EPM June 2012

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IN THIS ISSUE: Milling & Granulation Drying Tablet Production Liquid Handling Packaging Contract Research

European Pharmaceutical Manufacturer June 2012

Volume 12 | Issue 04

Front cover: Next Generation Tabletting Technology — Fette Compacting’s FE35 is the next tablet press in the FE-series.

Like the FE55, it follows the TRI.EASY design for smooth handling. The FE35 combines all the advantages of the new FE range of models from Fette Compacting with the shortest product changeover times of its class.

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editorial editor elizabeth valero, ellie@rapidnews.com

in this issue

publishers mark blezard, michael taylor

production art adrian price production peter partley

advertising

page 5–8

BEST OF BRITISH MANUFACTURING PRODUCTS & EQUIPMENT

pages 9–20

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

robert anderton tel: +44 (0) 1829 770037, fax: +44 (0) 1829 770047, rob@rapidnews.com

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9–18 20

Latest News Roundup Corporate News & Events

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SHOWCASE:

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Europe - Free, ROW - £115

SPECIAL FOCUS: 9–11

Milling & Granulation

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BUYERS’ GUIDE:

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18

Tablet Production

LABORATORY PRODUCTS & EQUIPMENT

pages 21–26

Equipment, IT solutions and supplies for preparation, analysis and storage of samples through to formulation and lab-scale manufacture of pre-clinical/early clinical phase pharmaceuticals.

21–24 26

SHOWCASE: 25

Liquid Handling

SPECIAL FOCUS: 21–23

Milling & Granulation

INGREDIENTS & CONTRACT SERVICES

pages 27–34

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

REGULARS: Latest News Roundup Events

27–31 34

SHOWCASES: Packaging Contract Research

32 33–34

page 35

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Welcome to the June issue, back to the normal size following the bumper ACHEMA Preview issue. As mentioned in my previous ‘From the Editor’, this issue includes a ‘Best of British’ feature (opposite) — to coincide with the Queen’s Diamond Jubilee — with news from this year’s Queen’s Awards for Enterprise winners, as well as general announcements from companies that are simply proud of their British heritage and ability to state their products are ‘Made in the UK’.

Also in this issue and particularly worthy of mention are two case studies. The first — which forms part of the Milling & 11 Granulation Special Focus and can be found on page 11 — has been provided by Hosokawa Micron and details its design of a contained API particle size reduction facility for one of the world’s largest pharmaceutical companies. The facility is for ultrafine milling at R&D and small-scale production volumes, and — according to Hosokawa Micron — is the first of its kind in terms of operational flexibility.

The second, which appears on page 12, has been submitted by Jet Environmental and outlines its successful installation of a bespoke system that maintains the internal operating temperatures of two warehouses belonging to Kent Pharmaceuticals, helping the generic pharmaceuticals manufacturer comply with MHRA guidelines. The company fitted a Jet Air Induction System at each of the two sites, as well as air sensors (eight at the larger and six at the smaller), and a single temperature monitoring system that simultaneously monitors and records the temperatures at both locations.

This issue’s instalment from Regulatory Affairs columnist Dr. Paolo Biffignandi is on page 31 and advises on the key factors that should be taken into consideration when choosing a regulatory affairs partner.

And that just about wraps up another 2012 issue, seeing us half way through the year already. If you have any suggestions for improving the magazine’s content — such as new topics or burning issues you would like to see addressed — I would be keen to hear them, so please email me at ellie@rapidnews.com.

ADVERTISERS’ INDEX Company

Page

Müller

Alexanderwerk

14

Natoli

Catalent

29

Process Components

Cremer Speciaalmachines

10

Rommelag

GEA Pharma Systems - Courtoy

2

Thomas Engineering

Mediplas 2012

8

Verderflex

Mettler Toledo

24

Xcellerex

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36

12

17 16 15

13

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

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

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

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

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

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

Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer, working for the wellknown French pharmaceutical company Sanofi.

