facilities. Elizabeth Europe-EPMO +33 2 54 90 21 20 service@epmo.com www.epmo.com
Aseptic Packaging with BFS Technology Hall 3.0, Stand A71 rommelag — a renowned global market leader and developer of Blow-Fill-Seal (BFS) technology — will be exhibiting the flagship model of its current product portfolio, the BFS bottelpack 324 aseptic machine for manufacturing IV solutions (LVP), in hourly demonstrations. Because it is servo-driven without the use of hydraulics, this new generation of BFS aseptic machines provides numerous advantages during operation and maintenance, in addition to higher equipment availability and increased production efficiency. BFS aseptic machines are designed to produce ampoule blocks or single bottles ranging from 0.1 to over 2000 ml using a variety of plastic materials such as low-density and high-density polypropylene (LDPE and HDPE) and polypropylene (PP), among others, to produce both monolayer and CoExmultilayer containers. Hourly outputs can reach 35,000 ampoules. The reportedly unique feature of the BFS process is the sterile, pyrogen-free manufacture of the containers, sterile filling of product under aseptic conditions and hermetic sealing of the container — all in a single operation. The machines come equipped with an integrated US class 100 (ISO 3) cleanroom in the filling area, as well as automatic CIP/SIP cleaning, providing maximum product and process reliability at an extremely economical per-unit cost. Because they employ an automatic machine process that requires no human intervention, BFS machines are simple to operate and particularly suited to 24/7 operation. CoEx BFS aseptic
machines are used to manufacture multilayer containers with barrier layers for filling sensitive products. Along with its BFS machines, the company also supplies cap welding machines and high-voltage leak detector systems for non-destructive leak testing of small-volume and large-volume containers. Also included in the scope of delivery and services are FAT and SAT tests with the associated documentation for qualification and validation. In-house laboratory and production facilities are available for project- and customerspecific container and sealing developments, as well as stability tests and contract filling. This exceptional portfolio provides customers with the ideal prerequisites for successfully packaging liquid and viscous pharmaceutical products using BFS aseptic machines. rommelag +41 62 834 5555 mail@rommelag.ch www.rommelag.com EPM 5
ACHEMA 2012 0.25–600 L Mixer-Granulators and Pilot Plant Fluid Bed Granulator
Fluid Bed System and Tablet Coater
Hall 3.0, Stand B4
Hall 3.0, Stand D49
The key theme for DIOSNA at this year’s event is containment and the company will be exhibiting various mixergranulators, with volumes from 0.25 to 600 l, and a pilot plant fluid bed processor. The smallest mixer is installed in an isolator and is designed for bowl volumes of 0.25–10 l. The completely redesigned pilot-plant mixer P/VAC 0.25-60 is the most interesting machine. Its through-the-walldesign is characterised by especially fast and simple changeover of the mixing bowls without the need for any tools. They are moveable and lock automatically with the base station. The motors and the controls are situated in the technical area. Seals, filters and bowls are available in a CIP design. Therefore, this machine is ideal for operation under containment conditions. For feeding, the cost-saving Flecotec-System is installed and the outlet is provided with a split butterfly valve (both Andock brand). A corresponding production machine will also be shown. The P 600 pharmaceutical mixer, with high containment design, is for the processing of dry
mixtures. Feeding and discharging run down automatically by means of a guideless transport system. Diosna will also display the new generation of DIOSNA P 1-6 laboratory mixer-granulator and also the DIOSNA Midilab XP fluid bed processor, which is designed for drying and top-spray, tangential-spray and Wurster-coating, with exchangeable material bowls of 7–20 l. DIOSNA Dierks & Söhne GmbH +49 541 33 104 0 info@diosna.com www.diosna.com
The German engineering company L.B. Bohle Maschinen + Verfahren will present the Bohle Fluid Bed System BFS 240 and the Bohle Tablet Coater BTC 100. The BFS 240 is a drying system specifically optimised for pharmaceutical applications. It features a broad range of extension options for bottom tangential spray granulation and bottom tangential spray coating. The BTC 100 is the smallest version of the BTC. Benefits of the Bohle coating technology are: • excellent mixing thanks to patented spirals; • careful product movement thanks to low tablet bed thickness; • easy discharge by changing the rotating direction of the pan; • nozzles with ABC caps ensure long service life; • highly efficient suspension system thanks to the reduction of spraying losses; • faster processing due to a high number of nozzles and an efficient air system; • high batch size variability from approx. 35 to 100% filling volume; • same pan geometries for easy scale-up; • and rapid and simple cleaning.
Visit us at ACHEMA in Frankfurt, Germany from 18th - 22nd June 2012 Hall 3.1 Booth F3
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L.B. Bohle has also announced a world debut at the event. The company will be unveiling its latest technology in a press conference, which is to take place on its stand at 11 am, on 18 June. L.B. Bohle Maschinen + Verfahren GmbH +49 2524 9323 150 t.borgers@lbbohle.de www.lbbohle.de
ACHEMA 2012 Tablet Tooling Maintenance Range
Developments for Liquid and Solid Pharmaceuticals
Hall 3.0, Stand H100
Hall 3.1, Stand C70–72
I Holland will be exhibiting a selection of products from the PharmaCare 7-Step maintenance range. These include: the sophisticated Holland automated cleaning system, demonstrating exceptional punch and die cleaning; the MF automated polisher, allowing the implementation of a consistent repeatable tool polishing regime; storage solutions for tooling and die segments; the new Holland Minicam for quick and easy tooling/tablet inspection and precision measuring equipment for gauge die bore wear. As well as displaying its range of high quality tooling, I Holland also has research projects underway that the company is keen to discuss with the tablet manufacturing community at the show. This ongoing research is developed from I Holland’s commitment to understanding the science behind
Bosch Packaging Technology will highlight the sale of its 100th isolator and the introduction of its new Fast Air Lock ISS 1000, designed for the fast transfer of pharmaceutical equipment into and out of isolators. The inspection technology section will present newly acquired manual, semi and fully automated inspection equipment from Eisai Co., Ltd. In addition, Bosch will display an entire process chain for solid pharmaceuticals. Bosch is celebrating the sale of its 100th isolator to an international pharmaceutical customer, which will be showcased with an FLC filling machine for injection vials and infusion bottles. At the customer’s site, the isolator will be used in combination with an entire vial filling and sealing line and ensures a sterile filling process for highly potent APIs. Bosch has extended its isolator equipment range with the Fast Air Lock ISS 1000, developed for the transfer of pharmaceutical equipment into and out of isolators. An efficient evaporation process and an optimised loading unit result in very fast cycle times of approximately 20 minutes. Bosch has extended its expertise in the inspection of liquid and solid pharmaceuticals following the acquisition of machinery business companies belonging to Japanese company Eisai Co., Ltd. (hereafter Eisai Machinery). The portfolio ranges from manual to semi-automated and fully automated inspection systems. One of Eisai Machinery’s highlights will be the new ETAC Easy View, a visual inspection device for particle and cosmetic inspection of very small batches. Bosch will also demostrate an entire pharmaceutical solid process chain. The different machines comprised in the process cover all steps from mixing,
Printing Equipment Hall 3.1, Stand C98 Printing International produces printing equipment that utilises the newest hightech solutions and therefore offers very high print quality. For the confectionery market, Printing International offers printing equipment for chocolate lentils, pralines, chewing gum, etc. For the pharmaceutical market, the company provides machines that print onto tablets, soft gelatin capsules or freeze-dried tablets. According to Printing International, with an integrated camera-vision system, the quality of the prints is inspected and special software rejects products at individual level that do not meet the highest printing standards. The patented print technology offers the following advantages:
tabletting, which has already led to the development of many reportedly innovative processes, materials, coatings and bespoke tablet/tool designs. The company has found that these advances can add up to serious increases in productivity for its customers. The process of continuous improvement is part of I Holland’s commitment to provide the best problem solving solutions to its customers around the globe, so visitors will be welcomed on the company’s stand to discuss how I Holland can contribute to their success. I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk
• print quality up to 0.1 mm with closed ink cup (no evaporation of solvents) in order to maintain the right ink-viscosity level during the printing process; • correct print at the right position; • possibility of printing with waterbased or solvent-based edible inks; • FDA approved printing pads; • print capacity of up to 750,000 tablets per hour; • possibility of printing various formats or sizes of tablets (breakline, different coatings and different print consisting of text and logo); • 15 minutes changeover and quick and easy cleaning; • camera inspection system with individual reject mechanism; • cGMP compliant; • software based on GAMP (21 CFR, Part 11); • and validation files available. Printing International NV +32 9 325 85 85 sales@printinginternational.com www.printinginternational.com
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granulating and coating to tablet pressing and filling of capsules. Last year, Bosch acquired process technology specialists Hüttlin and Manesty (now Bosch Packaging Technology Ltd). With the jointly developed laboratory device Solidlab 1, all process modules are combined into one single machine — powder mixing, drying, granulating and coating of pellets and tablets. The fluidised bed module processes batches from 0.05 to 2 kg. According to the same principle, Solidlab 2 handles batches from 0.5 to 12 kg. Further exhibits complete the pharmaceutical portfolio, including new track and trace equipment and a new rod inserter and labeller for syringes, complemented by developments in CIP and sterilisation, filling and packaging. Bosch Packaging Technology +49 7951 402 648 www.boschpackaging.com
ACHEMA 2012 Bin Blenders Hall 3.1, Stand D4 Blending systems from Servolift can be used for containers with clamping bars and also for various nominal container sizes. The blending process is fully automated and works with a tumbling movement. By doing without blender blades, mixers, etc., a blending process could be developed that protects the product and is 100% compliant with hygiene standards. This involves less cleaning effort and thus contributes to savings in time and costs. Examples of extended functions in addition to blending include lifting/lowering, slewing and emptying after blending, which can be enhanced by a weighing system built into the supporting arm. An advantage of the reengineered clamping system is the greater ease in positioning the containers with clamping bars. The blender also comes in versions suitable for use in potentially explosive areas. A space saving single column principle can be
implemented as an in-front-of-the-wall or behindthe-wall construction, making the system architecture as flexible as possible. Servolift GmbH +49 781 6100 0 info@servolift.de www.servolift.de
Focus on Sterilisation Solutions for Bio-Pharma and Medical Device Customers Hall 3.1, Stand E28 This will be the first major international event that Getinge will be exhibiting at since the reorganisation of its business to form a new Life Science Division. The reorganisation allows for greater focus on those clients involved with biopharmaceutical and medical device production, allowing Getinge to more effectively tailor its products and services to their needs. One particular objective, which will be highlighted at the show, is to further help clients to reduce their costs, while improving quality and productivity. Getinge’s show slogan is ‘Right from the Start’ and highlights the company’s intention to bring its expertise to clients early on in their projects, maximising the potential of its solutions and therefore achieving set objectives. Equipment on display will include: • the GEW 9109 GMP washer-dryer, one of a complete series that uses 10–40% less WFI than competitive models, saving potentially more than the value of the washer over its lifetime; • a new generation of compact sterilisers with significantly faster cycle times, meaning clients can either produce more in the working day
and/or can use a smaller machine (equalling less expensive GMP area floorspace) for their production needs; • and STERSTAR 2, the next generation of e-beam steriliser for the decontamination of nested syringe tubs, with an improved, clean design and reduced installation space requirements. Getinge Infection Control +46 10 335 00 00 info@getinge.com www.getinge.com
Tablet/Capsule Weight Sorters and Checkers Hall 3.1, Stand F34 CI Precision’s new fast and versatile tablet/capsule weight sorter will be on display at this year’s show. The SP440 offers sorting rates of up to 22,000 per hour and up to 500,000 per 24-hour period. The compact unit combines four of CI’s proven SADE SP sorting modules fed from just one, easy to fill bulk hopper that offers around the clock operation, so once set up, it can work for long periods of time without the need for operator intervention. Also on show will be CI’s SADE SP Series, including the SP240, the SP B40 Benchtop and SP-4C Sample Weight Checker. Simple to set up and use, the SADE SP units can handle a wide range of shapes and sizes without the need for any change parts. They are also quick and easy to dismantle for cleaning. Units can be linked to a printer or a PC, and with SP Connect, statistical reports are automatically saved as secure pdf files. Applications for production and manufacturing departments include 100%
weight sorting of products for complete quality assurance and reclamation of ‘good’ product from weight rejected batches. For R&D and clinical trials departments, SADEs are ideal for accurate weight sorting of clinical trial or development batches. Visitors to the CI Precision stand will see demonstrations of the equipment and technical staff will be happy to discuss special applications. CI Precision sales@ciprecision.com www.ciprecision.com EPM 11
ACHEMA 2012 Host of Tablet Compression Products and Services Hall 3.1, Stand J9
Natoli Engineering Company provides a comprehensive collection of tablet compression products and services to the global tableting industry. Founded in 1973 on the philosophy to provide a quality tool at a fair price with
exceptional customer service, Natoli is dedicated to developing exceptional solutions that reportedly exceed the highest industry standards. At this year’s event, Natoli will be highlighting its: • Tablet compression tooling — The company manufactures a complete variety of tablet compression tooling from the highest quality steel, tested by an independent laboratory to ensure batch-to-batch consistency. • Laser punch inspection system — Utilising dual laser technology, the LVS 500 system provides non-contact inspection of punches, delivering simultaneous measurements that
enable the system to instantly calculate cup depth. • Tablet Compression Accessories Catalog — Reportedly the most comprehensive collection of accessory products available today, Natoli’s catalogue serves as a valuable resource with over 180 pages of product, equipment and references on tablet compression. All products in the catalogue are available for worldwide delivery. • Single-station tablet press — The NPRD10A is a single-station, semiautomatic, laboratory tablet press designed to quickly and efficiently produce tablets for research and
Natoli Engineering Company, Inc. +1 636 926 8900 info@natoli.com www.natoli.com
Autoclaves with Touchscreen Controls
Kit for Bi-Layer Tabletting
Hall 4.2, Stand D37
Hall 4.0, Stand F44 GEA Pharma Systems - Courtoy will present an exciting new development in its tablet compression equipment range. The already well-established Courtoy PERFORMA P tablet press is known for its outstanding high-output performance and exceptional process capabilities such as full dwell time control and equal porosity tabletting. From now on, the PERFORMA P will be available with a bilayer kit, which quickly transforms the standard machine, making it capable of both single- and bi-layer production. The bi-layer kit consists of only a few
development. Fully equipped and CE certified, the NP-RD10A is safe, easy to use and incredibly efficient. • Tablet press replacement parts and refurbishing services — With over 300,000 replacement parts and turrets in stock for nearly every make and model, most are available for next-day delivery. Natoli also offers press refurbishing for various press types, leaving them looking and running better than new.
