EPM Jan/Feb 2013

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IN THIS ISSUE: Mixing & Blending Tabletting Analytical & Testing Services Logistics & Distribution

European Pharmaceutical Manufacturer January/February 2013

Volume 13 | Issue 01

Front cover image provided courtesy of I Holland Ltd.

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in this issue MANUFACTURING PRODUCTS & EQUIPMENT

pages 5–16

Equipment, IT solutions and supplies for all aspects of pilot- and full-scale pharmaceuticals manufacturing through to their packaging and anti-counterfeiting.

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production art samantha hamlyn production peter bartley

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INGREDIENTS & CONTRACT SERVICES

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APIs, excipients and intermediates supply and drug development and manufacturing services — from clinical research and formulation through to commercial manufacturing, packaging and logistics.

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European Pharmaceutical Manufacturer is distributed in electronic and print formats to a combined readership of 25,000 pharmaceutical manufacturing professionals.

Send address changes to European Pharmaceutical Manufacturer, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE, UK. © February 2013.

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A belated Happy New Year and welcome to the first 2013 issue of EPM. Perhaps the most important piece of information I have to impart is that we will be launching the new EPM website within the next month. The new site will effectively mirror the magazine with the menu headings ‘Laboratory Products’, ‘Manufacturing Products’ and ‘Ingredients & Contract Services’ as well as include a ‘Blogs’ section, comprehensive ‘Events’ search page and ‘Directory’. Visitors will find the site easier to navigate and more interactive with the option to post comments and questions on the majority of content. Readers will be notified via HTML as soon as the new site is available and your feedback would be much appreciated.

We are also in the process of strengthening EPM’s online presence with a new look Facebook page and LinkedIn Group so please help us by joining these online communities.

Returning to this issue, on page 5 there is an interesting story from

Powder Systems concerning the provision of a clinical trial isolator for customer Helsinn Advanced Synthesis’ new cytotoxic facility in Switzerland, opening this year. The high containment isolator has been installed in a small scale GMP area that will produce cytotoxic APIs for clinical and registration purposes.

This issue’s Regulatory Affairs instalment on page 33 — titled ‘Asia’s Changing Regulatory Environment and Pharma 15 Outsourcing’ — takes an in-depth look at the emerging and increasingly buoyant Asian pharmaceutical market. Dr. Biffignandi and colleague Lini Subin, Head of Regulatory Affairs at ELC Group, outline Asia’s increasing appeal to global companies ‘owing to its strong economic growth, large population and ageing population’, although they stress that in order to harness this growth and the fruitful opportunities it presents in the drugs, medical devices and in vitro diagnostics sectors, pharmaceutical companies must keep abreast of Asia’s frequently changing regulatory landscape.

23 You will also find Asia’s Changing 25 Regulatory Environment and Pharma Outsourcing in the new website’s ‘Blogs’ section, where as mentioned previously you are able to comment and ask the authors questions.

The EPM team is looking forward to the launch of the new website in the next few weeks and to the many expected positive responses from readers who we anticipate will appreciate its fresh new design and agree that it makes finding what they are looking for far easier.

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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 Contained Cytotoxic Installation for In-Line Clinical Trial Production Powder Systems Ltd (PSL) is supporting Helsinn Advanced Synthesis SA’s expansion into the cytotoxic market through the recent installation of its clinical trial isolator.

Helsinn Advanced Synthesis SA (HAS), located in Biasca, Switzerland, is the chemical manufacturing business unit of the Helsinn Group. To meet the demand of anticancer molecules, HAS will open a new cytotoxic facility this year. The facility will be dedicated to cytotoxic compounds that require safe product handling in a contained area for operator, environment and product protection.

PSL worked closely with Helsinn to develop suitable solutions for its cytotoxic facility and provided a suite of high containment systems, including contained agitated nutsche filter dryers, charging gloveboxes with slurry vessels and a clinical trial isolator.

Helsinn’s cytotoxic plant comprises a small scale GMP area for the production of reduced quantities of cytotoxic APIs for clinical and registration purposes.

PSL installed the clinical trial isolator into this small scale GMP area. Numerous operations will be processed inside the high containment isolator.

The clinical trial facilities present a total synthesis solution for manufacturing and handling cytotoxic compounds on a small scale. The isolator allows the following operations to be performed in one unit in a completely contained environment: • transfer and reactor charging • reaction in glass reactor

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• • • • •

hydrogenation filtration drying discharging dispensing, packing and transfer.

The clinical trial isolator consists of several in-line synthesis processes, including reaction or hydrogenation within a glass reactor of 20 l, Buchner filtration and drying within PSL’s CakeStand tray dryer. The vacuum tray dryer overcomes the inherent difficulties with traditional vacuum drying ovens — through its direct tray heating, the CakeStand performs proven heat uniformity up to a maximum temperature variation of 1˚C. The tray dryer integrated within the clinical trial isolator

SPECIAL FOCUS

Blender Range Offers Variety of Load Bearing Capacities L.B. Bohle blenders feature standard arm connection and clamps, round forks on the lift arm, lift arm with eccentric clamps, lift arm with power clamps and lift arm with hydraulic clamps.

The fact that the customer can also order a blender that swivels about its vertical axis to function as a post-hoist provides a large number of variations.

The blender can be designed to precisely meet the customer’s requirements for everyday production.

Other advantages of L.B. Bohle blenders are long service lifetime and extremely low maintenance.

The range of L.B. Bohle blending systems demonstrates the flexibility of the company’s engineering and manufacturing departments. L.B. Bohle blenders can be adjusted and used in any imaginable pharmaceutical production situation.

No matter what kind of containers used — round or square — L.B. Bohle blenders can handle them with excellent blending results.

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

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has four heated shelves, a pivot door and is contained in a PSL isolator to ensure high containment during transfer of the cytotoxic compounds.

The full synthesis containment system has HMI/PLC control, washing and CIP capabilities, with an OEL of <50 ng/m3 in eight hours TWA. The new cytotoxic facility is 3b category and provides full protection for the operator, environment and product when handling cytotoxic compounds throughout PSL high containment systems.

Powder Systems Ltd +44 151 448 7700 info@powdersystems.com www.powdersystems.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Isolation and Laminar Flow Solution Enables Rapid Powder Charging with Room Air

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SPECIAL FOCUS

Mixing Developments Ensure Complete Discharge Up to 100%

Open charging through the manhole is no longer acceptable. A new development being successfully used by Dec clients worldwide is the DEC Isocharge — combining the open aspects of a laminar flow booth with a glove box isolator to enable the rapid and safe charging of powder products.

The DEC Isocharge is a low cost method of both dispensing and charging bags into reactors or receiving systems via the PTS (Powder Transfer System).

The DEC Isocharge combines the advantages of isolation and laminar flow technology, providing high containment of <1µg/m3 per eight hours TWA. The station’s chamber is open to the side allowing easy bag introduction. A simple door only needs to be closed during WIP to prevent splashes. All WIP fluids can be drained from the chamber

via the PTS into the reactor, which also cleans the transfer hose and the PTS. Using the gloves, the operator will move the bag of powder into position on the charging bars above the integrated hopper. The bag is then split and the powder emptied through the bars. The empty bag is disposed through the adjacent continuous liner bag-out port.

The operator then starts the PTS and charges the required amount of powder to the vessel.

Dec Group +41 21 694 20 44 g.mikhaiel@dec-group.ch www.dec-group.ch

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amixon is known for the exceptional mixing quality provided by its vertical mixing systems. With the application of its new SinConvex mixing tools and ComDisc system, complete discharge of the mixer can now be achieved.

SinConvex mixing tools mix faster and gentler ComDisc. than standard screw band mixing tools. The energy input into the mixing good is less. Due to the convex sloping surfaces, mixes flow down particularly well during draining and the complete discharge is effectively improved. This way, only a small trace of ideal mixed material remains on the bottom plate of the mixer.

The ComDisc system then comes into play, discharging these residues without segregation. While mixing, the ComDisc tools raise off the ground and float through the mix. In the last phase of the discharge, they lie back down on the ground and wipe the

remaining mixed goods to the outflow without segregation. ComDisc tools are located in the flow shadow of the mixing arm and are not functional during mixing. They are interchangeably attached, very hygienic and suitable for wet and dry cleaning.

Both SinConvex and ComDisc can be installed on new amixon mixers and retrofitted to existing machines. amixon GmbH +49 5251 688888 0 info@amixon.com www.amixon.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Rotary Vial Washer Offers Cost-Effective Alternative for Small Batches

Sorbency Prediction Capability to be Highlighted at Pharmapack Europe

PennTech Machinery Corp has released the compact RW250, the latest in the established RW series of rotary vial washers.

The RW250 rotary vial washer is an inexpensive alternative to fully automated batch washers and offers significantly reduced WFI usage, versatility and quick parts changeover.

According to PennTech, the RW series are the smallest vial washers in the industry thanks to an innovative engineering approach. The footprint of the RW250 is just 60 x 60 cm, small enough to fit into facilities where space is at a premium. The simple, near maintenance-free design also ensures there are no moving parts in the washing area that could generate particulates and risk contamination.

The non-penetrating nozzle design used on the RW series eliminates the risk of vial damage and nozzle bending whilst improving wash quality.

Owing to the design of the vial holders and dedicated spray manifolds, WFI consumption can be optimised with intermittent spraying to ensure that each vial format is sprayed with a specific media only as long as needed.

The RW250 is the latest addition to the family and provides a very low cost, standalone vial washer, ideal for small batch use and start-up facilities. Loading

Multisorb Technologies will be promoting its â&#x20AC;&#x2DC;Calculations through Operationsâ&#x20AC;&#x2122; programme and sorbent products (e.g., desiccants, oxygen absorbers, volatile absorbers) for pharmaceutical stability at Pharmapack Europe, 13â&#x20AC;&#x201C;14 February 2013, Paris, France. Pharmapack Europe is a leading European conference and exhibition devoted to packaging technologies and drug delivery systems.

Multisorbâ&#x20AC;&#x2122;s Calculations through Operations programme provides a system for predicting and supporting pharmaceutical stability using optimised sorbents and by providing reliable sorbent dispensing.

Optimised sorbent formulations are calculated using Multisorbâ&#x20AC;&#x2122;s SimulSorb and SimulOx pseudoempirical modelling programmes. Using empirically derived data from the drug and its packaging, the modelling can predict the stability outcome for a given pharmaceutical formulation and dosage form. This predictive model can eliminate sorbent ranging studies, saving 6 to 12 months of development time.

The modelling allows Multisorb to determine if a sorbent is required and if a traditional sorbent or IntelliSorb Sorbent Formulation is needed. IntelliSorb offers multifunctional moisture, oxygen and/or volatile control within healthcare product packaging by monitoring and reacting to environmental changes within the packaging headspace.

Multisorb spooled sorbents and canisters are components of its custom

is manually performed yet the automated wash sequence is identical to larger, fully automated systems in the range and can provide a throughput of up to 4,000 vials per hour.

The RW series is available in the UK and Ireland through processing equipment specialist Biopharma Process Systems.

Biopharma Process Systems +44 1962 841092 sales@biopharma.co.uk www.biopharma.co.uk

designed systems, which are engineered to meet each customerâ&#x20AC;&#x2122;s needs by providing an optimised sorbent, a highly reliable sorbent dispenser and personalised consultation and support.

Dispensers are available in low-, midand high-speed configurations with a variety of options to suit most packaging needs. Additionally, smart dispensing technology transmits data, such as lot number, manufacture date and quantity, from the packet spool to dispenser, easily integrating information into a quality system.

Multisorbâ&#x20AC;&#x2122;s Calculations through Operations is a solution for maintaining product integrity and stability. Visit Multisorb on stand 141 in Grand Halle de la Villette.

Multisorb Technologies +1 716 362 9562 kkrause@multisorb.com www.multisorb.com

13-14 FEBRUARY 2013, PARIS HOW INNOVATION IN PHARMA PACKAGING AND DRUG DELIVERY TECHNOLOGIES ENHANCE PATIENT SAFETY AND COMPLIANCE t "OOVBM FWFOU JO &VSPQF GPS PWFS LFZ EFDJTJPO NBLFST GSPN UIF QIBSNBDFVUJDBM JOEVTUSZ MPPLJOH GPS QBDLBHJOH BOE EFMJWFSZ UFDIOPMPHJFT GPS UIFJS ESVHT t &YIJCJUJPO CSJOHT UPHFUIFS NPSF UIBO JOUFSOBUJPOBM MFBEJOH NBOVGBDUVSFST BOE TVQQMJFST PG QBDLBHJOH BOE BEWBODFE ESVH EFMJWFSZ UFDIOPMPHJFT t 5XP EBZT PG DVUUJOH FEHF UFDIOPMPHZ MFDUVSFT GPDVTJOH PO UIF MBUFTU JOUFSOBUJPOBM NBSLFU USFOET GPS QBDLBHJOH EFWFMPQNFOUT BOE OFX ESVH EFMJWFSZ TZTUFNT t /&8 XPSLTIPQT GPS B EFFQFS JOTJHIU JOUP DVSSFOU IPU UPQJDT BGGFDUJOH UIF JOEVTUSZ JOEVTUSZ 7BMJEBUJPO PG UFSUJBSZ QBDLBHJOH 4FSJBMJTBUJPO .FEJDBM QBDLBHJOH TUFSJMJTBUJPO BOE WBMJEBUJPO $PNCJOBUJPO QSPEVDU BQQSPWBM QSPDFTT

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Crush and Kink Resistant Silicone Hose Offers Durability for Critical Applications Reinforced silicone hose from AdvantaPure allows high purity fluid flow without the worry of kinking or crushing.

Called APSW, the hose is made from a liner of low-volatile grade, platinumcured silicone that is fabric wrapped and wire reinforced for durability in pharmaceutical, biopharmaceutical, biomedical and food applications.

A wrapped hose offers advantages over unreinforced tubing and other types of reinforced hose. The polyester mesh fabric wrapping adds significant strength to the silicone material and the spiralled 316 stainless steel reinforcing wire enables the finished hose to resist crushing, kinking and ultimately flow

restriction. An outer layer of silicone is added and the hose is cured, resulting in a product that works equally well in pressure or full vacuum (29.9” Hg) applications.

The all-silicone liner of APSW is certified free of animal-derived ingredients. The silicone is also certified by the National Sanitation Foundation for use with food equipment materials (NSF51).

APSW has undergone extensive physical, chemical and biological testing and meets many USP standards, including Class VI. FDA, European Pharmacopoeia, ISO 10993 and 3-A standards are also met. Additionally, the

contact surface liner material has an extensive extractables test portfolio.

APSW hose is well suited for applications such as ultrapure water transfer, flexible high purity processing junctions, washdown stations and other suction and discharge uses.

Two styles are available: smooth OD (outer diameter) and, for an improved range of flexibility, convoluted OD. Both are made in the US and are well stocked for immediate availability. Smooth OD hose is offered in eight sizes from 1/2” through 4” ID; the convoluted style is available in five sizes from 1/2” to 2” ID. APSW is sterilisable by autoclave, SIP, CIP or gamma irradiation.

Controlling Nucleation Made Possible on Production Freeze Dryers

SP Scientific has announced that ControLyo Nucleation On-Demand technology can now be retrofitted to a wide range of previously installed production freeze dryers.

The ControLyo technology, patented

by Praxair Inc., was licensed exclusively

by SP Scientific in 2010 for use on development freeze dryers with shelf surface areas <1 m2. The technology was incorporated into the SP Scientific Lyostar 3 freeze dryer, reportedly the first commercial dryer to offer controlled nucleation capability.