Grégory started working in one of the group’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment. He later moved to Spain and continues to lead new equipment installation projects at one of the group’s Spanish solid form plants and since 2009 has been in charge of process maintenance and improvements.

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

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

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

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

BEST OF BRITISH

Containment Valve Manufacturer Acknowledged for Success in Overseas Markets ChargePoint Technology has been named as a winner of the Queen’s Award in International Trade, recognising an outstanding achievement in enterprise, specifically the company’s success in overseas markets.

ChargePoint Technology is a market leader in the supply of containment valves and integrated material handling equipment for the pharmaceutical industry. ChargePoint split butterfly valves are a widely used solution for contained charging/filling or discharging/dispensing of potent ingredients from a wide variety of pharmaceutical and chemical process equipment, from reactors and isolators to mixing and tabletting equipment. The flexible ChargePoint split valve design also enables it to be applied within bulk formulation, aseptic processes and SIP applications.

“We are proud to receive this recognition of our exceptional performance in export business,” said MD Chris Eccles. Export sales now

account for over 85% of the company’s turnover, with notable success in emerging growth markets, including India and China, as well as existing strong markets US, Japan and Central Europe.

ChargePoint has invested in a new manufacturing facility at its Liverpool HQ, which is ISO9001 accredited and uses the latest production technologies.

This investment strategy has been critical to its success, coupled with a strong R&D programme and a dynamic sales and marketing strategy to achieve a 160% increase in turnover in three years. “We are able to maintain our market leading position by providing high quality, innovative products to succeed against competition overseas,” concluded Eccles.

ChargePoint Technology Ltd +44 151 728 4500 info@thechargepoint.com www.thechargepoint.com

Export Success for British Designed and Manufactured Blisterpack Inspection System

According to Sepha, it launched the world’s first tool-less, non-destructive blisterpack inspection device, Visionscan, in June 2011. The product reportedly represents the best of British innovation and engineering, having been developed, designed and manufactured exclusively at Sepha’s R&D and manufacturing headquarters based in Belfast.

Visionscan has been a British export success story for Sepha, with the product now having been exported to five continents and to clients such as

Coding and Printing Technology Provider’s Continual International Success Earns Prestigious Award

Novartis, Boehringer, Sanofi and Jansen, where Visionscan forms an integral part of their quality control process.

Visionscan uses high-resolution camera imaging technology to detect defects down to 15 µm in individual blister pockets and weak seals in less than 60 seconds. Because it is tool-less, 21 CFR Part 11 compliant and provides accurate objective results, it is becoming the technological replacement for Blue Dye testing in modern pharmaceutical manufacturing.

Sepha has been able to increase employment levels at its Belfast base by over 20% in the last year due to the global demand for Visionscan, and expects this level to increase in 2013 as more pharmaceutical manufacturers shift towards objective and technology driven solutions to blisterpack inspection and quality control.

Visionscan is a true ‘Best of British’ product, highlighting engineering skill and genuine commercial application across the global pharmaceutical market.

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

Domino Printing Sciences has won the Queen’s Award for Continuous Achievement in International Trade. This recognition, the company’s fifth since 1985, affirms Domino’s position as one of the UK’s leaders in continuous growth and export.

The Continuous Achievement in International Trade Award has been awarded to Domino for substantial overseas earnings with growth and commercial success, sustained over not less than six years, to levels that are outstanding for the goods or services

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concerned and the size of the company’s operations.

“We are extremely honoured and proud to be selected for a Queen’s Award,” commented Nigel Bond, Group MD of Domino Printing Sciences plc. “Over 95% of our revenue is generated outside the UK, with our unbroken 33-year record of annual revenue growth due to our continued investment in R&D, the hard work and dedication of our employees, and efforts of our partners and distributors globally.

Receiving one of the most famous, globally recognised, prestigious awards for our international trade performance is the ultimate testimony of our continued progress as a business.”

The Queen’s Award Office hosts a celebratory reception for the winners with a congratulatory speech usually given by a member of the Royal Family.

