EPM October 2013

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IN THIS ISSUE: Single-Use Tabletting Equipment Maintenance & Training Granulation & Milling LIMS Lyophilisation

European Pharmaceutical Manufacturer October 2013

Volume 13 | Issue 07

Front cover image: The Pmax turret with F12 punches allows users to increase the output quantity of the tabletting process by up to 40% in the same production time. It is available with 45, 66 and 110 stations as well as a retrofit kit.

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epm head office Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE. Tel. +44 (0) 1244 680222 Fax. +44 (0) 1244 671074 Web: www.epmmagazine.com

editorial editor elizabeth valero, ellie@rapidnews.com publishers mark blezard,

in this issue

michael taylor

production art samantha hamlyn production peter bartley

advertising robert anderton

MANUFACTURING PRODUCTS & EQUIPMENT

pages 5–18

tel: +44 (0) 1244 680222, fax: +44 (0) 1244 671074, rob@rapidnews.com

REGULARS: 5–13 18

Latest News Roundup Industry News & Events

BUYERS’ GUIDE: 13

Granulation & Milling

SPECIAL FOCUS: Single-Use 5–10

SHOWCASES:

qualifying readers Europe - Free, ROW - £115

16 17

Drying Tabletting Equipment Maintenance & Training

subscriptions subscriptions@rapidnews.com

outside qualifying criteria

ARTICLE:

UK - £80, ROW - £115

14–15

New Technique for Cleaning-In-Place of Coaters Written by Horst Spittka, Head of Life Science Technology Sales at Gebrüder Lödige Maschinenbau GmbH, and Martin Huber, Process Consultant at AquaDuna GmbH & Co. KG.

please subscribe online at www.epmmagazine.com Address changes should be emailed to subscriptions@rapidnews.com.

LABORATORY PRODUCTS & EQUIPMENT

pages 19–26

European Pharmaceutical Manufacturer is published by Rapid Life Sciences Ltd.

REGULARS: 19–22 26

Latest News Roundup Industry News & Events

SHOWCASES: 24 25

LIMS Sterilisation

INGREDIENTS & CONTRACT SERVICES

SPECIAL FOCUS: Single-Use 19–20

pages 27–34

REGULARS: Latest News Roundup Events Regulatory Affairs

27–32 34 34

SHOWCASE:

SPECIAL FOCUS: Single-Use 27

European Pharmaceutical Manufacturer is distributed in electronic and print formats to a combined readership of 14,000 pharmaceutical manufacturing professionals.

Volume 13 Issue 7 © October 2013.

While every attempt has been made to ensure that the information contained within European Pharmaceutical Manufacturer is accurate, the publisher accepts no liability for information published in error, or for views expressed. All rights for European Pharmaceutical Manufacturer are reserved and reproduction in part or whole without written permission is strictly prohibited.

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Lyophilisation

BPA Worldwide Membership

page 35

CLASSIFIEDS EPM 3

ISSN No - 2052-4811

“

Welcome readers to the penultimate 2013 issue; already officially midway through Autumn here in the UK. I am delighted to report that the EPM team continues to receive a vast number of quality announcements.

Unfortunately, there is never enough space in the magazine to include all worthwhile stories but we endeavour to publish as much extra newsworthy content as possible at www.epmmagazine.com.

Returning to the issue in hand, for those readers preferring a little more indepth reading, on pages 14–15 is an article entitled ‘New Technique for Cleaning-In-Place of Coaters’, written by Horst Spittka, Head of the Life Science Technology Sales division at Gebrüder Lödige Maschinenbau, and Martin Huber, Process Consultant at AquaDuna. Adhering strictly to all EU GMP cleaning validation criteria, the companies have jointly developed a “highly effective” and cost-efficient CIP system for Lödige coaters, reducing cleaning times “by more than half.”

Once again, this has been a good issue for customer stories, with two featuring in the Laboratory Products and 14 Equipment section. The first of these can be found on page 21 and details CRO Corialis Pharma’s use of Malvern Instruments’s resonant mass measurement (RMM) system in biopharmaceutical formulation development. The verdict from Corialis Pharma’s Chief Strategy Officer Dr. Andrea Hawe is that the analytical instrument “enables [the company’s teams of scientists] to more easily measure protein aggregates and silicone oil droplets in a critically important size range,” thus extending their characterisation service capabilities.

The second forms part of the LIMS Showcase on page 24 and concerns pharmaceutical manufacturer Thornton and Ross’s adoption of Autoscribe’s LIMS system in its QC laboratory for raw materials and finished products. The 24 software is “used to control, manage, organise, document, analyse and report information, leading to improved efficiency and functionality of data storage and manipulation.”

EPM’s new ‘In the Spotlight’ feature on page 32 is based on an interview conducted by myself with Bente Korsgaard, Head of Cargill Texturizing Solutions’s Aliginates division, on the business’s 32 plans to spend $15 million on upgrading and expanding its production facility on the Brittany coastline, in France. Alginates, derived from brown seaweed, offer a number of beneficial properties for pharmaceutical applications; they can be used to make syrups more viscous or tablets more chewable, and they possess drug delivery characteristics, enabling them to be used as an excipient, dispersant and controlled release agent.

Lastly, this issue’s Regulatory Affairs instalment on page 34 is an Overview of the EMA’s ‘Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form’, written by Dr. Biffignandi’s colleague Lini Subin, a Senior Regulatory Affairs Manager at ELC Group. The Draft concept paper was published on 4 July 2013 for public consultation and addresses the need to revise the guideline ‘The note for guidance on manufacture of the finished dosage form’, introduced in 1996. Mrs. Subin highlights some aspects that necessitate the revision of the guideline so that pharmaceutical companies can provide their comments to the EMA during the consultation period of this draft concept paper.

I hope this issue affords you some insightful reading. As always, we are keen to hear your views on EPM’s content so please take a few moments to email any comments to myself: ellie@rapidnews.com.

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eab members

from the editor

Henrik Broholm, Senior Specialist, H. Lundbeck A/S Henrik has been working in the pharmaceutical industry for the last 15 years, mainly in connection with finished goods packaging (blisters, ampoules and containers). At H. Lundbeck, he has gained valuable experience of working at both vendor and customer sites, further extending his pharmaceutical packaging expertise.

Henrik is for the most part involved with user requirement specifications, machinery and process qualification and validation, the introduction of new products on packaging lines and incorporating new features as required by authorities, e.g., 2D matrix coding with track and trace and child resistant blisters and packs.

James Cartwright, Global Granulation Leader, Particle Generation, Control & Engineering, GlaxoSmithKline James began working within the pharmaceutical industry in 1996.

During this time, he has been instrumental in developing and launching three products for various clinical indications spanning acute Otitis Media, Lymphatic Filiarisis and Type II Diabetes Mellitus.

James studied Chemistry and Chemical Engineering and is a Fellow of the Royal Society of Chemistry.

Dr. Dimitris Dogramatzis, RPh, PhD Dimitris is a registered pharmacist and pharmacologist, whose industry career encompasses medical affairs, marketing, country and regional management positions.

Dimitris has served as Regional VP — Northern Europe for SERONO and authored two textbooks entitled ‘Pharmaceutical Marketing: A Practical Guide’ (2001) and ‘Healthcare Biotechnology — A Practical Guide’ (2010).

Dr. Dave Doughty, Director of Pharmaceutics, GlaxoSmithKline In his 30 plus years in the pharmaceutical industry, Dave has a superb track record in leading teams to develop and commercialise products. This is underpinned by his expert knowledge of the science and mechanistic principles of dosage form design and processing, including PAT, manufacturing operations and GMP. Dave has co-authored product and process patents. Product innovations include oral and transdermal dosage forms.

Process innovations include compression and coating of tablets and continuous manufacturing methods and associated PAT. Continuous processes include feeding, mixing, granulation, drying, coating and a novel method of manufacturing low-dose, high-potency drugs.

John Gamble, Senior Research Scientist, Bristol-Myers Squibb After graduating from the University of Salford in 1998 with a degree in Chemistry with Industrial Experience, John began his career in quality control analysis of parental vaccines, later moving on to physical analysis of inhaled drugs, before arriving at his current position as Senior Research Scientist within the Powder Properties Optimisation group at Bristol-Myers Squibb.

John has a keen interest in understanding the interrelationships between the physical properties of drugs and excipients and their subsequent behaviour during formulation and manufacturing.

Aidan Mc Nabola, Engineering Director, UCB Group, SCHWARZ PHARMA Ltd Aidan is Engineering Director at Schwarz Pharma Ltd, based in Shannon Co. Clare, Ireland, and is responsible for site infrastructure, engineering systems — including capital projects — utilities, IT and automation on site.

Aidan holds a B. Eng Degree in Mechanical Engineering and has more than 23 years experience in primary and secondary manufacturing in the pharmachem and medical device industries.

Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer. He started working in one of Sanofi’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment.

In 2009, Grégory moved to one of the group’s solid form plants in Spain to lead new equipment installation projects as well as take charge of process maintenance and improvements. He returned to France in 2013 and continues with projects at one of Sanofi’s API production plants.

Grégory has experience of the most well-known providers of solid form equipment.

Kostas Saranteas, Senior Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc. Kostas is Senior Director of the Process Chemistry and Engineering Dept. at Sunovion’s R&D Division. He holds BS/MS/PhD degrees in Chemical Engineering and an MS degree in Environmental Engineering.

For 15 years, Kostas worked at Polaroid Corp., specialising in batch process equipment modelling, process optimisation and scale-up.

For 11 years, Kostas has been employed at Sunovion. He leads cross-functional teams, championing accelerated process development for drug substance and drug product synthesis from laboratory-scale to full-scale manufacturing.

MANUFACTURING PRODUCTS & EQUIPMENT Video Capture and Synchronisation System Takes Texture Analysis to Next Level Equipment from Stable Micro Systems now provides outstanding texture analysis data and analysis capabilities for pharmaceutical and supplement manufacturers. The company’s new video capture and synchronisation system enables customers to record tests and replay them frame by frame simultaneously with corresponding force-distance-time graphs. According to Stable Micro Systems, this is an industry first, meaning that even the quickest tests or those involving complex breaking patterns like multilayer tablets can be viewed and analysed in minute detail.

The new system includes a moveable video camera, a transparent test platform, which permits recordings from underneath the sample, and an optional light attachment. To conduct a test, the camera is positioned in the most appropriate location for testing. As the TA.XTplus texture analyser begins collecting data, a signal is relayed to the video capture interface, which initiates recording at up to 50 frames per second. Data is collected and analysed

by Stable Micro Systems’s proprietary software Exponent. When replayed afterwards, each video frame is automatically synchronised with the data

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points on the force-time graph, allowing graph events to be related simply to visual events on the product.

Jo Smewing, Applications Manager at Stable Micro Systems, said: “This new system represents a huge leap forward in texture analysis for the pharmaceutical industry.

Decisive visual aspects of a test can be easily missed by the human eye but are critical to understanding a product’s performance.

A chalk tablet, for example, can break or crumble very quickly, making it impossible for human observers to note the exact point at which it failed.

Similarly, it’s difficult to see with the naked eye how much a gel capsule deforms before bursting.

“Automatically correlating the peaks and troughs of a force-distance-time graph with frame by frame video recordings means the exact behaviour of a sample can be recorded, interpreted simply and re-examined as often as required. It also enables users to identify

anomalies in a test without the need for re-testing at a later date and to undertake far more detailed comparative analyses.”

The new video capture and synchronisation system will be invaluable to R&D professionals and quality control departments as they seek to optimise the appeal and effectiveness of their products.

Stable Micro Systems Ltd +44 1483 427 345 sales@stablemicrosystems.com www.stablemicrosystems.com

SPECIAL FOCUS

Bag Tester Eliminates Risk of Leaks in Single-Use Bioreactors Sartorius Stedim Biotech (SSB) has launched the new Sartocheck 4 plus Bag tester, the latest addition to its well established Sartocheck line. According to SSB, the new system is the first device allowing reliable pre-use testing of single-use bioreactors after installation, based on the proven pressure decay measurement method.

The Sartocheck 4 plus Bag tester directly responds to the market needs for increased security and quality assurance when single-use components are used. Designed for cell cultivation, single-use BIOSTAT CultiBag STR bioreactors with working volumes of 50 and 200 l can now be conveniently tested by this new system.

Later this year, the newly developed technology of this device will be extended to permit testing of 500 and 1,000 l BIOSTAT CultiBag STR systems.

The Sartocheck 4 plus Bag tester performs a pre-use test of the entire bioreactor, including tubing. This device is capable of detecting typical leaks

that might have been caused by operator handling errors upon installation of a bioreactor.

Therefore, the bag tester is ideal for eliminating the risk of filling a defective single-use bioreactor with expensive cell cultures. The reason is its patented fleece, which is inserted between the plastic film of the BIOSTAT CultiBag STR and the bag holding device of the tester. This fleece acts as a porous spacer, preventing SSB’s Sartocheck 4 plus Bag tester performs a direct contact between the bag pre-use test of the entire bioreactor. and the smooth stainless steel surface of the holder. In addition, the The Sartocheck 4 plus Bag tester is fleece substantially reduces an important contribution by Sartorius environmental heat transfer and, most Stedim Biotech towards enhancing risk importantly, eliminates the effects of mitigation for single-use equipment in masking of any potential pinholes. The biopharmaceutical manufacturing. high accuracy of the Sartocheck 4 plus Bag tester in measuring the pressure Sartorius Stedim Biotech S.A. drop, along with its patented fleece +49 551 308 3324 technology, provides outstanding dominic.grone@sartorius.com reliability and reproducibility for testing. www.sartorius-stedim.com

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Chromatography Media and Prepacked Columns Improve Process Efficiency Merck Millipore, the Life Science division of Merck, has introduced two additions to the company’s comprehensive chromatography portfolio that further accelerate downstream purification.

Eshmuno A is a rigid, high capacity, acid and alkaline resistant Protein A affinity chromatography media for the purification of monoclonal antibodies and other Fc-containing proteins. Higher binding capacities offered by Eshmuno A media in comparison with other commercially available Protein A media delivers increased productivity and lower costs.

Eshmuno A media can be cleaned and sanitised under acid and/or alkaline conditions while maintaining high dynamic binding capacity at high flow rates with no significant change in product purity. In addition, the media offers an orthogonal solution for aggregate removal at both the front and tail ends of the elution peak from the Protein A column. This property of the Eshmuno A media is advantageous in reducing the burden of subsequent chromatography steps typically used in the purification of Fc-containing proteins.

Chromabolt prepacked, pre-validated chromatography columns, available with a range of Merck Millipore chromatography resins, are designed for early clinical stage manufacturing. Prevalidation indicates the columns meet bioburden, endotoxin, HETP and asymmetry specification for the resin.

Offered in three sizes — 10, 20 and

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SPECIAL FOCUS

Single-Use Quaternary Diaphragm Pumps Help Optimise Radial Flow Chromatography in Biopharma

Eshmuno A media.

32 cm i.d. — Chromabolt prepacked columns eliminate laborious packing and equipment cleaning. The columns are currently available packed with Fractogel SO3, Fractogel TMAE HiCap and Eshmuno S resins. Going forward, additional resins will be made available in the Chromabolt format.

The prepacked columns are compatible with all currently available chromatography systems and connectors, have easily accessible inlets and outlets and offer faster setup times compared with traditional columns.

Ergonomic and easily transportable by a single person, the 20 and 32 cm sizes are on wheels.

For more information about Eshmuno A media, visit www.merckmillipore.com/EshmunoA, and for more information about Chromabolt prepacked columns, visit www.merckmillipore.com/Chromabolt.

Merck Millipore +1 781 533 5336 pegeen.dossantos@emdmillipore.com www.merckmillipore.com

Quattroflow is offering a full line of single-use quaternary diaphragm pumps that are ideal for incorporation into radial flow chromatography (RFC) systems that are used to adsorb and purify APIs during the downstream stage of biopharmaceutical production.