Since that time, considerable research has been done at the development scale with controlled nucleation. ControLyo technology offers many benefits to freeze drying in the biotechnology and pharmaceutical industries, including improved vial-to-vial uniformity, reduced cycle times, easier process scale-up, reduced protein aggregation and better conformance to the FDA’s PAT and QbD Initiatives.

In order for the benefits demonstrated in development work to offer economic benefits to companies, the technology has to be scalable to production freeze dryers. SP Scientific and Praxair have demonstrated that many commercial production dryers can be relatively quickly and easily retrofitted to benefit from the advantages offered by ControLyo technology. It has also been demonstrated on production freeze dryers as large as 27 m2 that controlled nucleation was achieved in nearly 9,000 vials, ranging in size from 20 to 100 ml, with fill volumes of ¼ and ½. Economical retrofits and scalability of the technology open opportunities to significantly improve production cycles of lyophilised products, with a concomitant reduction in costs.

SP Scientific Inc. +1 845 255 5000 (+44 1473 240000 in Europe) shireen.scott@spscientific.com www.spscientific.com EPM 9

NewAge Industries AdvantaPure +1 215 526 2151 info@advantapure.com www.advantapure.com/apsw-siliconehose.htm

GE Healthcare Life Sciences Now part of GE Healthcare Life Sciences

Xcellerex adds full automation to the mix

Introducing the XDUO™ Quad™ Intelligent Single-Use Mixing System.

One of the first plug-and-play mixers in its class featuring powerful onboard automation. With XDUO, there’s no tedious manual titration and fewer process deviations. Just instant startup and effortless operation for automated mixing of buffer, media, product and intermediates, and other process fluids, upstream

www.gelifesciences.com/xcellerex E: webinquiry@xcellerex.com P: 508.480.XCEL(9235) or

or downstream — plus full data capture for GMP batch records.

The XDUO even offers exclusive remote operation via our XDR™ single-use bioreactors or FlexFactory® biomanufacturing system.

For fully automated processing of viral inactivation, pH adjustment, formulation, and more, get XDUO in the mix today!

Download our white paper “Automated pH Adjustment in an Intelligent Single-Use Mixing Platform” at www.xcellerex.com/mixerpaper

1.866.XCELLEREX

GE, imagination at work and GE monogram are trademarks of General Electric Company.

Xcellerex and FlexFactory are registered trademarks of Xcellerex, Inc. XDR and XDUO are trademarks of Xcellerex, Inc. © 2012 General Electric Company — All rights reserved.

First published September 2012.

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Gated Outlet Provides Complete Control of Screening Operations Russell Finex strives to provide new solutions to customers screening requirements and the new Russell Gated Outlet has been designed to ensure the screening of product is performed more efficiently, helping to enhance productivity.

In some instances, particularly on high capacity check screening or grading applications, product can be discharged from the mesh before it has time to be fully screened. When materials are discharged prematurely through the oversize discharge outlet, this can result in the loss of good quality product. A way to overcome this has been to decrease the feed rate, however this reduces the throughput rate while also reducing overall efficiency. The Russell Gated Outlet eliminates the need to reduce the feed rate and ensures that the product is sieved effectively.

The Russell Gated Outlet operates via a pneumatically controlled gate, which is placed neatly inside the oversize discharge outlet to control the flow of material. The gate can be automatically opened and closed, providing complete control of product discharge. While the gated outlet is closed, the product remains on the mesh to ensure it has been screened fully before opening the gate to discharge the product.

The outlet can be used on the entire range of Russell Finex sieves and separators and can be easily retrofitted to any existing Russell Finex sieve. The gate is available in FDA approved

Single-Use Bottles and Carboys Now Meet USP 788

Deflated-open

Inflated-closed

natural rubber, neoprene or polyurethane to comply with the needs of a wide range of industries, including food, pharmaceutical and chemicals.

The key benefits of the Russell Gated Outlet are: • Increased productivity — oversize material is ejected automatically with no need for manual intervention.

• Improved screening efficiency — product to be sieved and only oversize material is ejected through the oversize discharge outlet.

• Increased profitability — loss of good product is reduced.

Russell Finex Ltd +44 208 818 2000 enquiries@russellfinex.com www.russellfinex.com

Cellon’s entire range of PharmaTainer bottles and carboys are now certified ‘clean’, meeting USP 788 Particulate Matter in Injections and the equivalent EP and JP quality standards.

PharmaTainer products are currently manufactured in PC and PET in sizes from 125 ml to 20 l. Cellon opened its production moulding facility in Luxembourg in 2011. The plant is 100% dedicated to production of clean, singleuse products for use in the vaccine and bio-processing sector and operates under an ISO 9001–2008 quality system.

PharmaTainer carboys and bottles are manufactured in an ISO class 5 (class 100) environment and sterilised by irradiation to a SAL of 10–6. Certification to the USP 788 is based on liquid particle count analysis on a lot-by-lot basis.

Designed specifically for the storage and transport of bulk vaccines, biopharmaceuticals, bulk intermediates and other biotechnology materials, PharmaTainer products also provide tamper evident packaging and are reportedly first in the industry to provide bottle labelling for individual bottle traceability and inventory control.

Speaking for Cellon, Managing Director Richard Fry said: “The PharmaTainer range addresses directly the main quality concerns for single-use storage and transport containers in the industry, i.e. particulate and traceability. By dedicating our facility to production of clean products, we ensure that all our products are made to a single, high standard. We

10/25 micron particulate in 125 ml bottle vs. limit.

reduce risk by manufacturing for a single purpose and quality standard so there is less opportunity for error in our operations than in multipurpose moulding facilities that manufacture products of differing levels of cleanliness using multiple grades of materials.

“We welcome customers and prospective customers to visit and audit our facility so they may see first-hand the quality systems we have in place.”

Cellon SA +35 2 263 373 richard.fry@cellon.lu www.cellon.lu / www.biofluidfocus.com

Purity through innovation Global sieving and filtration specialists

Ultra-Clean

ng 5 pi EL m O cla ing nt ed vid e nt ro m te p ain Pa em ont st c sy

Improve your product quality with the Russell Compact Airlock Sieve™ ...

The new cGMP-drum offers process reliability by validated cleaning procedures Details of the Ultra-Clean line: – Sanitary welded edging – Geometry of beads and bottom optimized for clean discharge of product and for drum cleaning – Body, base and lid in stainless steel AISI 316 – FDA-approved silicone elastomer seal ring, USP Class VI – Choose from a range of 20 different sizes – Compliant with FDA and cGMP guidelines

High containment check screening for the pharmaceutical industry

What makes us specialists..?

Customized solutions - Applying innovation to meet your requirements Comprehensive customer service - Technical support & global stocking Specialized testing facilities - Trial your products for total peace of mind

Müller GmbH - 79 618 Rheinfelden (Germany) Industrieweg 5 - Phone: +49 (0) 76 23 / 9 69 - 0 - Fax: +49 (0) 76 23 / 9 69 - 69 A company of the Müller group info@mueller-gmbh.com - www.mueller-gmbh.com

Call us on: +44 (0) 20 8818 2000 EPM 11

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Continuous Film Coater Achieves Excellent Quality and Uniformity

Checklist Offers Expert Guidance for Choosing Batching Control Systems

In addition to its well-known range of batch-coaters, DRIAM now offers a continuously operating machine, which allows for the application of film coatings in a cycled, continuous mode.

The machine is divided into individual chambers in which the process can be individually realised. Therefore, exactly controlled steps are executed during the film coating process. Since the residence time of the mini-batches is unlimited, complex and elaborate, coatings can be applied continuously. As a result, an excellent quality and uniformity level as well as even product flow are achieved.

The production machine in the DRIAM laboratory has seven chambers. Of course, the DRIACONTI-T pharma machines are customised with regard to the number of chambers to meet particular requirements.

The most recent development in the DRIAM range is the DRIACONTI-T pharma LAB, which is a three-chamber laboratory size version of the production machine.

Manufacturers in the market for a batching control system can find the number of options overwhelming. The systems are complex and there are few resources available regarding best practices because many batch processes produce proprietary formulations. However, a new expert resource provides insight and advice to make the process of selecting the right batch control system easier.

The ‘Checklist for Designing Batching Control Systems’ is a new tool from Mettler Toledo to advise manufacturers on how to maximise productivity and minimise costs by implementing a batching operation. The checklist outlines considerations for manufacturers to help them choose the right system for their application. It shares the keys for getting the most, in terms of cost and time savings, from a batching control system. If manufacturers select the right system for their application, additional benefits include improved product quality and consistency.

This laboratory coater is available for trials at DRIAM's premises and can also be rented for trials at the customer’s facility.

DRIAM Anlagenbau GmbH +49 7541 9703 11 carla.krause@driam.com www.driam.com

“This new checklist is a valuable tool for efficiently determining the right batching system for any application,” said Brian Howell, Mettler Toledo Marketing Manager.

Download the Checklist for Designing Batching Control Systems at www.mt.com/ind-batching-checklist.

Mettler Toledo +41 44 944 2568 eugen.schibli@mt.com www.mt.com

Stainless Steel Equipment and Furniture Specialist Launches Catalogue Teknomek is celebrating 25 years of excellence with the introduction of a new and improved annual product catalogue.

Launched in October, the catalogue showcases over 1,500 products from what Teknomek claims is the largest and most comprehensive range of stainless steel hygiene furniture and equipment in the UK.

According to the company, the 148page bumper edition is the new ‘go to guide’ for all things Teknomek, with a bright, clear layout designed for easy browsing. Products have been divided into 12 sectors for ease of use, with each product having a full description, dimensions and price.

Alongside the extensive standard product range, Teknomek also offers a

bespoke service where products can be custom-made to meet specific requirements. Its in-house CAD team provides a full design and advisory service to ensure the most costeffective solution is delivered.

A new digital version of the catalogue is planned, providing an online page-turner at www.teknomek.co.uk, from which

customers can view the product range, share with colleagues or print off as required.

Copies of the catalogue can be obtained by calling or emailing Teknomek.

Teknomek Ltd +44 1603 788833 www.teknomek.co.uk

Single-Use Platform Switches from TFF to Chromatography with Minimum Effort Merck Millipore has launched the Mobius FlexReady solution with Smart Flexware assemblies for tangential flow filtration (TFF). The fully automated system is ready to implement and features scalable filtration technologies for exceptional performance and operational flexibility.

Unlike traditional single-use processing systems, this modular system is quick and easy to set up, providing the ability to switch from TFF to chromatography with a minimum number of component changes, making it ideal for pilot plants and CMOs that have rapidly changing demands.

The system is suited for a wide range of concentration and diafiltration processes. In addition to the feed pump and retentate valve control loops, the system also includes an automated flow

control valve on the filtrate line to enable open ultrafiltration and microfiltration operations, increasing the overall flexibility for clinical development and manufacturing facilities.

A variety of recycle vessel configurations are available with the Mobius FlexReady Solution to provide maximum process capability. In addition to different vessel volumes, users can select a plastic carrier or a doublejacketed stainless steel carrier, depending on whether or not temperature control is required. All recycle vessels come with integrated load cells, mixer and temperature sensor and have been designed so the containers can be easily and accurately installed by a single operator.

“With the introduction of this fully

automated Mobius single-use TFF system, we are able to provide our customers that require a high level of processing control with a choice for performing their ultrafiltration/diafiltration operations,” noted Vin Donovan, Vice President of Biopharm Process Solutions, Merck Millipore.

The Smart Flexware single-use flow path delivers equivalent or better performance to that of traditional stainless steel systems while maximising system flexibility. Smart Flexware assemblies are easy to install, reducing the risk of operator error and challenges typically associated with installing singleuse flow paths. Additionally, the flow path significantly reduces dead-legs and moving parts, decreasing the risk of contamination to virtually zero.

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

TLMI Selects Void Label for Innovator Award Schreiner MediPharm was able to score yet again with an intelligent solution at this year’s Tag and Label Manufacturers Institute (TLMI) awards competition. The Pharma-Comb Void label received the international Innovator Award of the North American TLMI. Furthermore, the two-layered label, with an integrated void effect and a detachable label part, secured the first-place award in the ‘flatbed screen printing category’. The labels were developed with and for SciClone Pharmaceuticals, Inc., a USbased, China-focused specialty pharmaceutical company, for its product

ZADAXIN (thymalfasin), an immunostimulatory agent for the treatment of cancer and hepatitis and a vaccine adjuvant.

Every year, the TLMI recognises the best products of the label industry.

Innovation as well as printing and finishing quality are aspects that receive particular attention. Schreiner MediPharm convinced the judges with the Pharma-Comb Void label and won the Innovator Award plus the first-place award in the ‘flat-bed screen printing’ category. “Thanks to its unique design, the Pharma-Comb Void label prevents

an undetected reuse of a vial with an original label,” said Ann L. Merchant, Global President of Schreiner MediPharm. “The TLMI accolades underscore the novelty value and technical sophistication of this concept for product security.”

The label disintegrates into several components when used for the first time.

In addition, when pulling off the tear strip that wraps around the closure cap, two indicator fields are exposed with the words ‘Opened’ and ‘Used’. This helps avoid used vials being refilled for the purpose of selling them as perceived

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originals. Patients are thus protected from administration of substances that are ineffective or may even be harmful to their health. Furthermore, the PharmaComb Void label offers a value-added benefit to healthcare staff because the integrated label part can be used to reliably mark filled syringes.

Schreiner MediPharm, a business unit of Schreiner Group GmbH & Co. KG +49 89 31584 5400 info@schreiner-medipharm.com www.schreiner-medipharm.com

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Sterility Indicators

Sterilisers — Dry, Heat, Electric

Sterilisers — Dry, Heat, Gas

Sterilisers — Gas (ETO)

Sterilisers — Ionising Radiation

Sterilisers — Laboratory

Sterilisers — Membrane Filtration

Sterilisers — Ozone

BMM Weston Ltd, UK +44 1795 533441 gpinks@bmmweston.co.uk www@bmmweston.co.uk

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Etigam, The Netherlands +31 55 5211721 info@etigam.nl www.etigam.nl

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IMA S.p.A - IMA Life division, Italy +39 051 651 4111 mktg.life@ima.it www.ima-pharma.com

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Cleaning equipment (washers), isolators for sterility testing and steam generators.

Cycle development, D & Z value studies, EN285, HTM2010, HTM01-05.

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Synergy Health plc +44 8456 88 99 77 assistance@synergyhealthplc.com www.synergyhealthplc.com/sterilisation

Waterwise Technology Ltd, UK +44 1844 215570 info@waterwise.co.uk www.waterwise.co.uk

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Priorclave Ltd, UK +44 208316 6620 sales@priorclave.co.uk www.priorclave.co.uk

Teknomek Ltd, UK +44 1603 788833 mail@teknomek.co.uk www.teknomek.co.uk

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Getinge Infection Control, UK +44 1623 510033 stephen.morley@getinge.com www.getinge.com Honeyman Group Ltd, UK +44 1833 696425 enquiries@honeyman.co.uk www.honeyman.co.uk

Sterilisation Equipment Servicing

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Sterilising Tunnels

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Sterilisers — UV Radiation

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Sterilisers — Autoclaves

sterilisation

Steriliants — Liquid

buyers’ guide

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Aragan Chooses Slider Packaging for Probiotic Drug Relaunch Burgopak Healthcare & Technology has been selected by Aragan, a French laboratory that specialises in the use of natural ingredients, to package the relaunch of its probiotic drug Restaure.

The drug is a combination of two probiotic strains that help maintain or regain balance of intestinal microflora.

The product, which is available in pharmacies throughout France, utilises Burgopak’s patented slider packaging.