components, which are very quick and easy to install. By adding this new asset to the many benefits of its advanced compression technology, GEA Pharma Systems - Courtoy has further enhanced the flexibility of its machine range. GEA Pharma Systems - Courtoy +32 2 363 83 26 veerle.chiau@gea.com www.gea-ps.com
Priorclave will showcase a number of new developments, including a range of front-loading steam sterilisers with Tactrol Touch — new touchscreen controls that will be on show for the first time. The latest version of the EH150 Priorclave, a 150 l front-loading autoclave, which offers a 20% larger loading area than conventional models of similar size, is the company’s first steam steriliser to be released with the newly developed touchscreen controls. Developed by Priorclave, Tactrol Touch provides for easier setup and monitoring of the autoclaving process and is expected to be made available on all Priorclaves later this year. Also on display will be the popular toploading EV100, a 100 l electrically heated autoclave, the C60 compact top-loading Priorclave, which incorporates cooling and automatic timed freesteaming, and the H60 compact front-loading autoclave, which offers a level of setting and operating flexibility usually only available with larger machines. The models to be featured have been chosen to highlight the broad design spectrum of the company’s smaller autoclave ranges, a versatile selection catering for low-volume, periodic sterilising requirements to higher volume and more frequent application. These autoclaves are available with an extensive range of options, not often found in smaller machines, enabling Priorclave to tailor a machine build to satisfy virtually any laboratory sterilising requirement. Priorclave Ltd +44 20 8316 6620 sales@priorclave.co.uk www.priorclave.co.uk EPM 12
ACHEMA 2012 High Throughput Tablet Hardness Tester Hall 4.2, Stand G78 The SOTAX HT 100 tablet hardness tester is ideal for high throughput production settings because of the ability to separate different batches regardless of tablet shape and size. This unit uses a multi-chamber carousel in order to hold hundreds of tablets for automatic processing. The HT 100 is a fully automated system that incorporates a built-in balance to measure tablet weights in addition to tablet thickness, diameter/width and hardness. It is fully supported by IQ and OQ documentation and user training. QDoc software is fully validated software for collection of data that can be
configured for auto-export into Excel or into one’s data tracking system. The measurement principle of tablet hardness can be changed from Constant Speed to Constant Force. This feature is easily selected per product method to compare with and reproduce results of all common hardness testers available. Features of the HT 100 are: • Automated tablet separation — The SOTAX HT 100 separates even the smallest tablets using the reportedly unique vibration-free Auto Separator. • Automated tablet alignment — The SOTAX HT 100 is equipped with the patented Auto Alignment device that
automatically aligns the tablet in the correct orientation for hardness testing. This ensures proper positioning of the tablet and therefore reliable, reproducible hardness readings. • Fast tablet testing — According to the company, the SOTAX HT 100 is the fastest hardness tester on the market. For demonstrations, get in touch with SOTAX or visit the company’s stand. SOTAX AG +41 61 487 54 54 info@sotax.com www.sotax.com
Semi-Automatic Tablet Tester
AC
HE See u Ha Ju MA s a ll 3 ne Fr t .0, 18- ank Sta 22 fur t nd A7 1
Hall 4.2, Stand G58
The SmartTest 50 — to be exhibited for the first time at this year’s event — reportedly sets new standards in semiautomatic testing of up to five physical parameters (weight, thickness, width, diameter/length and hardness) of virtually all tablet shapes with one single unit. Tablet samples are placed in a carousel by the operator and all further testing is done automatically. The patented SmartAlign system guarantees reliable orientation in the integrated measuring stations and can automatically turn oblong and oval shapes for width and length measuring prior to hardness (breakforce) testing if required. In order to ensure correct alignment at all times, a sophisticated cleaning function removes debris and broken tablet fragments from all contact surfaces of the hardness station, including platen surfaces, after each measurement. Combining proven Dr. Schleuniger hardness measuring technology with high-performance electronics and intuitive touchscreen operation, the SmartTest 50 has been designed to maximise efficiency of physical testing processes. At the same time, it allows for an extremely wide range of tablet shapes to be tested and is very easy to operate and calibrate. From performing simple tests to running large sample sizes using up to 100 programmed products — including nominal values and T1/T2/PL limits — the SmartTest 50 is a true multi-purpose instrument. On completion of a test, comprehensive test reports, including statistics, can be directly printed from the tester on a serial, USB or Ethernet LAN printer, without requiring any PC software. Dr. Schleuniger Pharmatron AG +41 33 227 5000 info@pharmatron.ch www.pharmatron.com EPM 14
ACHEMA 2012 Range of Flexible Containment Systems Hall 5.1, Stand B17 Dec specialises in the manufacture of containment and powder handling systems. One of the highlights on display at this year’s event is the company’s newly developed flexible isolator range. Tailored to each operator’s requirements, the SafeFlex range of isolators offers improved ergonomics, effective and user-friendly operation and high levels of safety. The newly developed film is tear resistant and allows for reliable protection against cross-contamination. The systems can achieve low OEL
values of <1 µg/m3 and are designed for the handling of all products, including toxic and sterile. The isolators can be designed for use with over or under pressure and, depending on the application, with different drum connecting systems (double O-Ring technology). Insertion and removal can be completed in several ways from the simple continuous liner to the more complicated RTP. After completion of the work process, the films are easily removed and disposed of, thus keeping cleaning to a
minimum. Dec’s improved flexible containment technology is cost-effective, of high quality and a reliable solution for closed processes. Dec Group +41 21 694 20 40 info@dec-group.ch www.dec-group.net
High Containment Filtration and Drying Technology Hall 5.1, Stand C31
Powder Systems Ltd (PSL) will be exhibiting its high containment production filter dryer as part of its FilterBox range. The FilterBox that will be displayed on PSL’s stand is a production scale isolator surrounding an agitated nutsche filter dryer (ANFD) with a filtration area of 0.125 m2. The FilterBox is the optimum contained filtration and drying solution for handling highly potent APIs and other highly cytotoxic compounds, as all the following operations can be performed in a completely contained environment: • filtration and drying with PSL’s Filter Dryer; • contained sampling; • discharging, dispensing and packing in the same high containment isolator; • safe and contained base opening and washing; • and filter mesh inspection and swapping. The FilterBox solution is easily scalable for laboratory to industrial production, including 0.002 to 0.3 m2 ANFDs. The FilterBox will be installed in a new cytotoxic plant at PSL’s customer’s site in Switzerland. Their customer required an OEL test result of <50 ng/m3 during the sampling period. PSL’s philosophy is to exceed its client’s OEL requirements to provide optimum containment levels. Powder Systems Limited (PSL) +44 151 448 7700 sales@powdersystems.com www.powdersystems.com EPM 15
ACHEMA 2012 Micronisation of APIs Hall 6.0, Stand B6 The comminution or desagglomeration of APIs is called micronisation and brings about several advantages. The increased particle surface caused by the comminution results in a considerably better dissolution rate and bioavailability of the agents, and therefore the APIs act faster. Due to the increased bioavailability, a lower amount of APIs is required, which in turn leads to a more costefficient product with less risks and side-effects for the patient. The NETZSCH Grinding & Dispersing Business Unit offers equipment for all process engineering tasks in the fields of mixing, dispersing, deaeration, wet and dry grinding and classifying. Based on comprehensive
experience with the production of GMP-compliant pharmaceutical products, all sizes of NETZSCH DELTAVITA machines, from laboratory to production size, excel due to the following specific features: • all product wetted parts are designed and manufactured according to the latest GMP standards; • material, production and calibration certificates are supplied with the machine; • optional CIP and SIP; • all indirectly product-wetted surfaces are made of stainless steel; • optional data recording and formulation management; • operator management with
password protection for different levels of security; • laboratory mills can be used with variable grinding chamber sizes; • various materials like ZrO2, stainless steel 316 or nylon grinding chamber designs are available; • splash-proof machine stand; • comprehensive testing and qualification documentation, FAT, IQ, OQ, process validation; • production of GMP compliant machines in the US; • and availability of training and seminars. NETZSCH Grinding & Dispersing www.netzschgrinding.com/deltavita
Range of Sieves and Filters Hall 6.0, Stand C75 With more than 75 years of experience, Russell Finex is a worldwide leader in fine mesh separation, serving a variety of industries in more than 140 countries. Priding itself in offering the reportedly widest range of vibratory sieves and liquid filters in the industry, and with innovation and high quality at the core of its business, Russell Finex is able to
provide custom built solutions to suit customers’ unique requirements. By utilising the latest technological advancements and applying both industry knowledge and customer feedback, Russell Finex continually invests in R&D, ensuring a whole new range of innovative products will be displayed on the company’s stand.
Along with well-established machines such as the Russell Compact Sieve, Finex Separator and self-cleaning Russell Eco Filter, new developments will be making their debut on the stand, including the Russell Hygiene Filter, designed specifically for the food and pharmaceutical industries. A specialist team of representatives
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and engineers, fully equipped with knowledge and expertise, will be on hand to help visitors find solutions to their sieving or filtration requirements. Russell Finex NV +32 15 27 59 19 sc@russellfinex.be www.russellfinex.de
ACHEMA 2012 Mixer Dryer for Pharma Production Hall 6.0, Stand C76 When pharmaceutical active ingredients are thermally dried during the manufacturing process, the use of mixer dryers is advisable. For a long time, classical scoop dryers or ploughshare dryers were predominantly used. A more efficient alternative is the vertical singleshaft mixer from amixon, which will be displayed on the company’s stand. The amixon vacuum-mixer dryers and reactors work with a helical blade mixing tool, which rotates very closely to the walls and the floor within a thickwalled cylinder. The constant small distance of the mixing tool to the fully heated walls reportedly guarantees an
ideal thermal transfer, particularly as all surfaces of the patented tool are tempered; the mixing shaft, the scooptype arms and the helical blade. The special shape of the helical blade creates mixing and flow, without compacting or pressing the materials. amixon vertical dryers are already in use in the pharmaceutical industry as, for example, industrial dryers for penicillin, analgesics, cardiac medication and x-ray contrast media. In chemical production facilities, amongst other things, the machines dry fungicides, adhesive glues and ceramic pigments. The batch sizes vary from 50 up to 18,000 l. Every user of the mixer dryer has judged the vertical type of construction to be good or very good. Users are extremely satisfied with the
amixon vacuum-mixer dryers, because they reduce the usual drying times by 40%, as the amixon laboratory has proved during system comparison tests. Therefore, production processes can be more efficiently scheduled or a smaller dryer can be selected. Not only powders, but also pastes and viscoplastic phases are reliably dried. Even crystalline materials, which can often be encountered as initial pharmaceutical products and the even distribution of which is particularly difficult to handle as far as processing is concerned, can be processed homogenously and efficiently to the desired drying degree. The dryers are built in accordance with the most recent EHEDG guidelines and conform to GMP and FDA
requirements. They can be used in all pharmaceutical fields. In the amixon laboratory, single-shaft alloy and Hastelloy mixer dryers are available for testing with users’ products. amixon GmbH +49 5251 688888 0 info@amixon.de www.amixon.com
Optimum Process Engineering Guarantees Exceptional Results in Tablet Coating Hall 6.0, Stand D1
Gebr. Lödige Maschinenbau developed the new LC coater series specially for coating tablets. Besides user-friendliness and ease-of-cleaning, great importance was attached to optimum process engineering. All three sub-processes relevant for film-coating of the tablets were optimised — spraying on the coating, mixing and drying. The distinguishing feature of the LC coater series is a new nozzle arm concept for spraying on the coating, which allegedly permits perfect adaptation to the tablet bed. The innovative technology enables easy adjustment of the spraying distance and angle in order to achieve a perfect result at all times. The optimum arrangement and number of nozzles accelerates the process compared with other similar coaters. The high performance air technology used also ensures speed. A fullyperforated drum, with a free surface of over 50%, permits an extremely high air flow. This provides excess energy to guarantee a problem-free and reliable coating process. Efficient mixing elements likewise contribute to excellent product quality. They permit uniform and gentle mixing of the tablets, even with variable filling levels of 30 to 100% — absolutely essential for achieving the highly even coating demanded by the pharmaceutical industry. Due to the sophisticated process technology, the coaters of the LC series operate up to 40% faster than conventional devices and they save about 20% of the costs. The coaters also score brownie points in terms of user friendliness. In its design, high priority was given to convenient feeding, emptying and maintenance. Gebr. Lödige Maschinenbau +49 5251 309 0 info@loedige.de www.loedige.de EPM 18
ACHEMA 2012 Highly Engineered Products for Fluid Handling Applications Hall 8.0, Stand C94
CRANE ChemPharma and CRANE Energy Flow Solutions, providers of highly engineered products for fluid handling applications worldwide, will present their various trusted brands.