Typical chromatography-column design is axial, wherein the chromatographic media (usually a resin) are packed in a flat, broad, pancake-like cylinder, which is both extremely heavy and space-consuming. RFC, on the other hand, takes the horizontal chromatography cylinder and orients it vertically so that the media is wrapped around it, which reduces both the system’s footprint and weight while maintaining the high level of purification and fractionation of the API that is required.

A critical step in optimising the performance of an RFC column is the packing of the chromatography media (resin). Quattroflow pumps — which are available in QF-150, QF-1200, QF4400, QF-5050 and QF20K sizes — are perfect for this application because their four-piston/four-diaphragm method of design and operation delivers low pulsation, gentle product

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handling, a large turndown ratio, high flow-rate accuracy, low noise and a compact construction.

All Quattroflow pump models also offer the option of single-use configurations with replaceable plastic heads, which eliminates the need for time-consuming cleaning between batches. This increases the product’s speed-to-market capabilities, which is a crucial consideration when attempting to maximise the product’s availability within its patent window.

Quattroflow +49 2842 961 0 frericks@almatec.de www.quattroflow.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Air Rental Service Avoids Need for Capital Funding

Capsule Filler Customers Benefit from Powerful Online Service

West Midlands-based building temperature control systems specialist Jet Environmental has recently launched Outsourced Air, a new initiative in temperature and energy management.

Providing energy efficient temperature control solutions for large-volume industrial and commercial buildings, keeping occupants and temperature sensitive products at their optimum temperature, Jet Environmental’s new service aims to appeal to those companies that have a requirement for a temperature control system and would prefer to rent a system as an alternative to an outright purchase.

JET’s Managing Director Jason Hibbs said: “Introducing this new commercial option makes it easier for customers to enjoy the benefits of what we believe to be the best systems on the market supported by a package that incorporates maintenance, system performance reporting and proactive energy management. Following a simple commercial agreement, JET will provide a continuously optimised service for a fixed monthly fee as low as 50 per m3 per year.

“Outsourced Air is a hassle-free concept with two clear benefits: access to JET’s temperature control management expertise and ongoing support without the need for capital purchase funding. The interest in Outsourced Air to date has been significant, particularly on the back of a warm summer and in view of the continuing need for businesses to be prudent with available funds.”

Every MG2 capsule filler customer is automatically given access to an online tool that provides customised information and after-sales services 24 hours a day, seven days a week.

Any company that purchases an MG2 capsule filler gets free, unlimited access to the new website onliservice.mg2.it, which enables customers to check their documentation in interactive mode with just a few clicks. Through the login details, which are supplied when the machine is delivered, it is possible to access this service via any PC connected to the web. It is possible to remotely consult technical information, receive offers and forward spare parts orders, to name just a few of the functions.

These functions are carried out through two applications, called e-DOC and eSPARES, which are constantly updated

by MG2 technicians. The wider functions offered by MG2 onlineservice applications are inspired by the principles of usability and immediacy typical of the 2.0 web, which the company has summarised as four e-advantages: • e as ever up-to-date — For each modification required for a machine, for each additional dosing unit supplied and for each component replaced, the documentation is updated and immediately published on line. An archive is available to consult requested offers and submitted orders.

Kent Pharmaceuticals benefits from Jet Environmental temperature control solution.

Established in 1981, Jet Environmental designs and manufactures systems comprising of a network of self-balanced air induction nozzles that direct warm, cool and fresh air into the space from roof level, providing uniform temperatures throughout a building space. The nozzles are connected via ductwork to an air handling unit and selected heating/cooling source. Jet’s systems are designed to capture and recirculate any waste heat generated in the space and use free cooling techniques to lower the energy consumed in both heating and cooling modes.

Jet Environmental Ltd +44 7818 422880 jasonhibbs@jetenvironmental.com www.jetenvironmental.com / www.outsourcedair.com

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• e as environment-friend — No more paper. The online service allows the customer to browse manuals and documents through PCs, smartphones and tablets, thereby reducing the need for distribution of paper copies in several offices.

• e as easy — The user-friendly interface allows the customer to easily browse through documents and spare parts diagrams in order to find the information needed in a quick and intuitive way.

• e as efficiency — The MG2 onlineservice is the archetype of a fast and right first time system. Any information required by the customer is always available in a very short time, without any misunderstanding. Spare parts requests are recorded in real time, without the risk of mistakes, therefore optimising the purchasing process and the logistics of spare parts management.

MG2 S.r.l. +39 051 4694111 sales@mg2.it www.mg2.it

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Crevice-Free Control Valves Protect Against Growth of Bacteria Eliminating areas in process systems that may increase the potential for bacteria growth, such as traps and crevices, is an important requirement for control valves used in aseptic applications. Samson Controls offers a range of products incorporating these features, which are manufactured to quality assurance systems certified to ISO 9001 and meet stringent FDA requirements.

For example, the type 3347 control valve has polished steel parts to ensure the highest purity for the process medium and special PTFE bushing along with an additional steam line connection that is used to meet very stringent purity requirements, preventing bacteria from spreading at the actuator stem guide.

Another example is the type 3249 valve, which is equipped with an EPDM diaphragm and a backup safety packing box to ensure total protection against bacteria spreading and prevent product leakage. These sealing systems, which constitute the main components of the valve construction, have been thoroughly developed and designed to ensure a long and reliable service life.

Process applications that involve pasty, fibrous or highly viscous products are best controlled by Samson’s type 3345 cavity-free valve body, which features a diaphragm available in either rubber, nitrile, butyl or PTFE that acts both as a seal and a valve plug.

These valves can be easily installed into

the process line as they are available with various connections, including hygienic couplings, flanges and clamp connections according to ISO 2852 and welding ends.

Samson Controls Ltd +44 1737 766391 sales@samsoncontrols.co.uk www.samsoncontrols.co.uk

Packaging Integrity Expert Launches Non-Destructive Multi-Bottle Leak and Seal Tester A tool-less, non-destructive, multi-bottle integrity tester for induction-sealed pharmaceutical bottles has been developed by Sepha, which is now part of the TASI Group.

BottleScan uses force decay technology to detect weak seals and defects down to 15 µm. It has a tool-less design and can test up to four bottles simultaneously in a quick test cycle of approximately 60 seconds. The system produces objective pass/fail results, enabling good bottles to be returned to the production line. BottleScan has the ability to run in compliance with 21CFR Part 11, offering pharmaceutical manufacturers and packagers a more technologically advanced, accurate and efficient solution for testing the integrity of induction-sealed bottles.

Commenting on its launch, Paul Kelly, Sepha’s Head of Sales & Marketing, said: “BottleScan is the latest addition to Sepha’s integrity testing product range and has been developed in response to increasing market demand for a more advanced technology-based integrity test for induction-sealed bottles. Its tool-less design and configurable methods make it ideal for pharmaceutical lines running multiple products. Operator error is also eliminated as the quick, repeatable test provides objective data, which is securely stored and can be built into cGMP and used as part of robust QA testing.”

Bottlescan has been designed, developed and manufactured at Sepha’s UK headquarters.

Sepha Ltd +44 28 9048 4848 sarah.lamont@sepha.com www.sepha.com

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Ready-to-Use Sterile Vials Guarantee to be PyrogenFree

ATMI, a global technology company and leader in single-use bioprocess solutions, has introduced a line of pyrogen-free vials in collaboration with Disposable Lab (D-Lab), a Bordeaux, France-based contract-manufacturing company.

Designed to meet biopharmaceutical filling and final packaging needs, the patent-pending Pyrofree vials are reportedly the only cost-effective, ready-to-use vials guaranteed to be both pyrogen-free and sterile upon delivery.

“We have come together with D-Lab to offer this comprehensive solution in support of our customers’ end goal of advancing patient health and safety,” said Senior Vice President and General Manager of ATMI LifeSciences Mario Philips. “Pyrofree vials can be incorporated into ATMI’s existing ultraclean sterile packaging and fill/finish technologies or used independently.”

Pyrogens induce rapid onset of fever with the potential to cause sepsis or progressive septic shock if they enter a patient’s bloodstream. This makes it critical to ensure that pyrogens are not present in biopharmaceutical products. While difficult, the most common techniques to remove pyrogens are inactivation or destruction of the molecule through depyrogenation.

ATMI subjects all Pyrofree vials to a thorough depyrogenation process that includes washing (with WIP) and heating the vials to high temperatures in a polyether ether ketone (PEEK) bag to achieve a three-log reduction.

Process specifications can be further modified based on customer requests.

“Pyrofree brings several clear benefits, including the most costeffective solution on the market, scalability from small to commercialscale batches and availability in both moulded and tubular formats,” noted Jean-Pascal Zambaux, inventor of Pyrofree and majority owner of D-Lab. “The vials may also be used for commercial safety stocks of injectables and feature sizes up to one litre.”

Pyrofree vials are made to withstand the high temperatures during depyrogenation and sterilisation. After these steps, the vials are doublevacuum-packed in a PEEK bag for tamper-evidence as well as to maintain sterility and guarantee no external contact. A third PE/PA film layer is added to the packaging under vacuum in a Class C cleanroom to protect the vials from any breakage during transportation and eliminate the need for a support tray.

More information on Pyrofree vials can be found at: www.atmi.com/lifesciences/products/p yrofree/.

ATMI, Inc. +32 16 76 80 70 www.atmi.com

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Smarter Downflow Booth Provides High Containment at Reduced Cost Hosokawa Micron has introduced a downflow booth design standard for companies seeking downflow booth options that do not break the bank but still retain the high levels of containment and personnel protection they would expect from a more expensive booth.

“We haven’t cut corners in any way,” said Hosokawa Micron Product Manager, Carl Emsley. “We’ve just developed a smarter design that is already proving popular with those customers who want multiple booths and those using downflow containment facilities for the first time. This simply better downflow booth design is capable of achieving OELs <1 µg/m3,

subject to use of a high containment screen and standard operating procedures.”

The new downflow booth is suitable for handling powders or liquids and, with a full, front opening retractable roller door, is suitable for storage as well as multiple dispensing activities.

Designed for ease of installation and flexibility of operation, the new downflow booth is plug and play,

design and technology, air handling efficiencies have been achieved, alongside easily adjustable fan speed control that allows for efficient air handling within the working environment.

With this new design, noise levels of sub 60 dba are realised, which make it ideal for positioning within quiet zones or multi-processing areas where high noise levels might be unacceptable.

requiring no complicated installation or qualified personnel to undertake the wiring work. By utilising EC plug fan

Coating Process Guarantees Precise and Uniform Results with Minimal Losses

With the Bohle Uni Cone BUC process, L.B. Bohle Maschinen + Verfahren provides a new, patented method for the precise coating of particles. “We have shown that our new method works much more accurately and evenly than the conventional Wurster process said CEO Lorenz Bohle.

The Wurster process is used in the pharmaceutical industry when small particles must be coated. Most of today’s coating systems are based on this method, which was developed by the American Pharmacist Dale Wurster in 1959. “The biggest weaknesses are hardly calculable setting parameters and the spray nozzles being at the bottom,” explained Bohle.

With the Wurster process, the adjustment parameters must be retested in long tests for each product.

This approach runs more on the basis of experience rather than on verifiable data.

Losses in production and large fluctuations in the coating uniformity are the results.

“We have developed two major changes that solve both problems of the Wurster process,” continued Bohle. “A sloping floor and a conical tip in the centre provide a uniform turbulence of the product. Simultaneously, the coating substance is sprayed from lateral nozzles. We therefore achieve a hitherto impossible coating uniformity. Using this process, customers can coat products containing an active substance with the highest precision. The losses are under one percent in a very complex process.”

The tangential nozzles have also enhanced handling. If a nozzle is blocked, it can be cleaned with aqueous operation during the process.

“Because of the tremendous benefits, we have secured a utility patent protection for the process and have protected the BUC as a European brand,” concluded Bohle.

L.B. Bohle Maschinen + Verfahren GmbH +49 2524 9323 150 t.borgers@lbbohle.de www.lbbohle.de EPM 11

Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk

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buyers’ guide Alexanderwerk GmbH, Germany +49 2191 795 0 contact@alexanderwerk.com www.alexanderwerk.com

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GEA Pharma Systems - Collette, Belgium +32 3 350 12 11 collette@geagroup.com www.gea-ps.com Gebrüder Lödige Maschinenbau GmbH, Germany +49 5251 309 371 lemperle@loedige.de www.loedige.de

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Hanningfield, UK +44 1702 549777 sales@hanningfield.com www.hanningfield.com

Size Reduction — Parts & Accessories

Size Reduction Equipment

Crushers

Containment Solutions

Mills — Sanitary

Mills — Pelletising

Mills — Homogenising

Mills — High-Shear

Compactors

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Solutions for mixing, coating, reacting, drying and emulsifying.

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Pin mills and pre-breakers.

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Netzsch Premier Technologies, LLC., US +1 484 879 2020 raj.mukherjee@netzsch.com www.netzsch-grinding.com

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Process Components Ltd, UK +44 1625 412000 james.atkins@pro-components.com www.pro-components.com

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Quadro Engineering Corp., Canada +1 519 884 9660 wsanguesa@idexcorp.com www.quadrocomil.com Willy A. Bachofen, UK +44 1707 327777 t.mangan@wab.uk.com www.wab.uk.com

OTHER

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Frewitt SA, Switzerland +41 26 460 74 00 r.herzog@frewitt.com www.frewitt.com

Kek-Gardner Ltd, UK +44 1625 665 999 sales@kekgardner.com www.kekgardner.com

Mills — Hammer

25

Dec Group, Switzerland +41 21 694 20 59 e.richardson@dec-group.ch www.dec-group.net

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

Mills — Granulating

5

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

Hosokawa Micron Ltd, UK +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk

Mills — Fluid Energy

Mills — Fine Grinding

Mills — Dispersion

Mills — Continuous

Mills — Colloid

Mills — Cone

Mills — Attrition

Kneading Mills

Grinders

Comminutors

Pelletisers

Granulators — High-Shear

Granulators — Vacuum Dryers

Granulators — Size Reduction

Granulators — Centrifugal

Granulators — Fluid Bed

Granulators — Particle Enlargers

granulation & milling

Granulators — Rotary

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29

5

9 10

12 13

1 2

15 16 17

15

19 20 21 22

24

Spare parts for centrifugal sifters, mixers and milling machines as well as contract and bespoke maintenance.

26 27 28 29

24

28

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Data Management Software Supports Latest Pharma Serialisation Criteria Atlantic Zeiser has released MEDTRACKER, a comprehensive data management software solution that enables users to comply with the expanding legal requirements associated with serialising pharmaceutical products and seamlessly integrates with Atlantic Zeiser’s family of printing and encoding solutions as well as legacy systems.

Government-mandated serialisation standards for pharmaceutical products are coming into effect in countries and regions throughout the world, requiring manufacturers to add different codes to products in accordance with where they

are sold. Depending on the area, a variety of coding schemes must be supported. Typically, this involves multiple data interfaces; an external one connected to a central database (often government-controlled) from a particular country or region and one or more internal interfaces linked to a company’s printing and/or packaging lines as well as enterprise-level software systems like ERP. Atlantic Zeiser’s MEDTRACKER system supports these different serialisation systems and automatically maps the related workflows. The software

generates unique codes based on random numbers, distributes them to all associated printers in the network, accumulates and manages additional track and trace information and provides necessary data through external and internal interfaces as required. All codes, along with track and trace data, are stored in a database for use in authentication or to create a secure, properly documented e-pedigree for each product.

MEDTRACKER is an ideal solution for manufacturers of pharmaceutical products, print shops that support

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pharmaceutical manufacturers and pharmaceutical product wholesalers.

Atlantic Zeiser GmbH +49 7465 291 103 ute.heiler@atlanticzeiser.com www.atlanticzeiser.com

ARTICLE New Technique for CleaningIn-Place of Coaters

EFFICIENCY PAYS OFF Cleaning-In-Place of pharmaceutical appliances has to meet the highest standards. However, the issue of cost efficiency is also becoming increasingly important as far as hygiene is concerned.

With this in mind, Gebr. Lödige Maschinenbau has developed a highly efficient cleaning system for tablet coaters in cooperation with the cleaning system manufacturer AquaDuna.