To open the pack and access the product, the consumer pulls on a highlighted tab. The pack slides open to reveal the blistered product on one side with the consumer information on the other. To close the pack, the consumer simply pushes the tab back to its original position.

Nicolas Brodetsky, Managing Director at Aragan, said: “Initially, I was looking for a standard packaging system. In the OTC and food supplement market, it is necessary to offer the patient a real benefit to attract their attention.

Burgopak provided the answer to this.”

The design of the pack is well suited for the modern consumer’s lifestyle. The functionality keeps the product, information and outer carton permanently connected. Important

product information is readily available every time the pack is opened, encouraging the consumer to take the product as instructed. The design also eliminates unnecessary space, keeping the pack compact and portable, which is convenient for the consumer on the move. The slider design also provides maximum protection for the blister, reducing the risk of tablets being accidentally released.

In addition, the slider design adds value for brand owners. Printable areas on the pack offer maximum opportunity for brand communication. The sliding

mechanism reportedly supplies a point of differentiation in a competitive market, encouraging consumers to engage with the product through the interactive opening and closing mechanism. The compactness of the design also optimises retail shelf space while simultaneously reducing shipping costs.

Working closely with Aragan and its manufacturing partners, Burgopak completed the blister tooling development and manufacturing to deliver the final product three months from order placement. Brodetsky

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concluded: “In addition to a higher quality of product, Burgopak were extremely responsive throughout the entire process, helping to deliver the product within three weeks of the artwork being signed off.” The quick turnaround of the project is testament to Burgopak’s commitment to design excellence while also demonstrating efficiency in manufacturing processes.

Burgopak Ltd +44 207 089 1950 pharma@burgopak.com www.burgopakhealthcare.com

SHOWCASE TABLETTING Tablet Tooling Specialist and University to Advance Tabletting Science with Anti-Stick Research I Holland is currently undertaking a twoyear research programme to solve a common ‘sticky’ situation in tablet manufacture with the assistance of Nottingham University’s School of Pharmacy.

TSAR (Tabletting Science Anti-Stick Research) is part of I Holland’s continuous improvement programme, a key element of the company’s PharmaCote range, which offers solutions for sticking, corrosion, pitting and abrasion.

The project investigates the cause of formulation sticking. As one of the main problems in tablet manufacture, tablet formulation is a dilemma that causes a lot of down-time and therefore loss of performance and profitability.

Using advanced technology, such as scanning electron microscopy, laser profilometry, atomic force microscopy, X-ray photoelectron spectroscopy, Raman spectroscopy, time flight secondary-ion mass spectrometry and adhesion mapping, I Holland and its partner will investigate what makes formulations stick to tablet tooling surfaces and analyse why certain coatings resist sticking when others do not. Currently, a number of interactions are believed to influence tablet sticking, including Van der Waals forces, capillary action, deformation mechanics and static electricity.

Rob Blanchard, I Holland’s Research, Development and Quality Systems Manager, said: “Sticking is the most

prolific problem within the tablet manufacture industry and causes many hours of downtime and reduces productivity. I Holland has seen increasing requests for assistance in solving sticking problems and we hope that the TSAR project will put an end to this complex phenomenon.

The aim of I Holland’s research and development team is to speed response times to solving customers’ problems, ultimately offering better customer service.”

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

Die Table Segment Technology Enables Up to 25% Increase in Production The tablet production rate figure is one of the most important criteria when assessing economic viability of a tablet press. For this reason, increasing the performance, particularly on presses that are already in operation, has enormous significance.

Fette Compacting’s die table segments offer an increase in production rate of up to 25%. The increased number of stations clearly demonstrates the

increased productivity and makes it easy to calculate.

There is a long list of additional factors that have a positive effect on the financial calculation. Fette die table segments reportedly put an entirely new perspective on the calculation of lifetime and total cost of ownership, in particular for presses that are already working productively.

The features: • Increased number of stations in each die table.

• No more individual dies.

• No more die screws and threaded holes.

• Greatly reduced number and length of joints.

• Special, high-alloy steel.

The benefits: • Calculable increase in production rate.

A new white paper on segment technology can be obtained by emailing: tablet@fette-compacting.de.

• Significantly shortened changeover time.

• Greatly improved cleaning.

Fette Compacting GmbH +49 4151 12 473 tablet@fette-compacting.de www.fette-compacting.com

• Sharply reduced product loss.

• Notably extended service life.

Tablet Press Offers Outstanding Flexibility and Rapid Changeover

Tablet Tooling Expert Provides Comprehensive Range of Options and Support

The KORSCH XL 400FT MFP (MultiFunction Platform) tablet press provides a flexible platform that permits the production of all tablet formats on a single machine. It reportedly boasts a new standard in GMP, with extreme accessibility to the compression zone and a combination of quick-disconnects and smooth surfaces that allow streamlined cleaning and changeover times.

The XL 400FT MFP is highly flexible and enables the production of all tablet formats: single-layer, bi-layer, tri-layer and core-coating tablets. Changing the turret is extremely quick and easy, only 13 parts have to be removed and thanks to its design this can be done in less than 10 minutes. High output capability is achieved owing to a 120 RPM press speed range, an extended feeder length for precise weight control at high speeds and a compression dwell bar for difficult products.

From tooling type and configuration to steel type and coating, Natoli Engineering ensures that every option is considered in order to provide the customer with the most effective tool set for their specific product. Whether what is needed is carbide-tip punches and lined dies for an abrasive formulation, a multiple-tip set to increase production efficiency or a completely custom set to meet their exact requirements, Natoli experts are available to educate and assist customers to ensure tooling provides exceptional performance and reaches its maximum lifespan.

Natoli also provides laboratory services to help the customer overcome common tabletting problems such as sticking and picking. Natoli experts evaluate tablet and tooling designs and experiment with dozens of combinations of steel types and coatings to determine the most efficient and effective solution to their specific issues.

In addition, the XL 400FT MFP features user-friendly controls, such as a standard PLC Platform and touchscreen HMI, and is fully compliant with 21 CFR Part 11.

KORSCH AG +49 30 435 76 0 chantal.lagarde@korsch.de www.korsch.de

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

Corporate News & Events

Comprehensive Training Schedule Helps Solve Tablet Tooling Issues I Holland will be providing training to the tablet manufacturing industry on how, by following a planned and organised tooling care and maintenance programme, it can help to reduce tablet press downtime and increase tablet output.

The first part of the educational campaign will take place in the form of a webinar on 21 February. Entitled ‘How punch and die maintenance SOP improves your profitability and productivity’, it will help to inform the industry on how to maximise trouble-free tablet production through seven simple key steps in the care of equipment.

Also as part of the campaign, a troubleshooting seminar will once again be held at the UK manufacturing plant on 6 and 7 March.

The popular seminar has been such a success in previous years that I Holland

decided to continue with this in 2013.

Clare Taylor, I Holland’s Marketing Manager, said: “The seminar is designed to give an in-depth technical view on troubleshooting from a tablet manufacturer’s point of view. By adopting I Holland’s recommended professional maintenance and storage programme, the PharmaCare 7-Step Process, early recognition of tooling and tabletting issues can be reduced, which makes for less press downtime.

“Combining a practical element and demonstrating the PharmaCare 7-Step Process as well as a tour of the plant, the seminar is once more gaining interest from those wishing to learn about optimising the life of tablet tooling.

“Both the webinar and seminar are a great way for I Holland to connect and share our expertise with a worldwide

audience and to help counter common issues that hinder and stop tablet compression. The seminar and webinar will not only be very informative for the audience but also an ideal platform from which I Holland can meet and assist end-users and gain positive and informative feedback.”

To sign up to the webinar on 21 February, visit https://vts.inxpo.com/Launch/QReg.htm?

ShowKey=12453. To register for the troubleshooting seminar at the I Holland UK manufacturing plant, which includes a tour of the site, email info@iholland.co.uk.

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

Founder of Packaging Machines Firm Names Sons Chief Executive Officers When Gerhard Schubert presented his first hot-melt box erecting and gluing machine to the public 46 years ago, his sons Gerald and Ralf were only two and five years old, respectively. It was the beginning of a huge success story. The box erecting and gluing machine was followed by a series of technical highlights, including the reportedly world’s first packaging robot, Schubert’s own packaging machine control unit, the F44 picker line and the TLM top-loading packaging machine for installation on an assembly line. This trend has continued up to the TLM transmodule, claimed to be the world’s first transport robot.

The characteristics of its founder have made Gerhard Schubert GmbH a recognised global market leader in its field, resulting in a group of companies with more than 900 employees worldwide.

Gerhard Schubert can now be especially proud of another achievement. His sons have been active within the company for more than 20 years and he has now appointed them Chief Executive Officers. Gerald Schubert, 48, is a father of two children with a degree in mechanical engineering. He headed up the Schubert subsidiary IPS (International Packaging Systems) before assuming the role of Schubert Sales Division Manager. Ralf Schubert, 51, a father of three children, graduated in computer sciences and leads the Technical Office and Assembly Division.

This proven management team is completed by Peter Gabriel (Dipl. oec. univ.) as Commercial Director and Peter Schneider (Dipl.-Ing./FH) as the head of the Materials Management

Division. Gerhard Schubert will retain his overall management role and continue to devote himself to the Marketing Department.

Gerhard Schubert GmbH +49 7951 400 0 info@gerhard-schubert.de www.gerhard-schubert.com

Plastic Packaging Producer Modernises Bensheim Plant Sanner is modernising its plant in Bensheim, Germany. With a focus on optimising logistics, infrastructure and energy efficiency, it will include a central transport corridor to improve the flow of goods as well as a technical services centre with a power/heat cogeneration system. The modernised facility will provide clearly defined production zones along with structural improvements in the GMP production environment.

Scheduled for completion in June 2013, the new construction will cost €4 million.

The modernisation of the building complex, located at Sanner headquarters in Bensheim Auerbach, follows a comprehensive design developed exclusively for this plant.

Focusing on environmental sustainability, one of the main objectives is to optimise material flow and ensure

energy-efficient production across the entire value chain. “We have continuously expanded and modernised our site since the 1960s,” said Sanner CEO Holger Frank. “In the past, the renovations took place in stages. This more comprehensive construction project will close the gaps in our overall logistics and infrastructure.”

In the future, a transport corridor will provide a central infrastructure axis across the 30,000 m2 site. The complete supply chain, from goods receiving to product delivery, will be integrated along this north-south axis. The separate production facilities will be connected to the infrastructure axis in a modular system organised according to the different production stages and product types. This will shorten supply lines and make production processes leaner.

A new building services centre with a power/heat cogeneration system will help counteract rising energy prices. The excess heat from two gas-powered generators is converted into cooling air and process refrigeration as required.

This method generates 50% of the required energy with gas. “These measures will help us reduce the risk of price increases for electrical power,” explained Frank.

Construction plans include a central receiving point and optimised utilisation of production space. The company’s Bensheim site includes administrative and storage buildings along with the main production operations. All of the construction work is scheduled for completion by June 2013. “The comprehensive renovation of our main plant will prepare us for the future and

EPM 16

ensure that we can maintain our position as an innovative market and technology leader,” concluded Frank.

Sanner GmbH +49 6251 938 0 info@sanner.de www.sanner.de

LABORATORY PRODUCTS & EQUIPMENT

Online HPLC Solution Secures Analytical Workflow of Pharma Labs HPLC has been and continues to be a workhorse of the pharmaceutical laboratory. Throughout the product lifecycle from pre-formulation to QC, HPLC coupled with dissolution and content uniformity/assay testing are some of the biggest sample sources for HPLC analysis.

SOTAX has developed a variety of offline autosampler solutions over the decades. Offline samples are withdrawn from the company’s instruments, immediately filtered and collected in a variety of formats. To further automate the analytical workflow and to avoid costly manual transfer mistakes, SOTAX has announced the latest addition to its line of autosamplers — the SAM Sample Manager.

SAM guarantees a seamless flow from dissolution samples to analytical results.

Totally flexible and scalable, the system is available in three different capacities to connect to semi-automated single, double and fully-automated systems: SAM S (small for up to 240 samples), SAM M (medium for up to 480 samples), and SAM L (large for up to 720 samples). SAM acts as a transfer platform, keeping samples protected and injecting them one by one into HPLC, all without any vial transfer. The system works with any HPLC instrument

Three different capacities are available: SAM S (for up to 240 samples), SAM M (for up to 480 samples) and SAM L (for up to 720 samples). with ready signal functionality and can be integrated with a variety of different injection valves.

SAM is driven by the WinSOTAXplus advanced dissolution software while the LC data is processed with the existing chromatography software. SAM will take care of the samples seamlessly from start to analytical finish.

SOTAX AG +41 61 487 54 20 petra.silbereisen@sotax.com www.sotax.com

The semi-automated SOTAX AT 7smart is pictured with pump, filter station, small capacity SAM S and HPLC.

epm

SPECIAL FOCUS

Mixing Granulator Offers Flexibility for Small Scale Applications The newly developed MGTL laboratory model from Gebr. Lödige Maschinenbau is a powerful mixing granulator for small batches to supplement the proven series.

Equipped with a double jacket and interchangeable vessels, it supports the process stages of small scale mixing, moistening, granulating and heating/cooling.

A three-arm mixing impeller rotates on the floor of the vertical, cylindrical mixing vessel, circulating the mixing product as a vortex. The result — even with product components that have heterogeneous properties, this process guarantees extremely short mixing times and excellent homogeneity. A separately driven

chopper enables agglomerates to be broken up according to the application, even moistening for wet granulation and — such as in the cosmetics industry — streak-free mixing of dyes.

Various, different, easily interchangeable drums make the laboratory mixing granulator from Lödige an ideal solution for diverse small scale applications. For example, it is ideally suited to product and process development, for the production of small batches in the pharmaceutical and cosmetics industry or ground spice production.

The MGTL is delivered ready for operation with a declaration of CE conformity.

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Lödige’s newly developed MGTL laboratory model is a new addition to the proven series of mixing granulators.

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

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP epm

SPECIAL FOCUS

Tumble Blender Guarantees Even Mixing of Powders in V-Shells and Bins The Maxi-Blend laboratory blender is a selfcontained tumble blender intended for blending of powders in V-shells and bins. As the shell rotates, the tumbling action brings about homogeneous mixing of the ingredients. An integral intensifier drive helps achieve homogeneous mixing of small dose ingredients.

Liquid addition is possible through the highspeed intensifier bar. PLC electronic controls permit precise control of the blending process and reduce maintenance problems. When the blender stops, the shell is automatically in the discharge position.

This blender accommodates interchangeable V-shells, bins and double cone shells made of 316 stainless steel. The easy-to-clean safetyinterlocked guard is made of crack-resistant polycarbonate to protect the operator from the rotating shell. The drive station is available in fixed or variable speeds.

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

Biochemistry Analyser Boasts Exceptional Speed and Accuracy

Weigh Module Wins Prestigious Design Award

YSI has announced an addition to its 2900 series of biochemistry analysers — the 2950. The 2900 series of instruments can measure a wide range of important chemistries, sugars and nutrients for the bioprocess, biopharmaceutical, biofuels and food and beverage markets.

The YSI 2900 series is a flexible, modular platform, with a range of configurations, options and accessories to meet laboratory needs. The base platform is the YSI 2900, with the 2950 platform being configurable with up to three sensor modules capable of measuring up to six chemistries from glucose, lactate, glutamine, glutamate, xylose, ethanol, methanol, sucrose, galactose, lactose, choline, glycerol and hydrogen peroxide, plus ISE measurement of ammonium and potassium.

Fast and accurate results are available in one minute or less, with integrated auto sampler, anti-clogging design, flexible sampling and connectivity.