There will be demonstration sessions of several products throughout the show. The range of products CRANE will showcase includes: • WTA bellows sealed globe valve for chlor-alkali applications; • Krombach specialty products for various applications, including steam/water isolations, condenser isolations, cooling tower isolations and seawater isolations; • Xomox lined ball valve (XLB) for managing corrosive chemicals through a lined solution that reduces ownership costs in a safe way; • Saunders XA diaphragm for erosion
resistance in both corrosive and abrasive applications, including fertiliser, metals, chemicals and mining; • Saunders S360 range of actuators, appropriate for sterile biopharmaceutical applications, including clean utilities, fermentation and downstream processing; • Saunders PV diaphragm, designed specifically for use during passivation of stainless steel systems in life science applications; • Resistoflex ATL PTFE advanced technology liner for permeation control up to 450˚F in severe service applications;
Manual Biochromatography Columns Hall 6.1, Stand B70
Novasep’s new Prochrom-Bio manual columns result from the company’s 25 years of experience in developing, supplying and operating downstream processes using preparative and process-scale high performance and low pressure chromatography columns. Prochrom-Bio manual columns are available with internal diameters ranging from 100 to 300 mm with adjustable column length as a standard feature, for operation at up to 5 bar. They complete the range of Prochrom-Bio automated columns, which range in size from 200 mm to 2 m diameter. The Prochrom-Bio manual column’s reportedly unique design is operator-friendly, allowing manual bed length adjustments and maintenance. The piston, equipped with an inflatable gasket, ensures both easy assembly and tightness. All these benefits are offered by Novasep at a very attractive price. Prochrom-Bio manual columns are ideally suited to all purification steps such as capture, intermediate purification and polishing in both R&D and cGMP environments. Novasep +33 383 497130 novasep@novasep.com www.novasep.com/prochrom-biom.asp EPM 19
• and Duo-Chek high performance check valve for low and high temperature applications in the LNG cycle (i.e. liquefaction, storage and loading, ocean transport, reception, storage and regasification), and others such as petrochemicals, marine, chemicals, water and wastewater, and pulp and paper. Crane Co. +1 513 745 6987 awashington@cranechempharma.com www.craneflowsolutions.com
ACHEMA 2012 Pharma and Biopharma Pump Lines Hall 8.0, Stand F43 Pump Solutions Group (PSG) will demonstrate a wide selection of pumps designed for pharmaceutical and biopharmaceutical applications at this year’s event. PSG’s pumping solutions, which reportedly provide superior containment, purity and cleanability, will be on display on the company’s stand. PSG is comprised of several leading pump brands such as its new Quattroflow line of piston-diaphragm pumps, which are known for transferring shear sensitive
media of aqueous solutions and biological products such as blood byproducts to vaccines without damage, ultimately ensuring product safety, efficiency and reliability. PSG’s Wilden Saniflo Hygienic Series (HS) and Almatec BIOCOR and E-Series lines of air-operated double-diaphragm (AODD) pumps offer pharmaceutical manufacturers improved process efficiency while meeting strict sanitary guidelines. Wilden and Almatec pumps are certified by FDA and EHEDG. PSG’s
Mobile-Optimised Continuous Monitoring System Hall 11.0, Stand A1 Vaisala has launched viewLinc 4.0, a new version of its monitoring, alarming and reporting software, which is the heart of the Vaisala Continuous Monitoring System. Aimed at highly demanding, controlled and regulated environments in the pharmaceutical and biotechnology industries, the new version offers an optimised mobile interface for remote monitoring and alarm management. This, along with the location-based reporting and data logging capability, allows users to act on alarms immediately, anywhere and anytime on their smart phones, to improve product safety and ensure compliance with GMP and other regulations. Other key features include a greatly enhanced user interface that is easier to navigate and more customisation capabilities in historical reports and live multiple-channel trend display for
Mouvex SLC Series Eccentric Disc pumps provide pulse-free, slip-free and low-shear flow, even with varying viscosity and backpressure conditions. This is ideal for applications such as tangential flow filters or in-line formulation/diluting systems where precise flow control is essential. In addition, the Mouvex SLC Series pumps offer full product containment as there are no mechanical seals. SLC Series pumps are designed for CIP cleaning, SIP sterilisation, and include versions with both 3A and EHEDG certifications. enhanced reporting. Users can now create reports more quickly in preparation for and during field quality audits. “We are ecstatic with the Vaisala viewLinc Monitoring System. It not only helps us meet FDA regulatory and accreditation requirements, but we can now monitor multiple sites from any location,” stated Brad Bayette, Tissue Services Manager at US-based tissue bank. The improved user interface facilitates easy access to product data in a more familiar Windows-type navigation. In addition, it shows data by location, which allows users to easily find their loggers, swap out devices and report data by location. With the mobile interface, users can acknowledge and pause alarms, view live trends on any monitored location under their control, and view trend data in real time. “Like its predecessors, Vaisala viewLinc 4.0 is easily deployed for monitoring
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Pump Solutions Group +1 909 422 1730 walter.bonnett@psgdover.com www.psgdover.com
temperature, relative humidity, CO2, differential pressure level, door switches and more. But, we built this version of viewLinc based on working closely with viewLinc users. Every new feature and interface capability came from feedback and suggestions we got. viewLinc 4.0 addresses the changing needs of our customers and integrates new technologies and user expectations, such as drag and drop and mobile usage,” said Jon Aldous, Product Manager for Vaisala’s Life Science business. Vaisala will offer its customers warranty, software upgrades, technical support and user training services. Language localised versions will be available in May 2012 in French, Chinese, German and Japanese. Vaisala +1 800 683 8374 jon.aldous@vaisala.com www.vaisala.com
MANUFACTURING PRODUCTS & EQUIPMENT
Fast Touchscreen Setup and Operation with Cap Sealer Enercon Industries, a world leading manufacturer of advanced induction cap sealing systems, has introduced its first touchscreen operated model, the Super Seal Touch. Designed for use in a wide range of packaging applications — including food and beverage, pharmaceutical, agrochemical and household — the Super Seal Touch can be used as a standalone line-side unit or be fully integrated into a continuous filling and capping line, giving complete flexibility of operation. The Super Seal Touch shares the same advanced induction head technology as the current family of Enercon cap sealing machines, providing an extremely wide and flexible window of operation to compensate for variations in line conditions, such as fluctuating line speeds or changes in cap, liner and container tolerances. This ensures that perfect cap seals can be produced consistently at line speeds of up to 25 m/min, with the added advantage that setup, programming, monitoring and diagnostics are even faster and simpler through the latest multi-language touchscreen operator interface. The interactive touchscreen offers multiple levels of control, with the ability to set password access to different functions for plant managers and line operators. The system also offers a range of powerful functions with, for example, full recipe management, preprogramming for closure inspection and rejection, and remote start/stop and power control. Additionally, the diagnostic functions provide continuous monitoring of all internal systems, with the option to set a variety of alarms if operating conditions exceed certain limits. Diagnostic information is available on the full colour touchscreen display, or can be exported via a USB port or network connections. The latest Super Seal Touch can be used to seal all common closures and containers, including standard screw CRC, sports caps and dispensing closures between 20 and 120 mm in diameter. The system incorporates a robust sealing head with stainless steel IP65 enclosure, is virtually maintenancefree and is backed by Enercon’s comprehensive European network of sales and technical support centres. Enercon Industries +44 1296 330 542 www.enerconind.co.uk EPM 21
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Novartis Opts for Tool-less Leak Inspection Machines Northern Ireland-based pharmaceutical engineering company Sepha has secured several significant new orders from pharmaceutical multi-nationals, in particular, Novartis, for its leak inspection machine Visionscan. Visionscan is part of a new range of machines that use high-resolution imaging technology to detect product defects in pharmaceutical blister packs. It is reportedly the world’s first tool-less, non-destructive inspection machine for detecting leaks in pharmaceutical blister packs and the new contracts with these global customers, which also include Jansen USA, is seen as a progressive achievement by the Sepha team, which designed and developed Visionscan at the company’s Belfast-based R&D facility.
Since its launch last year, Sepha has achieved export sales for Visionscan in all its major global markets, including the US, Brazil, India, Europe and even New Zealand. Paul Kelly, Head of Sales and Marketing, said: “Over the last five years there have been considerable changes in global pharmaceutical production, with significant production cost-saving measures implemented by most large drug producers. We developed our new range in response to these changes. Visionscan enables pharmaceutical manufacturers to significantly lower their production costs while at the same time improve their quality levels.” The machine, which is a mobile, tabletop device, uses the latest camera imaging technology to offer a flexible
and reliable cost-saving alternative to destructive blister pack test methods such as blue dye. It is easy to use and requires no tooling, making it ideal for high volume pharmaceutical manufacturers and packagers, where high levels of quality and cost control as well as multiple product changes are required. It can detect channel leaks and weak seals down to 15 µm and has a simple touchscreen operator interface. To watch a video of the Visionscan, go to www.epmmagazine.com. Sepha Ltd +44 28 9048 4848 marketing@sepha.com www.sepha.com
Laser Punch Inspection System Offers Non-Contact Approach Utilising dual laser technology, the LVS 500 system provides non-contact inspection of punches, providing simultaneous measurements that enable the system to calculate cup depth immediately. Unlike the sharp point on a gauge, a laser beam poses no risk of scratching the surface of the punch tip when trying to locate the deepest point of the cup. Also, with no moving parts, the LVS is virtually maintenance-free. The LVS 500 allows users to focus on the critical dimensions of the punch rather than attempting to measure tool wear that cannot be accurately detected
with most measuring equipment. The LVS 500 is also equipped with a zoomlens camera that provides a magnified view for convenient visual inspection during the measuring process, from which photos can be captured and stored along with inspection data. The LVS 500 interfaces with the powerful Tool Management II (TM-II) database application for automatic inspection data storage and analysis. Measurements are transferred directly into the database with the click of a button, increasing efficiency and eliminating data entry errors.
Proper analysis of the punch working length dimension is a critical function of the TM-II application. As such, the working length measurement of each punch is compared with the working lengths of the other punches rather than to preset tolerance values. Visit Natoli’s website to schedule a free webinar and download a trial version of the TM-II software. Natoli Engineering Company, Inc. +1 636 926 8900 catalog3@natoli.com www.natoli.com
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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP 50 L Single-Use Stirred Tank Bioreactor
Merck Millipore, the Life Science division of Merck, has expanded the Mobius CellReady Bioreactor portfolio with the launch of a 50 l single-use stirred tank bioreactor for process development and pilot scale mammalian cell culture. This new single-use bioreactor allows biopharmaceutical manufacturers to implement robust, single-use technologies that bring their drugs to market faster, with less risk. This singleuse bioreactor further demonstrates Merck Millipore’s commitment to support the industry’s focus on implementing complete single-use bioprocess platforms. “The Mobius CellReady 50 l bioreactor is an important addition to the Mobius family. We’ve integrated a number of innovative features that deliver ease of use, reliability and operational flexibility compared with existing single-use systems,” said Paul Chapman, VP of Biopharm Process Solutions. “With this introduction, biopharmaceutical manufacturers now have a wider range of scalable single-use bioreactors offered by Merck Millipore, from two to three-hundred litres, to support their needs from process development to clinical scale.” The Mobius CellReady 50 l bioreactor extends the company’s portfolio of single-use processing systems from cell culture through ultrafiltration/diafiltration. The Mobius SensorReady technology offers exceptional flexibility to configure process monitoring at the point of use, reducing the need to customise bioreactor process containers and enabling easy integration of new sensor technologies. The reportedly unique rigid base and top panel design of the bioreactor process container enables simple, reliable and robust installation, improving operator confidence in setup and system operation. The Mobius CellReady Bioreactor system is available as a turn-key system complete with Finesse automation or as a modular system that can be integrated with a customer’s platform of choice.