The pharmaceutical industry produces a large number of products that are subject to stringent quality requirements and increasingly demanding regulatory conditions. Good Manufacturing Practice (GMP) not only requires qualified personnel, high-quality appliances and suitable premises, it also requires validated cleaning procedures. This is generally realised with the use of CleanIn-Place (CIP) systems.

A quality management system meeting the requirements of GMP is particularly important in the pharmaceutical industry for guaranteeing product quality and compliance with the stringent requirements of the public health authorities. The manufacturing companies have to provide documented evidence within the framework of a cleaning validation that an approved cleaning procedure will ensure that a machine is in a suitable condition for the production of medicines. The cleaning validation requirements are laid down in the EU GMP Guidelines, Annex 15.

same product or a different product. The risk analysis shows how little residue from the previous product is allowed to carry over to the following product without causing a risk to the patients.

Quantity and dose criteria are used for defining the ‘cleanliness’. Using the dose-based calculation, at most 1/1,000 of the therapeutic daily dose of the previous product is allowed to contaminate the maximum therapeutic daily dose of the following product. On the basis of the quantity criterion, no more than ± 10 ppm of the active pharmaceutical ingredient of the previous product may be detectable in the following product.

Another aspect to consider in addition to the validation of the cleaning procedures is cost effectiveness; when estimating the time and expense required for cleaning machines and equipment in the pharmaceutical industry, it is necessary to take into consideration criteria such as media consumption and provision, cleaning agents and production downtimes.

In particular, maximum standards have to be met for cleaning machines and equipment for the production of potent substances. These days, thanks to increasingly sophisticated analysis methods, virtually every individual molecule can be detected, which makes quality control very precise. Without sufficiently efficient fully automatic systems, any remaining product residue has to be manually removed. Causes for an insufficient cleaning result may be, for example, incorrectly selected cleaning nozzles or suboptimal process parameters.

In unfavourable circumstances, the staff and the surroundings may become contaminated with potent pharmaceutical substances during manual cleaning. Manual cleaning — possibly carried out with full protection — is time-consuming and expensive.

Moreover, the validation of a semiautomated process is problematic. A larger number of work instructions, more expensive safety precautions and additional control mechanisms are necessary.

Subsequent manual cleaning takes up valuable resources, especially with regard to complex pharmaceutical equipment, using up staff capacities and leading to longer machine downtime.

This results in costs that companies often overlook when budgeting for new machines.

Cleaning validation Cleaning validation requires complex risk analyses. A risk analysis always forms the basis for the decision on how clean equipment has to be to allow processing of a further batch of the

Tablet coater with effective cleaning system Gebr. Lödige Maschinenbau, in cooperation with the cleaning system manufacturer AquaDuna, has optimised the cleaning of a Lödige coater for the

ABOUT THE AUTHORS: Horst Spittka Studied biology and chemistry. He has been employed by Gebrüder Lödige Maschinenbau GmbH — headquartered in Paderborn, Germany — since 1985. He began working in Lödige’s test centre, before moving to the sales division.

Spittka is now Head of the Life Science Technology Sales division, serving the pharmaceutical, food and cosmetic industries. +49 5251 309 208 spittka@loedige.de www.loedige.de Martin Huber Works as a Process Consultant at AquaDuna GmbH & Co. KG, located in Sternenfels, Germany. He possesses 30 years’ experience in chemical production and cleaning.

Huber spent two decades as a Master of Production and Quality Supervisor in the multi-purpose production of HPAPIs. During this time, he worked for several big international pharmaceutical companies. +49 70 45 2 04 98 0 martin.huber@aquaduna.com www.aquaduna.com

Fig.1: Gebr. Lödige Maschinenbau's coater, developed for the film and sugar coating of tablets, pellets, granules and other shaped items.

Fig. 2: Complex and asymmetric internal design of the Lödige coater.

Fig. 3: The user-friendly jet cleaners can be quickly and safely installed.

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MANUFACTURING PRODUCTS & EQUIPMENT ARTICLE film and sugar coating of potent products, placing special emphasis on all the aforementioned aspects. (Fig: 1) The surfaces of the tablet coater that come into contact with the product are very complex and asymmetric. The machine is equipped with a special supply air guide system to ensure laminar air flow of the drying air and a cranked nozzle holder. This allows all nozzle positions for filling levels of 15 to 100% of the effective volume. In addition, it is equipped with discharge elements for automatic discharge by reversal of the coating drum. (Fig: 2) When selecting the cleaning nozzles — in particular, for the areas with spray shadows — the decision fell on AquaDuna jet cleaners. For all cleaning nozzles, the pressure of the cleaning medium, the mass feed, the rotational speed and the drive of the jet cleaners have been adapted to the requirements.

Media-driven jet cleaners and cleaning nozzles were used because, owing to their design, they are easier to install than motor-driven or pneumatically actuated nozzles. Thanks to the small size of the selected cleaning nozzles, it was even possible to permanently install a rotating cleaning nozzle in the supply air guide system in the rear area of the coater. This ensures that this difficult to access area is also reliably cleaned. In contrast, the jet cleaners for cleaning the front coater interior are temporarily fitted after each coating process.

The AquaDuna jet cleaners used combine full area spray wetting of the surface with the action of powerful kinetic energy within the effective

radius. The position of the jet cleaners was selected to ensure that even the hidden areas of the coater can be reliably cleaned. As a result of the wiping action of the jet cleaner and flow redirection owing to the back pressure of the following medium, it is even possible to clean unfavourable geometries such as the container socket or the discharge elements of the coater. (Fig: 3) In preparation for the CIP process, the jet cleaners to be installed, the cleaning water drain and the dosing pump are connected via flexible hoses. These are user friendly and secure with quick coupling systems and non-return valves.

The cleaning time and detergent consumption have been considerably reduced.

All process engineering parameters — such as pressure and temperature of the cleaning media, the times of the individual process steps and the chemical action of the detergents — were perfectly coordinated during the creation of the cleaning recipes, thus the pressure in the individual cleaning branches is individually controlled. This allows problematic areas to be cleaned with higher pressures and higher amounts of cleaning medium and easily cleaned areas to be cleaned with a minimum amount of cleaning medium.

(Fig: 4) During the coater pre-cleaning steps, the cleaning media are flushed through only once and then dumped to drain.

During the steps using detergents, the contents are circulated, minimising water and detergent consumption. Only

Fig. 4: Subsequent manual cleaning is not required. A graphic representation of the CIP coater cleaning system. the last sections of the cleaning ducts are used for the final rinse of all surfaces with purified water to ensure that this expensive medium is used as economically as possible.

The lines carrying fluid to the spray nozzles of the coater for spraying the coating solution, and the nozzles themselves, are also cleaned during the CIP process. The pump heads, the return flow valve and the nozzles are opened for this, allowing the nozzles and the hoses inside the peristaltic pump heads to be cleaned as well.

In particular, the pump pressure of only 15 bar in the various cleaning branches and the resulting mechanical

EPM 15

energy of the cleaning medium, in combination with the other measures taken, achieve a reduction in the cleaning time and the detergents used.

In the framework of this project and in close cooperation with all those involved, Gebr. Lödige Maschinenbau and AquaDuna were able to reduce the cleaning time, including the subsequent drying process, by more than half. The slightly higher investment costs in comparison with conventional solutions have a correspondingly short payback time. Lödige will take into consideration the results of these optimisations for all future coating machines, in particular, the newly developed coater series LC.

SHOWCASE DRYING

Researchers Use PAT Software’s Model-Based Control to Transform Efficiency of Pharma Drying Process Scientists from the University of Puerto Rico at Mayaguez and the Universidad de Atlantico, Barranquilla, Columbia, have shown how model-based, closed loop control can have a dramatic impact on energy efficiency and performance in a widely used pharmaceutical drying process.

Their work, published in the latest, April 2013 edition of journal Control Engineering Practice, used an inline near infrared (NIR) sensor together with real-time control models to manage the temperature and air flow rate in a fluidised bed drier. The project demonstrates that closed loop control can deliver appropriate drying performance while cutting energy consumption by up to 60% compared with conventional open loop strategies. It also shows how such an approach can effectively handle process variability, caused, for example, by changes in initial moisture content or grain size.

Encouraged by regulators, there is considerable interest from the pharmaceutical industry in the adoption of process analytical technologies and closed-loop control strategies to improve quality, process reliability and manufacturing efficiency. In their new paper, chemical engineering researchers

Luis Obregón, Leonel Quiñones and Carlos Velázquez set out to evaluate the potential of such an approach in a common pharmaceutical process, using currently available industrial components and control technologies. synTQ software from Bristol, UKbased Optimal Industrial Automation played a vital role in the demonstration system, which relied on the tight integration of multiple hardware and software elements. In the system, synTQ was used to control the inline NIR sensor that analysed the material in the dryer during operation. The spectra recorded by the sensor were passed to the analysis package SIMCA QP, which used them to generate predictions about the current moisture content of the material. This data was passed back to the synTQ package, which processed it and passed it on in turn to the dryer’s Delta V control system, using the OPC protocol. Delta V then used the predicted data to alter the inlet temperature and air flow rate in the dryer, according to an empirically derived process model.

In tests, the closed-loop control model was able to achieve the desired state of dryness with substantially lower energy consumption than could be

achieved using traditional open loop techniques; as much as 60% in one case. Also of great significance for pharmaceutical companies, the researchers tested the robustness of the system by altering the granulation and moisture content of the test ingredients without adapting the control model parameters. In this test, the closed Closed-loop control using an NIR probe to monitor moisture content loop approach was promises significant improvements in the effectiveness and energy still able to achieve efficiency of a pharmaceutical drying process. the desired level of dryness, albeit without such dramatic organisations are now using our system improvements in energy efficiency. at every scale, from lab scale research “This project is a great demonstration, projects like this, all the way up to the both of the power of model-based control of multi-site, multi-country control to improve pharmaceutical manufacturing operations.” manufacturing and of the power of synTQ to enable that process,” said Optimal Industrial Automation Ltd Optimal Sales and Marketing Director +44 1454 333 222 Martin Gadsby. “Leading pharmaceutical mgadsby@optimal-ltd.co.uk research and manufacturing www.optimal-ltd.co.uk

Dryer Achieves Reduced Retention Times in Continuous Granulation Lödige has rounded off its product portfolio for continuous granulation with a new dryer — the LCF 5, which is distinguished by a defined retention time of the product inside the machine.

This enables shorter processing times to be achieved in production. With the LCF 5, CoriMix CM 5 laboratory ringlayer mixer and customised dosing technology, Lödige now offers a complete continuous GRANUCON granulation line.

The LCF 5 dryer is based on the fluid bed process in which the material is dried in the fluid bed by convection. The drying air is heated prior to entry into

the fluid bed processor and evenly distributed through the special sieve tray of the product container. The current holds the product in suspension and fluidises it. This guarantees excellent heat transfer and drying values while handling the product gently. Hitherto, this process required a broad retention time distribution inside the dryer. With the new design, Lödige has achieved a defined, narrow retention time in the new dryer of the GRANUCON line compared with conventional devices.

For this purpose, forced delivery by means of a screw was integrated into the LCF 5, enabling retention times to

be reduced in continuous production.

The fluid bed dryer is designed for throughputs of 5 to 30 kg/h and product moisture levels of up to 20%.

The LCF 5 also offers efficiency in terms of maintenance and cleaning; the screw is easily removed and the floor can be replaced. In addition, the dryer features the integrated WIP cleaning function. The filter elements are cleaned individually.

Technology and Services Offering Caters for All Spray Drying Cycle Requirements Spray drying is a technique preferred by a growing number of pharmaceutical companies to produce better drugs.

This ultra-fast and gentle drying technology offers unique possibilities for producing powders with advanced properties.

Several companies are already benefiting from the technology as an ‘enabling technology’ — to improve the performance of poorly soluble APIs by producing an amorphous solid dispersion, to achieve controlled release or taste masking or to produce advanced powders with specific properties. GEA Process Engineering —

the company behind GEA Niro spray drying technology — is a leading provider of spray drying technology to the pharmaceutical industry and one of the few companies that offers a full range of spray drying units as well as spray drying services. Services cover the complete development cycle, from the initial proof of concept tests where only a few millilitres of material is available to full-scale production of clinical trial materials and commercial products under cGMP conditions.

GEA Process Engineering’s Pharmaceutical Spray Drying facility in Denmark is for product and process

development and is available for contract spray drying under cGMP conditions. The benefits of working with GEA are two-fold, allowing customers to take full advantage of the company’s vast expertise in spray drying technology gained from decades of experience and to save on investments in spray drying facilities until the first approvals are in place and the product is ready for commercial production.

GEA Process Engineering +45 3954 5454 gea-niro.pharma@gea.com www.niro.com

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Gebr. Lödige Maschinenbau GmbH +49 5251 309 371 lemperle@loedige.de www.loedige.de

SHOWCASE TABLETTING EQUIPMENT MAINTENANCE & TRAINING

Ultrasonic Cleaning System Safely Prolongs Tablet Tooling Lifespan An effective cleaning programme improves the life of tablet compression tooling. Ultrasonic cleaning completes this crucial maintenance step more quickly, thoroughly and cost effectively than manual cleaning.

Natoli Engineering’s ultrasonic cleaning system has features that further improve the cleaning process, including a convenient side-by-side design that makes transfers from washing to rinsing to drying quick and easy and reduces the risk of tool damage during handling. Additionally, the wash unit offers 1,000 watts of ultrasonic power and includes filtration.

The drying unit features an additional air wand to ensure drying of the punch heads and a blower to dry the punch cups, ensuring that there is no water left

in the cups, barrels or keys. According to the company, its ultrasonic cleaning system is the safest, fastest and most comprehensive solution of its kind available and significantly prolongs tooling life.

Natoli Engineering also offers troubleshooting support through its technical service experts and Scientific and Metallurgy divisions. The company’s experts are at the forefront of the industry in training and have decades of professional experience to help customers with tablet design, steel and coating selection and troubleshooting.

Additionally, the Natoli Scientific and Natoli Metallurgy divisions were founded to solve customers’ most complex compression tooling challenges. Natoli Scientific uses research and testing to

find proactive and customised solutions to combat common manufacturing issues such as wear, sticking, picking and tablet press tool binding. Natoli Metallurgy’s on-staff metallurgist is dedicated to providing services that bring the highest return on tooling

investment, including material selection, wear testing and steel failure analysis.

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

Video Demonstrates Seven Steps to Maintaining Tablet Tooling I Holland’s 7 Step PharmaCare process has been adopted as a standard operating procedure by many companies worldwide. It offers simple steps for maintaining punches and dies to help improve profitability by limiting tablet press downtime.

By adopting the 7 Step PharmaCare process and simply maintaining tools, rather than replacing them, companies can extend the life of their tablet tooling, without the expense of replacement.

Correct maintenance is critical in obtaining maximum life from punches and dies, with a high proportion of problems being traced to poor handling and maintenance procedures. The seven

steps include clean, assess, repair, measure, polish, lubricate and store: Step 1, Clean — An essential start to the process to ensure tooling is free from contamination.

Step 2, Assess — Following cleaning, punches and dies must be inspected to determine general condition.

Step 3, Repair — Rectify any damage to the tooling, including any light corrosion and damage through polishing and repairing.

Step 4, Measure — This is essential after polishing and repair to ensure critical tooling dimensions have stayed within tolerance.

Step 5, Polish — Automated polishing is

recommended to ensure an even polish and consistent finish.

Step 6, Lubricate — This step is important to protect, preserve and aid the smooth operation of tooling in the tablet press.

Step 7, Store — The final step is important to protect and minimise damage of tooling. Correct storage facilitates good tooling management. It is recommended that specially designed storage cabinets are used.

I Holland’s video — available at www.tablettingscience.com/punch-anddie-maintenance.asp — shows just how simple the 7 Step PharmaCare process is.

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

Hands-On Solid Dose Production Seminars and Training Sessions The two process technology brands Hüttlin and Manesty, which have been part of the Bosch Packaging Technology portfolio since 2011, offer an extensive range of seminars and training sessions regarding the production of solid dosage forms. Hüttlin GmbH, based in southern Germany, specialises in modular designed equipment for mixing, granulating, drying and coating of fine particles, pellets and mircrotablets.