Calibrator and buffer bottles have optional reagent level sensing and the 2900 series can accept a wide range of sample holders, including any standard 96 well, 4, 8 and 24 place test tube holders and microcentrifuge tubes.

Evaporation of volatile analytes like

The Japan Institute of Design Promotion (JDP) recently awarded Mettler Toledo the ‘Good Design Award’ for its ultracompact WMC high-precision weigh module, which is now designated with the award’s G Mark label. This designation is recognised globally for innovative design.

The Good Design Awards are “a system that aims to channel the eminent powers of distinctive designs to build prosperous lives and encourage sound industrial development,” according to JPD. A jury of about 60 design experts fielded more than 3,000 submissions from more than 1,000 companies globally in this year’s competition.

The WMC is an ultra-compact electronic balance. It can be integrated in a small space for high-precision weighing with an accuracy of 10 µg. It can also easily be arranged to arrays with multiple units for parallel weighing to increase throughput.

According to the evaluators, it boasts a simple design with a rectangular column housing in stainless steel, which conveys a sense of high precision and may inspire machine designers when creating new solutions for automated processes.

For more information about the Good

methanol and ethanol is not a worry — the sipper needle is capable of piercing and sampling from a range of films available to seal 96 well plates.

The large, icon-driven touchscreen and on-board training videos make operation simple and the screen is programmable in a number of foreign languages.

YSI Incorporated +44 1252 819844 uksales@ysi.com www.ysi.com

Seattle Genetics Uses ELN to Capture Experimental Data for Efficient Study and Process Management IDBS has announced that Seattle Genetics, Inc., a leader in antibody-drug conjugate development, selected its EWorkBook, an ELN that supports a broad range of scientific disciplines within one single platform, increasing operational efficiency through secure and flexible management of all research and data.

E-WorkBook reduces deployment time and administration by enabling all experimental data to be available for more efficient analysis and easier sharing. It can also be integrated ‘just in time’ for rapid, informed decisionmaking.

Neil Kipling, CEO and Founder of IDBS, said: “To be able to capture, integrate and retrieve all scientific data in real time revolutionises drug R&D as well as producing measurable return on investment. Having the wealth of your scientific information only a click away enables faster, better decision-making. It also allows peer-to-peer collaboration, which is at the core of innovation. This leads to faster progress of good projects, which is the purpose of any R&D organisation.”

Mettler Toledo +41 44 944 2568 eugen.schibli@mt.com www.mt.com/wmc

Data Shows Value of Morphologically Directed Raman Spectroscopy for Bioequivalence Studies

When supported by top quality data management, workflow and reporting, scientists can focus on the science rather than spending time searching through countless documents.

E-WorkBook is proven to help scientists save between five and eight hours a week by enabling users to find data faster as well as complete projects quicker.

ID Business Solutions Ltd (IDBS) +44 1483 595 000 info@idbs.com www.idbs.com

Design Awards, visit www.mt.com/wmcg-award.

A new application note on the Malvern Instruments website describes the use of morphologically directed Raman microscopy in assessing the bioequivalence of a generic and innovator drug with a dual API. The work was carried out using the Morphologi G3-ID, which combines automated image analysis with Raman spectroscopy. The Morphologi G3-ID enables the determination of component-specific particle size distributions, which in this study were important because of the effects of particle size on tablet disintegration and subsequent bioavailability.

In order to show that a generic drug is bioequivalent to an innovator it must display comparable bioavailability when studied under similar experimental conditions. Bioavailability is the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of drug action. Bioequivalence refers to equivalent release of the same drug substance from two or more drug products or formulations.

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Morphologically directed Raman microscopy enables independent characterisation of individual components present within a blend or mixture. As well as its application in bioequivalence studies, it can be used to gain better product understanding across many areas of the pharmaceutical industry from regulatory to troubleshooting. In delivering this capability, the fully automated Morphologi G3-ID is designed to allow both particle characterisation scientists with limited spectroscopy experience and more experienced spectroscopists to get an in-depth understanding of their particulate samples.

‘Generic versus Innovator: an In-Vitro Bioequivalence Study with the G3-ID’ is freely available as a download from the Malvern website at www.malvern.com/generic-vs-innovator.

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

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Universal Phase Separators Solve Age Old Phase Removal Problem Biotage has introduced its new Universal Phase Separator, a flexible alternative to the traditional glass funnel separation of immiscible liquids. These columns are fitted with a selectively permeable insert that separates aqueous phases from organic solvents under gravity, solving the age old problem of how to remove an upper organic phase from a lower aqueous phase during a traditional liquidliquid extraction process, without creating additional process steps.

The design allows the organic phase to pass through the internal frit wherever it is located, providing a universal approach to separating two liquid phases, while its one-size-fits-all approach enables any volume under 80 ml to be processed in one step or larger volumes by serial batches. Made from inert proprietary polymers, the Biotage Universal Phase Separators come in an easy-to-use kit form and refill packs, ready to use in seconds straight out of the box.

“Biotage Universal Phase Separators are the modern day alternative to separating with the glass separating funnel. Ideal for working with a range of organic solvents or in parallel, this product is economical, flexible and extremely simple to use. There are no

epm

SPECIAL FOCUS

Interchangeable Attachments Enable Versatile Mixing

The Biotage Universal Phase Separator is a simple solution to the classic problem of separating an upper organic phase from an aqueous during a traditional liquid-liquid extraction. moving parts, with nothing to prime, it’s all achieved by fundamental physical principles and clever product design,” said Dr. Sunil Rana, Product Manager Chemistry Applications and Resins and Work-Up Products at Biotage.

Biotage GB Ltd +44 1443 811 849 james.churchill@biotage.com www.biotage.com

Ross has introduced a new, multi-purpose laboratory mixer model, the HSM100LCI-T. This benchtop unit is offered with interchangeable mixing attachments, including batch and inline rotor/stator sets, various size disperser blades and propellers.

Capable of multiple mixing tasks, including powder wet-out and dispersion, deagglomeration/particle size reduction, solubilisation, emulsification and homogenisation, the HSM-100LCI-T is equipped with the following standard features: • Type 316 stainless steel wetted parts polished to 150-grit finish.

• 1 HP drive, 115 volt, 50/60 Hz, single phase, 20 amp motor. Optional voltages are available.

• Variable speed control of 500–10,000 rpm (+/- 1% accuracy).

• Colour touchscreen controls and display for speed, percentage of load, batch timer and temperature.

• Can be used with different size vessels; 40.6 cm clearance under mixing attachment and 30.5 cm distance between the feet (base).

• Recommended batch sizes:

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- batch rotor/stator, disperser and propeller attachments for 0.95–18.18 l - inline rotor/stator attachments (single stage and four-stage) for 4.55–90.92 l - micro mixer attachment for 50–500 ml.

• Electronic push-button lift.

• Dust- and fluid spray-resistant enclosure.

• Easy to disassemble and clean with simple hand tools.

• Temperature probe, vessel/beaker clamp assembly, vacuum cover and mix vessel, data acquisition/PC control and other features available as options.

• Mixer and controls are wired and include a cord and plug.

Charles Ross & Son Company +1 800 243 7677 sales@mixers.com www.mixers.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Ultrafiltration Device Facilitates Fast Sample Concentration with High Recoveries Sartorius has introduced the disposable Vivaspin Turbo 15, optimally suited for protein, virus or nanoparticle concentration as well as desalting, dialysis and buffer exchange. It is available in a range of volumes from 4 to 15 ml and permits easy and complete recovery of the concentrate.

With Vivaspin Turbo 15, laboratory technicians can concentrate biological samples within 10 to 30 minutes and obtain macromolecular recoveries of more than 95%. In a single spin, 15 ml solutions can be concentrated up to 150 times. High flow rates are

achieved due to the twin vertical membranes, which minimise protein polarisation and subsequent fouling of the membrane. The optimised design and sleek internal profile of Vivaspin Turbo 15 ensures process speeds down to the last few microliters.

The 100 µl dead stop pocket is easy to access with standard 200 µl pipette tips due to the patent pending angular design of Vivaspin Turbo 15. It eliminates the risk of the sample running to dryness while allowing high recovery of the concentrate.

The use of highly chemically resistant plastic materials, such as polystyrene

and polypropylene, guarantee a stable shelf life, even in humid environments.

Polyethersulfone membranes are preferred for their low fouling characteristics, exceptional flux and broad pH compatibility. The combination of polyethersulfone, polystyrene and polypropylene enables Vivaspin Turbo 15 units to be readily sterilised and depyrogenated.

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

Increase in Demand for Vitamin-Modified Oligos to Improve Nucleotide Drug Delivery As a certified specialist in the provision of phosphoramidites and reagents for oligo synthesis, both direct to research groups and to oligo manufacturers, Link Technologies has observed a significant increase in requests for vitamin-modified oligo precursors, following on from the increasing use of vitamin-modified oligonucleotides in life science research.

The growing interest in such compounds is reflective of the current buzz that surrounds research into the enhanced targeting and delivery of nucleotidebased treatments. Such research is vital for the therapeutic industry, wherein accurate targeting and effective uptake of pharmaceutical compounds is essential, not only for positive medicinal value but also to avoid undesirable, potentially dangerous side effects.

For example, researchers have recently highlighted the value of utilising vitaminmodified oligonucleotides, such as those containing tocopherol1, to facilitate oligonucleotide transport across cell membranes. The sourcing of reliable and pure modified phosphoramidite precursors for oligo synthesis will prove an important step in the production of such therapeutics for use in gene therapy, RNA-induced gene silencing and further academic research.

The rise in demand for modified oligos is not only concurrent with the wealth of

research in the drug delivery sector but also with the progression of promising early-stage drug development into phased clinical trials. Such commercial progressions are utilising increasing quantities of these chemically-altered oligos and, as such, Link Technologies has witnessed a rise in order quantities of the constituent modified phosphoramidites to the kilogramme scale and beyond.

Dr. Catherine McKeen, Technical Manager at Link Technologies, commented: “As a company dedicated to the provision of quality molecular tools, Link Technologies has the expertise and capacity to rapidly upgrade a product from small scale generation to production in kilogramme quantities, as and when commercial progression dictates. Link Technologies can uniquely offer researchers supply and support throughout the entire research and testing lifetime of a Link product, omitting the need to change suppliers and thus eliminating any associated risk with product variation.”

The range of phosphoramidite modifications available is large and growing, fuelled in part by the extensive research and optimisation programmes being undertaken at suppliers such as Link Technologies. With over 20 years’ experience in the manufacture of

modified phosphoramidites and solid supports, Link Technologies continues to build good relationships with CMOs; partnering and providing expertise for the product journey from research compound to commercial reagent. This proactive approach not only assists the development of the chemical process but also allows Link Technologies to

recognise and react to early indicators of future product demand, ensuring that the company remains on top of trends to meet research needs.

Link Technologies Ltd +44 1698 849911 david.hannah@linktech.co.uk www.linktech.co.uk

HPLC Columns Now Available with 3 µm Particle Size Thermo Fisher Scientific has announced that Thermo Scientific Syncronis HPLC columns are now available with 3 mm particle size. This new particle size complements the existing 1.7 and 5 µm particle sizes.

“This builds on the heritage of the Syncronis family of LC columns, which offer consistent, reproducible separations with high loadability,” said Darren Thomas, Thermo Fisher Scientific General Manager, Chromatography Consumables. “This is an excellent solution for those scientists that have standardised their separations on 3 mm particle size. The expanded range of Syncronis columns matches a diversity of requirements from fast method development to rugged QC and high efficiency preparative LC.” Syncronis columns are built on a

Ultra Compact Weigh Module The innovative WMC is designed for easy integration into machines and instruments. The weigh module has a width of only 25mm and offers accuracy between 1mg and 0.01mg. It is the perfect combination of compact design, high speed and reliable accuracy. Exceeding the known performance for such devices, the WMC enables completely new applications. backbone of highly pure, high surface area silica. Dense bonding and double endcapping minimise variation due to silanol activity. Enhanced automated column packing methods drive consistency even further and each column is individually tested.

/CMG CP KPVGNNKIGPV OQXG KP VJG ƂGNF QH QPDQCTF YGKIJKPI YYY OV EQO YOE Y Y Y OV EQO YOE

Thermo Fisher Scientific, Inc. +1 408 481 4172 sonya.pelia@thermofisher.com www.thermofisher.com/syncronis EPM 21

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Latest Modular Flow Reactor Models Extend Synthesis Capabilities Uniqsis has announced a new portfolio of modular flow systems, based around its Binary Pump Module (BPM) and FlowSyn flow reactor technology to provide users with greater flexibility and broader synthesis capabilities.

Uniqsis developed the original twochannel FlowSyn flow reactor system as a fully integrated ‘one box’ solution to make the emerging technology of continuous flow chemistry easily accessible to anyone with an interest in exploring and exploiting this exciting field of research. This system, which handles simple homogeneous and heterogeneous reactions at the push of a button, represents an easy, hassle-free entry into continuous flow chemistry.

As users and applications have become more sophisticated, Uniqsis has developed more powerful and sophisticated FlowSyn systems, culminating in the FlowSyn Auto LF capable of executing multi-step, multireagent experiments completely automatically and unsupervised. Since then, the number and variety of

applications for continuous flow chemistry have continued to proliferate, requiring flow systems to be ever more flexible and more easily customised by users.

Uniqsis has responded to these requirements by developing the versatile BPM, a standalone, two-channel, highpressure reagent delivery system, which can form the basis of a modular continuous flow system. Users can add reactor modules of their choice to the BPM to create a modular system tailored to their specific application, with the BPM and its dedicated control software acting as the hub for the system. Uniqsis supplies a wide range of reactor modules and accessories for this purpose, including column, coil and chip reactors, heating and cooling modules, fraction collectors and data collection and reporting modules. The latest module in the lineup is the Polar Bear Plus Flow reactor module, which offers outstanding cooling technology in a compact and portable package.

Delivering temperatures from

-40˚C to 150˚C without the need for cardice or liquid nitrogen, it can operate independently or be controlled via the BPM as a standalone flow chemistry system.

Capable of pumping up to 100 ml/min and operating at up to 200 bar, the BPM is available in a choice of three flow paths — PTFE, stainless steel and Hastelloy — for optimum chemical compatibility. To help users configure systems for their applications, Uniqsis has included a useful interactive system builder on its website.

Paul Pergande, Managing Director of Uniqsis, commented: “It’s very exciting for us to be at the forefront of this dynamic new technology and to be able to develop our product offering in line with user requirements. When continuous flow chemistry first came into being, our goal was to make simple applications easily accessible to anyone who wanted to get to know the

technology. The emphasis now is to ensure that users can exploit the technology to its full extent by giving them the tools and flexibility to develop new and exciting applications not previously attempted.”

Uniqsis Ltd +44 845 864 7747 info@uniqsis.com www.uniqsis.com

Customisable Freeze Dryers Meet Host of R&D Requirements Designed for maximum flexibility and performance, IMA Life’s benchtop freeze dryers can be customised with a range of accessories to support the needs of laboratories and research and product development teams.

Machine and accessory selection depends upon: • The required ice condenser temperature, i.e. -55˚C for water based samples, -85˚C for substances with low freezing points or containing organic solvents.

• The number and shape of product containers per batch, e.g., vials, flasks, filter bottles, test tubes, pans, etc.

• The maximum ice condenser performance required, i.e. total quantity of ice produced until defrosting of the condenser.

Routine processes require freeze drying systems to have high degree of consistency, user-friendly and intuitive technical features and flexibility to function as a shared asset in the laboratory. IMA Life’s ALPHA and BETA Series, combined with the specially developed operator interface LDplus

(Lyo-Display), live up to the challenges of safe, successful and economical freeze drying.