A separate ceremony will take place at the winner’s premises, where a presentation will be made by the Queen’s representative, the Lord Lieutenant of the County.

Domino Printing Sciences, plc +44 1954 782551 sheila.richardson@domino-uk.com www.domino-printing.com

BEST OF BRITISH Biotech Company Receives Worldwide Recognition for 90% Sales Outside UK

NanoSight has been selected to receive the Queen’s Award for Enterprise in the category for International Trade 2012, which follows hot on the heels of many other prestigious awards in the past twelve months, notably the Technology World 2011 Business Innovation Award presented by Vince Cable, Secretary of State for Business, Innovation and Skills and President of the Board of Trade, and after being named the UK’s fastest growing biotechnology company by Deloitte.

NanoSight was founded in 2004 by Dr. Bob Carr and John Knowles after Carr

discovered a technology that allows particles so small they were below the normal optical microscope limit to be seen, sized and counted in less than a minute for a fraction of the cost of electron microscopes.

Since 2005, NanoSight has grown sales by around 70% annually, year-onyear, and now employs 25 people in the UK. The firm sells its products all over the world, with around 90% of its sales outside the UK. The most significant growth is in pharmaceuticals and life sciences, where budgets have remained largely unaffected by the global financial

condition. There are now more than 450 NanoSight instruments in use worldwide and this number continues to grow as the firm’s products are cited almost daily in fresh academic papers, a list which now totals over 400.

Speaking about the importance of this award, Dr. Carr said: “While we have naturally been proud of our progress to date, being considered worthy of such recognition as the Queen’s Award really does give us a huge boost in confidence and enthusiasm. It is particularly exciting to see the response of our international colleagues and customers to this award.”

Looking forward, the company expects to sustain growth in the coming years. Its nanoparticle tracking analysis technology has become increasingly important in the characterisation of nanomaterials. At the end of 2011, the EU announced a new definition for nanomaterials that suggests many companies will now be required to measure the number and size of the nanomaterials in their products. With NTA’s ability to handle this challenge, measuring particles in the 10 to 1000 nm range, the future for growth remains rosy.

NanoSight Ltd +44 1980 676060 jeremy.warren@nanosight.com www.nanosight.com

Electrophysiology Business Celebrates Significant Overseas Sales Achievement

Scientifica, a leading manufacturer of high quality equipment for electrophysiology researchers, has won a Queen’s Award in International Trade, which recognises the contribution that export has made to the company’s growth over recent years. Today, 70% of Scientifica’s business is achieved through overseas sales.

The US is its biggest market, followed

by France, Germany and the rest of Europe, but the company has also opened up new markets in the Asia Pacific region and is now successfully trading in China, Japan, South Korea, Singapore and Australasia.

Scientifica products are used by researchers around the world, predominantly in universities and pharmaceutical companies, the majority

of which are involved in research into neurodegenerative diseases.

Since it was launched in 1997, Scientifica has grown from a small business to a company employing 42 people across its two sites — its head office in Uckfield, East Sussex, and production facility in Maidenhead, Berkshire. Turnover has increased by more than 25% year-on-year for the past six years.

“Our success is due to a number of factors,” said David Rogerson, Joint MD of Scientifica (pictured right). “We focus solely on providing products for the electrophysiology market, which gives our customers reassurance that we understand their requirements.

“We manufacture and sell all the component parts of an experimental rig,

which means customers don’t have to go from one supplier to another to get all the different pieces of equipment they need.”

“We’ve found that building relationships with our customers is key,” said Mark Johnson, Joint MD of Scientifica (pictured left). “Researchers move around from university to university and from country to country and they consistently remain loyal to us.

The majority of our sales people are scientists themselves, so they understand our clients’ requirements.”

The close rapport with clients is essential in Scientifica’s ongoing product development as the company is constantly talking to researchers to understand the challenges they face and their future plans. The company has recently made some significant developments in multiphoton imaging.