R&D Press for Galenic Experimentation and First Clinical Batches Fully GMP and CE compliant, the Eliza-Press 200 is most suited to R&D plants and pharmaceutical colleges. Its small footprint — 55.8 x 70.4 cm — makes it easy to install. Eliza Press 200 is ideal for carrying out galenic experimentation and manufacturing first clinical batches. The turret can be provided with ‘D’, ‘B’ or combination ‘D’ and ‘B’ multi-tooling. Its large capacity motor (3 HP) and high torque gearbox ensure no-slip operation. The pre- and main compression rollers, together with the exceptional overall design of the press, allow for a full, six tonne final compression. This covers a diverse spectrum of compression development, from difficult products and formulae to large tablet sizes. The feeder mechanism has a double paddle design for optimum powder filling. The touchscreen MMI ensures that the control panel is easy to use. The interface is userfriendly. The GMP zonal separation guarantees that oil will not contaminate the product. Elizabeth Europe-EPMO +33 2 54 90 21 20 service@epmo.com www.epmo.com
Merck Millipore +1 781 533 5132 ian.davis@merckgroup.com www.millipore.com/mobius
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SHOWCASE SOLID DOSE INSPECTION Solutions for Eliminating Broken Tablets and Foreign Tablets and Capsules
Laser Inspection System Provides Clear 3D Images of Embossed Tablets
Designed specifically for pharmaceutical and nutraceutical manufacturers and contract packers, VeriSym optical inspection systems and Impulse/P size graders maximise product quality while reducing the labour costs associated with manual inspection. VeriSym is a compact, highperformance optical inspection system for tablets and softgel capsules that automatically verifies product colour, size and shape and removes foreign tablets and capsules, foreign material and defects from the product stream. VeriSym inspects up to 1,000,000 tablets or softgels per hour, while VeriSym SL inspects up to 500,000 tablets or softgels per hour. Symetix designed VeriSym/N and VeriSym SL/N for nutraceuticals and VeriSym/P and VeriSym SL/P for OTC and regulated pharmaceuticals. The /P models are FDS 21 CFR Part 11 compliant with secure and encrypted logs, secure passcode management, parameter histograms and guided changeover. Using proprietary colour cameras located above and below the product stream, VeriSym views product from top and bottom. Symetix’s image processing technology quickly analyses the product images, comparing each object with previously defined accept/reject standards. When a defective product or unconfirmed object is identified, the
Japanese manufacturer of automated inspection systems Viswill is reportedly the first to implement laser technology to take accurate and stable 3D images of embossed tablets. Compared with the conventional direct-lighting technology widely applied on other inspection systems on the market, the 3D laser provides stable, clear and sharp images of the embossing and 3D defects, without the unwanted noise caused by the reflection of light on the surface and edges of the tablet. The combination of this 3D laser technology with newly developed algorithms, which enables inspection of each character separately, results in very accurate tablet inspection, excellent yield and exceptional repeatability, while throughput is not limited by the number of algorithms used or the nature of the defects to be detected. This technology is available on Viswill’s high-end tablet inspection system TVISEX3-CD, which also features: colour CCD cameras, using all three colours for inspection; a single line transport system, combining vacuum with moving belts for stable conveying of tablets at high speeds (up to 360,000 tab/hour); a specific feeding table that increases the throughput of oblong and oval tablets to up to three times that of equivalent
system activates the close-coupled highspeed ejector system to remove it from the acceptable product stream. Impulse/P is a high-capacity size grader that removes broken tablets and fragments when grading tablets and removes twins, clusters, empties, twins, under-filled and over-filled capsules when grading softgel capsules as well as foreigners of a different size. Impulse/P achieves a throughput of up to 1,000,000 doses per hour, depending on the size of the tablets or capsules. With a large infeed hopper and an electronically-controlled infeed gate, Impulse/P can be easily integrated with upstream and/or downstream equipment or used as a standalone size grader for handling batches. Symetix +1 509 394 3524 jdonovan@symetix.com www.symetix.com
System Offers Inspection for Both Tablet Tooling and Tablets The Holland Minicam is the latest addition to I Holland’s PharmaCare range and has been developed for the close inspection of punch tips and tablets. The 20–200 x magnification with LED illumination gives a clear, precise, high quality image that allows for quick and easy identification of defects and wear, saving time and money in production. The image is viewed on a PC with included easy-to-use software, which can be saved for reference or emailed directly to I Holland for consultation. The Minicam provides both live and still images for close up inspection and photography of punch tips and cups, die bores, tablets, embossing and land. This light and workbench/desktop mountable system is easily transported or stored in its protective carry case. Also available is a new compact model of the HNC Laser, designed to accurately measure the overall and
working length of any punch, including multi-tipped tooling. The HNC Laser allows for critical punch dimensions to be measured with no contact to the delicate punch tip face, reducing the risk of damage to tablet tooling. The super accurate laser displacement sensor allows for 0.05 µm repeatability across the tool set, ensuring critical length dimensions are tightly controlled, helping to avoid issues such as tablet weight variation. Inspection and measurement are critical stages of I Holland’s recommended PharmaCare 7-Step process. For further information on the Holland Minicam, HNC Laser or any other aspect of the PharmaCare 7-step, contact the company. I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk
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equipment on the market; a user-friendly HMI; tool-free product changeover and cleaning. GEA Pharma Systems - Courtoy, the exclusive distributor of the Viswill range for Europe, has a full-option TVIS-EX3CD available for trials at its facilities in Halle, Belgium. Trials allow customers to experience the exceptional productivity and constant quality offered by Viswill’s latest automated tablet inspection system with 3D embossment inspection. Visit the website for webinar subscriptions or to learn more about the latest developments in tablet video inspection. GEA Pharma Systems - Courtoy +32 2 363 83 26 veerle.chiau@gea.com www.gea-ps.com
Corporate News & Events
Optimising API Production Processes Webinar
Bio-Processing Component Manufacturer Moves to State-ofthe-Art Premises
Mettler-Toledo has announced its latest ondemand webinar for the pharmaceutical industry. ‘Optimising API Production Processes’ explains the value of implementing in-line process analytical systems for API production. During the three major steps of API production — chemical reaction, crystallisation and drying — process control is central to maximising yield and efficiency. Although laboratory analysis of samples provides accurate measurements, it is frequently too slow to allow timely actions and often means expensive API rework. The U.S. Food and Drug Adminstration’s Process Analytical Technology (PAT) initiative recognises the importance of real-time process control, which is made possible only when continuous, real-time analytical measurements are available. Optimising API Production Processes was developed specifically to address the challenges faced by process engineers, instrumentation engineers and maintenance managers. Webinar participants will discover how process analytical systems can lead to increased yield and capacity, as well as faster batch runs and reduced laboratory costs. Access the webinar at: bit.ly/optimising-api-production-processes-webinar.
BioPure is now operational at its new c.1,765 m2 facility in Horndean, Hampshire, UK, where the company’s own range of products are manufactured in house. Investment has been made into 4 x ISO Class 7 cleanrooms, one as a manufacturing environment equipped with Servo electric moulding machines and three for assembly and finishing. Increased warehousing space has facilitated reduced lead times and from this new state-of-the-art facility, which follows procedures governed by ISO 9001:2008 and ISO 14644-1:1999, BioPure is in a better position to increase capacity and continue providing a reliable service to its customers. BioPure Technology Ltd +44 23 9249 9000 sales@biopuretech.com www.biopuretech.com
Mettler-Toledo, Process Analytics Solutions +44 11 6235 7070 http://uk.mt.com/gb/en/home/products/processanalytics.html
Nucleation Technology to Improve Yield and Reduce Cycle Time of Freeze Drying Range
GEA Lyophil, part of GEA Pharma Systems and one of the market leaders in freeze drying/lyophilisation technology, has signed a license agreement to use Praxair’s ControLyo nucleation on-demand technology. ControlLyo controls the freezing step of lyophilisation by controlling the nucleation temperature to within 1°C of its freezing point. The results are improved product uniformity, quality, yield and a reduction in cycle time by as much as 40%. The agreement is an obvious fit between the two companies: GEA Lyophil being a market leader in pharmaceutical freeze drying; Praxair, the reportedly largest industrial gases company in America producing atmospheric, process and specialty gases and high-performance surface coatings. “The integration of Praxair’s ControLyo technology into our laboratory and production scale freeze dryers is another important step in our approach to provide comprehensive lyophilisation
to our clients that combines predictable and reproducible product quality with the best drying performance,” said Heinrich Meintrup, MD of GEA Lyophil. “The addition of Praxair’s ControLyo nucleation on-demand technology to GEA Lyophil’s freeze-dryers provides drug manufacturers with precise control of the lyophilisation process using one of the most advanced and innovative freeze-drying tools on the market today,” said Rich Jarrett, Global Director of Marketing and Business Development for Praxair’s Biopharma business. GEA Lyophil has more than 55 years experience and a reference record of over 1,000 freeze dryer installations worldwide. The company is certified to ISO 9001 and performs in full compliance with the cGMP, GAMP and other relevant guidelines. GEA Lyophil GmbH +49 2233 6999 220 lyophil@geagroup.com www.geapharmasystems.com EPM 29
Signing of Supply and Distribution Agreement to Support Continuous Processing in Biopharma Manufacture GE Healthcare, the healthcare business of GE, has signed a worldwide supply and distribution agreement with Refine Technology, a manufacturer and supplier of filtration systems for use in biopharmaceutical manufacturing. Under the terms of the agreement, GE Healthcare will supply Refine Technology with its hollow fibre filtration cartridges for use with Refine Technology’s ATF system. Refine Technology’s ATF System is a cell retention device used in manufacture of biopharmaceuticals to generate extremely high concentrations of cells ready for further processing. Continuous processing offers a number of significant advantages over traditional batch manufacturing methods, such as more rapid isolation of cells, shorter
manufacturing times and improved safety profiles. GE Healthcare’s ultrafiltration and microfiltration hollow fibre cartridges, which are used with the ATF System, are ISO 9001:2000 certified, autoclaveable for sterile repeat use and available in a wide range of formats and specifications to help customers optimise their manufacturing process for maximum productivity. Catarina Flyborg, BioProcess Product Marketing Leader, GE Healthcare Life Sciences, said: “GE Healthcare and Refine Technology have established a platform for future collaboration, a crucial step in helping both companies meet the new and emerging demands of the rapidly-changing biomanufacturing market. The relationship also helps support the
FDA’s goal of achieving continuous processing across the industry.” Jerry Shevitz, President of Refine Technology, commented: “We are excited to be working in collaboration with GE Healthcare and to be able to supply our customers with a broad range of GE Healthcare’s high quality hollow fibre filters that will offer them enhanced flexibility in their processes.” GE Healthcare +44 7917 175 192 val.jones@ge.com www.gehealthcare.com Refine Technology +1 732 993 3003 jbonhamcarter@refinetech.com www.refinetech.com
Lab and Process Technology Provider Invests €25 Million in Building for Membrane Manufacture The Sartorius technology group has opened a new manufacturing building at its headquarters in Goettingen, Germany, for the production of membranes. After approximately one year of construction, the new building was officially dedicated in the presence of Lower Saxony’s Prime Minister David McAllister, the Mayor of Goettingen Wolfgang Meyer and many guests. Ranking among the world’s leading providers of laboratory and process equipment, the company invested some €25 million in extending its membrane production facility and in expanding laboratory capacity at its Goettingen site. With a floor space of 6,000 m2, the new building offers ample room to accommodate the new plant machinery for
manufacturing polyethersulfone membranes, as well as laboratories and offices for more than 120 employees. “We have not only invested in increasing our capacity but, at the same time, have also further enhanced our manufacturing processes, making them more adaptable. This investment enables us to respond even faster and more flexibly to high demand and to maintain our quality leadership in pharmaceutical filtration,” said Joachim Kreuzburg, CEO and Executive Board Chairman of Sartorius. Sartorius membranes are processed into specialty filters that are used to sterile-filter biopharmaceuticals or to recover active ingredients from liquids. Major customers for such membranes are companies in the pharmaceutical and biotechnology industries, which
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employ these filters for the production of medications in a large number of purification steps. Construction of the new membrane production facility in Goettingen is one of the three major building projects on the basis of which Sartorius is now expanding its capacity levels. To supply the North American market, the Sartorius Group is extending its site in Yauco, Puerto Rico. In Guxhagen, in the northern part of the Federal State of Hesse in Germany, a new manufacturing plant for bioreactors is being built. The Sartorius Group +49 551 308 3324 dominic.grone@sartorius.com www.sartorius.com
LABORATORY PRODUCTS & EQUIPMENT
Autoclave Manufacturer Launches Jubilee Promo At the start of its new financial year, UK autoclave manufacturer Priorclave is launching its own Jubilee Promotion that will run for a four month period — April to July. Throughout this period against all confirmed orders, Priorclave will present a Kindle — the e-book reader with facilities to shop for, download, browse and read e-books, newspapers, magazines, etc. at your finger tips. Not only is it a thank you for buying products designed and manufactured totally in the UK, it is part of a promotion in the run-up to Priorclave celebrating 25 years as an autoclave manufacturer. Priorclave is proud of its British heritage and believes the ‘Made in the United Kingdom’ label has gone a long way to influencing those looking for known quality, reliability and superior performance. Couple these factors with a large choice of standard steam sterilisers and an option to re-engineer and build in-house and Priorclave is able to satisfy most specific requirements. “Our build flexibility is very much key to our continued success,” said Priorclave’s MD Tony Collins.