Lyophilising valuable products requires robust system configuration. IMA Life offers extensive advice during machine selection and upon request can run freeze-drying tests in its applications laboratory. For advanced processes, IMA Life’s high quality freeze dryers are equipped with a modern, powerful interface known as the Lyo-ScreenControl (LSC). It stores up to 30 different drying recipes and has a PC connection for batch documentation and process control. IQ/OQ validation documentation is also available.

The EPSILON is a high performance unit for freeze drying larger batches of products in ampoules, vials, glass flasks, plasma bottles or dishes. All operations are possible inside the stainless steel chamber: • Pre-freezing of products on liquidcontrolled shelves down to shelf temperature of approx. –55˚C, according to preselected ramp time and temperature limits.

• Freeze drying (sublimation) of products according to preselected ramp time, temperature and pressure limits. Shelf temperature at the initial phase of the sublimation process is approx. –55˚C. • Final drying of products within preselected ramp time and temperature limits and high final vacuum to remove the capillary and molecular bound water. Final vacuum is approx. 0.001 mbar (depending on pump performance).

The EPSILON is excellent for freeze drying bacteria and virus cultures, blood plasma, serum fractions, antibodies, vaccines, pharmaceutical products, vitamins, fermentations and plant extracts for biochemical testing.

IMA S.p.A - Life division +39 051 651 4111 mktg.life@ima.it www.ima-pharma.com

Portable Gel Documentation System for Imaging Real-Time Nucleic Acid Gels A new, lightweight, portable gel documentation system that enables visualisation of real-time size fractionation of nucleic acids has been introduced by electrophoresis specialist Cleaver Scientific Ltd (CSL). The RunDOC gel documentation system is designed exclusively for use with CSL’s runVIEW system and comprises a darkroom hood and a 10 megapixel digital camera to capture images of nucleic acids gels stained with EtBr, SYBR and runSAFE. RunDOC is designed to be placed directly over the RVMSCHOICE gel tank located on the runVIEW base unit, which includes an integrated power supply and blue LED gel illuminator. The blue LED gel illuminator provides the excitation source for the DNA gel located within the tank and following excitation the light emitted is then

visualised using either one of the bluVIEW lid options supplied with runVIEW or the runDOC filter slide.

In addition to being lightweight, runDOC has a small footprint and so requires only minimal space within the laboratory. Once fitted quickly and easily over the gel tank and base unit, gels can be imaged either in real time or at the end of the electrophoresis run. Integral extractor fans in the bluVIEW lid and the runDOC darkroom hood remove any condensation to ensure that visualisation and resolution are not impaired during and after electrophoresis.

RunDOC’s high resolution 10 megapixel camera with 4GB memory card allows for storage of images in either RAW or JPEG formats while the interchangeable filter slide and bluVIEW filter options provide the user with optimum flexibility.

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Cleaver Scientific Ltd +44 1788 565300 sales@cleaverscientific.com www.cleaverscientific.com

SHOWCASE PIPETTING Advanced Pipetting Technology Helps Optimise Protein Purification Processes Rainin Instrument, a Mettler Toledo subsidiary, has published a white paper describing the optimisation of protein/antibody purification. The paper, entitled ‘Optimizing Protein Purification Conditions’, highlights the use of Rainin

PureSpeed protein tips. Using Rainin’s E4 XLS electronic pipette, PureSpeed tips allow for bidirectional sample flow over the purification resin bed, maximsing target protein capture by allowing the binding reaction to reach

equilibrium. Potential concentration steps, which can actually degrade protein quality, are eliminated, saving time and costly rework.

To demonstrate the process, a 6-Histagged protein and s 20 µL Ni-IMAC PureSpeed tips were used with a Rainin E4 XLS pipette. Back-and-forth capture flow was used to ensure complete resin exposure during all steps.

Concentrations of imidazole in the wash buffer and final elution were varied to help illustrate purification optimisation, targeting both quantity and purity of captured protein. The experiments illustrate that PureSpeed wash and elution chemistries, which are carried out at reduced volumes, generalise to larger scale preparative systems, making PureSpeed a cost-effective optimisation tool.

The paper also reviews aspects such as protein size that can affect the capture equilibrium as well as ways to

help enhance protein capture by adjusting pH and flow rate or increasing cycle numbers. Rainin’s ColorTrak Guide also proved useful at helping non-expert operators load and purify a specific protein or antibody.

For more on how Rainin and proprietary PureSpeed technology can help optimise protein purification processes for time and cost savings, download the complete white paper at bit.ly/optimisingproteinpurification.

Rainin Instrument, LLC +1 510 564 1736 terry.peckham@rainin.com www.mt.com

384-Channel Pipetting System Enables Simple Yet Accurate Sample Transfer Designed to enable laboratories to process samples simply and productively, the INTEGRA VIAFLO 384 is a new, handheld, 384-channel electronic pipette that enables fast, precise and easy transfer of 384 samples simultaneously.

The VIAFLO 384 offers all the benefits of increased sample throughput as well as lower sample and reagent use without the expense of having to invest in a robotic liquid handling system.

The compact VIAFLO 384 comes with a choice of two 384-channel pipetting heads, covering the volume ranges of 0.5–12.5 µl and 5–125 µl. The new system is fully compatible with VIAFLO 96 channel pipetting heads, enabling easy switching between 96-channel and 384-channel pipetting using the same unit.

Like the popular VIAFLO 96 handheld

electronic pipette, the VIAFLO 384 has been designed to be used just like a standard handheld pipette. Therefore, no special skills or training are required to operate it. Servo assisted motor steering ensures that operating the VIAFLO 384 is both effortless and precise. The VIAFLO 384 features the company’s popular Touch Wheel pipette user interface, enabling simple and fast programming of a wide range of pipetting modes, including repeat dispense, serial dilute and mixing routines.

The customer will immediately benefit from the increased productivity and high precision delivered by their VIAFLO 384.

Fast plate filling and replication, reagent addition or serial dilutions in 96- and 384-well plates is now as easy as pipetting with a standard electronic pipette into a single tube. The VIAFLO

384 comes with 10 pre-defined pipetting modes, enabling the system to be used productively almost immediately. A further 20 user designated custom programs allow diverse and complex pipetting operations. The VIAFLO 384 can be connected to a PC with VIALINK software, enabling easy custom programs exchange and firmware upgrades.

Using the VIAFLO 384, position settings, like pipetting height or tip alignment to the wells, can be defined by the user, ensuring optimal access to all types of 384-well plates. The VIAFLO 384 is fully compatible with VIAFLO GripTip pipette tips, which provide a perfect seal every time and will not fall off during use. New, extended length 12.5 µl GripTips ensure the system can be used to effectively process deep well blocks.

INTEGRA Biosciences AG +41 81 286 9530 info@integra-biosciences.com www.integra-biosciences.com

Pipette Supplier Celebrates 40th Anniversary Gilson Scientific recently reached a major milestone, celebrating 40 years in business. Four decades ago, the PIPETMAN pipette was reportedly created as the first continuously adjustable volume pipette on the market with its patented volumeter registered in 1972. Today, PIPETMAN is still one of the most popular pipettes in laboratories worldwide. Since then, Gilson has focused on launching new products based around the reputable PIPETMAN. With over fifteen different pipettes within the company’s manual liquid range, all Gilson pipettes are renowned for their accuracy, precision and

robustness. From the legendary PIPETMAN Classic, the new PIPETMAN G through to the fully motorised PIPETMAN M, PIPETMAN has evolved to meet even the most intensive pipetting routines, addressing the susceptibility of RSI, throughput and productivity. The latest model, the PIPETMAN L, offers incredibly low pipetting forces, a patented volume locking system and completely new, redesigned lightweight body for superior comfort and secure pipetting. It is now also available as a multichannel pipette combining absolute comfort and consistency across all channels.

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Gilson Scientific Ltd +44 845 5196 872 customersupport@gilsonuk.com www.gilsonuk.com

Corporate News

Princeton Facility to Support Sales of Terahertz Spectroscopic Imaging System Advantest America Inc, a subsidiary of Advantest Corporation, has announced the opening of an office in Princeton, New Jersey. The new facility, which incorporates offices and a laboratory, establishes a presence for the company in the heart of the pharmaceutical industry’s most research-intensive corridor, where many leading pharmaceutical companies are headquartered. According to Advantest, the TAS7500 delivers advanced terahertz spectroscopic technology for rapid, non-destructive imaging and analysis of pharmaceutical samples in the liquid or solid state, enabling previously unattainable levels of 2D and 3D visualisation, critical to the design, evaluation and manufacture of pharmaceutical products.

Since its introduction in 2011, the TAS7500 has attracted attention from several key drug companies. Leading

US pharmaceutical manufacturers as well as top-tier Japanese pharmaceutical firms have entered into consultation with Advantest regarding adoption of the system. The new Princeton office will conduct intensive sales and marketing activities in addition to offering system demos at its new laboratory, which is equipped for full operational research with state-of-the-art pharmaceutical tools, including NIR1, XRD2, DSC3, a TGA analyzer4 and Raman spectroscopy equipment as well as two TAS7500 systems, each comprising an imaging unit and a spectroscopic unit.

“Through a direct and localised presence, the establishment of a Princeton office allows us the opportunity to better meet the needs of our customer base,” stated Haruo Matsuno, Advantest Corporation’s President and CEO. “Because New

Jersey boasts a significant concentration of the world’s leading pharmaceutical companies, situating the office in close proximity to key R&D activities will help the company expand its reach in this major market,” he continued.

The TAS7500 utilises a proprietary method developed

by Advantest to achieve rapid, non-destructive imaging and analysis of pharmaceutical samples in the liquid or solid state. Crystalline qualities, the characteristics of constituents and even the thickness, density and internal structure of tablet coating may be analysed and visually rendered in two or three dimensions. The system offers lower costs and higher efficiency at all stages of drug development from laboratory research to process scale-up.

According to Advantest, the TAS7500 is

poised to contribute to the new pharmaceutical R&D paradigm, which is based on intelligent risk management and incorporates the ICH5 guidelines that are being adopted by an increasing number of firms.

Advantest Europe GmbH info@eu.advantest.com www.advantest.de

ELN Specialist Achieves Very High Rating in Six Categories of Research Report IDBS is one of only five firms out of 34 to be rated as an ELN Enterprise Vendor in Gartner’s research report titled ‘Manufacturers Must Consider Scientific Domain Expertise During ELN Selection’, published 11 January 2013.

The report, based upon hundreds of customer and vendor conversations, also gave a Very High/High rating to IDBS’ deep domain expertise across five of the six key scientific areas, namely Biology, Translational Medicine, Chemistry, Formulations and Regulated (process) Environments. It received a Medium rating for Engineering.

A ‘Very High’ rating means the vendor has excellent scientific domain capabilities and is approaching the ‘de facto’ standard. IDBS is the only Enterprise ELN Vendor to have a Very

High rating in more than one category.

The research is designed to be a starting source to create shortlists of vendors that best serve scientific and functional domains.

Neil Kipling, CEO and Founder of IDBS, said: “We have a 20-year history of helping customers treat their R&D data as a capital asset. As the largest independent company in our sector, we have moved fast and invested early to meet the needs of a newly data-centric R&D environment. For us, this report confirms that we provide an unparalleled breadth of capability in E-WorkBook. Our expanding customer base now ranges across multiple industries and scientific domains, from basic research through process development into translational research. All of them are benefitting from

improved business insights and measurable efficiencies.”

For more information or a full copy of the report, visit www.gartner.com (Gartner client access login required).

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

Lab Tools Provider Announces French Subsidiary

Partnership to Provide LIMS Software for Spectrophotometers

Following the 2012 acquisition of its long time French distribution partner Valdea Biosciences SAS, INTEGRA Biosciences has announced that from now on all its operations in France will trade as INTEGRA Biosciences SAS, St Ouen l'Aumône, France.

Leveraging an existing knowledgeable local sales and service team, INTEGRA Biosciences SAS has been given the resources to market and provide top quality local support for the company’s laboratory tools for liquid handling, media preparation, sterilisation and cell cultivation.

As part of its expansion of operations, INTEGRA has launched a new comprehensively featured French language website — www.integrabiosciences.com/fr — which provides detailed information on the company’s growing range of products and application solutions.

Two Fold Software has joined with Bibby Scientific to supply new Qualoupe Lite software for incorporation into Jenway brand 67 series spectrophotometers.

Qualoupe Lite provides users with an intuitive LIMS to automate data management and transfer. Using Qualoupe Lite, analysis results and method information can be transferred directly from the spectrophotometers to the database, removing the need for complicated traditional systems. The system is easy to use, with minimal training required to store and recall laboratory data, including the printing of result reports from the Sample Manager application.

“By creating a true Lite product that is affordable for businesses of all sizes, we make LIMS available to companies aiming to move towards automated laboratory data management,” said Clive

INTEGRA Biosciencesis committed to creating solutions that fulfil the requirements of its customers in research, diagnostics and quality control within the life science markets and medical industry.

Today, INTEGRA laboratory products are widely used all around the world.

More than ninety distribution-partners form a worldwide sales network, providing responsive and competent services to customers. These distribution partners are supported by a highly motivated and experienced team of specialists at the company headquarters in Zizers, Switzerland, and Hudson, New Hampshire, US. INTEGRA is an ISO 9001 certified company.

INTEGRA Biosciences AG +41 81 286 9530 info@integra-biosciences.com www.integra-biosciences.com

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Collier, Managing Director of Two Fold Software. “In the past, there have been Lite LIMS products available but the prices rarely made them accessible. This collaboration with Bibby Scientific means more companies can feel the benefit of an intuitive and effective Qualoupe Lite system without committing to large costs.”

Two Fold Software Ltd +44 844 208598 info@twofold-software.com www.twofold-software.com / www.jenway.com

INGREDIENTS & CONTRACT SERVICES

Global CMO Partners with Univerisities to Commercialise API Manufacturing Technologies Aesica has announced its second major innovation board partnership following the recent annual Genesis conference, a famed hotbed of future innovation.

The METRC Innovation Awards support new research between universities and companies in the fields of nanotechnology, science and engineering. Aesica, the University of Durham and the University of Leeds were jointly awarded the grant to investigate and accelerate the development of processes that will improve cost efficiencies and increase manufacturing capacity at Aesica’s Cramlington site.

Earlier this year, the company established the Aesica Innovation Board (AIB) to identify and commercialise new innovative technologies that help to bridge the growing R&D gap and the company is actively targeting academia and businesses to form development partnerships with.

This latest partnership builds on the successful collaboration with Bradford University earlier in the year. The new partnership with the University of Durham and the University of Leeds will be tasked with developing new or improved routes for the manufacture of an API. A detailed kinetic study is already underway and based on this new flow processes will be developed before being scaled up at the Aesica Cramlington plant.

“Professor Andrew Whiting from Durham University and Professor Frans Muller from Leeds University will work together on a new collaborative METRCfunded project with the global pharmaceutical manufacturer Aesica Pharmaceuticals,” said Prof. Steve Armes, Academic Director of METRC. “Alternative manufacturing processes will be investigated to increase the manufacturing capacity of the API as

Preparing the RC1 calorimeter in the API development laboratories at Cramlington.

API manufacturing plant at Cramlington. well as explore how to achieve cost efficiencies at the Aesica Cramlington manufacturing site, which is based in the North East of England. If, as expected, this joint collaboration leads to commercialisation of new processes, it would become a key partnership.”

“We are delighted to officially embark on this partnership with Andy at the University of Durham and Frans at the University of Leeds,” said Barrie Rhodes, Director of Technology Development, Aesica Pharmaceuticals.