The Scientifica team will be visiting London in due course to receive its Award from HM The Queen herself, following which, there will be a special presentation ceremony later in the year.

“The Queen’s Award is a significant achievement for our company,” added Rogerson. “We are very proud to be recognised for what we’ve achieved and what’s really significant is the continued success and growth in export sales that we have achieved since we submitted our figures to the Awards committee.”

Scientifica +44 1825 749933 info@scientifica.uk.com www.scientifica.uk.com

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Vacuum and Abatement Equipment Supplier Scoops Award for Seventh Year with Turbomolecular Pump

Edwards has once again been awarded the prestigious Queen’s Award for Enterprise. The recognition has been made for the company’s cuttingedge nEXT turbomolecular vacuum pump, over 8,000 of which have sold since its introduction in 2009.

This latest success follows six previous Queen’s Awards achieved by the company, including the Award for Enterprise in 2002.

Reportedly setting standards in the industry, the nEXT turbomolecular pump is used to create environments that are highly controlled and need to be particle-free.

Key amongst these are laboratory applications where the pump is used alongside mass spectrometry and electron microscopy equipment to perform often groundbreaking work in stem cell research and drug development. In these situations, vacuum pumps are vital to lower pressure, remove air molecules and permit ionised particles to travel to detectors.

Matthew Taylor, Chief Executive, commented on the award: “We are absolutely thrilled to receive this recognition, especially in this Queen’s Diamond Jubilee year. As Britain’s most coveted business prize, the Queen’s Awards recognise outstanding achievement by UK companies.

“We have a proud history of winning the Queen’s Award. It’s gratifying that the contribution of all Edwards’ staff worldwide to our company’s success is recognised at the highest level.

“The nEXT turbomolecular vacuum pump is certainly playing a huge part in our continuing success as a global leader and supplier to the world’s advanced industries. Indeed, we’ve already seen a return on the investment made in its development much earlier than the 19 months payback period we anticipated in our original plans.”

The nEXT turbomolecular vacuum pump is the result of considerable R&D, and provides an ultra-high vacuum performance and exceptionally fast pumping speeds, achieving a rotational speed up to 60,000 rpm or four times the speed of a Formula 1 car engine.

Blade velocity is 300 m/s or 90% the speed of sound.

Incorporating patented technology, the pump is highly reliable, easy to service and has low energy consumption.

Compared with alternative pumps, it has lower vibration and less stray magnetic fields — critical features when it is to be incorporated into scientific instruments with nano-scale resolutions.

Edwards +44 1293 603507 marie.tysall-blay@edwardsvacuum.com www.edwardsvacuum.com

BEST OF BRITISH Autoclave Manufacturer Offers Free Kindle with Confirmed Orders Priorclave has launched its Jubilee Promotion, which will run until the end of July. Against all confirmed orders, the company will present a Kindle — the e-book reader with facilities to shop for, download, browse and read ebooks, newspapers, magazines, etc. Not only is it a thank you for buying products designed and manufactured totally in the UK, it is part of a promotion in the run-up to Priorclave celebrating 25 years as an autoclave manufacturer.

Priorclave is proud of its British heritage and believes the ‘Made in the UK’ label has gone a long way to influencing those looking for known quality, reliability and exceptional performance.

Couple these factors with a large choice of standard steam sterilisers and an option to re-engineer and build in-house and Priorclave is able to satisfy most specific requirements. “Our build flexibility is very much key to our continued success,” said Priorclave’s MD Tony Collins.

It should not be difficult for anyone looking to purchase an autoclave to join in the Jubilee Promotion since Priorclave manufactures one of the most comprehensive selections of steam sterilisers. Standard Priorclaves are available as benchtop or floor standing, top or front loading and with round and rectangular chambers up to 700 l. Like

most autoclave suppliers, Priorclave offers a range of options to increase functionality, however the big difference is that virtually all the ‘extras’ are available on all sterilisers, even the smaller autoclaves.