Manesty, located in the north-west of England, operates under the name of Bosch Packaging Technology Ltd and specialises in tailor-made tablet presses and coaters with transferable parameters, which provide easy scale-up and flexible batch changeover.

Hüttlin runs a number of expert workshops for an international audience (in English) at its site in Schopfheim, including Statistical Design Space Development, Granulation, Coating and Scale-up, as well as provides on-site support for customers all over the world.

Bosch Packaging Technology offers training courses both in-house at its newly equipped laboratory and training

Technology offers participants invaluable hands-on experience with state-of-the-art equipment in a realistic production and development environment.

Courses in Schopfheim, Germany: • Statistical Design Space Development — from DoE to granules: 12–13 March, 2014 • Granulation — from powder to tablet: 3–5 June 2014 and 9–11 December 2014 • Coating — fine particles, granules, pellets and tablets: 8–10 July 2014 • Scale-up: 18–20 November 2014 Courses in Knowsley, UK: • Tableting Compression Technology: 8–10 April 2014, 15–17 July 2014 and 21–23 October 2014 • Tablet Coating Techniques: 20–22 May 2014 and 16-18 September 2014

centre in Knowsley, UK, and at customers’ sites. Amongst the current topics, customers can opt for tablet compression technology and tablet coating techniques.

By attending these courses,

participants gain a more comprehensive understanding of the processes behind the final product and associated challenges as well as increased awareness of current trends and developments. Bosch Packaging

EPM 17

Hüttlin GmbH +49 7622 6884 128 monika.foehner@bosch.com Bosch Packaging Technology Ltd +44 151 547 8056 peter.bradley@bosch.com www.boschpackaging.com

Industry News & Events

L.B. Bohle Opens Third Facility for Speedier Production of Process Equipment German machine builder for the pharmaceutical industry L.B. Bohle Maschinen + Verfahren has celebrated

the opening of plant number three at the Nordring in Ennigerloh, North Rhine Westphalia, Germany. Up to 60 new jobs will be created at the new, 3,700 m2 facility and L.B. Bohle plans to produce its process machines much faster and more efficiently.

Guests from the US, Bulgaria, Hungary, Canada and Spain attended the plant’s bavarian-themed opening ceremony. There were

speeches made by the company’s CEO Lorenz Bohle as well as local politicians Dr. Olaf Gericke, District Administrator Warendorf, Prof. Dr. Patrick Sensburg, Representive of the Bundestag, and the Vice Major Ingrid Halene, and one of the company’s customers. These were rounded off with the performance of a Sauerland traditional marching band.

The inauguration of the new plant, which is located just over half a mile from L.B. Bohle headquarters, is the next milestone in the company’s history.

The huge success of L.B. Bohle blending and coating machines, which

are technological leaders in the market, has led the machine builder to make this significant investment. “L.B. Bohle is the world leader in the blenders market, with more than 2,500 sold machines,” commented Bohle.

L.B. Bohle will produce all process machines in the new, ultramodern plant from November.

Connect 2 Cleanrooms is set to develop its product range and expand its already successful enterprise, both in the local and international cleanroom markets.

The company is on an exciting journey, witnessing growth each year since its inception over 11 years ago.

Managing Director Joe Govier commented: “Change with growth is inevitable, however when reflecting on our business and discussing business development with peers, resistance to change is frequently hailed as the biggest barrier to growth. Well here we are, receiving an award for embracing what all businesses collectively recognise as one of the biggest business challenges. I would like to thank customers, suppliers and my team for embracing change and for the support we have received to date.”

Connect 2 Cleanrooms’s solutions have huge market potential owing to

their flexibility and quality, and the company is positioning itself to actualise the opportunity presented in this growing market.

Govier added: “Over the last 12 months, we’ve invested in staff, so are equipped to improve our offering to customers. The workforce has expanded to include a Quality Manager, Finance Manager, European Project Manager and more Business Development Coordinators.”

The awards ceremony was a glittering event held at the Tower Ballroom in Blackpool and Eamonn Holmes presented the award. Highlights of the evening also included a performance by X Factor winner Matt Cardle.

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

Connect 2 Cleanrooms Celebrates BIBA Awards 2013 Accolade Connect 2 Cleanrooms announced that it has won an award at the BIBA Awards 2013 on 20 September 2013. Connect 2 Cleanrooms was shortlisted for three awards, Manufacturer of the Year, Exporter of the Year and Change for Growth, picking up the Change for Growth award at the ceremony.

BIBA stands for Be Inspired Business Awards and the event is organised by the North West Chamber of Commerce.

The awards recognise and honour the breadth of business achievement in Lancashire in all its variety.

Connect 2 Cleanrooms creates modular cleanrooms for critical environments in the UK and internationally. Its consumables division, Cleanroomshop.com, supplies a full range of consumables, equipment and furniture to the cleanroom industry worldwide.

Winning the Change for Growth BIBA Award is a true reflection of just where this company is heading. After a recent move to much larger The Connect 2 Cleanrooms team collecting its Change for premises in Lancaster, Growth Award at the BIBAs 2013.

Connect 2 Cleanrooms & Cleanroomshop.com +44 1524 813022 info@cleanroomshop.com www.cleanroomshop.com

Pharma Anti-Counterfeiting Forum Covers Bigger Picture on Access to Safe Meds A leading event on pharmaceutical anticounterfeiting and protection has rebranded in a move to open up debate on the wider issues covering access to safe medicines in recognition of global concern for patient access to quality medicines. The new Global Forum on Access to Safe Medicines will stimulate debate and international analysis of case studies and current best practices in the realm of patient-focused solutions and is now calling for papers and case study contributions covering this.

Reconnaissance International’s new Forum (formerly the Global Forum on Pharmaceutical Anti-Counterfeiting and Diversion) will take place on 2–4 April 2014, at the London Hilton Metropole, London, UK. It will expand the scope of the fight against harmful, falsified and substandard medicines through the expertise and insight of international health agencies, non-governmental organisations, regulatory officials and patient safety advocates battling on the front lines in every region of the world.

Together with anti-counterfeiting

technology providers, pharmaceutical companies and health professionals, their participation will make the 2014 Forum one of the largest gatherings to focus on improved access to safe medicines.

Now in its eleventh year, the revised Forum will provide a valuable meeting point for those involved in tackling counterfeit, diverted and other unsafe

medicines and will feature a broader agenda than previously, covering issues surrounding international strategies and technologies on controlling drug counterfeiting, diversion, false labelling and copycat products, among other key issues. The role of major donor agency health programmes in many emerging markets will be central to these discussions as participants explore new ways to leverage partnerships aimed at successful health outcomes through delivery of safe medicines.

Also on the agenda will be supply chain security, the safety of online medicines, legislative developments and EPM 18

policies, drug regulator (DRA) policies and implementation, NGA/third sector roles and capacity building and funding.

The Forum’s drive to encourage greater collaboration between the pharmaceutical industry, drug enforcement agencies, customs and police, pharmacists, doctors, nurses, policy makers and patients will see suppliers of anti-counterfeiting services and technologies stepping in to contribute to the debate about developing effective policies.

Woods International LLC, of Washington D.C., US, the Forum’s collaborating partner, will also help to highlight the critical goal of converging international solutions that merge developed world and emerging market needs.

Reconnaissance International Global Forum on Access to Safe Medicines +44 1932 785 680 info@reconnaissance-intl.com www.accesstosafemedicines.com

LABORATORY PRODUCTS & EQUIPMENT

Downloadable Study Examines Effects of Excipients on Protein Formulation Viscosities The effects of excipients on the viscosities of protein formulations are examined in a new application note published by Malvern Instruments in which low-volume viscometry was performed with the recently launched Viscosizer 200. This benchtop system performs automated viscosity measurements on very low sample volumes over a wide range of concentrations, which makes the instrument particularly useful in early stage biopharmaceutical development.

The work was conducted at Malvern

by Applications Engineer Dr. Oksana Leszczyszyn, who specialises in the analytical characterisation of proteins. It demonstrates the utility of the Viscosizer 200 in discerning differences resulting from different formulations and shows how the system can be used as a tool in screening for appropriate formulation candidates.

“As biotherapeutics are usually delivered by injection at relatively high concentrations, formulation viscosity is critically important, and a variety of small molecule excipients may be used to reduce viscosity by inhibiting protein aggregation,” said Dr. Leszczyszyn.

“Having the ability to screen formulations for viscosity issues or against a particular viscosity threshold at an early stage of development when sample volumes are limited, using a

epm

Measuring protein formulation viscosity with the new Viscosizer 200. system such as the Viscosizer 200, will facilitate and expedite candidate selection and contribute to quicker, more cost-effective routes to market.”

The new Viscosizer 200 from Malvern Instruments is the latest product to reach commercialisation as a result of Malvern’s highly focused Bioscience Development Initiative. Designed primarily to help solve key analytical challenges at the preformulation stage of pharmaceutical, and particularly

biopharmaceutical, development, the automated Viscosizer 200 delivers viscosity and molecular size data on UVactive samples, using volumes of less than 10 µl.

Download the application note at: www.malvern.com/formulation-viscosity.

Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com/viscosizer200

SPECIAL FOCUS

Dual End-Ported Biocontainer Cart Complements Single-Use Systems Portfolio Meissner’s FlexCessory dual endported biocontainer cart is a versatile accessory that supports the company’s One-Touch single-use systems portfolio. The rolling cart offers functional convenience for deployment and mobility of Meissner’s TepoFlex biocontainer assemblies and BioFlex tubing assemblies.

The FlexCessory cart is designed to support up to two 20 l end-ported biocontainer assemblies and is fully adjustable to a maximum height of 1.83m. It will support biocontainers directly placed on the notched head or suspended from an ergonomically

designed stainless steel FlexCessory biocontainer hanger.

The cart is equipped with two locking wheels to ensure security while stationary. It incorporates two polycarbonate drip trays that will contain fluid in the event of a spill, which can occur while making process connections or when venting filters.

EPM 19

The trays are removable and can be easily cleaned and replaced.

The FlexCessory end-ported biocontainer rolling cart can be ordered with optional accessories to secure capsule filters to the stand’s centre post. This arrangement can be used to accommodate preuse filter integrity testing procedures for single-use systems. For more information, visit www.meissner.com/FlexCessories.

Meissner Filtration Products +1 805 388 9911 leads@meissner.com www.meissner.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Cleanroom and Lab Products Range Grows Pharma Hygiene Products (PHP) has released a sneak preview of forthcoming additions to its growing product range.

A selection of open top drums, vaccine vessels and hygienic valves will be available soon, demonstrating the company’s commitment to providing a single source of supply for drug manufacturers.

Available in capacities from 10 to 400 l, in thicknesses of 1.2 and 1.5 mm and with or without swages, the brushed finish open top drums will be a significant addition to PHP’s current stainless steel range. Additionally, PHP plans to provide a drum refurbishment

service, where drums can be repolished for reuse and offer customers notable cost savings over time.

A supplementary range of ancillary products will also be obtainable, including, clamps, lids, seals and drum skids (to aid transportation), along with custom made discharge cones.

Vaccine vessels are designed for the safe transport of bulk vaccines in batches of between 20 and 50 l.

Constructed to hygienic standards with electro-polish finish inside and out, they will be fully autoclaveable. A range of lifting, carrying and insulating

products will also be available to aid sensible handling.

Manufactured from FDA approved materials, 316L stainless steel, silicon, PTFE and EPDM, the hygienic valves are suitable for powders, tablets and capsule production lines. Sizes range from 100 to 500 mm in diameter, supported by a comprehensive selection of accessories including caps, collars and clamps.

PHP’s new open top drums, ideal for applications where high standards of hygienic construction are required.

Pharma Hygiene Products +44 121 661 6548 sales@pharmahygieneproducts.com www.pharmahygieneproducts.com

RFID Tag-Enabled Calibration Delivers Pipetting Precision To support the pipette management efforts of researchers working in the pharmaceutical and chemical industries worldwide, Mettler Toledo has embedded RFID tags in all of its premium Rainin air displacement pipettes, including its recently released E4 XLS electronic model. This addition helps laboratories establish advanced calibration schedules through heightened pipette tracking capabilities for significant time savings and lowered laboratory management costs.

Regularly scheduled calibration is a key component of pipetting reliability. By combining Rainin pipettes with Rainin’s RFID reader and LabXTM Direct PipetteScan software, users can immediately determine an individual pipette’s

or LabX data integration into other asset management applications.

Rainin pipettes that offer RFID technology include manual, electronic, single-channel, multichannel and adjustable-spacer models to encompass all of a laboratory’s most intricate and complex pipetting needs. For more information on how Rainin RFID-enabled pipettes can help increase laboratory accuracy and decrease costs, visit www.mt.com/Rainin-RFID.

complete profile, including serial number, manufacture date, calibration-due date and any user-assigned attributes. This helps a user understand the status of the pipette and determine if calibration is needed to ensure its accuracy almost immediately. Context-sensitive help in 15 languages ensures that users worldwide can access the advantages of RFIDenabled pipettes. Fast data recall reduces the occurrence of costly performance issues.

User-defined attributes are housed in 12 customisable data fields contained on the pipette’s RFID tag. These fields, as well as ongoing calibration and performance data, can be exported to Microsoft Word and Excel or used as a text file, allowing custom report creation

Anachem Ltd +44 1582 455135 info@anachem.co.uk www.anachem.co.uk

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SPECIAL FOCUS

Lab Bioreactor Combines Proven Glass Design with Efficiency of Single-Use Systems Sartorius Stedim Biotech (SSB) has introduced UniVessel SU, the second generation of its successful single-use bioreactor. This single-use stirred tank bioreactor can be operated in a choice of working volumes ranging from 0.6 to 2 l and is suitable for the cultivation of mammalian cells, including stem cells, insect and plant cells. Typical areas of application for the UniVessel SU are process development and optimisation, as well as production of seed cultures and cell banks.

UniVessel SU combines the proven design of conventional glass vessels with the efficiency and flexibility of single-use systems. Supplied as a completely preassembled and presterilised unit, this laboratory bioreactor is instantly ready to use right out of the box. It eliminates the need for labour-intensive steps, such as autoclaving or installation of probes, minimising the time needed for preparation. The new UniVessel SU can be used interchangeably with glass vessels to help laboratories better manage peak workloads despite challenging timelines.

Each UniVessel SU is equipped with integrated single-use sensors for pH and dissolved oxygen measurement.

This proven single-use sensor technology, which SSB also uses in its

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BIOSTAT RM and BIOSTAT STR disposable bioreactors, measures the pH and DO values non-invasively, thus eliminating time-consuming autoclaving and risk-prone insertion of probes in the culture vessel.

UniVessel SU is compatible with SSB BIOSTAT controllers and can also be operated with nearly any other brand of bioreactor controller. This saves customers from having to buy expensive new equipment. The new UniVessel SU Connection Box enables the integrated single-use sensors of UniVessel SU to be used with existing controllers. Up to four bioreactor controllers can be interfaced per connection box. The sensor calibration data can be read in easily by a barcode scanner in an error-free manner.

Sartorius Stedim Biotech S.A. +49 551 308 3615 karin.kleist@sartorius.com www.sartorius-stedim.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY Coriolis Pharma in Martinsried, Germany, has become the first pharmaceutical CRO in the world to routinely use Archimedes, an analytical instrument supplied by Malvern Instruments. Coriolis Pharma specialises in formulation development for biopharmaceuticals such as proteins, peptides and vaccines and offers a wide variety of services to support product development.

Archimedes uses the technique of resonant mass measurement (RMM) to detect and accurately count particles from 50 nm to 5 µm in diameter and to measure their buoyant mass, dry mass and size. It has applications in the quantitative characterisation of protein aggregates in the size range currently of new regulatory interest, from 0.2 to 2 µm diameter, where aggregates are considered to have a high likelihood of eliciting an unwanted immune response. Unusually for this size range, Archimedes distinguishes between proteinaceous material and contaminants such as silicone oil.