It should not be difficult for anyone looking to purchase an autoclave to join in the Jubilee Promotion since Priorclave manufactures one of the most comprehensive selections of steam sterilisers. Standard Priorclaves are available as benchtop or floor standing, top or front loading, with round and rectangular chambers up to 700 l. Like most autoclave suppliers, Priorclave offers a range of options to increase functionality, but according to the company, the big difference is that virtually all the ‘extras’ are available on all sterilisers, even the smaller autoclaves. The huge choice in product specification has maintained buoyant UK sales for Priorclave, whilst the export market, particularly Europe, Asia and the Middle East, has grown exponentially — extremely good news for Priorclave and excellent news for the British government, which is looking towards increased exports to help the British recovery. Priorclave Ltd +44 20 8316 6620 sales@priorclave.co.uk www.priorclave.co.uk
Chromatography Medium for Large Biomolecules Offers High Sample Loads and Flow Rates GE Healthcare’s Capto Core 700 is a multimodal chromatography medium (resin) designed for intermediate purification and polishing of viruses and other large biomolecules. Capto Core 700 offers a range of performance advantages over a typical gel filtration step. Productivity is improved with up to 100 times greater sample loadings and significantly higher flow rates. Optimisation and scale-up are both straightforward. The Capto Core 700 medium employs core bead technology, with a ligandactivated core and inactive outer layer. The inactive outer layer excludes large molecules (Mr 700 000 [700 kDa] and above) from entering the beads, which can subsequently be collected in the column flowthrough. Smaller impurities bind to the internalised ligands, which are both hydrophobic and positively charged, resulting in a highly efficient multimodal binding of various contaminants small enough to enter the core. With Capto Core 700, flowthrough chromatography and a wide window of operation enable straightforward
optimisation. The prepacked HiTrap and HiScreen formats simplify process development and scale-up. Capto Core 700 is also available as a bulk medium in a range of pack sizes from laboratory to production scale. GE Healthcare Life Sciences +44 870 606 1921 www.gelifesciences.com/captocore
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SHOWCASE LABWARE Pipette Controller Brand Celebrates 30th Anniversary A specialist in laboratory liquid handling tools, INTEGRA has announced a special three-year warranty to celebrate 30 years of its PIPETBOY serological pipette controller brand. During the last 30 years, millions of scientists around the world have benefited from the comfortable, safe and effortless way that PIPETBOY pipette controllers have enabled them to reproducibly pipette liquids from 0.1 to 100 ml. PIPETBOY combines all essential features for productive work — precision, speed, comfort and reliability.
The tried and trusted smart valve design and speed regulation on PIPETBOY pipette controllers enable accurate control of dosing from drop-by-drop to fast pipetting using just finger pressure on trigger controls. Available in a large choice of colours, PIPETBOY pipette controllers offer a simple way of minimising the risk of crosscontamination and also enabling individual scientists to personalise their laboratory equipment, thereby avoiding mix-ups. PIPETBOY pipette controllers are used for a vast array of applications, including
liquid transfer in life sciences laboratories, fast pipetting for cell culture, gravity dispensing and precision dosing using all serological, glass or plastic pipettes in biology, pharmaceutical or microbiology laboratories. INTEGRA Biosciences AG +41 81 286 9530 info@integra-biosciences.com www.integra-biosciences.com
Hotplate Stirrer Safety Features Eliminate Need for Supervision With a strong emphasis on safety, the newly designed Asynt hotplate stirrer incorporates two independent control circuits, so that the set temperature values are held constant in the event of one circuit malfunctioning. According to Asynt’s Dr. Kerry Elgie: “The expanded range of safety features makes this hotplate stirrer eminently suitable for unsupervised operation in the chemistry lab. The safety circuit for the heating plate temperature can be adjusted between 50 and 360˚C, but cannot be changed accidentally. This ensures that the flashpoint of the
medium is not exceeded. A ‘Hot Top’ warning indicator to prevent burns and easy-to-read digital displays with error code warnings are also included.” Manufactured in an ISO9001-2008 production facility, the Asynt hotplate stirrer has a hermetically sealed design to protect the motor assembly from spillages and a highly polished aluminium hotplate for optimum heat transfer. New technology and a stronger motor provide greater capacity, a higher range of speeds, faster heating and improved magnetic adhesion. To enable all laboratories to benefit
from the new product, Asynt is offering the new hotplate stirrer, together with everything a chemist needs to stir and heat at precisely controlled temperatures — temperature sensor, electronic contact thermometer, holding rod, support rod and boss head clamp — at discounted prices. Asynt Ltd +44 1638 781709 sales@asynt.com www.asynt.com
Rack for Flexible and Safe Storage of Cryogenic Tubes Thermo Fisher Scientific has launched the Thermo Scientific Universal Latch Rack for use with 2 and 5 ml Thermo Scientific Nunc Cryobank tubes, as well as most standard Thermo Scientific Nunc and Nalgene cryogenic tubes. The rack enables easy and ergonomic tube storage and incorporates a highly flexible lid, which can pivot or be lifted off, making it suitable for handheld pipetting, as well as automated dispensing via robotic picking and placing. As a result, users have the ability to switch between manual and automated formats while protecting samples from the surrounding environment. Unlike other racks that lock tubes in
place, making it difficult to robotically pick and place them effectively, the nonlocking design of the new universal latch rack is automation friendly. Furthermore, a latch locks the lid in place, providing safe, stackable and secure storage to maximise freezer space with 48 tubes per rack for internally threaded caps or 24 tubes per rack for externally threaded caps. This reportedly novel format is also compatible with the complete portfolio of Thermo Scientific sampletracking and storage equipment, including handheld and automated decappers, as well as 2D barcode readers, allowing customers to create a fully integrated and traceable cold storage workflow.
The universal latch rack retains several of the proven features of the original 2 and 5 ml Cryobank rack, including an ANSI standard microplate footprint, open bottoms for 2D barcode readability and strategically placed automation orientation detection features. As a result, the universal latch rack is ideal for any laboratory storing biological, genomic or diagnostic samples at low temperatures. Thermo Fisher Scientific Inc. +1 978 905 1201 tracy.cartier@thermofisher.com www.thermoscientific.com/cryobank
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Corporate News & Events
Save up to 30% on ELA 2012 Conference Registration
Select Biosciences — organiser of the Second European Lab Automation (ELA) at the Congress Center Hamburg, in Germany, taking place on 30–31 May — is offering a ‘bring a buddy’ discount on conference registration fees. Industry and academic delegates can qualify for up to a 30% reduction in registration fees when booking in conjunction with colleagues or collaborators, providing delegates with the opportunity to save money. Registration for ELA 2012 is now open and all delegates have the option to attend eight different conference streams, each of which includes internationally renowned keynote speakers and research presentations. The eight streams available at ELA 2012 are:
Laser Diffraction Masterclasses Offer Re-Focus
• Drug Discovery Automation — HCS & Cell Based Assays; • Drug Discovery Automation — Chemistry Automation & Compound Management; • Biobanking — Preparation, Storage and Analysis; • Informatics for Automation; • Liquid Handling & Robotics; • Nano & Microfluidics; • Next-Generation Sequencing Automation; • and Separation & Detection. Registered delegates are invited to participate in the scientific discussions. In addition, the conference streams will be supported by leading technology vendors in a busy and topical exhibition, showcasing the latest in automated instruments and workflows. Together, the vendor exhibition and
scientific presentations reportedly make ELA 2012 an unparalleled opportunity to foster technological discussions and scientific collaboration. Accommodation for registrants of ELA 2012 is available at a discounted rate in the Radisson Blu Hotel, located adjacent to the CCH conference venue. For more information on the ‘bring a buddy’ scheme and to see what ELA 2012 has to offer, email Select Biosciences Business at the address provided or visit the website. Select Biosciences +44 1787 314955 s.marsden@selectbiosciences.com www.eurolabautomation.com
Integration and Re-Branding of Biomedical Products Manufacturer
Panasonic has announced the creation of a new business — Panasonic Biomedical Sales Europe BV (PHCBEU). The new organisation sees SANYO E&E Europe BV re-brand as PHCBEU and continue to offer a wide range of biomedical products, such as ULT freezers, incubators, medical refrigerators and cell processing systems, under the newly created brand. All products produced by PHCBEU will be manufactured in the same factories as in the past. However, PHCBEU will provide services and support to customers of previously branded SANYO products, both in and outside of the warranty period.
This change follows Panasonic’s full acquisition of SANYO in 2011 and the creation of Panasonic Healthcare Company Europe (PHCEU) in January 2012. This acquisition reflects its expanded healthcare offering. PHCBEU will be positioned within PHCEU, which possesses expertise in the manufacture, supply and service of laboratory equipment, hearing instruments, dental equipment, ultrasound diagnosis systems, medical monitors and robotic products. “The creation of PHCBEU signifies our strengthened healthcare proposition. By integrating the businesses and facilitating shared expertise, we are even better positioned to offer our
existing and prospective customers a bigger and better product range. In addition, we are confident that we have a stronger foundation for future business growth in Europe, in the medical industry,” said Hans Brok, Deputy Managing Director of PHCBEU. “We want to assure all former customers of SANYO that we will continue to support their products within and outside of the warranty period. In addition, they will now have the opportunity to have consultancy on, and access to, a wider range of technologies in this sector, as a result of the creation of PHCBEU,” concluded Brok. Panasonic Biomedical Sales Europe BV +31 76 543 38 33 biomedical.export@eu.panasonic.com www.panasonic.eu/biomedical
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Malvern Instruments has refocused its popular Mastersizer Masterclass webinars to encourage exploitation of the full potential of the new Mastersizer 3000. The Mastersizer Masterclass series provides all the information required to apply best practice and get the most from laser diffraction measurements. The course is open to all laser diffraction users, whether or not they are Malvern customers. Subscription is free at bit.ly/malldm1. “Clear well-presented basics with good slides and no cluttering by undesired info. Well done!” said a previous attendee. The first in the series, ‘Laser Diffraction Masterclass 1: Laser Diffraction Explained’, introduces the basic principles behind laser diffraction. It explains how measurements are carried out, how particle size distributions are calculated; some of the differences that exist between laser diffraction and other techniques for particle size analysis, and provides example applications of laser diffraction. Subsequent classes add a deeper understanding of various aspects of the laser diffraction technique such as method development, experimental practice, optical property selection and troubleshooting. Further information on all laser diffraction and Mastersizer training courses may be found at bit.ly/malevents. Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com
INGREDIENTS & CONTRACT SERVICES
CMO to Strengthen US Market Share as Site Secures Significant FDA Approval Aesica has strengthened its links with the US market after its site at Queenborough, UK, passed its first FDA inspection for the production of solid dosage forms. The success paves the way for the fast-growing pharmaceutical manufacturer to transfer production of its US-based client’s solid dosage form product to the Aesica site in
Queenborough, Kent. The FDA inspection officer made no specific observations. This audit follows a long history of successful inspections by the FDA for API production. Jeremy Drummond, Sales Director, Formulated Products, said: “This is a particularly significant development for Aesica and will help us gain credibility in the US market. At a time when
Aesica is expanding its presence in North America, receiving this positive feedback from the FDA shows we are well-positioned to satisfy the manufacturing needs of US-based pharma companies.” The Aesica site in Queenborough has been FDA approved for the manufacture of APIs for over 20 years and now offers US pharma companies peace of mind when sourcing either API or dosage forms from the Queenborough facility. The Queenborough site is already transferring in other solid dosage form products for the US market, including one based on bi-layer tablet technology with which it has many years experience. The successful audit of the Aesica site in Queenborough follows recent positive repeat audits by the FDA at Aesica’s European sites in Zwickau and Monheim, Germany, and Cramlington, UK. Aesica Pharmaceuticals Ltd +44 191 218 1960 info@aesica-pharma.com www.aesica-pharma.com
Sterile Filling Specialist Clinches Business Award UK-based CDMO SCM Pharma has topped off a record year by winning a prestigious prize at the UK’s biggest regional business awards. The company, which has almost doubled in size over the last 12 months, fought off stiff competition to be named as the winner of the Science & Technology Award at the North East Business Awards for the Northumberland and Tyneside region. Along with its exceptional growth that has seen the business add over 30 new jobs in the last year, the company was also commended for its commitment to innovation relating to its aseptic processing and filling capabilities. Dianne Sharp, MD at SCM Pharma, said: “This is without doubt the most significant award we have won to date and is a reflection on the commitment of every single member of the team across the business in helping us become one of the leading sterile contract manufacturers in the world. “Given that we are proud ambassadors for the science and technology industry in the UK, it feels
extra special to win in this category. This tops off a superb year for SCM Pharma and long may the success and growth continue.” This latest piece of silverware closely follows two award wins by SCM Pharma at the back end of last year. Sharp won the Best Woman in International Business at the WIN North East Woman Entrepreneur of the Year Awards and this was followed by SCM Pharma being named as the winner of the Outstanding Growth Award at the Cels Business for Life Awards. SCM Pharma recently invested over £500k in new vial filling equipment at its manufacturing facility to help deal with several contract wins for clinical trials and the supply of licensed drugs needed in niche markets. This followed the launch of its own in-house formulation development capability last year after acquiring new facilities to provide developmental services for liquid formulations,
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including emulsions and suspensions for parenteral, oral and topical administration. SCM Pharma differs from many contract manufacturers with its ability to provide cGMP sterile services for C14 radiolabelling and potent products such as cytotoxics. It delivers aseptic processing and sterile manufacturing services and has specific expertise in ampoule filling and syringe filling of liquids, gels and powders. SCM Pharma +44 1661 838 186 raman.sehgal@scmpharma.com www.scmpharma.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Extended Solubilisation and Dermatology Excipients Portfolios After acquiring Cognis in 2011, BASF has significantly expanded its range of solubilisation and dermatology excipients. The new dermatology and solubilisation portfolios, launched on 1 April, offer a wide range of pharmaceutical-grade solubilisers, emulsifiers, solvents, consistency factors and emollients for all dosage forms. To make the portfolios easier to navigate, BASF has developed a new naming system for these products. The new names are related to compendial designations, so customers can easily identify each excipient’s application. All products within these portfolios now have ‘Kolli’ as the stem, plus a suffix reflecting the chemical structure — ‘phor’ for solubilisers and emulsifiers, ‘solv’ for solvents, ‘wax’ for consistency factors and ‘cream’ for emollients. “The new naming structure ensures a consistent branding for all products compliant with pharmaceutical regulations and to better facilitate customer orientation through strong and clear branding and clustering,” explained Dr. Thomas Rosen, Head of Global Marketing Dermatology & Solubilization. “The change in trade names in no way affects the quality of the products and production processes.” All affected products will continue to be manufactured to the same high standards at the same sites, with the same tried-and-tested QA systems in place.