The huge choice in product specification has maintained buoyant UK sales for Priorclave, whilst the export market, particularly Europe, Asia and the Middle East, has grown exponentially — extremely good news for Priorclave, and excellent news for the British government, which is looking towards increased exports to help the British recovery.

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

Metal Detection Systems Supplier Receives Royal Seal of Approval

Mettler-Toledo Safeline has been honoured with The Queen’s Award for Enterprise 2012 in the International Trade category, which is the highest official award for businesses in the UK, for its outstanding export growth over the last three years.

“Award officials cited Mettler-Toledo Safeline’s strong brand strategy, executed through multiple sales channels, commitment to innovation and expert support team as drivers for our international success,” said Alan Purvis, MD, Mettler-Toledo Safeline.

Mettler-Toledo Safeline manufactures high-performance metal detection systems for global food, beverage and pharmaceutical producers. It works in collaboration with international standard bodies and multinational retailers to develop guidelines for food and pharmaceutical safety in order to protect consumer welfare and brand reputation.

Recent innovations include the launch of the Profile Select variable frequency technology to enhance detection of metal contaminants in difficult applications.

Quality standards governing the food, beverage and pharmaceutical industries are becoming increasingly stringent worldwide, with the introduction of global initiatives, such as the British Retail Consortium (BRC) Version 6, International Food Safety (IFS) and the US’s 2011 Food Safety Modernisation Act. Mettler-Toledo Safeline’s metal detection technologies enable manufacturers to ensure compliance with best practice and due diligence to protect consumers whilst minimising the risk of reputation-damaging product recalls. The company forms part of Mettler-Toledo’s Product Inspection Division, which supplies metal detection, x-ray inspection, checkweighing and vision inspection solutions. All solutions can be linked through the company’s bespoke Prod-X data management software.

Mettler-Toledo Safeline Ltd +44 116 235 7070 www.mt.com/metaldetection

Powder Characterisation Specialist Wins Award for Growth in World Markets

Freeman Technology is to receive the 2012 Queen’s Award for Enterprise in the category International Trade.

Recognised around the world, the Queen’s Awards for Enterprise are Britain’s most coveted commercial prizes and this appreciation of Freeman Technology’s rapidly growing international presence follows the company’s 2007 Queen’s Award in the category of Innovation.

“Freeman Technology’s first Queen’s Award in 2007 celebrated our

development of the FT4 Powder Rheometer and the unique contribution it makes to understanding powders and supporting the manufacturing industry in its drive to improve efficiency and productivity,” said MD Tim Freeman.

“Five years on, not only do we have a proven instrument, we have unparalleled real-world experience, expertise and applications knowledge that supports the use of the system. It is this combination that has driven our international business growth, resulting

in a doubling of our export sales in just three years.”

The FT4 Powder Rheometer delivers information that helps powder processing industries to maximise process and product understanding, and accelerate R&D, formulation and commercialisation, as well as support process optimisation. FT4 systems are installed in many different sectors, including the chemical, pharmaceutical, foods, powder coatings, metals, ceramics, cosmetics and other industries.

Paying tribute to colleagues around the world, Freeman confirmed that 2012 is proving to be a highly significant year for Freeman Technology, with a great deal of planning and development coming to fruition: “Winning this Queen’s Award in the International Trade category really affirms Freeman Technology’s establishment in world markets and reflects the commitment and hard work of all our teams and partners. Ever since the launch of the FT4 Powder Rheometer more than eight years ago, strong sales have been supported directly in Europe and the US, and through distribution partners in Japan. Now, with our experience and expertise across many different applications, we are successfully entering many new markets where the FT4 is helping to solve the same

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problems that challenge powder processors the world over.”

In response to increasing demand for the FT4, Freeman Technology has strengthened sales and applications support in a number of territories. In the past 12 months, the company has established a new direct operation in North America and extended its distribution partnerships to include China, India, Japan, Malaysia, Singapore, Taiwan and Thailand, all underpinned by a move last year to larger premises in the UK, extending the scope for manufacturing and support.