“The teams at Coriolis Pharma have extensive expertise in protein analysis, especially in the field of protein aggregation and degradation, and were quick to recognise the benefits of applying resonant mass measurement within our formulation development regimes,” said Dr. Andrea Hawe, CSO from Coriolis

ANALYTICAL SYSTEM SCORES TOP MARKS FOR PROTEIN AGGREGATION AT CORIALIS PHARMA

Pharma. “Our pioneering testing and adoption of the highly innovative Archimedes now enables us to more easily measure protein aggregates and silicone oil droplets in a critically important size range.

This has added a new dimension to our protein characterisation capabilities and to the service we provide for our clients.”

In the July 2013 issue of the Journal of Pharmaceutical Sciences, scientists at Coriolis Pharma, together with colleagues at Leiden University in The Netherlands and Ludwig Maxmilians University in Germany, published a paper reporting work using RMM and micro-flow imaging to examine the quantitative differentiation of protein particles and silicone oils over a large size range.

Distinguishing between these two entities is pertinent to the development of biopharmaceuticals, in particular for products in prefilled syringes or cartridges where silicone oil may be used as a lubricant in the delivery device. The high accuracy of discrimination using Archimedes for different types of protein particles, and different ratios of protein particle to silicone oil droplets, and also the robustness of the technique were all attributed to the straightforward categorisation of particles and droplets according to buoyant mass.

“Archimedes is now part of our routine offering for clients seeking support in formulation development.

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In addition, we can run samples as part of feasibility studies for future work or as standalone projects,” continued Dr. Andrea Hawe. “Having this technique available means we are able to offer more extensive protein characterisation services to our clients that help them in the drive to more rapidly develop and commercialise new therapeutic solutions.”

Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com/archimedes Coriolis Pharma +49 89 5 42 44 98 0 contact@coriolis-pharma.com www.coriolis-pharma.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Workstation with Two Airlocks Improves Workflow Don Whitley Scientific has launched a four-port anaerobic workstation that has two airlocks, one at either end of the chamber. Unveiled at the Biomedical Science Congress in Birmingham, UK, in September, this workstation has been designed for busy laboratories where two people may need to use the workstation simultaneously. The positioning of the two airlocks at either end of the chamber allows samples to be introduced at one end and removed at the other, significantly improving laboratory workflow.

The A55 incorporates all the latest Whitley workstation features such as a colour touchscreen interface, sleeveless instant access ports, automatic commissioning and a range of options and accessories to tailor the

workstation to the customer’s requirements. A removable front is fitted as standard on the right hand side of the cabinet to facilitate the introduction of bulk samples and equipment that may need to be used inside the chamber. The A55 can accommodate up to 1,400 x 90 mm Petri dishes.

Evan Kitsell, Design Director, commented: “Our research into customer requirements confirmed that there was a need for a larger workstation with an airlock at either

end. We discovered that the increased throughput in some laboratories has led to a need for improved workflow, larger cabinets and the ability for additional staff to work simultaneously in the chamber.”

Options for the A55 include a fully integrated anaerobic conditions

monitor, internal power sockets, single plate entry system and fully comprehensive maintenance contract.

Don Whitley Scientific Ltd +44 1274 595728 deborah_robinson@dwscientific.co.uk www.dwscientific.co.uk

Wet Sieve Makes UK Debut at Lab Innovations Hosokawa Micron, a powder and particle processing technology expert, will exhibit a range of new units from its analytical equipment range as well as units from its laboratory- and pilot plantscale processing equipment range at Lab Innovations 2013, 6–7 November 2013, the NEC, Birmingham, UK, Stand V7.

To be shown for the first time in the UK, the Viblette VBL is a new wet sieve developed for sieving of cohesive or dielectric materials or slurries. The Viblette VBL offers shorter mixing times,

up to one third that of conventional wet sieves.

With new, updated versions of its industry standard Alpine air jet sieve and the PT-X powder characteristics tester on show, visitors will be able to see for themselves the latest developments in technology that make these new units quicker and easier to use with reduced operator intervention and how repeatable accuracy has been increased.

The Picoline range of laboratory machines for the milling, mixing and

classifying of ultra-small batches between less than one gramme and several grammes will also be exhibited.

Ideal for use in R&D departments, processing carried out on one of the Picoline units can be seamlessly transferred to production-sized Hosokawa Micron machines because of identical principles of operation.

Viblette VBL wet sieve particle size analyser.

Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk

Butterworth Highlights Extended Contract Analytical Capabilities at Lab Innovations

Exhibiting at Lab Innovations 2013 — 6–7 November 2013, the NEC, Birmingham, UK, Stand G7 — Butterworth is a fully independent contract analytical chemistry laboratory, which has been delivering a cost-effective, timely and reliable service for nearly 40 years. The company offers the following outsourcing solutions: • QC testing • method development and validation • stability storage and testing Using a wide range of instrumental techniques operated by experienced scientific staff, the analytical fields served include: • chromatography • atomic and molecular spectroscopy • general and wet chemistry • phys/chem testing • elemental microanalysis Increasing demand for trace metals analysis, resulting from the proposed changes to the USP, EP and ICH Q3D Guidelines for Elemental Impurities, has EPM 22

led to the refurbishment of Butterworth’s laboratory, increasing its capacity by 15%. One of the newly created laboratories will house Butterworth’s recently purchased Agilent 8800 ICP triple quadrupole (ICP-QQQ), together with its current ICP-MS. In addition, the company has extended its capabilities in residual solvents analysis with the purchase of a Perkin Elmer HS110 headspace trap sampler along with an additional Claris 580 GC and is currently developing methods for low level benzene and vinyl chloride applications.

This commitment underpins Butterworth’s core values of quality, reliability and confidentiality in analytical chemistry outsourcing.

Butterworth Laboratories Ltd +44 20 8977 0750 info@butterworth-labs.co.uk www.butterworth-labs.co.uk

SHOWCASE LIMS

Data-Centric ELN Supports Collaboration and Multidiscipline Activity

Workflow Configurable LIMS Enables Paperless Operations Management to Lower Total Cost of Ownership

Today’s R&D market needs to be able to create and work in secure, flexible communities supported by trusted data. It requires powerful informatics platforms with broad capability.

Modern, data centric electronic laboratory notebooks (ELNs) are well aligned to support this collaboration and multidiscipline activity, managing data security and access control.

Legacy sticker-book or paper on glass ELNs are being superseded with enterprise systems like IDBS’s EWorkBook Suite data management platform. By extending the sticker book paradigm strong ontology, fact data management and workflow management enable scientists to move beyond unstructured data capture and IP protection, towards real-time data centric collaboration.

IDBS’s E-WorkBook Suite recently saw major enhancements to its web client.

Furthermore, the latest 9.3 release also includes integration with IDBS’s workflow and analytics engine and new asset tracking and management technology.

The extended web capabilities include editing and content creation as well as the ability to complete tasks and workflows. The inclusion of new

Laboratory professionals in a variety of industries — including pharmaceutical QA/QC, oil and gas, food production, process industries and contract laboratories — can improve laboratory process mapping, management and automation with new Thermo Scientific SampleManager 11 tools and user-interface enhancements.

The newest, most configurable version of one of the world’s most widely deployed laboratory information management systems, SampleManager 11 empowers users by giving control to personnel at the point of decision, enabling them to: • connect quality and product data from the lab to enterprise systems such as enterprise resource planning (ERP), achieving a paperless operations management infrastructure • build workflows to reflect individual laboratory processes without an IT specialist • automate the logical decisions driving laboratory activities, improving throughput by saving time and simplifying user interactions • configure and deploy more easily for a lower cost of ownership

customised personal and project dashboards provides fast and easy views of critical information and data that are surfaced automatically, meaning users do not have to spend time searching.

Also launched with 9.3 is InforSense, a sophisticated analytics and workflow system. It allows users to combine data from any source inside or outside their organisation and to link that to any application to build up integrated, validated and performant data analysis workflows.

E-WorkBook Suite provides a single environment for data capture, integration, analysis, searching and reporting.

IDBS +44 1483 595 000 info@idbs.com www.idbs.com

• comply with international standards such as ISO17025 SampleManager 11 delivers workflow configurability, user-intuitive multiple sample login, point-and-click extensibility and enhanced data mining and tracking capabilities to benefit a wide range of industries. In each of these sectors, productivity and compliance must be in constant balance, even as requirements shift. Enhanced traceability features in SampleManager 11, including the ability to track aliquots and composites, enable finer control over samples and more reliable data for decision-making and compliance.

Thermo Fisher Scientific Inc. marketing.informatics@thermofisher.com www.thermoscientific.com

CASE STUDY Thornton & Ross Ltd, in Huddersfield, UK, has introduced the Matrix Gemini LIMS system from Autoscribe to improve efficiencies in its quality control laboratories for raw materials and finished products. Thornton & Ross Ltd is the largest independent pharmaceutical manufacturer in the UK and its QC laboratory has an important function in both raw material evaluation and in production. Enhancing laboratory productivity leads to improved manufacturing efficiency, and information management in laboratory operations is essential to improving laboratory efficiencies.

THORNTON & ROSS USES LIMS TO IMPROVE PHARMA QC LAB EFFICIENCY

Data management requirements The Matrix Gemini LIMS was chosen as it met all of the Thornton & Ross requirements and the company already had experience of using an earlier version of Matrix Gemini for stability testing. Matrix Gemini is used to control, manage, organise, document, analyse and report information, leading to improved efficiency and functionality of data storage and manipulation. The system manages data for a wide range of analytical techniques, including high performance liquid chromatography (HPLC), gas chromatography, thin layer chromatography, UV

spectroscopy, IR spectroscopy, nuclear magnetic resonance spectroscopy (outsourced to a contract analysis company), a range of gravimetric measurements, potentiometric titrations and a wide range of sample preparation techniques.

Raw materials and finished products conform to European pharmacopoeia and relevant product licenses. All tests are carried out in accordance with the ‘Orange guide’ (Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by the Medicines and Healthcare products Regulatory Agency, London, UK). Matrix Gemini provides compliance with all of the relevant regulations and practices. In addition, the software is used to generate Certificates of Analysis and monitor laboratory efficiencies whilst trending results for the finished products team. It is also used to speed up processes that are currently very time consuming. It is currently being used as an independent software in parallel with the current paperwork system with a view to eventually phasing out the current systems wherever possible.

A flexible solution Matrix Gemini is a configurable LIMS solution that requires no coding to create a system that matches the specific requirements. The easy-to-use configuration tools allow the definition of screen and menu designs, customer specific tables/modules and multiple screens for the same function (e.g., different login screens for different product classes

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such as raw materials and finished products). The Workflow user interface graphically represents the progress of a sample through the laboratory. Matrix has the tools and design to help with cGLPs and cGMPs compliance, including audit trails, time and date stamping of all actions, version control of all reference data such as test definitions and extensive features to help with 21CFR Part 11 compliance such as data entry authentication and comprehensive password management capability. The Matrix Gemini solution provided a very quick way to generate a host of reports, allowing efficiencies to be evaluated quickly.

Autoscribe Ltd +44 118 984 0610 john.boother@autoscribe.co.uk www.autoscribe.co.uk

SHOWCASE STERILISATION

Benchtop Autoclave Range Provides Affordable Option for Start-Up Labs The feature packed C40 benchtop autoclave available from Priorclave, at an affordable price and supported by a superb extended warranty, gives longterm peace of mind of assured performance and reliability.

The C40 is a front loading 40 l capacity autoclave with a 350 mm diameter chamber and is designed specifically for placing on a benchtop. A key feature of the Priorclave is its small footprint, which enables even the smallest laboratory to own a highly efficient machine.

Designed and built by Priorclave at its UK manufacturing centre, this versatile range is produced in two formats, as a standard operating autoclave or with a highly efficient vacuum system for laboratories where infrequent sterilisations take place or a more demanding medium requires faster processing.

The Priorclave C40 autoclave is designed to appeal to those wanting a simple to operate machine. Out of the box, the benchtop autoclave requires

plugging into a 230V, single-phase supply and all operational functions are governed by the established, simple to programme and totally reliable TACTROL2 microprocessor system — just set the temperature and time required, select any options needed and press start; operation is fully automatic once the cycle has started.

TACTROL2 provides easy pushbutton control, whether requiring simple cycles or a fully featured multi-programme operation. By fully automating the sterilising process and with features to assist with autoclave management, TACTROL2 allows laboratory staff to continue with other tasks secure in the knowledge that autoclaving is proceeding safely and efficiently.

Priorclave autoclave customers can feel secure in the knowledge that every care has been taken to build robust autoclaves with a superior exterior finish to body panels and frames, preventing potential for cross-contamination within laboratories. During manufacture,

Priorclave has incorporated Biomaster Protection into the exterior epoxy coating, a highly effective and permanent treatment for control of harmful bacteria, making any surface cleaner and more hygienic and providing durable lifelong protection against the threat of cross contamination.

As with all Priorclaves, the C40 benchtop range of autoclaves come with the full support of a dedicated service team. At the end of the initial warranty period, Priorclave is able to maintain full autoclave functionality, reliability and performance through Planned Maintenance programmes. These are designed to ensure the longevity of the original purchase, helping reduce the overall cost of ownership.

For UK-based customers, an optional two-year warranty with installation, preventative maintenance servicing and any repairs for the first two years of ownership all included at one advantageous price is available. This

should especially appeal to start-up laboratories and those with low-volume sterilising throughput where investment in that initial purchase needs to be protected.

Priorclave Ltd +44 20 8316 6620 sales@priorclave.co.uk www.priorclave.co.uk

Compact Autoclave Doubles Sterilisation Capacity with Two Chambers Astell’s Duaclave is a space-saving development in sterilisation technology. It comprises two independently functioning autoclave chambers, one above the other, in a single frame, thus providing twice the sterilising capacity within the smallest possible footprint.

Available in capacities from 33 to 153 l (per chamber), the Duaclave has been specifically designed to ensure maximum capacity where floor space may be at a premium. It also has the added advantage that each chamber can be used for the separate, independent sterilisation of specific load types, e.g., clean loads such as media and dirty loads such as laboratory waste.

Like all Astell autoclaves, the Duaclave can be ordered with a wide range of options and accessories to ensure that

users’ requirements can be met in the most demanding of situations. These options include load sensed processed timing, which is recommended for the accurate sterilising of fluid loads, and a variety of cooling systems to improve cycle times. Options for data transfer include RS232, USB and Ethernet interface, enabling either monitoring or recording of cycle progress. The optional data printer provides a hard copy report for every cycle, often an essential requirement in today’s quality-conscious laboratories.

Each autoclave chamber is independently controlled by the LogiColor touchscreen control system, which is now supplied as standard on all standard and custom-designed Astell autoclaves.

A delayed start facility, multi-level password protection, simple cycle creation/selection and data archiving for up to 5,000 cycles are just a few of the many standard features on Astell’s controller. In addition, an integral self-help tutorial ensures ease of operation for even the most inexperienced of users.

In common with all Astell models, the Duaclave is CE marked and manufactured to comply with UK and international standards, including the Pressure Equipment Directive PD97/23/EC and the Medical Devices Directive MDD 93/42/EEC. Astell Scientific Ltd +0208 309 2024 (UK) / +44 208 309 2031 (Rest of World) sales@astell.com www.astell.com

Autoclave Range Stores Data for Up to 5,000 Cycles Data acquisition and logging of laboratory equipment cycle data is becoming increasingly important for many laboratories and institutions. LTE Scientific’s Touchclave-Lab autoclave range addresses this issue in a number of ways.

A standard feature on all Touchclave-Lab models is internal memory. Up to 5,000 cycles are stored on an internal flashcard, which when full, is simply replaced. The flashcard data is easily downloaded to a PC using LTE’s Touchclave-NET software.

All data is checksum protected and thus tamper-proof.

Alternatively, data can be downloaded in real time to a remote PC. This is achieved either through a hard-wired installation for PCs that are close to the autoclave or via

Ethernet for data tends to be collected centrally.

In addition, LTE can supply a wide range of graphic recorders or data acquisition systems that provide graphical and historical cycle data.