BASF has made great strides with regards to solubilisation and bioavailability enhancement in recent years, developing innovative solutions for even the toughest solubilisation challenges. Soluplus, for example, is ideal for solubilising poorly soluble APIs via hot-melt extrusion (HME), and Solu-HTS, BASF’s high-throughput screening robot, helps customers quickly pinpoint the right excipient or combination of excipients for their actives. BASF’s recently published Solubilization Compendium, the result of many years of research, provides expert advice on solubilising compounds with poor solubility and bioavailability profiles. The publication provides an overview of all relevant BASF excipients and offers guidance on selecting the most suitable solubilisation product. In addition, it features chapters on the basic principles of solubilisation and offers practical advice on creating solid solutions and dispersions. Interested parties can request a free print copy of the Solubilization Compendium by contacting BASF. BASF +41 27 766 1606 andres-christian.orthofer@basf.com www.pharmaingredients.basf.com
Life Sciences Manufacturer Opens Shanghai Facilities to Meet Increasing East Asia Demand
Freeze Drying Specialist Announces Cytotoxic Capability Biopharma Technology Ltd (BTL) has completed the construction of a new standalone cleanroom, enabling it to provide freeze drying R&D services for cytotoxic products. Freeze drying is a complex operation and many drug developers outsource development to contract research organisations specialising in this field. However, few CROs with freeze drying expertise have the ability to handle cytotoxic drugs safely. Cytotoxic therapies are most commonly used in cancer chemotherapies and work by preventing the growth of cells. However, normal cells can also be damaged both in patients and anyone else exposed. Cytotoxics are highly potent, which means that from R&D to actual administration there is a need for secure handling. In R&D, the safe handling of cytotoxic drugs requires measures that are significantly more stringent than standard practice. Cleanroom containment, protective clothing and additional handling procedures are used to protect staff, to prevent product from escaping from the laboratory and to prevent crosscontamination with any other products that may be under investigation. These factors make it common for cytotoxics to be handled in a separate suite specifically designed for handling them. Rather than take on the costs of an additional laboratory, many drug developers benefit from partnering with contract research organisations with existing facilities and additional expertise. Freeze drying is a process used to stabilise high value products, including pharmaceuticals, although it can be an
expensive process. “When freeze drying cycles are inefficient, they become long and costly,” said BTL’s Commercial Director Dr. Laura Ciccolini. “This is why many developers choose to partner with an organisation specialising in this field. However, there are a limited number of companies with this expertise and few have the capability to handle cytotoxic compounds.” BTL’s new standalone cytotoxics laboratory has been built to provide both an outsourcing capability to smaller developers and specific product development expertise to more established enterprises. The suite contains a full range of characterisation and analysis equipment, as well as a pilot-scale freeze dryer. This enables BTL to offer its full range of freeze drying product and process development services and small scale production runs for cytotoxic products. Dr. Ciccolini said: “BTL are now able to provide a really exceptional combination of worldwide reputation for freeze drying expertise and safe cytotoxic processing.” Biopharma Technology Ltd +44 1962 841092 btl@biopharma.co.uk www.biopharma.co.uk
Novasep has announced the opening of a new 2,000 m2 facility in Shanghai Pudong district, China. The site will boost Novasep’s process development and engineering capabilities to cater for ever-increasing Chinese and East Asian demand. These facilities will also add to Novasep’s existing 12 global synthesis and process sites in France, US, Germany, Belgium and The Bahamas. Novasep launched its previous facilities in Shanghai in 2006 and quickly outgrew the site whilst the company doubled its staff to almost 50 employees between 2010 and 2012. The expanded facilities include 800 m2 dedicated to innovation and process development through new laboratory, piloting and FAT testing areas. The ongoing growth of life sciences industries in China and Asia stretches local demand for domestic production and innovation capabilities. Novasep has seen continued growth in demand in East Asia for its design and supply of purification technologies and integrated processes in batch and continuous membrane filtration, ion exchange and chromatography. Novasep is also facing increasingly challenging purification requests, driven by the need for life science industries to reach maximum throughput with low capital and production costs and minimum environmental impact. The increased innovation capabilities at the Shanghai site will allow Novasep to meet this demand and advance on the 50 purification processes already developed by Novasep in Shanghai. By increasing engineering capabilities, Novasep will expand output for its turnkey purification
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process solutions for its key markets: • industrial biotech — fructose, starch sweeteners, organic acids, amino acids, bulk antibiotics, nucleotides, polyols, white biotech applications, functional ingredients, including whey products, oligosaccharides and omega 3; • biopharmaceuticals, including recombinant proteins, peptides and biosimilars, including monoclonal antibodies and insulin; • and pharmaceuticals, especially optical isomers and certain anticancer APIs. “Novasep, as the leader in the supply of purification processes for industrial biotech and biopharmaceutical applications in China, has ensured that its supply capabilities can satisfy ever increasing demands in China and East Asia,” said Antoine Baule, President of Novasep Process, the biomolecule division of Novasep. “With food and feed industry ingredient volumes rising above 100,000 tonnes per year in some Chinese productions, this requires more cost-effective and environmentally friendly processes and strong engineering capabilities,” said Jean de Lataillade, General Manager of Novasep Asia. “The Shanghai site will further enable Novasep to compete globally in both low volume pharma markets, as well as large volume industrial biotech markets.” Novasep +33 383 497130 novasep@novasep.com www.novasep.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Global Chemical Distributor Adds High-Purity Oleochemicals Range to Portfolio Univar has expanded its agreement with BASF Pharma with the introduction of BASF’s legacy Cognis Pharmaline range for pharmaceutical applications to its portfolio. Cognis Pharmaline is a range of high-purity oleochemicals for topical applications and solubilisation, consisting of more than 20 brands. Univar has been distributing BASF’s specialty pharmaceutical ingredients in Sweden, Finland and Norway since 2003 and expanded into the Baltics in 2011. “The expanded range will provide high-performance products that meet the specific needs of the pharmaceutical industry,” said Dr. Jochen Seifert, Senior Key Account Manager, BASF Pharma. “Univar’s extensive on-the-ground distribution network and strong links in the region has given us a valuable insight into this marketplace.” “The addition of the Cognis
Component Manufacturing Process Meets High-Quality Needs of Pharma Manufacturers
Pharmaline range follows very positive customer demand we are experiencing with BASF Pharma products,” said Per Berntson, Sales and Marketing Director Nordics, Univar. “The Cognis Pharmaline range works well with our current portfolio and will fuel the continued growth in the territory.” The Cognis Pharmaline range includes Kolliphor solubilisers and emulsifiers with high bioavailability, Kollisolv monographed solvents, Kolliwax consistency factors and Kollicream emollients with adaptable spreading value and water permeability. The products provide a high performance, stable formulation, while ensuring appealing look and feel for the user. Univar Europe +32 2 525 05 63 catherine.lennon@univareurope.com www.univareurope.com
Partnership to Solve Bioavailability Issues
Catalent Pharma Solutions and BASF have entered into a broad collaboration and open alliance to provide solutions to overcome bioavailability challenges of new molecular entities with solubility or permeability challenges. The companies aim to combine their world-leading expertise to provide pharmaceutical customers with a unique range of seamless solutions to address pipeline challenges with a large majority of BCS Class II and IV poorly bioavailable compounds. From feasibility studies across multiple technologies, solid state chemistry, consulting and training, expert formulation services, excipients and optimal dose form development, to scale-up and supply, BASF and Catalent provide a full solution to one of the most important pipeline challenges in the industry — getting better treatments to market faster. BASF has extensive ingredient formulation and material science expertise, as well as world-class excipient products, and has been a leader in developing hot melt extrusion technology solutions. Catalent is a leading global partner in drug formulation and development, as well as in finished oral dose manufacturing, with more than 75 years of experience in providing bioavailability solutions. Ian Muir, President of Catalent’s Modified Release Technology business unit, stated: “We are very pleased to collaborate with BASF to bring this unique and impactful solution to our customers. BASF brings significant strengths and expertise that match very well with Catalent’s expertise in offering multiple solutions for poorly soluble compounds, including our Softgel platform and OptiMelt hot melt extrusion technologies. Our proven
track record of developing, scaling up and manufacturing pharmaceutical products globally also provides for an important seamless integration from development to commercialisation and ongoing supply.” “We are glad to bring our in-depth knowledge of polymeric excipients, including innovations like SOLUPLUS into this open alliance,” said Ralf Fink, VP Global Marketing at BASF Pharma Ingredients & Services business unit. “With our broadest portfolio of solubilisers and excipients for hot-melt extrusion, coupled with Catalent’s strengths in development, formulation and manufacturing, we are in a unique position to solve the solubility challenge. With this open alliance, we help our customers in the development and commercialisation of drugs with poor bioavailability.” Catalent has made significant investments in OptiMelt hot melt extrusion and fluid bed laboratory, pilot and commercial scale equipment at its Schorndorf, Germany, facility, OptiMelthot melt extrusion at its Somerset, New Jersey, US, facility, training and seamless method development to operationalise this open alliance. BASF is continuously investing in new excipients to provide advanced solutions for the pharmaceutical industry. Catalent +1 732 537 6407 media@catalent.com www.catalent.com BASF +41 27 766 1606 andres-christian.orthofer@basf.com www.pharmaingredients.basf.com
West Pharmaceutical Services has introduced a new line of high-quality components under its NovaPure brand at the PDA Annual Meeting. Through a product development process that incorporates QbD principles, NovaPure components, including serum and lyophilisation stoppers and syringe plungers, will help to ensure the safety, efficacy and purity of injectable drug products. “QbD is an essential element in helping pharmaceutical manufacturers meet regulatory guidelines for safety and efficacy,” said Donald E. Morel, Jr., Ph.D., West’s Chairman and CEO. “West is embedding QbD in manufacturing from raw materials through delivery. NovaPure components incorporate a variety of high-quality processes and features designed to ensure component reliability and provide an unrivalled level of quality for our customers, which ultimately can aid in the safety and efficacy of their drug product for the patient.” NovaPure components help pharmaceutical companies lower total cost of ownership, improve transparency between component and pharmaceutical manufacturers, ensure quality driven by patients’ needs, and are manufactured with the deepest product and process understanding. For NovaPure components, West developed a comprehensive quality target product profile based on the needs of its customers and their endusers. Critical quality attributes, determined with the patient in mind,
have been built into the development process to help ensure quality, safety and efficacy throughout a drug product’s lifecycle. Features and processes that help to ensure reliability include: • FluroTec barrier film — a proven, effective barrier against extractables that provides lubricity without the need for silicone oil; • validated wash and sterilisation processes that help ensure consistency of stopper preparation; • 100% vision verification to assure low particles; • and lot-to-lot extractable profile to assure material consistency. NovaPure components are available globally with reduced lead time and are provided in optimised packaging that helps ease transition through manufacturing environments. The components are supported by a series of reportedly unique service features that help assure the latest compliance and customer satisfaction requirements are met. West Pharmaceutical Services, Inc. +1 610 594 2900 / +49 2403 7960 www.westnovapure.com
Two Tablet Film Coating Systems Integrated into Single Product Line Ashland Specialty Ingredients, a commercial unit of Ashland Inc., has announced an expanded tablet film coatings portfolio as part of its pharmaceutical excipients business. The new product line integrates the Advantia coating systems line, formerly marketed by International Specialty Products Inc., which Ashland recently acquired, with Ashland’s Aquarius coating systems line. The result is one of the broadest product lines in the industry today. “Combining these two great product lines under the Aquarius brand, while applying our polymer know-how to the formulation of ready-to-use film coatings, has led to an extensive tablet coating systems portfolio,” said Timothy Bee, Business Director, Pharmaceutical and Nutrition Specialties, Ashland Specialty Ingredients. “Aquarius coating systems will include aesthetic and functional coating solutions for the global pharmaceutical and nutraceutical industries. Our offering includes the full spectrum of colours, in addition to barrier systems against moisture, odours and tastes, as well as sustainedand delayed-release coatings.” Ashland has full technical service capabilities to support the expanded Aquarius coating systems line with laboratories in the US, Mexico, Brazil, Argentina, Turkey, India and China. “Our technical experts at these stateof-the-art facilities work on customised coating systems, colour matching and troubleshooting, and can also provide tablet formulation development or onsite trial support,” explained Tom Durig