Freeman concluded: “The key to our success and the success of our customers is that we now have many years of research to draw upon. This gives us a deep understanding of powder characterisation and how to interpret and apply the data to the many different challenges that powder processors face. We have some exciting times ahead as we continue to grow and learn about new and existing powders and processes.”

Freeman Technology Ltd +44 1684 851 551 info@freemantech.co.uk www.freemantech.co.uk

MANUFACTURING PRODUCTS & EQUIPMENT

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SPECIAL FOCUS

Milling Specialist Develops Standalone Filter System for Product Recovery The newly developed and patent-pending ProFi – Clean filter is easily installed by a clamp connector as a module on the milling chambers or inlets/outlets housings of all Frewitt mills (OscilloWitt, HammerWitt, ConiWitt and TurboWitt). Sieve mills in existing systems can be retrofitted in a few simple steps.

Just a few of the numerous advantages that set this filter system apart from others are: • Low-pressure filling — Exhaust air at atmospheric pressure escapes from the milling chamber via the filter, which traps any product. To prevent product build-up on the filter, the exhaust air filter is cleaned by a time-controlled pressure surge. The advantage of this method is that continuous, uninterrupted product filling is possible. The product is fed back into the process by means of the exceptionally efficient pressure surge cleaning.

• Dust-free atmosphere — Particles less than 5 µm can be filtered out, thus fulfilling the requirements for class M filters (BGIA) of DIN standard EN 1822 (H12). The high filtration efficiency results in a dust-free atmosphere corresponding to OEB level 3. The exhaust air escapes in a controlled manner via the filter, thus protecting the operator and the environment from contamination.

Various options enable a broad range of applications. For instance, stainless steel cartridges can be used for processes that demand higher mechanical stability, a Venturi system ensures reduced power consumption, and

H13 class HEPA filters can be used when high quality is expected.

• Compact and standalone — The filter system consists of the housing, the filter cartridge, and the compressed air and control unit, which is attached to the filter housing.

This design allows the user to mount the unit on any new or existing Frewitt sieve mill. At this point, it should be mentioned that the HammerWitt is equipped with a connection for an ISO 2852-compliant DN 32 clamp as a standard feature.

Frewitt took a bold step in a new direction that really paid off. The company applied its expert sieve technology knowhow to the development of a filter system that fulfills a critical need, namely the efficient recovery of costly products.

Frewitt SA +41 26 460 74 00 www.frewitt.com

Aseptic BFS Machines Manufacturer Boasts Worldwide Coverage According to rommelag, it was the inventor of Blow-Fill-Seal (BFS) technology and is the worldwide leading manufacturer and supplier of bottelpack advanced aseptic BFS machines. bottelpack machines have been supplied for packaging sterile liquids, creams and ointments. rommelag also supplies complete finishing lines, as well as leak detectors and cap welding machines.

The rommelag organisation consists of several factories and commercial offices.

Today, there are two sales companies for the marketing of bottelpack systems, rommelag ag, located in Buchs, Switzerland, and rommelag KunststoffMaschinen Vertriebsgesellschaft GmbH, headquartered in Waiblingen, near Stuttgart, Germany. They are supported by two contact offices located in Evergreen, US, and Shanghai, P.R. China. In total, more than 1,000 employees are at the customer’s service. bottelpack aseptic machines have a modular design, an integrated cleanroom class A (US-class 100) and an optional dark/white machine separation. The fully automatic machines

work either intermittently with one and two moulds or continuously with rotating moulds. All are automated CIP/SIP capable. The machine capacities vary according to the container characteristics.

0.1 to more than 1,000 ml size containers are filled at rates of up to 30,000 containers per hour. The filling is done by an extremely accurate timepressure dosing system.

The rommelag companies are represented in many countries and utilise outstanding specialists to advise customers all over the world regarding pharmaceutical container selection and design, product compatibility of plastics, closures design and requirements. They also provide competent advice on environmental matters. rommelag works closely with plastics manufacturers’ technical application departments and other related institutions.