“Andy and Frans have been hugely supportive of the mandate of the Aesica

Innovation Board: to bring together the best that industry and academia have to offer in the interests of pharmaceutical innovation. The successful METRC application will allow us to invest in researching an improved manufacturing process and, critically, establish a successful model for future collaboration with Durham and Leeds universities.”

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

Major Investment to Expand Inhalation Capabilities at Research Triangle Park Catalent Pharma Solutions announced that it will make a major investment to expand its inhalation drug development, delivery and supply capabilities by enhancing its Inhalation Center of Excellence in Research Triangle Park (RTP), North Carolina, US. The $20 million planned investment will focus on expanding pressurised Metered Dose Inhaler (pMDI) clinical and commercial supply capabilities as well as other enhancements to the facility.

Catalent provides a broad range of inhalation services, including API optimisation, pre-formulation, formulation, analytical testing and manufacturing across all inhaled dosage forms at the RTP facility and advanced

aseptic development and fill/finish supply solutions facility in Woodstock, Illinois, US. “Pulmonary and nasal represents the second largest drug delivery market by delivery route. Catalent’s investment in commercial manufacturing at our Inhalation Center of Excellence not only fits with our advanced drug delivery growth strategy but also positions us as a world leader supporting inhaled products,” commented Scott Houlton, President of Catalent’s Development and Clinical Services business. “In addition to the introduction of scalable processes for micro-dosing inhalation powder formulations and the recent commissioning of our new nasal filling

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suite, this $20 million investment will upgrade our pMDI manufacturing capacity and allow us to better support our customers from early development all the way through to commercialisation, bringing more products and better treatments to market faster.”

Catalent Pharma Solutions +1 877 587 1835 sales@catalent.com www.catalent.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP Drug Product Development Capacity Doubles with Non-GMP Facility

EXCiPACT Approves European Certification Body for Pharma Excipients

Almac has announced the expansion of its drug product Pharmaceutical Development services with the creation of a new non-GMP formulation development facility and two new analytical laboratories at its UK headquarters in Craigavon. The new facilities double the company’s current pharmaceutical development capacity to meet the growing demand for its services, both from existing and new clients.

The new, non-GMP formulation development facility offers clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the GMP environment at an appropriate stage. Although the new facility will be dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs. Whereas the existing GMP facilities can support drug product manufacturing from phase I up to registration and commercial scale, the new non-GMP facility will primarily focus on laboratory scale experiments, with batch sizes

Supported by extensive professional knowledge of blue inspection body GmbH, the mdc (medical device certification) GmbH represents the first European certification body for pharmaceutical excipients. mdc and EXCiPACT have signed a respective framework agreement. The EXCiPACT certification scheme is an initiative of industrial associations from excipient and pharmaceutical suppliers, aiming for a professional surveillance of GMP and GDP compliance. The initiative provides a certification scheme for regular monitoring of excipient suppliers by auditors from accredited certification bodies. The resulting EXCiPACT certificate and the respective audit report may be issued from the excipient supplier to their pharmaceutical customers.

According to Directive 2011/62/EC for pharmaceutical excipients such as Lactose, Cellulose or Glycerole, appropriate GMP shall be ascertained based upon a formalised risk assessment. Increasing regulatory GMP and GDP requirements for pharmaceutical excipients demands a tighter monitoring of the excipient supply chain by drug product manufacturers. Regular audits are therefore mandatory. Up to now, these GDP and GMP audits were coordinated by every drug product manufacturer individually. Manufacturers of certain excipients are facing more than 100

ranging from <1 kg up to an expected maximum of 15 kg scale for most technologies.

John McQuaid, VP of Technical Operations, explained: “Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities. Duplicating equipment trains means that we can conduct nonGMP work efficiently and then transfer rapidly to GMP manufacturing for clinical and registration batches. We are finding that demand for non-GMP process development work has increased as clients seek to better understand their processes in line with the principles of QbD. This type of work also creates large sample sets for analytical testing and multiple stability studies, which is why it was also important that we doubled our analytical capacity in parallel.”

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

Chemistry CRO Bolsters US Team Onyx Scientific has strengthened its US presence with the appointment of a Chicago-based Business Development Director. Dan Brisard will oversee the contract manufacturing organisation’s business development activities across the eastern half of the US. An experienced commercial executive, Brisard has worked across the pharmaceutical manufacturing sector for around fifteen years, including seven years with Ricerca Bioscience.

A graduate in Chemistry from the University of Illinois and in Analytical Chemistry from the Illinois Institute of Technology, he also brings technical knowhow to his new role that will assist the company’s US-based pharmaceutical and biotech clients.

Denise Bowser, Commercial Director at Onyx Scientific, said: “Having Dan on board is a massive boost to the company as he brings exceptional commercial experience Dan Brisard joins Onyx Scientific. gained in the industry along with a strong chemistry background.

“At the request of our customers, we have really looked to expand our offering over the last year to minimise the need for clients to use several suppliers on the same project. Dan will play a key role in communicating the breadth of our services in addition to our track record and achievements to the US market.”

With MHRA and FDA facilities in the UK and India, Onyx Scientific assists companies from medicinal chemistry and preclinical through Phase I–III, scaling up to large scale commercial API production.

Brisard said: “I have been really impressed with Onyx Scientific over the last few years and was attracted by the company’s strong reputation in the contract chemistry and manufacturing marketplace.

“The team is very experienced and we have some serious capabilities when it comes to lead optimisation, process development, solid-state chemistry and GMP synthesis. I look forward to working with my new colleagues to help the company meet its commercial ambitions and increase market share in the US.” In recent months, Onyx Scientific has expanded its services to the global pharmaceutical market by striking alliances with purification and separation specialist Reach Separations and contract research and manufacturing organisation Molecular Profiles to support its end-to-end services from drug discovery through to late phase manufacturing.

Onyx Scientific’s UK-based laboratories deal with complex chemistry to deliver early stage programmes and the company is then able to scale-up, tech transfer and increase project efficiency using its commercial manufacturing sites in India.

Onyx Scientific www.onyxipca.com www.twitter.com/onyxscientific1 EPM 26

audits per year. It is the aim to pool and to improve these audits. For this purpose, EXCiPACT qualifies independent third-party auditors that are capable of auditing the companies according to pre-defined, fixed standards. Instead of conducting their own audit visits, drug product manufacturers will be able to refer to these audit reports and the EXCiPACT certificates.

“EXCiPACT has defined particularly high standards in order to ensure approval of these audit reports by the health authorities,” reported Dr. Stefan Kettelhoit of blue inspection body GmbH. “The manufacturing of excipients shall, for example, only be evaluated by auditors that belong to a certification body accredited by a national accreditation body such as the German Association for Accreditation in Germany.” blue inspection body GmbH +49 251 625620 40 stefan.kettelhoit@blue-inspection.com www.blue-inspection.com

Nasal and Pulmonary Devices Specialist Elects President for Prescription Division Jean-Marc Pardonge has been appointed as the new President of Aptar Pharma’s Prescription Division.

Pardonge succeeds Salim Haffar and becomes the new General Manager of Aptar Stelmi (the Stelmi company was recently acquired by Aptargroup).

After graduating from the French ENSAM engineering school (Ecole Nationale Supérieure d’Arts et Métiers), Pardonge joined Aptar Pharma Prescription Division in 2000 as R&D Manager. He was promoted to the position of Vice President R&D in 2003.

In January 2010, he became President of Global Market Development (GMD) of Aptar Pharma’s Prescription Division. In this role, he managed and co-ordinated worldwide activities that included scientific and regulatory affairs, business development, communication, engineering, innovation, marketing, projects and R&D. Aptar Pharma’s Prescription Division will leverage Pardonge’s in-depth knowledge of both the pharmaceutical market and its customers to take full advantage of market opportunities for growth.

Aptar Pharma, Prescription Division +33 1 39 17 20 41 elisa.eschylle@aptar.com www.aptar.com/pharma

INGREDIENTS & CONTRACT SERVICES ROUNDUP Packaging Solutions Provider Announces Restructure Following Integration of US and European Teams

AndersonBrecon has announced two senior promotions in line with the recent realignment of the Brecon Pharmaceuticals and Anderson Packaging businesses. Peter Belden, Managing Director, AndersonBrecon Europe, will step into the role of Senior Vice President of Global Commercial Services, while Dr. Sue Miles will assume responsibility for all four of the UK facilities in the role of UK Site Director.

These promotions support the further integration of the US and European businesses.

Belden will oversee all activities conducted by the global sales and marketing team, have responsibility for the US project management team and retain his overall responsibility for AndersonBrecon Europe. Recently named Outsourcing Executive of the Year at the European Outsourcing Awards for his work in aligning the US and European businesses, Belden will return to the US after three years operating at the UK site in Hay-on-Wye, Wales.

Miles will be responsible for overseeing operations at all of the four UK sites. In this role, She will lead and provide advice and support to the UK team.

CDMO Boosts Senior Management Team with Marketing Appointment

Responding to the evolving pharmaceutical marketplace and provision of efficient and more competitive solutions to meet customers’ global needs, the restructure underpins the company’s commitment to providing customers with a holistic, truly global healthcare packaging solution, from clinical trials support right through to commercialisation.

Belden commented on the move: “As a fully integrated global business with 12 facilities across two continents, serving over 100 countries around the world, the position changes are a natural progression for AndersonBrecon. It is essential that the teams are able to embrace and share each others’ skills and expertise in a broad range of markets. We are confident that this will provide us with the combined knowledge and capabilities that will allow us to provide our customers with an allencompassing skill-set following the pivotal re-brand.”

AndersonBrecon www.andersonbrecon.com www.twitter.com/andersonbrecon

Penn Pharma has appointed Kat Jones as Director, Marketing and Commercial Operations. Based at the company’s Tredegar offices in South Wales, UK, Jones will strengthen the executive board in relation to marketing, communications and commercial planning. She joins at a crucial time for Penn Pharma as it gears up ready for the launch of its brand new Contained Manufacturing operation situated at the same site.

With over eighteen years’ experience in various senior sales and marketing roles, Jones brings a wealth of expertise to reinvigorate Penn Pharma’s brand image and route to market to both large and small pharmaceutical companies.

Previously working on a consultancy basis to other leading healthcare brands, Jones has also held positions at Bupa where she was Commercial Director, Archimedes where she was Sales Director as well as senior roles within Pfizer Marketing and Aventis.

A brand new role on the Penn Pharma executive board, Jones’s position as Director for Marketing and Commercial Operations has been created as the company looks to strengthen its appeal to international companies in the pharmaceutical sector. In particular, Jones will be tasked with marketing the new Contained Manufacturing facility in South Wales to clients internationally and continue to build on Penn’s heritage.

Jones will report to Chief Executive Dr. Richard Yarwood, who is delighted to have her on board. “2013 is going to be

a significant year for us at Penn Pharma and so it is vital we have the right components in place to support the demand for both our existing and new services,” he said.

“Kat has the perfect attitude, experience and approach to making sure our clients continue to receive the expertise and service they require whilst making sure the world knows about our new contained facility. I am confident that Kat is just the person to help us make that known to the industry and really put Penn Pharma on the map.”

On joining the team, Jones said: “The next six to twelve months are certainly going to be a period of change for Penn Pharma and I feel privileged to be a part of this. Having come from a different side of pharmaceuticals, I am hoping to bring a fresh approach to communications and commercial operations that will give the business a new look and feel.”

Penn Pharma has a wealth of experience in successfully providing an integrated range of services for the development, manufacture and distribution of medicinal products to the global pharmaceutical market. The company’s new containment facility includes equipment and systems for the development, clinical and commercial supply of tablets and capsules containing highly potent actives.

Penn Pharma Ltd +44 1495 711 222 www.pennpharm.com

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INGREDIENTS & CONTRACT SERVICES ROUNDUP Production Site Receives European Organic Certification for Plant-Based Capsules Capsugel’s Colmar manufacturing facility in France has been awarded European Organic certification for the production of finished products using its new generation, plant-based Licaps capsules. Initially, six formulations, as well as the manufacturing process, have been certified as organic. Capsugel is working with customers to develop new products to expand its list of organic finished products. The European Organic certification is recognised by all European Union member countries.

Organic certified products have been gaining in popularity as they are produced without the use of artificial chemical products while using environmentally responsible approaches. According to the Global Organic Foods & Beverages Market Analysis (2010–2015), Europe is the largest consumer of organic food, beverages and supplements.

“With growing customer demand for high quality organic health and nutrition products, Capsugel worked closely with the Bureau Veritas to secure organic certification for finished products using our established plant-based Licaps liquid-filled capsules,” said Erasmo Schutzer, Senior Vice President and

Chief Marketing Officer for Capsugel.

“With our expertise, we can support customers in developing new organic finished products — including feasibility testing and certification requests — using our next generation plant-based Licapscapsules.”

Capsugel’s next generation, plantbased Licaps liquid-filled capsules are based on the company’s well-known Vcaps Plus capsule technology, made from plant derived cellulose called Hypromellose (HPMC). The new Licaps

capsules ensure pH-independent release of active ingredients because the capsule shells do not contain any additional gelling agents. The capsule is hermetically sealed using the company’s fusion technology, resulting in a perfectly tight, one-piece capsule.

“The organic certification of Capsugel’s Colmar facility for plantbased Licaps capsules adds to the company’s comprehensive line of vegetarian products for the healthcare market,” said Catherine Lehmann,

Director of Marketing for EMEA. “From our recently introduced Plantcaps capsules to our innovative Vcaps Plus capsules and DRcaps acid resistant capsules, customers have a range of vegetal origin capsule options that meet the demands of the savvy green customer.”

Capsugel EMEA +33 3 89 20 57 25 marketing.emea@capsugel.com www.capsugel.com

CRAMS Provider Appoints Vice President and General Manager of Large Scale Manufacturing AMRI has promoted Richard A. Saffee to the newly created role of Vice President and General Manager of Large Scale Manufacturing. He will continue to report to Steven R. Hagen, Ph.D., Senior Vice President of Pharmaceutical Development and Manufacturing.

Saffee will assume oversight for large scale manufacturing in Aurangabad, India, in addition to his current responsibilities for leadership of AMRI’s large scale manufacturing and GMP business in the US in the Capital Region of New York. Additionally, he will work with AMRI’s Holywell, UK site to assist in its large scale manufacturing business.

Saffee will be positioned to drive synergies between the locations that will improve quality, efficiency and delivery of world class APIs. “We are pleased to announce this promotion of Mr. Saffee,” said Dr. Hagen. “He joined AMRI in 2009 with more than 23 years of industrial and

leadership experience in the chemical manufacturing of bulk APIs for both human and animal health. Since joining AMRI, his leadership has been instrumental in many successes achieved at the Rensselaer large scale manufacturing location. We look forward to his leadership in our continued efforts to achieve closer integration among all of our manufacturing facilities.”

Backed by an excellent compliance history and track record, AMRI’s worldwide manufacturing facilities are equipped for Phase I through commercial API manufacturing. As a part of AMRI’s SMARTSOURCING initiative, this closer integration of facilities under Saffee provides an added advantage as customers move their compounds from early development to high potency and large scale manufacturing. These global sites in the US, Europe and Asia also provide tailored solutions for the biotechnology and pharmaceutical

industry and enable the efficient, costeffective transfer of products and projects. AMRI also provides raw materials and starting materials for cGMP manufacturing of APIs. Before coming to AMRI, Saffee led manufacturing activities for multiple USbased operations for Pfizer Global Manufacturing and Pfizer Global Human Health. Prior to the acquisition of ParkeDavis by Pfizer, Saffee held roles of increasing responsibility at Parke-Davis, including Director of Chemical Manufacturing and Area Production Manager. He has extensive knowledge in the areas of chemical manufacturing, technology transfer, regulatory compliance and quality standards, purchasing and materials management and managing global relationships. He is also trained in Lean Six Sigma techniques.