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Ph. D., R. Ph., Director, Pharmaceutical and Nutrition Specialties R&D, Ashland Specialty Ingredients. “We’re committed to aggressively growing our global technical presence and continuing to invest in our technical organisation and capabilities to better serve the global tablet coatings market.” All tablet coating systems will be manufactured at Ashland’s cGMP plant in Wilmington, Delaware, US. Ashland Specialty Ingredients provides a reportedly unparalleled range of functional excipients for solid, semisolid and liquid dosage forms. Delivering pharmaceutical and nutraceutical performance since the 1950s, it provides solutions for applications in controlled release, solubilisation, binders, film coatings and disintegrants. Ashland Specialty Ingredients creates value for its customers through applications knowledge, market insight, regulatory support and a powerful product portfolio, including: Aquarius coating systems; Aqualon ethylcellulose; Aqualon and Blanose sodium carboxymethylcellulose; Benecel methylcellulose and hypromellose; Klucel hydroxypropylcellulose; Natrosol hydroxyethylcellulose; Plasdone povidone; Plasdone copovidone; and Polyplasdone crospovidone. Ashland Specialty Ingredients +1 302 594 6850 rrruberti@ashland.com www.ashland.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP
REGULATORY AFFAIRS EXCIPACT — A NEW CERTIFICATION SCHEME FOR EXCIPIENTS HAS BEEN LAUNCHED The safety of medicines for patients is a major concern to the pharmaceutical industry. To assure the quality of medicines, risks in the supply chain need to be evaluated and minimised to assure the quality of medicines. The efforts to strengthen GMP and supply chain issues and to fight counterfeit medicines at an international level recently launched another valuable certification scheme known as EXCiPACT. This is a set of certification standards for drug excipients producers that have been developed by the European Fine Chemical Group (EFCG), European Association of Chemical Distributors (FECC), International Pharmaceutical Excipients Council (IPEC) Europe and Americas and Pharmaceutical Quality Group (PQD) since 2008. The second draft of guidelines was released for consultation in May 2011. EXCiPACT was finally launched in January this year and it will ensure patient safety through supplier quality, while minimising the overall costs for assessing the excipient supply chain. According to this scheme, a pharmaceutical excipient supplier is
CDMO Expands Business Development Team with Strategic Senior Appointment
certified upon completion of a satisfactory audit and a positive certification issued by a qualified third party auditor. The third party audit organisation, in turn, will have been assessed and judged as competent by an accreditation body and EXCiPACT. In order to receive a valid certificate, the pharmaceutical excipient supplier shall select a third party audit organisation that is approved and licensed by EXCiPACT and should undergo the process as available at www.excipact.org. The overall process scheme and the relationship with different parties are shown in the diagram below. If the appropriate quality standards are not followed, excipients may pose a hazard to end patient safety. Thus, the requirement to have a robust quality system in place that assures the quality and purity of excipients remains an imperative, particularly as events with fraudulent claims of pharmaceutical raw material purity have resulted in so many tragedies. This voluntary self-regulated scheme, which uses ISO 9001:2008 as a framework, consists of two annexes covering GMP and GDP (without major changes to these standards) and also covers the competency and quality requirements for third party auditors, based on ISO 19011:2002 and ISO/IEC17021:2006 respectively. There will be a two-stage initial audit (pre-audit, full audit, Corrective and Preventive Action (CAPA) Certification). The duration of audits
will be adjusted according to the scope and complexity of the GMP/GDP system and the excipients produced. Costs (both financial and time) are comparable with an overall ISO 9001 certification. Thus EXCiPACT ensures cGMP and cGDP requirements are applied to pharmaceutical excipients through a recognised auditing and certification process, thereby increasing safety and reliability as well as transparency of the pharmaceutical supply chain. As an independent organisation, EXCiPACT will be able to objectively set cGMP and cGDP standards today and in the future. The certification provides a cost-efficient method of ensuring cGMP and cGDP are applied throughout the pharmaceutical supply chain by reducing the audit burden. The benefits of the scheme are: • ease of access — certification from many third party audit organisations; • evolutionary — builds on existing ISO 9001 certification and uses well known IPEC-PQG GMP guides; • simple — easy to understand and apply for all stakeholders; • inclusive — applicable to all pharmaceutical excipients manufacturers and distributors; • and permits the supplier to proactively demonstrate commitment to cGMP and cGDP in the manufacture and supply of their pharmaceutical excipient. The authorities on both sides of the Atlantic have indicated that the use of third party audits is acceptable, so this scheme to aid excipient qualification will be beneficial to all. This international GMP and GDP certification scheme will provide manufacturers, suppliers and users of excipients with additional confidence that suppliers of these critical components of drug products are safe to use. Dr. Paolo Biffignandi paolo@elc-group.com
Dr. Paolo Biffignandi, MD, PhD, QPPV, FTOPRA, former President of The Organisation for Professionals in Regulatory Affairs (TOPRA), is an advisory board member of the pan-European pharmaceutical regulatory affairs organisation ELC Group. He is a renowned physician who graduated in Medicine with PhDs in Endocrinology and Pharmacology. Dr. Biffignandi started his highly successful career in the pharmaceutical industry after a period at the University of Torino, Italy, and in 1989 he became an independent consultant in medical and regulatory affairs. He is the author of more than 160 scientific articles and co-author of three books on European Regulatory Affairs and a member of several scientific societies, including DIA, RAPS and TOPRA. From 2003, he was a member of the Board of Directors of TOPRA, of which he was President in 2009–10. In 2009, he was appointed Fellow of The Royal Society of Medicine, in the UK. EPM 38
Penn Pharma is further driving the expansion of its UK operations with the strategic appointment to its Executive Team of Jerome Detreille as Senior Director of New Business Development. Detreille’s appointment comes after Penn Pharma recently announced a £14 m investment in its South Wales, UK, facility to expand its specialist high containment facilities. Jerome’s role will be integral to the success of the new facility, due to open in January 2013. Detreille joins Penn from Catalent Pharma Solutions where he headed up a European Sales and Business Development team. He brings with him 13 years experience in selling services for conventional and highly potent drugs covering all dosage forms, from oral solid dose to sterile injectables. Speaking on his appointment, Detreille said: “I am fortunate to have joined such a dynamic business at a significant point in the company’s development. The expansion of our high containment operations will give us a competitive advantage in the provision of highly potent development and contract manufacturing. I am looking forward to using my experience in negotiating large and complex deals to secure contracts for our expanded unit and hence drive growth for Penn.’’ The construction of the new, approximately 1,394 m2 development and commercial manufacturing unit for tablets and capsules has already commenced and it is designed to meet the highest international quality standards. The new facility will enable the team at Penn to further build upon its established 15 years expertise in the manufacture of highly potent drugs for the worldwide market. Chief Executive Dr. Richard Yarwood believes that Penn staff are key to the company’s continued success. He said: “We are delighted to welcome Jerome to the business development team. He has an outstanding track record and has already made a positive contribution to the team. “We aim to employ high calibre experienced professionals at Penn in order to deliver excellent service to our clients and this new appointment is going to help us meet that objective.” Penn Pharma has a wealth of experience in successfully providing an integrated range of services for the development, manufacture and distribution of medicinal products to the global pharmaceutical market. Penn Pharmaceutical Services Ltd +44 1495 711 222 www.pennpharm.co.uk
Q&A APTALIS PHARMA
Aptalis Pharma Inc., formed in 2011, when Axcan Intermediate Holdings, Inc. acquired Eurand N.V., is a privately held specialty pharmaceutical company that provides pharmaceutical products with therapeutic indications in the areas of gastrointestinal and cystic fibrosis. The company has several compounds in various stages of development, including Aeroquin in Phase 3 clinical trials for the treatment of pulmonary infections in patients with cystic fibrosis. Aptalis has manufacturing and commercial operations in the US, the EU and Canada. Aptalis Pharmaceutical Technologies (Aptalis Pharma Tech), a division within Aptalis Pharma, offers a broad portfolio of oral drug delivery technology platforms, including customised drug release, bioavailability enhancement and taste masking. This portfolio enables Aptalis Pharma Tech to provide customised drug formulation solutions that incorporate multiple technologies or drug combinations in order to optimise the drug development process for partners. These technologies are employed in more than 40 prescription and OTC pharmaceutical products around the world by commercial partners such as Pfizer Sanofi, Novartis, Johnson and Johnson, Bayer, GSK and more. EPM recently spoke with Robert Becker, Ph.D., Chief Research Officer, Aptalis Pharma, about the role of Aptalis Pharma Tech in today’s evolving pharmaceutical marketplace.
Robert Becker, Chief Research Officer
As a recently formed company created by the merger of two specialty pharmaceutical companies, what role does Aptalis Pharma Tech play in the organisation? Through the combination of the two businesses, Aptalis has created a company that has a robust portfolio and growing pipeline of products to treat gastrointestinal disorders and cystic fibrosis, supported by a set of innovative development platform technologies. Aptalis Pharma Tech has one of the broadest drug delivery technology portfolios in the industry. The portfolio includes customised oral drug release technologies, oral fast-dissolve/taste-masking formulation technologies and a bioavailability enhancement technology. Together, these flexible technology platforms combined with Aptalis Pharma Tech’s licensing, manufacturing and R&D capabilities, enable Aptalis Pharma Tech to produce customised drug formulation solutions across a range of dosage forms and therapies for its partners and for the Aptalis Pharma specialty pipeline. On a broader level, drug delivery technologies are significant in many stages of the drug lifecycle and should be considered a pivotal driver in today’s pharma market. Previously, patent expirations were the major market driver as technologies were primarily used for lifecycle management of drugs when the drugs lost patent rights. However, technology advances and increasing demand for safer and more efficacious drugs have broadened their applications and now drug delivery technologies are also utilised early in the drug development process.
Customised drug release is another key area and Aptalis Pharma Tech offers several technologies with a variety of release profiles. Of these technologies, Diffucaps stands out because it addresses an issue currently faced by many pharmaceutical manufacturers, facilitating a timed release of multiple doses in just one dose. How is this achieved? Diffucaps patented technology is used to formulate products with release profiles designed to eliminate drug fluctuations, to more accurately target drug tolerability limits and, therefore, decrease side effects. This technology can be applied to drugs with an extreme pH-dependent solubility profile, as in environments with a pH above 8.0 and below 4.0 or in physiological fluids. Diffucaps enables novel drug combination therapies that incorporate multiple release profiles all in one dosage form — for example, two different drugs and two release profiles — overcoming potential incompatibility issues. When used in combination with AdvaTab ODT technology, Diffucaps technology allows for the novel delivery of a controlled release ODT. Are there any further acquisition and/or expansion plans in the pipeline for 2012? Broadly speaking, the Aptalis Pharma Tech strategy is to develop enhanced pharmaceutical and biopharmaceutical products based upon our drug formulation technologies. To support that strategy, we will continue to invest in and improve our drug delivery technologies to enhance the development of products that offer therapeutic, market and patient benefits. Specifically, Aptalis Pharma Tech will continue development of its specialty and established pharma partnerships in the US and Europe, as well as increase the number of partnerships in emerging markets, especially in South East Asia and Latin America. Aeroquin®, Microcaps®, AdvaTab®, Biorise® and Diffucaps® are registered trademark products.
To watch Aptalis Pharma Tech’s Biorise video, go to www.epmmagazine.com. Aptalis Pharmaceutical Technologies +1 908 927 9600 www.aptalispharmaceuticaltechnologies.com
Aptalis Pharma Tech offers the taste-masking technology Microcaps and ODT technology AdvaTab. What can the client expect to achieve by applying these to drug formulations? Microcaps is a market-proven microencapsulation technology that uses a proprietary coacervation process to create a complete and uniform physical barrier around individual drug particles, resulting in outstanding taste- and/or odour-masking and high patient acceptability. Encapsulation of an assortment of drug particle shapes and sizes, as well as liquids, can be achieved. Microcaps is also compatible with AdvaTab technology. Combined, these dual technologies offer patients a pleasant taste experience with a smooth and creamy mouth feel in an easy-to-swallow dosage form, thus allowing for enhanced patient compliance. Aptalis Pharma Tech’s bioavailability enhancement platform BIORISE is applied to poorly water soluble molecules to enhance solubility profiles, improving the rate and extent of absorption. What is the process used and what are the key benefits for the end-user/patient? Biorise technology enhances bioavailability of poorly water soluble and readily permeable drug molecules by breaking down crystalline forms into nanocrystals and/or amorphous (noncrystalline) drug. The drug is then stabilised in a carrier system, which increases the intrinsic solubility and dissolution rate of the drug to enhance the rate and extent of absorption for a faster onset of action. Thus, equivalent therapy at lower doses and/or oral dosing of poorly soluble drugs can be achieved. Biorise has two distinct proprietary activation systems that employ either a top down or bottom up approach. Aptalis Pharma Tech offers a flexible development process, allowing customers various entry points within the development stages to optimise the ‘risk to spend’ ratio. Biorise is protected by multiple granted and pending patent applications. By utilising this technology, our partners who have a NCE in their pipelines can advance poorly soluble compounds that may otherwise be discontinued. For commercialised drugs, this technology can reduce dosage amounts and frequency of administration, enhancing patient safety, compliance and convenience, as well as extending the product lifecycle. EPM 39
NEWSFLASH At the time of publication, Aptalis Pharmaceutical Technologies learned that it had won the company's appeal against generic versions of the muscle relaxant Amrix as a result of a 16 April 2012 verdict by the U.S. Court of Appeals for the Federal Circuit. The ruling extends patent protection for the company’s Orange Book Amrix patents until 2023 and 2025. For the full release, see overleaf.