Touchclave-Lab autoclaves are available in a range of capacities from 150 to 450 l and can be supplied with internal heaters, steam generators or fed from customers’ own steam supply as required. The range incorporates a touchscreen control system for entering and displaying all commands, cycle and program data. ‘K’ models include a water jacket cooling system to enhance cycle performance and can also be fitted with steam jackets to allow effective drying of porous and other loads.

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All LTE products are supplied with Sterling anti-bacterial powder coating.

A choice of eight user-programmable cycles can be stored in the memory, with an optional memory expansion facility boosting the total to 20. All TouchclaveLab autoclaves can be supplied with a number of additional features, including vacuum, air ballast, effluent retention and high security filters.

For after sales care, LTE employs a 12strong team of UKAS and HTM-qualified engineers to carry out servicing, maintenance, calibration and validation.

LTE Scientific Ltd +44 1457 876221 info@lte-scientific.co.uk www.lte-scientific.co.uk

Industry News & Events

Reagents Specialist Acquires Rights to Gene and Drug Therapies Development Technology Cambridge Research Biochemicals (CRB) has announced that it has licensed the rights to a patentable method for parallel assembly of a large number of peptide-therapeutic cargo combinations. The company aims to

launch a service in October to provide both researchers and pharmaceutical companies with custom-made libraries of peptide-cargo conjugates to help accelerate the delivery and development of new therapeutics.

The method originated at the Medical Research Council’s Laboratory of Molecular Biology (MRCLMB), where scientists have been working to develop cell-penetrating peptides capable of carrying therapeutic drug cargoes into cells. The sorts of diseases that could benefit from such peptide-delivered therapeutics are broad ranging and include muscular dystrophies, cancer and metabolic diseases. In Dr. Peter Deuss, MRC-LMB, Alison White, Operations order to develop such Director, CRB, Dr. Mike Gait, Group Leader, MRC-LMB, therapeutics, it is necessary Emily Humphrys, Commercial Director, CRB.

to test a wide variety of peptide-cargo combinations to determine the optimal peptide for delivery of the drug cargo for the condition being treated. This new technology enhances the speed of the early stage drug screening process and helps those without the necessary chemistry expertise to more rapidly prepare and test a much greater number of peptide-drug conjugates towards the delivery and development of potential novel therapeutics.

Emily Humphrys, Commercial Director at CRB, said: “We are really pleased to be able to provide a long-awaited service for the selection of the most appropriate cell-penetrating peptide for delivery of drugs to both academic researchers and industry. As a company, CRB has extensive peptide chemistry capability and enjoys a longstanding relationship with the MRC-LMB both from the formation of the company in 1980 to the ongoing supply contract for

peptides and antibodies in place since 2010. This collaboration marks another accolade from the partnership.”

Dr. Mike Gait, the MRC scientist who has directed this work, commented: “We are very excited that CRB has taken on our new method and will open it up to a wider number of researchers and to industry, ultimately enabling the development of new treatments.”

The method was licensed to CRB by MRC Technology on behalf of the MRC. MRC Technology provides the MRC with technology transfer services.

Cambridge Research Biochemicals +44 1642 567182 emily.humphrys@crbdiscovery.com www.crbdiscovery.com MRC Laboratory of Molecular Biology +44 20 7391 2700 lmb-news@mrc-lmb.cam.ac.uk www.mrctechnology.org

Industry’s Major International Players Choose analytica 2014 The international trade fair for the global analysis, laboratory technology and biotechnology industry takes place in Munich, Germany, for the 24th time on 1–4 April 2013 and already 714 exhibitors have registered (compared with 664 exhibitors in 2011), an increase of 7.5%.

Laboratory-equipment suppliers Hirschmann, Köttermann and Waldner are just some of the industry’s key players that will be at the fair. Susanne Grödl, Exhibition Director for analytica, commented: “The presence of major manufacturers and suppliers of laboratory equipment alone proves that analytica is number one in the industry.”

Other companies that have registered to date include Analytik Jena, Becton Dickinson, Eppendorf, Fisher Scientific,

GE Healthcare, Merck Millipore, Miele, Olympus Deutschland, Shimadzu Deutschland, Sigma and Waters.

Countries planning large joint exhibition stands currently include China, France, Spain and the UK. Hall A3, which is analytica’s gathering for the biotech and diagnostics industry, will also have two new regions — Berlin and Biosaxony. The latest high-quality equipment solutions are in great demand, especially among representatives of the pharmaceutical research sector. In 2012, some 6,706 visitors came from this branch of industry. Above all, they profit from the complete market overview and marketable products. The analytica Conference, a leading international conference for the scientific elite, also

features lectures on topics related to chemistry, biochemistry and laboratory medicine. The Biotech Forum gives scientists and industry representatives as well as routine analysts and engineers practical tips and inspiration for their everyday laboratory work.

An initial overview of all the companies that have registered for the fair is available in the online exhibitor database.

Messe München GmbH analytica 2014 +49 89 949 114 88 info@analytica.de www.analytica.de

Other areas in which we have seen growth include protein aggregation and the study of viruses and vaccines. Now we look to expanding into more areas as our technology is being used in more and more applications areas.”

To find out about the business and to learn more about particle characterisation using NTA solutions, visit NanoSight’s website and register to receive the next issue of NanoTrail, the company’s electronic newsletter.

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

NanoSight Named Sunday Times Tech Track 100 Company NanoSight, a leader in nanoparticle characterisation, has been listed in the 2013 Sunday Times Tech Track 100 league table supplement published in The Sunday Times on 15 September with title sponsor Hiscox. Tech Track ranks Britain’s private tech (TMT) companies with sales over £5 million that have had the fastest-growing sales over the last three years.

NanoSight was placed in 70th position in recognition of continued exponential growth reflected in sales performance since 2006, when sales of its Nanoparticle Tracking Analysis (NTA) technology took off. Speaking of this latest award for excellence, CEO Jeremy Warren said: “On behalf of NanoSight's team, I am very pleased for the company to be recognised in this way; Tech Track recognition certainly validates our work.

2013 has seen us continue to grow sales on the back of new technology developments, such as the launch of our new NS300 system at Pittcon and more recently, the addition of dynamic light scattering (DLS) capability to the flagship NS500 system.”

Founder and Chief Technical Officer Bob Carr is particularly excited by the recognition of the technology through the publication of nearly 1,000 peerreviewed papers citing NTA. “I am very proud to see the work of our development team provide technology that is making a significant difference in nanotechnology, the life sciences in particular. We have seen tremendous advances in the study of exosomes where they are used as biomarkers with potential for early stage diagnosis of various cancers.

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INGREDIENTS & CONTRACT SERVICES

External Clinical Trial Lab Testing Reduces Costs While Promoting Data Quality and Consistency Covance, one of the world’s largest and most comprehensive drug development companies, has announced the launch of external laboratory management services, a new offering that provides biopharmaceutical companies with a comprehensive management solution for external laboratory testing associated with clinical trials.

Covance’s external laboratory management services are designed to maximise the quality and integrity of clinical study data by ensuring that laboratory testing is seamlessly managed for the client along with services provided by a central laboratory. These services include laboratory selection and qualification, auditing, vendor management, contracting and data cleaning. The new Covance services will be managed by a dedicated team within Covance’s central laboratory services and complement the company’s capabilities in central laboratory testing, biosample management and data services, resulting in a streamlined solution that frees pharmaceutical companies from the challenges of managing multiple laboratory testing vendors.

By leveraging economies of scale and minimising duplication of effort, Covance’s external laboratory management services can reduce the cost of managing external testing by as much as 65% when compared with clients’ in-house management of the

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process. In addition, improved data cleaning can decrease the length of trials, accelerating data lock.

“Through our external laboratory management services, ISO-15189 accreditation and understanding of the regulatory landscape, Covance is uniquely positioned to enable our clients to meet higher levels of data scrutiny from agencies around the globe,” said Gary Paul, Global Director of Quality Assurance for Covance Central Laboratory Services. “As the pioneer of the central laboratory model, this new offering further establishes Covance’s position as a leader and innovator in clinical trials testing and sets a new industry standard for the management of data quality.

Paul Kirchgraber, Vice President Global Laboratory Operations & Medical Affairs, added: “By providing an enhanced laboratory data solution that reduces regulatory risk and lowers drug development cost, we enable our clients to focus on their core competencies, ultimately accelerating development and commercialisation timelines.”

In recent years, increased regulatory scrutiny of clinical programmes has led to the creation of an industry standard, ISO 15189, to help control laboratory

data consistency and quality. While the majority of clinical trial testing occurs at central laboratories, an increasing percentage of trials include at least one specialised test that is sent to an external laboratory. Covance’s external laboratory management services are designed to help biopharmaceutical companies address their growing testing needs while mitigating potential risks, increasing data consistency and decreasing the cost and time associated with clinical development. More information about Covance’s central laboratory services can be found at www.covance.com/products/clinical/ central-lab.

Covance Inc. +41 798236706 sabine.schneidernash@covance.com www.covance.com

SPECIAL FOCUS

Merck Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre Merck Millipore, the Life Science division of Merck, has announced that its Biodevelopment Centre in Martillac, France, has been recertified by the French National Agency for Medicines and Health Products Safety (ANSM), the competent authority of France. The certification confirms the 3,440 m2 facility complies with the principles of GMP for active substances.

The audit included a thorough review of quality systems, supplier management, control of raw materials, documentation, calibration and validation. Prior certification consisted only of stainless steel equipment, while this recertification included complete single-use upstream and downstream suites, as well as a 2 x 1,250 l stainless steel suite.

Merck Millipore’s Provantage biodevelopment and clinical supply

services are delivered at the facility. This approach for biologics manufacturing incorporates the latest technologies in upstream, downstream and single-use systems. This Provantage offering includes process development and GMP drug substance for preclinical to phase II and is available to a global customer base.

“We are proud to be one of the first facilities to attain GMP compliance utilising single-use equipment for each unit operation from upstream through downstream. This recertification reflects the teamwork and dedication of our entire staff and provides our customers with complete confidence in our technical expertise

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and quality,” noted Richard Pearce, Business and Operations Director of the Biodevelopment Centre.

Merck Millipore +1 781 533 5336 pegeen.dossantos@emdmillipore.com www.merckmillipore.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP Japan Approves Recipharm’s Manufacture of Cancer Pain Relief Tablet for Kyowa

Demanding Formulations Call for Higher Purity Grade Polysorbates

Recipharm was informed on 20 September 2013 by the R&D-based pharmaceutical company Kyowa Hakko Kirin Co. Ltd. that the Abstral sublingual (under the tongue) tablet has been approved for manufacturing and marketing by Japan’s Ministry of Health, Labour and Welfare (MHLW).

The approval allows Recipharm to carry out commercial scale manufacturing and packaging of Abstral for supply to the Japanese market through Kyowa Hakko Kirin.

Abstral is a highly potent, rapid disintegration, sublingual formulation of fentanyl citrate. This well-established opioid is used extensively for fast relief and management of episodes of breakthrough pain experienced by cancer patients that are already in receipt of opioid analgesics for cancer pain.

The Japanese regulatory agency assessed Recipharm’s suitability through detailed analysis of the company’s history, capabilities, proven track record and the reliability of the supply chain set to take the product through to Japan, together with a thorough review of all clinical data and product documentation.

Recipharm will compress and formulate Abstral in tablet dosage at its manufacturing site in Årsta, Stockholm, Sweden, with all packaging performed at the company’s Jordbro complex, also in Stockholm. Quality control will be initiated in laboratories located in central Stockholm.

Thomas Beck, Director of Quality and

Avantor Performance Materials has introduced a higher purity Super Refined grade of polysorbate products to improve solubilisation and stability in a variety of biopharmaceutical and smallmolecule drug formulations.

The new Super Refined grade products join Avantor’s current high-purity versions of the two most widely used types of polysorbate products: J.T.Baker brand Polysorbate 20 and Polysorbate 80. These products are commonly used in pharmaceutical formulations such as parenteral, otic, ophthalmic, oral and topical preparations.

Avantor’s high-purity and Super Refined grades of J.T.Baker polysorbates are manufactured under cGMP conditions, in FDA-registered ISO 9000-certified facilities.

While Avantor’s existing high-purity grade of polysorbates offers low levels of impurities for better performance in formulations, the new Super Refined grade takes advantage of a proprietary flash chromatographic process that removes even more polar and oxidative impurities, such as peroxides and aldehydes, which can degrade APIs. “Pharmaceutical manufacturers are increasingly facing challenges to ensure the stability of their formulations and improve the shelf life of their products,” said Paul Smaltz, Avantor Executive Vice President for Pharmaceuticals. “We’re pleased to now offer these additional options in our polysorbate products so customers can match the right level of purity to their formulation needs.”

The surface activity of polysorbates helps to stabilise proteins by reducing the alteration or aggregation of proteins during manufacturing, distribution and storage. With poorly soluble drugs,

Qualified Person at Recipharm Stockholm, commented: “We are delighted to receive Japan’s MHLW approval to carry out a combination of both the manufacturing and the packaging of such a product for onward supply to the Japanese market. Indeed, we are pleased, both because securing such authorisation from a regulatory body outside of the EU is an extremely complicated process, especially in the case of Japan, and due to the fact that Abstral is a highly innovative drug that enables fast relief of pain endured by patients undergoing cancer treatment.”

Recipharm AB +46 8 602 52 00 info@recipharm.com www.recipharm.com

Avantor’s Super Refined J.T.Baker Polysorbate 20 and 80. polysorbates provide improvements in solubilisation while enhancing the stability of emulsions.

J.T.Baker polysorbates are vegetablebased, with a non-peanut origin, providing low endotoxin and other impurities, which is critical for formulation of biopharmaceuticals. The products meet the rigorous multicompendial requirements of the National Formulary (NF), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) or Japanese Pharmaceutical Excipients (JPE).

The new Super Refined polysorbates are available in bottle sizes ranging from 200 ml to 4 l and are packaged under nitrogen to ensure premium product integrity.

Information on Avantor’s J.T.Baker polysorbates is available on the Surfactants and Detergents product page and in the Technical Literature Library product profiles section for pharmaceuticals at www.avantormaterials.com.

Avantor Performance Materials, Inc. +1 610 573 2600 info@avantormaterials.com www.avantormaterials.com

Reusable Shippers Provide Cost Efficiencies for Clinical Services Customers Almac’s Clinical Services business unit has announced the addition of refrigerated reusable shippers to its trusted portfolio of solutions for the management and global distribution of temperature controlled clinical supplies.

Available as an option to replace singleuse shippers for refrigerated shipments, 2 to 8˚C, the reusable shippers can significantly reduce shipping and storage costs while maintaining payload capacity.

This latest addition is complementary to an already extensive range of cold chain management solutions, which include a global team of cold chain experts, a strategic depot network, over 3,000 pallets of dedicated, refrigerated storage facilities and a proprietary shipping temperature electronic monitoring system (STEMS) that allows for same day temperature data.

Features of the reusable shippers include identical product space with a smaller overall volume than single-use shippers, therefore reducing shipping and storage costs. In addition, the environmental impact caused by singleuse shippers is virtually eliminated, and EPM 28

clients will benefit from the removal of tedious destruction processes often required with single-use shippers. The refrigerated shippers have been verified

by Almac Quality for temperature accuracy and meet Almac’s rigorous quality standards.

Commenting on the latest enhancement, Leon Supplee, Director of Logistics at Almac’s US headquarters in Souderton, Pennsylvania, US, stated: “With an increase in biologics and temperature sensitive shipments, Almac strives to offer the best in temperaturecontrolled distribution. The addition of reusable shippers is one more way that Almac has risen to meet the changing needs of our clients and provide further efficiencies in the supply chain.”

Almac also plans to release reusable options for controlled, ambient shipments, 15 to 25˚C, and frozen shipments, -25 to -15˚C, in the near future.

Almac Group Ltd +44 28 3833 2200 clinicalservices@almacgroup.com www.almacgroup.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP £30 Mn High Capacity Manufacturing Facility to Produce Type 2 Diabetes Solid Dose Medication Aesica has announced the creation of a new High Capacity Manufacturing Facility following a £30 million investment at its Queenborough, Kent site. The 10,000 m2 expansion has been constructed for the production of a solid dose medication used in treating one of the world’s most common lifestyle diseases: type 2 diabetes in adults.