Saffee earned a Master’s degree in Business Administration from Grand

the sterile manufacturing and filling of drugs so we need to always ensure we have the right level of expertise and resource to meet regulatory requirements. At present, almost a third of our entire workforce sits within the quality function, which demonstrates our commitment to achieving the highest quality standards across our development, clinical trial supply and commercial production operations.

“Mark is an exceptional addition to our board of directors and will bring a great deal to our clients’ projects in terms of ensuring quality systems are robust, manufactured products are fit for purpose and the efficient release of products.”

The CDMO specialises in the sterile production of products for clinical trials along with the supply of licensed drugs in niche markets. It is currently gearing up for the opening of its new commercial

facility that will reinforce its expertise in vial, ampoule and syringe filling, particularly when dealing with highly potent and toxic products that require aseptic processing using isolator technology.

SCM Pharma’s newly appointed Quality Assurance Director said: “I am delighted to be joining such a dynamic and reputable manufacturer such as SCM Pharma. I’ve worked with many pharma companies over the years and my aim here is to develop quality metrics so they help drive the right behaviour that supports the business in its delivery of finished products.

“I am looking forward to the challenge of simplifying systems, making them more efficient and future proofing them to withstand increasing volumes and up and coming legislation.

A QP since 1992, Edwards has undertaken a Post Graduate Diploma in

Valley State University in Allendale, Michigan, US, and a Bachelor’s of Science degree in Chemical Engineering from the University of Michigan in Ann Arbor, Michigan.

Albany Molecular Research, Inc. (AMRI) +1 518 512 2512 www.amriglobal.com

CDMO Strengthens Quality Team SCM Pharma has bolstered its quality department and board with the appointment of a new Qualified Person (QP). Senior quality professional Mark Edwards joins the UK-based company as Quality Assurance Director to manage the QC function and be responsible for quality across the organisation’s three sites.

Edwards has spent over 30 years in the global pharmaceutical and biotech industry, having worked with the likes of Merck, Abbot and Fujifilm, and becomes the third QP at SCM Pharma. He brings extensive knowledge of quality systems, a variety of different dosage forms, production management and the undertaking of the preparation for preapproval inspections and other regulatory authorities to his new role.

Dianne Sharp, Managing Director at SCM Pharma, said: “There are hugely important quality requirements around

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Industrial Pharmaceutical studies at Brighton University. He is also a Graduate of the Society of Biology, specialised in Microbiology from the North East Surrey College of Technology, Surrey, UK, and a Fellow of the Institute of Biomedical Sciences from Paddington College, London, UK. SCM Pharma Ltd +44 1661 833 693 info@scmpharma.com www.scmpharma.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP Rebranding Aligns Recombinant Human Albumin Portfolio Novozymes Biopharma, part of Novozymes A/S, has introduced a new brand and visual identity for its recombinant human albumin (rAlbumin) portfolio. As part of the rebrand, Novozymes will bring both of the company’s rAlbumin products under its well-established Recombumin brand.

Albucult will be renamed Recombumin Alpha while Recombumin will now be known as Recombumin Prime in order to better synchronise the company’s product offering and create clarity for customers.

The newly announced changes are purely to the brand and visual identity of Novozymes rAlbumins. Customers can be reassured that the products themselves as well as the product codes will remain exactly the same. As part of the rebrand, customers will see the changes reflected on both marketing materials and product labelling.

The molecule in Novozymes’ two rAlbumin products is identical in respect of amino acid sequence and protein structure. They are both expressed in

Novozymes’ proprietary Saccharomyces host and are manufactured in compliance with ICH Q7 cGMP guidelines. The products’ physicochemical properties and customer applications are essentially identical and the name change has been introduced to allow Novozymes to market these two albumins under a single family name.

Novozymes’ rAlbumins provide a secure supply of batch-to-batch consistent materials and are supported by a strongly documented safety package and drug master file. With excellent purity profiles and offering an established pathway through the regulatory approval process, the products have earned a strong reputation in the industry for helping customers to facilitate the safe and successful commercialisation of new products.

“Novozymes is delighted to announce that it is synchronising the branding of its rAlbumin products under the Recombumin family name to enhance

Director of ICRA Receives Accolade for Environmental Research to Minimise Impact of Pharma Residues

CDMO Recipharm has announced that the Recipharm International Environmental Award 2012 has been awarded to Dr. Damià Barceló, Director of the Catalan Institute for Water Research (ICRA) and research professor at the Institute of Environmental Assessment and Water Studies (IDAEA).

The award is presented annually for the best environmental performance or environmental best practice and innovation by the pharmaceutical industry or the academic community.

Since Recipharm was founded in 1995, its commitment to environmental best practice has been a pivotal corporate mission.

Dr. Barceló’s longstanding and highly recognised work has played a vital contribution in achieving a shift in the scientific community’s focus towards tackling emerging pollutants as these chemicals are harmful to mankind due to their persistence and continuous introduction. Amongst Dr. Barceló’s main contributions are method development for pollutants, endocrine disruptors and pharmaceutical compounds.

Commenting on winning the award, Dr. Barceló remarked: “I feel very honoured to receive such an accolade from within the pharmaceutical industry in recognition of research efforts

including stabilisation of drugs and vaccines, device coating, advanced cell therapy products and in sealants and hemostats.

Novozymes Biopharma +44 115 955 3355 nlan@novozymes.com www.novozymes.com

Solid Dosage Specialist to Manufacture and Distribute Tablets for Mercury Pharma Group

devoted to first understanding and then minimising the impact of pharmaceutical residues on the environment.”

Lars Backsell, Chairman of Recipharm, said: “Dr. Barceló’s important work in finding solutions for environmental problems in water and soil by new and innovative ways of method development and monitoring gives an excellent and solid base for hands-on guidance for all interested parties — manufacturing industry, water treatment companies and authorities.”

The purpose of the Recipharm International Environmental Award is to encourage and inspire best practise and innovation, to promote good examples and to encourage environmental dialogue within the pharmaceutical industry.

Previous awardees are: • 2011 — Professor Benoit Roig, École des Hautes Études en Santé Publique, France.

• 2010 — Wellcome Trust Sanger Institute, Hinxton, Cambridge, UK. • 2009 — Professor Klaus Kümmerer, Freiburg University, Germany.

• 2008 — Apoteket AB, Sweden.

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

the clarity of the company’s product offering while still providing customers with the same superior solutions,” said Dermot Pearson, Marketing Director, Novozymes Biopharma. “Since we launched our rAlbumins, the portfolio has gone from strength-to-strength, helping Novozymes to become one of the fastest growing companies in the industry.”

Novozymes’ rAlbumins are compliant with the National Formulary (NF) rAlbumin human monograph published by the United States Pharmacopeia (USP) and have been optimised to deliver stable, safe and regulatory compliant ingredients for the medical device, drug delivery and formulation markets. Manufactured without animalderived materials, the products can be used in a wide range of applications,

Kemwell has signed an agreement with Mercury Pharma Group Ltd for the contract manufacture of pharmaceuticals in the new production facility in Uppsala, Sweden. “This agreement shows that we are indeed competitive in Sweden. Our new modern facility gives great opportunities for pharmaceutical manufacture in collaboration with both new and existing customers,” said the company’s CEO Agneta Bergvall.

Kemwell is a Swedish-Indian contract manufacturer with production facilities in both India and Sweden. Kemwell established itself on the European market six years ago when the company acquired a facility from Pfizer. Here, the company manufactures tablets, suppositories and capsules. Strong business development has allowed Kemwell to double production space in Sweden through expansion in new facilities.

Mercury Pharma Group is an international pharmaceutical company specialising in the sale of prescription drugs. The company’s products are

marketed worldwide with a focus on the European market. Kemwell’s agreement with Mercury Pharma Group covers the manufacture of tablets and release and distribution of products to Great Britain and Ireland.

“It is always exciting to start a new collaboration with a client,” said Bergvall. “We aim to serve our customers with the highest levels in quality and service, ensuring that the customer gets the right product at the right time. At Kemwell we strive daily to live up to our ambition of being a contract manufacturer of merit and to help our clients become more competitive. We focus on being a continually developing company with a reputation for trustworthiness and dedication.”

Kemwell AB +46 18 164117 agneta.bergvall@kemwell.se www.kemwellbiopharma.com

Pharma and Biotech Outsourcing Partner Completes Sale of US Affiliate NextPharma Technologies Holding has announced the sale of Bioserv Corporation, its US affiliate based in San Diego, to KESA Partners, Inc. The sale supports NextPharma’s growth strategy of focusing on its core specialty and conventional product and technology operating platform in Europe. NextPharma continues to expand its sales and marketing presence in North America and to develop long-term partnerships with North American customers.

Franck Latrille, Chief Executive Officer, NextPharma, commented: “The divestment of Bioserv represents a successful step in the implementation of NextPharma’s strategy, enabling us to focus our growth strategy on NextPharma’s core strengths and areas of expertise. I would like to thank Bioserv’s employees for their efforts and

EPM 30

contributions over the past years and I wish each of them, as well as Bioserv’s customers and new owners, a successful future.”

Al Hansen, Managing Partner, KESA Partners, added: “This is an exciting time for Bioserv. For almost 20 years, Bioserv has been known for its quality, flexibility and responsiveness to customers’ unique requirements. Bioserv is well positioned to benefit from the increased outsourcing in the pharmaceutical industry. Bioserv has a strong foundation to build upon. By enhancing our capabilities and emphasising excellence in quality and execution, Bioserv will become a leader in the contract manufacturing space.”

NextPharma Technologies Holding Ltd +44 1483 479 120 www.nextpharma.com

arvato Healthcare, Germany +49 5241 80 89073 andreas.olpeter@bertelsmann.de www.arvato-healthcare.com ByBox Field Support, UK +44 844 800 5219 andrew.gedny@bybox.com www.bybox.com Deutsche Post DHL, Germany +49 228 182 24104 www.dhl.com / www.dp-dhl.com

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Pallets, Containers and Packaging

Product Tracking (Data Matrix Codes, RFID)

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Temperature and Humidity Monitoring and Mapping

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Hellmann Worldwide Logistics, UK +44 1753 688 500 andreas.lohmeier@gb.hellmann.net www.hellman.net

Pharmadex Logistics Ltd, UK +44 845 678 0081 tonypage@pharmadex.uk.com www.pharmadex.uk.com UPS Europe, Belgium +32 2776 9818 sbueldt@ups.com www.ups.com

OTHER

Provides outsourced order-to-cash commercial distribution solutions in Europe — includes multi-lingual customer service warehousing activities, transport management and financial services. Also offers re-packing and labelling solutions.

Provides a complete end-to-end supply chain solution to companies around the UK and Europe — encompasses warehousing, distribution, repairs and technical services, to help companies reduce costs and improve efficiency.

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LifeConEx, LLC, US +1 954 626 4359 federico.lupp@lifeconex.com www.lifeconex-lcx.com Palletways (UK) Ltd, UK +44 1543 418000 sales@palletways.com www.palletways.com

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Eskimo Express, UK +44 1932 560222 simon@eskimoexpress.co.uk www.eskimoexpress.co.uk Geodis Calberson, UK +44 1494 446 541 nigel.watts@geodis.com www.geodis.com

Transportation — Shipping

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logistics & distribution

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Lead cold chain solutions provider of end-to-end temperature controlled transportation solutions for the life sciences industry worldwide.

Specialises in distribution of 1–6 pallets. Door-to-door distribution service to and from mainland Europe.

Provides specialised distribution, customer care and transportation services to maximise supply chain efficiency, meet regulatory reguirements and protect products from temperature excursions.

INGREDIENTS & CONTRACT SERVICES ROUNDUP European Commission Approves Paediatric Indication of Oral Granule Formulation

Co-Crystal Supply Collaboration to Provide for Improved Drug Solubility

Aptalis Pharmaceutical Technologies, formerly Eurand Pharmaceutical Technologies, focused on developing differentiated oral products utilising its pharmaceutical technologies, has announced that the European Commission granted marketing authorisation for a new paediatric indication of a new oral granule formulation of Gilead Sciences, Inc.’s Viread (tenofovir disoproxil fumarate) for HIV-1 infected children aged two to less than six years and for HIV-1 infected children above six years of age for whom a solid dosage form is not appropriate.

This authorisation, which covers all 27 countries of the EU, follows the January 2012 FDA’s NDA approval of Viread oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients aged two to five.

The oral powder, which utilises Microcaps taste-masking formulation technology, will be manufactured and

Hovione and Solvias have established a collaboration focused on the development and GMP supply of pharmaceutical co-crystals. This partnership draws together Hovione’s expertise and experience in overcoming drug delivery challenges and also the supply of GMP materials from phase I to commercial scale with Solvias’ excellence in solid state chemistry.

Hovione offers a series of particle engineering technologies focused on amorphous solid dispersions, crystal design and reduction and control of particle size. The collaboration provides Hovione with access to Solvias’ cocrystallisation expertise and capabilities, thus reinforcing and complementing the crystal design solutions to overcome poor bioavailability and other drug delivery challenges. Solvias continues its strategy of partnering to enhance access to its solid-state solutions.

“We are delighted to announce this collaboration with Solvias increasing

supplied to Gilead by Aptalis Pharmatech, Inc. Gilead will be responsible for product commercialisation.

John Fraher, President of Aptalis Pharma, commented: “The FDA and European Commission approvals of the oral granule formulation of Gilead’s Viread for use in the US and Europe respectively are examples of how our company’s turnkey business model differentiates our services in the drug development process. We leverage our breadth of capabilities, experience and expertise to provide a comprehensive resource for our partners to establish effective pathways to commercialisation.

To this end, we are pleased to have had the opportunity to co-develop the paediatric oral powder formulation of Viread with Gilead using our Microcaps proprietary technology.”

Aptalis Pharmaceutical Technologies +1 908 927 9600 www.aptalispharmatech.com

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the breadth of drug delivery solutions through our particle design offering,” said Dr. Colin Minchom, Hovione’s Vice President of Particle Design. “Solvias has a tremendous reputation for science, quality and expertise in crystal design for improved drug performance.

This agreement reinforces our strategy of combining strengths with innovative companies to allow our customers a seamless and integrated approach to their drug delivery challenges.”

Dr. Martina Diekmann, Solvias’ Global Head of Business Development Analytics, commented: “Solvias is delighted to work with Hovione. In establishing this agreement with Hovione, we are able to generate added value for our customers and help them solve their drug delivery requirements.”

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

SHOWCASE ANALYTICAL & TESTING SERVICES CDMO Invests in Analytical Development Services at Solna Facility Recipharm has announced a significant strategic investment to expand capacity in analytical services and stability studies at its facility in Solna, Sweden. The facility is equipped with advanced laboratories and technology for

pharmaceutical formulation as well as a GMP suite for development and manufacturing of sterile and non-sterile clinical trial materials.

It will now be reconstructed to facilitate expansion of analytical development within the Recipharm group. “This is a very important step for us as increasing this capacity will enable the company to enhance the high quality services to our customers,” said Maria Lundberg, General Manager at Recipharm Pharmaceutical Development. “Our analytical development service is already an integrated and vital part of the pharmaceutical development work and this investment will enable our business to continue to grow, creating more flexibility and a better service offering.

We are convinced that it is vital to small and large pharma companies that competent service partners can supply high quality pharmaceutical development services, including high quality analytical development.”