SHOWCASE DRUG DELIVERY Oral Drug Delivery Specialist and Biopharma Company Win Appeal Against Generic Versions of Muscle Relaxant
Oral Lipid-Based Drug Delivery Solutions to Meet Complex Bioavailability Challenges Presented at AAPS Workshop
Aptalis Pharmatech, Inc., previously known as Eurand, Inc., Cephalon, Inc., a whollyowned subsidiary of Teva Pharmaceuticals Industries Ltd, and Anesta AG prevailed in their appeal to the U.S. Court of Appeals for the Federal Circuit, which reversed a lower court’s determination and held that two patents covering the Amrix muscle relaxant (Cyclobenzaprine Hydrochloride Extended-Release Capsules) are valid. The two patents, owned by Aptalis Pharmatech and licensed to Cephalon, expire in 2023 and 2025. The patents, along with other additional patents that protect Amrix, are all listed on the FDA’s Orange Book and will be enforced to the fullest extent possible. Amrix is a convenient extended-release (once-daily administration) dosage form of Cyclobenzaprine that is indicated for short-term relief of muscle spasm as an adjunct to rest and physical therapy. Prior to the approval of Amrix in 2007, only immediate-release formulations of Cyclobenzaprine were available, such formulations often requiring administration two to three times daily. According to recent IMS data, Cyclobenzaprine is the most frequently prescribed drug for muscle relaxation in the US. The use of Aptalis Pharmaceutical Technologies Diffucaps technology in Amrix satisfies an unmet medical need by providing a modified-release formulation, oncedaily dosing of cyclobenzaprine, thereby allowing for increased patient compliance. “Aptalis Pharmaceutical Technologies endeavors to offer to our partners the most effective patent protection possible of our broad and diversified portfolio, and this court decision confirms the strength of these formulation patents,” said John Fraher, President of Aptalis Pharma. The Aptalis portfolio is composed of numerous patents with broad claims directed to its formulation technologies and related materials, processes, equipment and methods of manufacture. Aptalis also has many product-related patents, which contain more specific claims directed to particular drugs or classes of drugs in combination with the company’s formulation technologies. Aptalis’ owned and in-licensed patent portfolio consists of over 900 granted patents and pending applications. Amrix® is a registered trademark product
Jeffrey Browne, Ph.D., Technical Director, Pharmaceutical Softgel Business Development, and Julien Meissonnier, Director, R&D Platform – Rx Softgel, Catalent Pharma Solutions, presented ‘Dosage Form Options for Oral Lipid-based Drug Delivery Systems — Challenges and Possibilities’ and ‘Lipid-based Drug Delivery Systems for Permeability Enhancement’, respectively, at the recent AAPS Workshop on ‘LipidBased Delivery for Improving Drug Absorption: Mechanistic Understanding and Practical Approaches’. Dr. Browne concentrated on the considerations that influence final dosage form selection for the successful commercialisation of liquid and semisolid lipid-based formulations. Two important factors discussed in detail were the melting point and the hydrophilic/lipophilic balance of the formulation. Dr. Browne reviewed other considerations, including the manufacturability of the dosage form and its ability to protect the formulation throughout the shelf life of the product. Meissonnier focused his discussion on the oral delivery of poorly permeable entities (large and small molecules) and their increased focus over the past few years. As an example, he reviewed the conversion from an intravenous or subcutaneous dosage form to an orally administered dosage form and what this offers to the pharmaceutical industry, patients and also drug products with
Aptalis Pharmaceutical Technologies +1 908 927 9600 www.aptalispharmaceuticaltechnologies.com
Catalent +1 732 537 6407 media@catalent.com www.catalent.com
Specialty Pharma Company Signs $27 Million Deal for Dermatology Drug Delivery
CRO Acquires Exclusive License to Drug Delivery Technology Particle Sciences, Inc. (PSI), a leading pharmaceutical CRO, and Lyotropics Therapeutics, Inc. (LTI), a drug delivery technology company, have announced that Particle Sciences has acquired the exclusive rights to the Lyotropics’ LyoCell patent portfolio. The LyoCell technology allows for the solubilisation, stabilisation and delivery of a wide range of compounds — both small and large molecule. According to Particle Sciences’ VP Pharmaceutical Development Robert Lee: “LyoCells are proprietary lyotropic liquid crystalbased formulations that contain both polar and nonpolar nano-domains. These unique structures create ideal conditions for the solubilisation and stabilisation of many pharmaceuticals and biopharmaceuticals. Made from GRAS ingredients, this technology is already in late-stage clinical development in an intravenous product and has applications in most routes of administration.” Under the revenue-share agreement, PSI obtains a full license to the technology except for several compounds previously developed by LTI. Particle Sciences will offer the technology to its clients looking to increase bioavailability or develop parenteral formulations of difficult-to-solubilise compounds. Intellectual property around the stabilisation of macromolecules is also included in the transaction.
established, yet currently unmet safety profiles, for usage in long term/chronic indications. Meissonnier also reviewed recent case studies that illustrate the successful application of lipid-based formulation approaches for the oral delivery of poorly permeable drugs. Dr. Browne is an active member of the American Association of Pharmaceutical Scientists (AAPS), who serves on several Focus Group committees and frequently presents at regional and national AAPS meetings, and Meissonnier is an expert in his field and currently sits on the Board of Directors with the Alsace BioValley life sciences and healthcare cluster based in France. Recently, both Dr. Browne and Mr. Meissonnier participated in a Catalent webinar on improving oral bioavailability, ‘Unlocking the Therapeutic Potential of BCS Type II & IV Compounds: Oral Lipid-based Drug Delivery’, which can be viewed at: bit.ly/unlocking-potential-of-bcscompounds-webinar.
Vince Conklin, Lyotropic Therapeutics’ CEO, said: “The LyoCell technology has proven to be highly effective in solving very difficult formulation problems and is the basis for several drugs now in or poised to enter the clinical stage. We are very pleased to have a partner like Particle Sciences, a leader in the formulation and drug delivery space that is well positioned to further broaden exposure for the LyoCell technology and to employ its enormous utility.” Lee added: “The technology is protected by a family of very young patents offering protection to 2028 and beyond. Particle Sciences is very excited to bring the technology to our clients as it addresses the top technical issues we face every day, namely solubility and bioavailability, while also providing solid patent protection. Lyotropic liquid crystals has proven to be an outstanding approach that utilises GRAS ingredients, something very unusual today. We anticipate our clients using this for NCEs as well as in lifecycle extension efforts. In both situations, the LyoCell technology has a lot to offer.” Particle Sciences, Inc. +1 610 861 4701 info@particlesciences.com
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Sol-Gel Technologies has entered into a second development and licensing agreement with a leading US pharmaceutical company for the development and commercialisation in the US and Canada of a major dermatologic drug. Under the terms of the new agreement, Sol-Gel will receive $27 m, comprised of an initial non-refundable payment, as well as additional license fees and development payments upon the successful completion of various milestones. The US partner will fund the product’s development. Sol-Gel will be entitled to receive royalties from net sales. The new agreement follows a similar $25 m deal made with the same company. “This repeat collaboration reinforces Sol-Gel’s position as a leading player in the development of encapsulation technologies for application to topical drug products,” said Dr. Alon Seri-Levy, co-founder and CEO. Sol-Gel Technologies Ltd +972 8 9313433 info@sol-gel.com www.sol-gel.com
Events
11th World Drug Manufacturing Summit
Merck Millipore Pharma Forum to Address Latest Developments in Pharma Raw Materials
The World Drug Manufacturing Summit 2012 — 26–28 November, Swissôtel, Düsseldorf — will bring together leading drug manufacturing professionals from across the globe to examine the latest technological developments and strategic advancements affecting the industry. The increasing competition from generics has only added to the immense pressure the industry is under. Companies are responding to the pressure by focussing more than ever on achieving excellence in manufacturing. This will be a central focus to this year’s summit. Based on industry case studies, the programme will analyse how each stage of the manufacturing process can be improved to overcome these challenges. The summit is split into three topic areas, which are Operational Excellence, Pharmaceutical Quality and Pharmaceutical Engineering and IT. Featured presentations within these areas include: Operational Excellence — ‘Titrating excellence throughout the organisation’, ‘What is the next level of operational excellence?’ and ‘Do holistic lean models really work in a globalised arena?’. Pharmaceutical Quality — ‘Structuring quality system improvements using QFD strategies’, ‘Product quality and safety — preparing your organisation for product recall & outbreaks’ and ‘ Understanding the RTRT 2012 guidelines and its implications on API and finished product manufacturing’. Pharmaceutical Engineering and IT — ‘Clarifying the industry’s definition of tech transfer in strengthening standardisation’, ‘Best practices in converting an inhouse facility into a successful CM venture’ and ‘Introducing new technologies to accommodate the personalised therapy trend’. Speakers confirmed for this year’s event include: • Kirk Nicholas, Director, Lean Six Sigma Programme, Office of Process Improvement, Office of Business Transformation, US Army; • Gerald Heddell, Director, Inspection, Enforcement and Standards Division, MHRA; • Jurgen Polak, Director, Industrial Engineering, Astrazeneca; • Justin O. Neway, PhD., Vice President & Chief Science Officer, Aegis Analytical Corporation; • Dieter Unseld, Ph.D., Senior Practice Manager, Quality Intelligence, Altran; • Christoph Ebensperger, Principal, Head of Business Segment Life Sciences, Horváth & Partner Management Consulting GmbH; • Markus Mattern, Head, Production, Roche; • Idwin Bouman, Director SHEQA & Food Safety, FrieslandCampina; • Jean-Paul Kaczmarczyk, Head, Lean Six Sigma & Transformation, Eli Lilly; • Gorm Herlev Jørgensen, Head of Department PharmaBiotech, Danish Medicines Agency; • Maria Arfwedson, Director and Head, Pharmaceutics & Biotechnology, Medical Products Agency (MPA); • Robert Miller, Executive Director, Shingo Prize Initiative; • Dr Hans-Walter Hoehl, VP Global Strategy & Projects, Pharmaceutical Production, Bayer HealthCare; • Timothy Largen, Sr Director, Industrial Operations, Dendreon Pharmaceuticals; • Tim Schwarting, Master Black Belt, Novo Nordisk; • Norbert Rasenack, Team Leader CM-Downstream Solid, Novartis Pharma AG; • Amarish Singh, Director, Global Regulatory Sciences-CMC, Bristol-Myers Squibb; • Richard Williams, Lead, Manufacturing IT, Eli Lilly; • and Mayo Pujols, Director, Technical Operations, Merck & Co.
Merck Millipore, the Life Science division of Merck, will host the third annual Merck Millipore Pharma Forum on 12 June, at the company’s headquarters in Darmstadt, Germany. The event will bring together industry experts and manufacturers of pharmaceutical raw materials to discuss the state of the market and challenges facing the industry. Presentations and discussions will explore the recent launch of the new excipients certification programme EXCiPACT, Qualified Person’s responsibility for GMP compliant raw materials and liability issues surrounding deficient pharmaceutical raw materials. Results from a recent Merck Millipore study focusing on leachables and extractables will also be examined. “We are very excited to host the third annual Merck Millipore Pharma Forum,” said Dr. Matthias Bucerius, Head of Pharma Raw Materials. “This event will allow manufacturing and pharmaceutical professionals to learn about the latest regulatory and quality assurance issues facing the pharmaceutical raw materials market today. Attendees will have a rare opportunity to engage and interact with industry experts on the topics that matter most in our industry.” Merck Millipore Pharma Forum 2012 speakers will include: • Dr. Iain Moore, IPEC Europe and Croda Europe; • Dr. Bernd Renger, European QP Association; • Dr. Najib Sehat, Merck Millipore, Darmstadt; • Dr. Martin Wesch, Wesch & Buchenroth Lawyers; • and Dr. Christian Wolf, Central Analytical Services, Merck KGaA, Darmstadt. For a complete event programme, schedule of presentations or additional details about the Merck Millipore Pharma Forum 2012, visit www.merck4pharma.com/forum. Merck Millipore +1 781 533 5197 janice.paquette@merckgroup.com www.merckmillipore.com
World Trade Group +44 20 7202 7690 enquire@wtgevents.com www.wdmsummit.com
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EPM CLASSIFIEDS CLEANROOMS EQUIPMENT & SERVICES CONTAINMENT
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Müller GmbH
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INDUSTRIAL SERVICES DESIGN & INSTALLATION
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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
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Glatt GmbH
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MANUFACTURING ANCILLARIES PUMPS
Fristam Pumpen F. Stamp KG HOSOKAWA ALPINE Aktiengesellschaft Tel: +49 (0) 821 5906-0 Email: pharma@alpine.hosokawa.com Web: www.alpinehosokawa.com
Tel: +49 (0) 40 725 56 0 Email: info@fristam.de Web: www.fristam.de Peristaltic pumps accurately transfer fluid through a sterile and fully validated tube from source to delivery. Tel: +44 (0) 1326 370370 Email: info@wmpg.co.uk
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