Following the official opening on 19 September, commercial production at the facility will commence in November.

The facility contains a large amount of highly technical and specialist equipment, including spray granulators, coaters, tablet presses, a delumper, blender and sieve system.

Her Majesty’s Lord-Lieutenant of Kent, Viscount De L’Isle, attended the ceremony to unveil the opening of the new facility, doing so in recognition of the contribution that Aesica is making to the regional economy, both in terms of the creation of new jobs and commercial expansion.

Aesica Pharmaceuticals is wellestablished as a manufacturer and major exporter of formulated products, with this latest investment reflecting the continued growth in export demand experienced by the company. The specific product manufactured at the

new facility has global sales and is set for worldwide export.

Aesica is already a strong, committed, local employer in the Queenborough area, and with this latest investment and expansion, the facility will have a dedicated workforce of 55 technicians who will be recruited locally and trained on site. The design of the facility will allow the current capacity to be more than doubled in the future, which would require a further 50 staff.

Dr. Robert Hardy, CEO of Aesica Pharmaceuticals, commented: “The new investment and opening of the High Capacity Manufacturing Facility

marks another key milestone for our company and a further step towards achieving our vision to be the world’s number one supplier of APIs and formulated products to the pharmaceutical industry.

“The formulation of the solid dose product for the treatment of type 2 diabetes is a perfect example of the type of high quality and high healthcare demand drugs that we manufacture for supply to the international marketplace.”

Aesica Pharmaceuticals Ltd +44 191 218 1960 info@aesica-pharma.com www.aesica-pharma.com

Inhalation Sciences Announces US Patent Approval for Precision Dosing System

Fredrik Sjövall, CEO, Inhalation Sciences Sweden.

Inhalation Sciences Sweden, a portfolio company of Karolinska Development, has received US patent approval for its flagship technology the PreciseInhale system.

The PreciseInhale system is a combination of a highly efficient aerosol generator and a precision dosing aerosol exposure unit. The recently issued US patent protects methods of transporting an aerosol from an aerosol generator to a target lung by an operation including a specially designed aerosol holding chamber. Patent expiry is 2028.

With several key patents protecting the Inhalation Sciences technology around PreciseInhale, three patents issued in the US and three more pending, the recent approval for the core delivery technology at the heart of Inhalation Sciences’s next generation PreciseInhale system is a powerful confirmation of the maturity and gold standard of the platform.

“This patent approval confirms that our approach to generating and dosing aerosols is truly innovative and it makes us even more comfortable with speeding up the ongoing partnering activities,” said CEO Fredrik Sjövall.

Inhalation Sciences Sweden AB +46 8 5088 45 80 contact@inhalation.se www.inhalation.se EPM 29

INGREDIENTS & CONTRACT SERVICES ROUNDUP EPO Grants Hovione Inhaler Patent The European Patent Office (EPO) has granted a patent for Hovione’s XCaps, a dry powder inhaler (DPI) that addresses a pulmonary inhalation market need for a very inexpensive device combining high efficiency in powder dispersion with ease of use. Lung fractions in excess of 70% have been achieved from a device that only requires two steps to inhalation and only has two components plus a dust cover. This makes XCaps highly suited to inhalation applications where minimal training of patients is desirable, and it has the versatility to treat almost all pulmonary diseases, including asthma and COPD as well as infection, which typically require very large dose delivery.

XCaps follows on the heels of another successful Hovione DPI, TwinCaps, which was developed specifically for an influenza application and is licensed to Daiichi Sankyo and Biota for this application.

Hovione is offering XCaps as a part of its inhalation device portfolio, enabling business partners to take their candidate drugs from the API stage all the way to the unit dose with a single partner.

“We give our customers an edge in speed of development because we are perhaps the only independent company developing DPIs with expertise in every aspect of the inhaled drug development

process,” said Peter Villax, VicePresident and co-inventor of the device.

“Granting of the European Patent on the XCaps inhaler, within 30 months after initial filing, underpins Hovione’s capabilities in innovation and intellectual property management to successfully design, develop and deliver innovative products, namely, a quality inhalation device addressing a market need.”

“The XCaps addresses a gap for a simple, easy-to-use, cost-effective, multiple use, capsule-based inhalation device,” said Gonçalo Andrade, Business Development Manager. “This allows our business partners to take

advantage of additional patent protection for their inhalation drug product and effective drug product lifecycle management.”

Hovione is currently executing inhaled drug development projects, involving API process development, particle engineering, formulation and clinical supplies, for multiple pharmaceutical companies and is looking for partners willing to incorporate the XCaps into their inhalation drug development.

Hovione +351 21 982 9362 ipina@hovione.com www.hovione.com

Support Service Speeds Up Nutra and Pharma Product Development Manufacturers of nutraceutical and pharmaceutical products that want to get new products onto the market more quickly and reliably now have access to a new solution: Boost your NutraPharma project, a service provided by Roquette based on the company’s 80 years of ingredients and related equipment expertise.

With Boost your NutraPharma project, Roquette fills a missing link in the

galenic form development chain: the expertise and equipment required to maximise the efficient support of a new product development project.

“To achieve such support requires a variety of the latest and most efficient laboratory equipment, some of which is rather rare, like the Stylcam compression simulator,” explained Philippe Lefevre, Global Coordinator for Pharmaceutical Applications at Roquette’s Application Development Centre for Food, Nutrition and Health.

“This kind of equipment covers the majority of solid forms and the different progressive galenic steps: mixing, dry and wet granulation, compression and coating. A variety of equipment sizes is also available: laboratory, pilot, pre-production and

production. All this enables us to acquire the necessary data and to treat them in real time, thereby deepening understanding of the formulation’s behaviour. While the customer can participate in the tests, the products require expert handling, both to ensure our expertise is put to good use and for reasons of safety, insurance and materials handling.”

Roquette’s Boost your NutraPharma project completes the services provided by today’s CROs. Pricing depends on size of project, equipment and level of expertise. Provision of equipment represents just one part of the support model; the other part is the multidisciplinary expertise built on decades of experience.

“Our customers’ expertise is mainly centered on their nutraceutical or pharmaceutical assets and in their marketing positioning,” said Sophie Lecuyer, Customer Solutions

Development Manager at Roquette’s Global Market Unit. “Our expertise is in excipients and is combined with our highly evolved knowledge of finished product forms. Our ability to perform raw materials tests is significant whereas that of our customers tends to be constrained by price, availability and asset regulation. Our specialists also keep in close touch with Roquette Application Development Centres around the world, which pool knowledge and regional experience. A linked advantage is that they can draw inspiration from food formulations developed by our food application laboratories. The resulting transfer of technologies is likely to further benefit the developers of nutraceutical and pharmaceutical products.”

Groupe Roquette +33 321 633 600 www.roquette.com

Range of Off-the-Shelf Testing Methodologies Support Biosimilar Characterisation BioOutsource, a leading international contract testing organisation (CTO), has consolidated its position as a leading expert in the biological analysis of biosimilar monoclonal antibodies for the biopharmaceutical industry. Strategic internal R&D investment has enabled the creation and launch of a wide range of off-the-shelf testing methodologies to support comparability, stability and lot release testing for biosimilars. As a

result, the company has achieved excellent market penetration and sales growth this year and is now working in collaboration with many of the world’s leading biosimilar companies.

BioOutsource CEO Gerry MacKay commented: “Our extensive experience in developing and validating cell-based assays and strategic R&D investment has created a niche position for us within the

industry, which enables BioOutsource to provide testing solutions that can significantly reduce the time and cost of biosimilar development programmes.

“We are continuing to invest and expand our testing capabilities in Glasgow, Scotland, and are significantly increasing commercial activities in the North American and Asia-Pacific regions to support surging

demand for biosimilar characterisation and comparability testing. We are delighted to be working with more than 30 of the top biosimilar players globally and look forward to continued strong growth in 2014.”

BioOutsource Ltd +44 141 946 4222 vmcerlane@biooutsource.com www.biooutsource.com

Telormedix Chooses Molecular Profiles to Develop Topical and Oral Psoriasis Products Pharmaceutical formulation development and manufacturing services provider Molecular Profiles, a subsidiary of Columbia Laboratories, Inc., has been chosen by clinical stage biopharmaceutical company Telormedix SA to develop both topical and solid dosage formulations for use in the treatment of psoriasis.

The project, operating under the acronym PAT (Psoriasis Antiinflammatory Treatment), will involve other consortium partners Biopta, Midatech Biogune and the University Hospital Zurich. Telormedix raised funding from the European Eurostars Programme to coordinate this international research project for one of its promising drug candidates, TMX-302, which will use Midatech’s glycan-coated gold nanoparticles formulated using Molecular Profiles’s expertise.

Dr. Johanna Holldack, CEO at Telormedix, said: “We are absolutely delighted to have secured this funding with such a world-class consortium to bring TMX-302 to pre-clinical proof of concept. The team at Molecular Profiles will play a key role in developing new oral and topical formulations of TMX302, both of which are viewed as practicable administration options for the treatment of psoriasis.”

The deal comes just weeks after Molecular Profiles announced the official opening of its new facility following a successful inspection from the Medical and Healthcare products Regulatory Agency (MHRA), and on the heels of its acquisition by Columbia Laboratories, a company with a rich heritage in drug development based in Boston, US. Molecular Profiles CEO Nikin Patel said: “We are pleased to have been

chosen as the formulation development partner for this high-profile, multi-partner project. Our team is ready to apply our technologies to deliver a robust topical and oral formulation.

“We anticipate that this is just the start of a longer-term clinical development and manufacturing initiative to support a future trial. Beyond the formulation work, our new facility gives Telormedix the reassurance we can also support their finished dosage form production requirements.”

Working with leading pharmaceutical companies across the globe, Molecular Profiles specialises in advanced characterisation, pre-clinical and clinical development, clinical manufacturing and analytical support. The company’s new clinical manufacturing facility enables it to handle a range of dosage forms such as solids, liquids, semi-solids and

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Dr. Nikin Patel, CEO, Molecular Profiles. inhaled products. Supporting clients’ projects up to phase IIb, Molecular Profiles can manufacture controlled drugs and highly potent compounds up to OEB level 4, with a batch scale of up to 30 kg.

Molecular Profiles Ltd +44 115 871 8888 enquiry@molprofiles.co.uk www.molprofiles.co.uk

INGREDIENTS & CONTRACT SERVICES ROUNDUP Penn Pharma Officially Opens Contained Manufacturing Facility A £14 million state-of-theart facility for the development and manufacture of tablets and capsules containing potent compounds was formally opened on 26 September 2013 by Penn Pharma. An official representative of the Queen, the Lord Lieutenant of Gwent, was in attendance to mark the economic importance of the occasion.

The celebration is the culmination of an important investment at the hi-tech facility in Tredegar in south-east Wales, UK, positioning the pharmaceutical company so that it is able to respond to the huge growth in the number of potent molecules coming to market.

The facility employs nearly 300 highly skilled staff with 1,394 m2 devoted to the new contained facility that will develop and commercially manufacture tablets and capsules meeting the highest international quality standards.

It caters for the growing range of highly potent compounds, such as the proliferation of cancer drugs, which require extremely specified contained manufacturing processes to produce safely on both a development and commercial scale.

Cutting-edge technology within the new facility includes highly contained equipment trains designed to minimise the need for personal protective equipment (PPE). Penn has adopted a clear design-for-manufacture approach, ensuring reproducibility from development scale (1 kg) to commercial scale (120 kg).

In May of this year and less than a year since the expansion plans were announced to build the facility, the first batch of coated tablets were produced, putting this project ahead of schedule.

Penn Pharma Chief Executive Officer Richard Yarwood said: “This celebration marks the huge efforts by everyone at Penn Pharma. Tomorrow we’ll be hard at work as usual but today is a chance to

IN THE SPOTLIGHT HEAD OF CARGILL’S ALGINATES BUSINESS REVEALS $15 MN PLANT INVESTMENT STRATEGY stop briefly, see how far we’ve come and officially launch our new facility. We’re delighted now to be able to meet both the current and evolving needs of our clients.

We’re a successful and growing company attracting more and more clients from around the world.”

Penn Pharma Chief Operating Officer Mark Dean-Netscher added: “The new facility is key to bringing greater efficiency and capacity to our operations. It’s another important step in our ongoing expansion. Our new facility ensures we are positioned to become a trusted partner to our customers who required contained services. Our strength lies in the fact that we can take highly potent compounds from molecule to market under one roof.”

The opening is a key moment for Penn Pharma since it was launched in 1979 well over the border in Penn, Buckinghamshire, from which it takes its name. Just seven years later it moved to its now well-established base in Tredegar, Blaenau Gwent.

From the start, it has targeted foreign markets, so that by 2013, just over half of sales (51%) were in the US, with a third quarter comprising Japan, Europe and Australia and only the last quarter (24%) in the UK. Accolades have included the Queens Award for Enterprise in the International Trade category in 2003, which the company scooped again in 2010.

system and high-speed capsule printing capability.

• Livingston facility in the UK — Expanded with additional laboratory space, equipment and analytical scientists at this FDA/MHRA-accredited site. The latest generation CFS 1500 capsule filling and sealing machine, which incorporates proprietary Fusion technology, has been installed, and the proprietary lipid expert system has been incorporated into the team’s finished dosage form development process.

• Greenwood facility in the US — Commissioned and validated a new commercial scale liquid-fill encapsulation unit for pharmaceutical applications. The installation of commercial production capability for the new solid lipid pellet (SLP) technology has also been initiated.

SLP technology is currently being used on select customer development projects as a lipid-based formulation option for bioenhancement and other formulation issues.

Editor Elizabeth Valero spoke to Bente Korsgaard, Head of Cargill Texturizing Solutions’s Aliginates business, about the company’s announcement on 11 September that US$15 million (GB£9.41 million) is to be spent on upgrading and expanding its alginates production plant on the French coast, in Lannilis, Brittany.

Used in a variety of Brown seaweed (Laminaria). applications by the food, pharmaceutical and personal care industries, these alginates are derived from a secure and sustainable source of fresh brown seaweed harvested by local fisherman. In Bente’s words: “It’s a very effective operation because the plant is located so near to the coastline.”

Cargill Texturizing is one of the largest suppliers worldwide. “There aren’t many suppliers,” stated Bente. “There is a clear leader and it is our strategy to be a clear number two. There are two other significant players in EMEA and we see a growing presence in China. Europe is our strongest market but we sell globally — with sales in North America, South America and Asia — and we have commercial teams globally.”

The $15 million investment is to fund not only increased capacity at the plant and therefore overall growth in the alginates market but also sustainability and safety. As summarised by Bente: “Sustainability, namely through more efficient wastewater processing, and safety, that is the safety of our employees, are key priorities for Cargill.

“Sustainability is extremely important,” she continued. “Many people live off the ocean, therefore we must do our utmost to safeguard its ecosystem. A substantial amount is going towards increasing wastewater safety, making sure that regulations are adhered to and nature respected when injecting produced water back into the sea.

We work with nature and respect it; this part of the project is a very big deal for us.”

Cargill produces different types of alginates to be used in a variety of applications.

The type of brown seaweed obtained by the Lannilis fishermen depends on the season, and the different types of seaweeds produce alginates that have varying characteristics, for example, gelling or thickening. It therefore follows that one particular season of alginate is going to be more suitable for a particular industry.

Alginates are primarily known for their texturising benefits, so in relation to the pharmaceutical industry, for example, certain products from Cargill’s Satialgine US line can be used to make a syrup more viscous or tablet more chewable. However, there are also those products that possess drug delivery characteristics and can be used as an excipient, dispersant and controlled release agent.

Bente was keen to highlight the many advantages brought by alginates to a wide range of applications. They are also commonly used as absorbing and gelling agents in wound dressings and, more recently, to create dental impressions. Describing the dental impression process, Bente said: “If you lose a tooth, the dentist presses a product that is highly viscous — a key ingredient being alginate — into the area where it has been lost to create a perfect imprint, which he then uses to create an accurate artificial replica tooth.”