Analytical services normally included

Capsule Dosage Forms Specialist Unveils QC Lab Capsugel has doubled its laboratory capacity with the opening of its new Quality Control Laboratory in Greenwood, South Carolina, US. The new laboratory serves as a global resource to its extensive network of manufacturing sites and R&D laboratories Capsugel’s Quality Control Laboratory serves as its global center of located in Boston, excellence for quality control.

Strasbourg and Colmar. The company invested more development of colour formulations. than $3 million to create this facility that With the new capacity, Capsugel has is a global centre of excellence for QC expanded its Global Stability Program and testing of all raw materials and with walk-in stability chambers and specialty testing of finished products for photo stability chambers. This critical Capsugel sites around the world. The equipment is used to support the shelf facility’s opening marks a significant life of the finished products, to register investment that demonstrates new products in different countries and Capsugel’s commitment to designing, to conduct excursion studies to manufacturing and delivering premiere determine the impact of different healthcare products and services. temperature and humidity conditions on “Our new Quality Control Laboratory the quality of the capsules. By the time positions Capsugel for future growth in a product is considered ready for an increasingly complex regulatory market, it may have gone through up to marketplace,” said Guido Driesen, 23 individual quality tests at the President & CEO of Capsugel. “Quality company’s new Quality Control is the hallmark of our business and a Laboratory. The facility is the latest in a core principle at Capsugel that provides series of recent upgrades and added value for our customers. Our expansions as Capsugel grows to meet thorough testing equates to faster time increasing global demand for its high to market as our products are designed quality capsule products. to comply with today’s strict regulations.”

Capsugel EMEA The approx 892m2 facility is equipped +33 3 89 20 57 25 to provide a wide range of analytical marketing.emea@capsugel.com and microbial testing as well as www.capsugel.com

in the pharmaceutical offering comprise development and validation of stability indicating analytical methods, supply and execution of method transfer protocols, establishment of new product assay and degradation methods, graduated validation plans to suit the phase of drug development, cleaning validation, report writing and of course stability studies according to ICH. This

expansion means that Recipharm will have the capability to support more projects in parallel with these services.

The analytical laboratory in Solna will be ready and fully compliant with ICH, EU and FDA GMP in May 2013.

Recipharm +46 8 602 52 73 www.recipharm.com

Analytical and Formulation Services Provider Receives Manufacturer’s/Importer’s Authorisation Following further successful GMP inspections by FDA and MHRA, Melbourn Scientific has been awarded a Manufacturer’s/Importer’s Authorisation (MIA) and is to be named as the EU testing and release site for an aseptically prepared medicinal product on a client’s pending Marketing Authorisation Application.

Melbourn Scientific has one of largest teams in Europe offering contract research, including formulation development, analysis, stability studies and small scale manufacture of clinical trials materials. Carol Barbour, Quality Director, said the new licence is a good endorsement of the quality of Melbourn’s procedures and will extend its capabilities.

“With the MIA, we will be able to import commercial products that have been manufactured outside the EU and to test them prior to release for sale within the EU/EEA. “We have secured the services of experienced QPs to audit the supply chain and provide assurance that imported products have been manufactured in accordance with the Marketing Authorisation and GMP. We will also liaise with the wholesale/distribution company to ensure adherence to Good Distribution Practice.

“This extends the scope of our services to cover more of the product lifecycle and will be valued by clients who want to outsource these critical activities. Also with our stability storage capabilities, we are able to provide this service if the client requires on-going stability to be performed in the EU.”

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QC testing, which includes stability testing of investigational and marketed medicinal products, is regarded by the MHRA as part of the manufacturing process, so laboratories providing this service need to operate in compliance with the EU Guide to GMP. Melbourn is already GMP certificated so the new licence means that it can offer a complete service, including raw material testing, QC and finished product testing and QP certification prior to release.

Melbourn already has an MIA/IMP (Manufacturer’s/Importer’s Authorisation for Investigational Medicinal Products,) which allows the manufacture and importation of investigational medicinal products.

Melbourn Scientific Ltd +44 1763 261648 www.melbournscientific.com

REGULATORY AFFAIRS Asia’s Changing Regulatory Environment and Pharma Outsourcing

Written by Dr. Paolo Biffignandi, advisory board member of the pan-European pharmaceutical regulatory affairs organisation ELC Group and former President of TOPRA (The Organisation for Professionals in Regulatory Affairs), in collaboration with Lini Subin, Head of Regulatory Affairs at ELC Group.

Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing. Consequently, pharmaceutical regulations in this region are fast gaining attention among pharmaceutical companies worldwide.

Following the global recession, Asia began steadily emerging as the largest player in the pharmaceutical market. China, Japan, India and Korea now rank among the top 15 economies in the world, with Asia proving a highly attractive market to global companies due to its strong economic growth, large population and ageing population.

In order to expand sales to the Asian market, pharmaceutical companies need to be aware of new and changing regulatory environments for drugs, devices and in vitro diagnostics. New or improved regulations are implemented frequently in Asia, including changes in GMP standards, drug price controls and medical device regulatory systems. The regulations and registration activities are not harmonised in this region and it can be a challenging task.

Pharmaceutical and drug registration is also becoming more regulated throughout Asia. Indeed, the requirements for local drug clinical trials are becoming more prevalent in some countries like Korea and Taiwan.

With innovation key to growth in emerging markets, regulatory policies are becoming more open and supportive of innovative drugs. There are several challenges around pharmacovigilance in Asia. India plans to begin interacting with international pharmacovigilance bodies in 2013/14 — by which time it will be among the biggest pharmaceutical markets in the world — before creating an Asia-Pacific centre of excellence for pharmacovigilance in 2014/15.

The complicated regulatory landscape in Asia can be a barrier to success for foreign companies that do not have the experience or resources that are essential to overcome the obstacles in countries such as China, India, Japan, Korea and Taiwan. Third-party guidance and advice may be required as part of any acquisition or any improvement of current standards. In particular, special attention may be required in the following areas: • Implementation of electronic document management systems.

• Implementation of international regulatory standards.

• Managing local and international regulatory requirements (GMP harmonisation, PIC/S, WHO) and audit preparation.

• Addressing the rising costs of labour, compliance and production.

• Choosing companies for partnership or investment, cataloguing the products and capabilities of a company, including compounds in their drug development pipeline, as well as correctly understanding their strategic relationships and costs of doing business.

• Due diligence, as any acquirer, foreign or domestic, will be looking for certain attributes in targets shortlisted for acquisition. Quality of information is very important.

As a result of these trends and shifting of outsourcing to Asia, companies are setting their strategic sights to make Asia a provider of key contributions to drug discovery and research innovation as well. Increasingly, third-party outsourcing service providers will play a greater role in supporting and managing the delivery of the key business functions like drug development, sales and marketing and regulatory compliance services.

An outsourcing index from a recent article published by PricewaterhouseCoopers in 2008 is provided above right. China tops the list as best outsourcing destination, followed by India, Korea and Taiwan.

The pharmaceutical companies should determine the services that need to be outsourced and have a strategy for execution of these services and managing the relationships successfully. Selection of suppliers and determining the services that need to be outsourced is a challenging task. The ideal partner will

Dr. Paolo Biffignandi

Lini Subin

have a very good track record, in-depth knowledge about the industry and long business history of building relationships with agencies. A successful service provider should also have the staff capacity to perform the developmental and registration activities. Finally, flexible and cost-effective fee arrangements is another factor that needs to be considered when small companies look for a partner to register their products in Asia.

References 1. ‘The changing dynamics of pharma outsourcing in Asia: Are you readjusting your sights?’, PriceWaterhouseCoopers white paper, 2008.

2. ‘Regulatory Challenges in the Asia-Pacific Region’, Paraxel enews letter, July 2008.

3. ‘Regulatory Updates for Drugs, Devices and IVDs in Asia’, By: Ames Gross and Rachel Weintraub, 1 May 2005.

4. ‘Medical Product Registration in Asia’, Pacific Bridge Medical website.

5. ‘Realizing the Promise of Asia-Pacific: The Region’s Strategic Shift from Outsourcing to Innovation’, Quintile white paper, 2010.

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Events PHARM Connect Congress Organiser Outlines 2013 Programme TEG has announced the third annual PHARM Connect Congress, which will run on 27 and 28 February 2013 at the luxurious five star Corinthia Grand Hotel Royal in Budapest, Hungary. It has established itself as a must-attend event for pharmaceutical and biotechnology professionals in Central and Eastern Europe and the CIS market.

The event is bringing together over 500 senior decision-makers from Europe’s leading pharmaceutical and biotechnology manufacturers, giving them the opportunity to share their knowledge, discuss their key priorities and evaluate solution providers.

Participants can take advantage of a high quality conference programme presented by leading industry professionals along with an exposition and meeting area, where various types of service providers are represented and where the pre-scheduled one-to-one meetings are taking place.

Chairing on the first day is Prof. Dr. Tamás L. Paál, Senior Adviser, National Institute for Quality and Organizational Development in Healthcare and Medicine, Hungary, and on the second is Prof. Dr. Thomas Friedli, Chair of Production Management, University of St. Gallen, Switzerland.

The congress also provides an opportunity to visit the GSK Biologicals plant in Gödöllő limited for 50 delegates only and available on a first come first serve complimentary basis. The excursion will provide an opportunity to

get more information about the activities of the Gödöllő site, the vaccine manufacturing process and the manufacturing facility of the biotechnology site. The site visit will start with a short movie about the activities of the GSK Vaccines business division and the Gödöllő site, followed by a site tour that includes a visit to the manufacturing facility.

The conference programme will cover topics such as: • ‘The Next Generation of OPEX: Professionalizing — Embedding — Sharpening’, Prof. Dr. Thomas Friedli, Chair of Production Management, University of St. Gallen, Switzerland; • ‘The Future of Personalized Medicines — How Diagnostics & Biosimilars Can be More Affordable?’, Dr. István Peták, Scientific Director & Founder, KPS Diagnostics; • The New EU Pharmacovigilance Legislations’, Amer Alghabban, Director, Global Quality Assurance Auditing, Merck Serono; • R&D Pipeline — How to Keep it Innovative?, Dr. Zsolt Szombathelyi, Research Director, Gedeon Richter; • ‘How to Best Serve your Customers?

— Building a New Logistics & Pharma Service Strategy for the CEE Region’, Zoltán Kelemen, Business Development Manager CEE Region, Phoenix; • ‘Trends in Medicated Skincare’, Dr. Stefan Hellbradt, VP Business Development, Consumer Healthcare, Aptar Pharma;

Registration Opens for RDD Europe 2013 The Respiratory Drug Delivery (RDD) Europe 2013 scientific conference will welcome pulmonary and nasal drug delivery experts from all over the world to Berlin, 21–24 May 2013. The joint organisers of this prestigious event, RDD Online and Aptar Pharma, have announced the opening for registration at: www.rddonline.com/rddeurope2013.

RDD conferences take place in both Europe and the US in alternate years and are reportedly widely regarded as the premier venues for presenting the latest pulmonary and nasal drug delivery advances. After RDD 2012, which was held last May in Phoenix, Arizona, the upcoming RDD Europe 2013 is eagerly awaited.

More than 450 delegates are expected to attend the meeting to be held at the Intercontinental Hotel Berlin, Germany.

The scientific symposium will welcome an audience of high level academic, industrial and regulatory experts involved in the research, development, investigation and marketing of existing and new therapies for delivery through the nose or lungs.

The meeting will begin with a plenary lecture titled ‘Biomarkers and Targeted Treatments for Small Airways Diseases — The Past, Present and Future’ presented by Dr. D.S. Postma, M.D, Ph.D., Professor at the Department of Pulmonary Medicine and Tuberculosis, University Medical Centre Groningen, Groningen, The Netherlands.

The symposium will then focus on:

• Drug Development — New Drugs, Targets and Formulations.

• Weighing the Evidence in Support of Bioequivalence.

• Orphan drugs — Opportunities, Regulatory and Clinical Challenges.

• Harmonising the Clinical Requirements for LABA/ICS Combinations in the US and Europe.

• Designing Devices for the Marketplace.

• Optimising Formulation and Device Partnerships.

As part of the event, RDD Europe conferences highlight innovative research contributions through podium and scientific poster sessions. These are enhanced by 12 technical interactive workshops from vendors and service providers in the industry. In all sessions, the latest technological advances related to nasal and pulmonary drug development will be presented.

RDD Europe 2013 also features an expanded high-profile exhibition, showcasing the latest technologies and equipment in this exciting field.

RDD Europe 2013 offers numerous opportunities for networking, including a cocktail reception on the evening of 21 May and a gala dinner on 23 May. Previous RDD Europe events have been over-subscribed so early registration is strongly recommended.

Respiratory Drug Delivery +1 804 827 1490 info@rddonline.com www.rddonline.com/rddeurope2013

• ‘Distribution and Cold Chain Management of Biosimilars’, Dr. Dávid Domonkos, Head of Biotechnology Plant, Gedeon Richter.

TEG (The Events Group) +36 1 219 57 25 marketing@tegevents.eu www.pharmconnect.eu

CPOs from Leading Pharma Companies to Speak at ProcureCon Healthcare 2013 Following hot on the heals of its inaugural healthcare procurement event in 2012, WBR has announced an impressive speaker line-up for ProcureCon Healthcare 2013, which is set to take place at the Renaissance Zurich Hotel, Switzerland, on 19–20 March. Keynote speakers will include: • Friedhelm Felten, Chief Procurement Officer, Merck.

• Martin Dolezel, Senior Director Global Procurement and Operations, EMEA, Pfizer.

• Vasco Marcal Grilo, Chief Procurement Officer, VP, Janssen EMEA. • Paula Gildert, Head of Development Strategic Sourcing, Novartis.

• Jari Kaunisto, Purchasing and Logistics Director, Orion Corp.

• Jean-Yves Rotte-Geoffroy, Senior Vice President Procurement and Chief Procurement Officer, GlaxoSmithKline.

• Ashley Readshaw, Chief Procurement Officer, AstraZeneca.

The expected audience of over 120 senior pharmaceutical and biotechnology procurement practitioners will also hear a detailed out-of-industry case study from Andrea Sordi, Director of Procurement at Kraft Foods Europe. ProcureCon’s Production Director, Vidya Gunapala, reasons that: “From our existing procurement events, pharma represents one of the verticals with a particularly strong appetite for knowledge in the procurement space. This cross-industry case study will provide our audience with

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vital transferrable solutions to common challenges from a lower-margin vertical.”

Over the course of the two days, delegates will be able to network and benchmark on high-level strategy with fellow procurement leaders from the biotechnology, pharmaceutical, generics and medical devices sectors. Through a wide range of case study presentations, panel debates and streamed sessions, the delegates will discover the tools to tackle their most pressing direct and indirect sourcing challenges and garner proven strategies to bring the procurement function in line with business needs.

A complimentary 10% discount off the stated web price is available to all EPM readers. To take advantage of this offer, enter codeword ‘EPM’ on the website’s ‘Register Now’ page.

WBR (Worldwide Business Research) +44 20 7368 9465 procurecon@wbr.co.uk www.procurecon-healthcare.com

EPM CLASSIFIEDS

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

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

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Transflow Industrial Services Limited The Passivation Specialists

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

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Mettler Toledo

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ADVERTISERS’ INDEX Company Alexanderwerk Bibby Scientific Biopharma Process Systems Driam

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Elizabeth Carbide EPM Website I Holland Mediplas 2013 Mettler Toledo Müller

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Natoli Pharmapack Europe Pharmintech Russell Finex TechnoPharm 2013 Xcellerex

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