Alginates are also known for their cold solubility, especially popular with the food and pharmaceutical industries. As outlined by Bente, an alginate product recently launched for bakery cream perfectly demonstrates this property: “If you apply alginates to a bakery cream, which is then added to the dough, the bakery cream maintains its texture on removal from the oven.”

As well as the amazing versatility offered by alginates, Cargill also places huge emphasis on their having been derived from nature. The natural origin of ingredients is becoming an increasingly meaningful factor for the pharmaceutical and personal care industries. “Yes, alginates bring all these functional elements to our customers’ products, but the added benefit is that this is a nature derived and approved ingredient,” affirmed Bente. “Of course, it all began with the food industry, but now a lot of pharmaceutical and personal care products benefit from adding texturing or active components that are nature derived.”

A huge undertaking, the project is scheduled for completion in two years, by which time Cargill may well have claimed the title of leading worldwide alginates supplier.

Bente concluded: “Alginates constitute a very important part of our portfolio, and we are exceptionally proud to announce this major step forward."

Capsugel +1 610 680 6214 christina.chnaider@capsugel.com www.capsugel.com

Cargill Texturizing Solutions +32 15 400 532 isabelle_larsonneur@cargill.com www.cargill.com

Penn Pharmaceutical Services Ltd +44 1495 711 222 www.pennpharm.co.uk

Capsugel Expands Global Manufacturing for Finished Dosage Capsugel’s Dosage Form Solutions (DFS) business unit unveiled extensive upgrades and expansions to three of its manufacturing facilities in the US and Europe, deepening the company’s finished dosage form capabilities as part of its LIPIDEX technology platform. The multi-million dollar investments broaden the company’s global capabilities to handle hormonal as well as high-potency compounds for soft gelatin and liquid-fill hard capsules (LFHC), responding to a growing demand from its pharmaceutical and health and nutrition customers.

“Investments at our soft gelatin and LFHC facilities reinforce Capsugel’s leadership in liquid-fill technologies and our commitment to offering customers a comprehensive range of services from formulation development to commercial manufacturing,” said Anthony Macci, SVP of Global Operations.

Investment highlights include: • Ploermel facility in France — Increased containment capacity to handle hormonal as well as high potency compounds in softgel manufacturing at this FDA-inspected and MHRA/ANVISAaccredited site. Specific upgrades include a new, high precision dosing

Bente Korsgaard, Head of Cargill Texturizing Solutions’s Aliginates business.

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SHOWCASE LYOPHILISATION

BPS Represents Popular Lyophiliser Brands in France Freeze drying specialist Biopharma Process Systems (BPS) is now the point of contact for SP Scientific products in France. SP Scientific is a well-known manufacturer of a range of laboratory and processing equipment that includes the lyophiliser brands VirTis and FTS. As a scientific equipment supplier, SP Scientific distinguishes itself by providing equipment that matches solutions with particular application needs.

BPS has supplied and supported process equipment for the pharmaceutical, biotechnology and food industries in the UK and Ireland for near 25 years, with particular expertise in

lyophilisation. BPS is a leading lyophilisation equipment provider in the UK and Ireland and currently supports over 350 systems from benchtop to fully automated production systems.

As well as equipment, BPS provides system maintenance and support, IQ/OQ qualification, a range of specialist analytical equipment (e.g., cryomicroscope), laboratory services and training in lyophilisation. BPS’s laboratory services include formulation characterisation and development, cycle design and optimisation, production and training.

The SP product range starts with the flexible benchtop BTPro and the

benchtop AdVantage system that incorporates precise process control into a laboratory-friendly design. Other popular models include Genesis and Lyostar, which feature SMART technology for automating process development and ControLyo controlled-nucleation technology.

Ultra and Benchmark models are designed for scale-up and production.

Sales and support will be managed from BPS’s UK office but will be supported by SP Scientific’s Regional Manager Antoine Babin, based near Lyon, France.

Biopharma Process Systems Ltd +44 1954 782551 sales@biopharma.co.uk www.biopharma.co.uk

Choosing Packaging Components for Lyophilised Drug Products Lyophilisation Enables Market Entry for Increasing Number of Injectables When selecting primary packaging systems for drug products, pharmaceutical manufacturers must ensure that components do not interact with the drug product itself and are applicable for the intended use. For moisture-sensitive lyophilised drug products, packaging components must be designed for long-term drug protection, machinability and patient safety. Various requirements include: • proper and reproducible lyophilisation position of a stopper on the vial • good insertion forces and reliable closing performance • clean high-quality rubber composition (low extractables/volatiles) • lowest possible level of foreign contamination (particulate) • optimal moisture protection of the drug product over time — moisture and gas barrier — optimal stopper drying West’s lyophilisation stoppers have been developed with the patient in mind.

By using a QbD approach for NovaPure components, West focuses on controlling and minimising variability during the manufacturing process. Such methodical and science-based methods help assure quality through well-understood product and process parameters. By following

QbD principles, significant improvements in various manufacturing processes result in a variety of benefits, including: • enhanced quality assurance • increased risk mitigation through improved product understanding, development and manufacturing • lower total cost of ownership • improved transparency between the component manufacturer and the pharmaceutical company West’s NovaPure ready-to-sterilise and ready-to-use packaging components can help to mitigate risk and may make a difference in the efficacy and safety of a lyophilised drug product.

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

For many pharmaceutical or biotechnology products, lyophilisation is essential to maintain the function and integrity of the drug or biomolecule. In 2012, over 130 pharmaceutical products on the market required lyophilisation processing with significantly more under clinical and pre-clinical development. The increasing demand for injectable lyophilised drugs is driven by the entry of new products and technologies.

Without the use of lyophilisation, it is estimated that 60% of biotherapeutics — including peptides, recombinant proteins, antibodies and antibody drug conjugates (ADCs) — could not be made commercially viable. The freeze-drying process has become increasingly more efficient in recent years, making it easier to use, more cost-effective and extremely good at maintaining product integrity.

Symbiosis, a small-scale contract manufacturer of injectable pharmaceuticals for use in clinical trials, has two LYO-5 lyophilisers supplied by Tofflon. Each lyophiliser is located in a fully separated cleanroom and supports manufacturing for conventional pharmaceuticals and cytotoxics/highly potent compounds.

The optimal size of the lyophilisers

were chosen to support manufacturing for phase I and II clinical trials. The large shelf area (5.4 m2) allows small to medium scale batches to be undertaken in one lyophilisation cycle with the resulting advantage to customers of increased speed and lower postlyophilisation testing costs. The lyophilisers can support a full range of vial sizes from 2 to 100 ml. The flexibility also allows Symbiosis to support manufacture for small batches in the range of 100 vials. For bulk lyophilisation, Symbiosis has validated procedures in place for 45l batch sizes, with the possibility of increasing to 100 l batch size.

Symbiosis has experience in the lyophilisation of small molecules, peptides, antibodies, cytotoxics and ADCs. In addition, through its partners, the company can help with lyophilisation cycle development, optimisation and formulation development throughout all stages of the product development lifecycle.

Symbiosis Pharmaceutical Services +44 1786 220 000 enquiries@symbiois-pharma.com www.symbiosis-pharma.com

Recipham Expands Lyophilisation Capacity with €32 Mn Investment in Germany Recipharm has announced an investment of €32 million (£27.13 million) in its Wasserburg site located near Munich.

The capital will be used to create a new building that will house a fourth production area, adding to the three already in operation. This development will significantly increase the company’s lyophilisation capacity and will result in a brand new state-of-the-art facility, equipped with the latest automatic loading and unloading technology. The building will also have the flexibility to accommodate further production lines.

The number of employees will be increased from the current 282 to 320 and the new area is expected to be operational in 2016.

The Wasserburg facility has a long history of producing products in vials and ampoules for large, medium and small pharmaceutical companies and was established almost 40 years ago. It has emerged as a world leading specialist in aseptic filling and lyophilisation of injectable drugs, supplying Europe, the US, Brazil and Asia Pacific.

Armin Dallüge, General Manager of Recipharm in Wasserburg, said: “We are absolutely delighted with this decision to significantly expand our facility. We have been operating at full capacity for several years now and we see this investment as vital to maintain and increase our leadership in this field. Demand for lyophilisation is expected to increase in

the coming years and we intend to be at the forefront of servicing this.”

Thomas Eldered, CEO of Recipharm AB, commented: “Lyophilisation is a fast growing technology which we believe will become even more important.

Recipharm is one of the few CDMOs with the capability to make such a significant commitment to this dose form and our financial stability sets us apart from our competitors.

Given the excellent track record of Wasserburg and in particular the highly skilled workforce, we are very confident that this investment will help us to consolidate our position as one of the world’s leading CDMOs.”

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Recipharm AB +46 8 602 52 00 info@recipharm.com www.recipharm.com

Events REGULATORY AFFAIRS OVERVIEW OF THE EMA’S ‘DRAFT CONCEPT PAPER ON THE NEED FOR REVISION OF THE NOTE FOR GUIDANCE ON MANUFACTURE OF THE FINISHED DOSAGE FORM’

This issue’s contribution comes from Dr. Paolo Biffignandi’s colleague Lini Subin, a Senior Regulatory Affairs Manager at panEuropean regulatory affairs organisation ELC Group. With almost a decade of expertise in global pharmaceutical regulatory affairs and holding an MSc in Chemistry (Pharmaceuticals), Lini Subin is a Lini Subin knowledgeable strategist who lini.subin@elc-group.com understands the entire application lifecycle, from pre-approval to post-approval activities. Well versed in EU DC/MR and ICH national strategies, her specialities include dossier development for a variety of markets, including Europe, Asia, Africa, Latin America, CIS countries and the US. She is also an expert in managing eCTD/NeeS conversions and MA transfers. Based in India, her insightful knowledge of market trends gives her a unique perspective on implementing business development initiatives.

On 4 July 2013, the European Medicines Agency (EMA) published the ‘Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form (EMA/CHMP/QWP/324350/2013)’ for consultation.

The existing guideline ‘The note for guidance on manufacture of the finished dosage form (CPMP/QWP/486/95)’ came into operation in 1996. Since then, many other quality guidelines, references to directives and formats of dossier have been changed. Additionally, manufacture of a variety of finished dosage forms is gaining worldwide attention. Duly, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed the new guidance ICH Q8(2), Q9(3), Q10(4). In this scenario, technical terms such as the holding time of bulk products are now an important part of the description of manufacturing process. This necessitates the revision of the existing guideline. The objective of the EMA concept paper is to address the need to update and revise the current guideline.

The guideline on manufacture of the finished dosage form underlines all aspects of manufacture that are important for both applicant and regulator. The concept paper outlines some of the aspects that are mentioned in the current guideline and that need revision/updating as per new development. For example, the guideline indicates that information that falls under GMP should not be part of the MA file and that only product-specific issues need to be described. Hence the intention of revision is not to repeat the information provided in other guidance documents or create new guidelines but to update the information in line with recent development.

The following recent aspects should be described in the new guideline as they impact on the drug’s manufacture, for example: • holding time conditions of bulk product • ongoing revision of guideline on process validation and real-time release testing • ICH guideline Q8 on Pharmaceutical Development, Q9 on Risk Management and Q10 on Quality Systems • shipping transportation conditions It should then follow CTD structure.

The Quality Working Party now recommends the revision of the Note for Guidance on manufacture of the finished dosage form and updating the information about manufacture of finished dosage form in line that the with recent development and the current EU legislation.

It is anticipated that the draft guideline could be available six months after adoption of the concept paper and that this would then be released for external consultation for six months before its finalisation within another six months. It is also expected that requirements for regulators and industry will be better clarified in the updated guidance, taking into account the concepts of recent development.

The consultation period for this concept paper is open until 31 December 2013 and The Committee for Medicinal Products for Human Use (CHMP) invites comments from interested parties.

Pfizer, Eli Lilly and Sanofi-Aventis Join Pharma Integrates 2013 Speaker Line-Up Pharma Integrates organiser Life Sciences Index (LSI) has announced the addition of Adrian Peskett, Director, Clinical Supply Logistics, Pfizer, to the opening panel session on 26 November that will address ‘Building a Resilient Supply Chain’. In addition, from Eli Lilly, Alan Lamont, Executive Director Global External Research & Development, will join the debate on ‘Investing in innovation to make a return — organising the value chain to deliver a return on shareholder capital?’, and from Sanofi-Aventis, Denis Croisat, Director Lead Generation — CMC, Biologics Sourcing & External Business Opportunities, will offer his expertise and exchange opinions with fellow panellists on ‘East vs West: Future Trends in Partnering Discovery and CMC Activities.’

Joining one of the opening sessions on day two that will explore ‘The Tougher Side of Iintegration — What Part Should Regulators and Patients Play?’ will be Drew Hope, Head of Advanced Therapy Quality, ATMP GMP Unit, NIHR Biomedical Research Centre, Guy’s and St Thomas’s NHS Foundation Trust and King’s College London.

Also, Zach System S.p.A and GXPi are the latest companies to endorse Pharma

Integrates, joining Nextpharma, Recipharm and 3M as Silver sponsors this year. Additional Platinum and Gold sponsors of the widely acclaimed, annual pharmaceutical conference include Catalent Pharma Solutions, Patheon Inc., Baxter BioPharma Solutions, SAFC Global, Piramal Pharma Healthcare and CordenPharma.

Pharma Integrates 2013 will take place on 26–27 November at the Riverbank Park Plaza, London, UK. Further information is available on the LSI website.

Life Sciences Index Pharma Integrates 2013 +44 20 8667 2117 miranda.zouheir@lsi-uk.com www.lifesciencesindex.com

1st International Symposium on Solubility Enhancement Takes place on 27–28 November 2013, a seminar with a hands-on practical session will be an excellent opportunity for laboratory managers and senior scientists from formulation development, scale-up, production or process development who have a specific interest in solubility enhancement with EUDRAGIT polymers and want to learn more about spray drying and hot-melt extrusion (HME) for pharmaceutical applications.

International experts and guest speakers from industry and academia will present relevant topics as well as industrial case studies. Furthemore, several interactive sessions will provide room for individual discussions.

Attendees will be able to directly apply their learnings from this workshop to their daily work.

Highlights from the agenda include: • Formulation options for solubility enhancement of poorly soluble actives • Processing drugs via hot-melt extrusion — a physico-chemical view • PAT in hot-melt extrusion — a spectroscopic study • Miniaturised screening of polymers for amorphous drug stabilisation (SPADS): rapid assessment of solid dispersion systems • Special challenge: Solubility enhancement for HPAPIs via hot-melt extrusion • A novel convenient technology to generate core shell particles • Spray drying vs. HME: two methods, one result?

• Beyond solubility: methods for bioavailability enhancement • Industrial case studies EPM 34

• Practical lab demonstrations The guest speakers and industry experts are: • Dr. Maria Flores, Ingeniatrics Tecnologías, S.L., Spain • Filip van der Gucht, ProCepT, Belgium • Dr. Susanne Page, F. Hoffmann-La Roche Ltd, Switzerland • Katharina Paulsen, Thermo Fisher Scientific, Germany • Lien Saerens, University of Ghent, Belgium • Prof. Dr. Hartwig Steckel, University of Kiel, Germany • Dr. Markus Thommes, University of Düsseldorf, Germany • Mike Wipf, Three-Tec, Switzerland The theoretical part of the workshop will take place at Fleming’s Conference Hotel in Frankfurt, Germany, about 15 minutes away from Frankfurt airport and Frankfurt city centre. The practical part will take place in the Evonik laboratories.

Evonik recommends the Fleming’s Conference Hotel for accommodation.

There is a room contingent available for the special price of €109 per night, including breakfast. To get this special price, quote ‘Solubility Enhancement Symposium’ when booking.

Registration for this symposium is quick and easy with Evonik’s online platform e-Lab: www.evonik.com/e-lab.

Simply register and then sign up for the seminar.

Evonik Industries AG 1st International Symposium on Solubility Enhancement +49 69 5060400 dennis.buettner@evonik.com www.evonik.com

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