In 2011, sister company maropack in Zell, Switzerland, opened the reportedly worldwide first Biosafety Level 2

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production site for contract packaging of biological products, e.g., vaccines, with BFS technology.

In 2012, sister company Holopack in Sulzbach, Germany, will open the new Pharma 2020 factory, reportedly the world’s most modern liquid packaging plant for contract manufacturing with BFS technology. rommelag +41 62 834 5555 mail@rommelag.ch www.rommelag.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Presaturated Wipe Reduces Endotoxins to Guaranteed Levels

Contec has added PROSAT Sterile Polynit Heatseal wipes with 70% IPA and 30% WFI (EP) to its range of market leading presaturated wipes. Manufactured with the highest grade distilled Water for Injection (EP), each batch of wipes has a guaranteed endotoxin level of less than 1EU per wipe.

Polynit Heatseal is a 100% knitted polyester wipe with sealed edges that produces a very low level of particles and fibres. Laundered in a cleanroom environment and treated for additional

Sterile Single-Use Containers for Storage and Transportation of Biological Solutions

sorbency, the wipe is ideal for use in product contact areas. Each resealable pouch only contains 10 wipes, eliminating any wastage at the end of a session. Triple bagged, the pouches are validated sterile, so are suitable for use in the highest grade of pharmaceutical cleanroom.

Contec, Inc. +33 2 97 43 76 90 krossington@contecinc.com www.contecinc.com

Cellon has launched PharmaTainer single-use containers, a range of low particulate, single-use bottles and carboys for the storage and transportation of bulk vaccines, biopharmaceuticals, culture media and other biotechnology materials.

PharmaTainer plastic containers are injection blow moulded in an ISO Class 5 (Class 100) environment and radiation sterilised. These rigid ultra-clean containers are available in sizes from 125 ml to 20 l. PharmaTainers are manufactured from resins approved for medical applications in PET or polycarbonate with HDPE closures.

PharmaTainer packaging features three inner layers of poly wrapping to facilitate delivery into cleanroom areas. The inner most layer is vacuum-sealed, providing tamper evidence and assurance of an intact sterility barrier.

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PharmaTainer products feature traceability down to the individual container. Each bottle/carboy is printed with a unique serial number, batch number, expiration date and a machinereadable data matrix. The machinereadable serial number can be readily integrated with the user’s inventory management system.

All PharmaTainer products are produced in a new, state-of-the-art moulding facility, dedicated solely to production of sterile, single-use products for biotechnology industries. Cellon encourages visits and audits of its facility.

Cellon S.A +352 26 33 73 1 sales@cellon.lu www.cellon.lu

SPECIAL FOCUS

Comprehensive Spare Parts and Servicing for Kek-Gardner Machines

Process Components is the OEM of spare parts for the Kek-Gardner range of mixer, blender, sifter and milling machines. Consequently, the company can provide everything needed to maintain the correct function of KekGardner machines, from a complete replacement agitator through to gland packing for the shaft seals.

Spare parts supplied by Process Components are all manufactured to original standards and supplied with a full warranty. In addition to its ability to produce spare parts, the company has expert knowledge of the manufacturing techniques required to meet the demanding process requirements often met by these machines.

Process Components’ experienced service engineers can assist in providing preventative maintenance, machine inspection and repairs for all Kek and Gardner mixer, blender, sifter or milling machines.

As the company has extensive records of Kek and Gardner machines going back many years, customers have come to recognise that this high level of traceability ensures that they receive the correct genuine replacement parts, resulting in minimal downtime, increased customer confidence and maximum machine reliability and longevity.

Process Components Ltd +44 1625 412000 sales@pro-components.com www.pro-components.com

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP epm

CASE STUDY

SPECIAL FOCUS

Close cooperation with one of the world’s largest pharmaceutical companies has enabled DESIGN OF Hosokawa Micron to develop CONTAINED API a unique contained particle size reduction facility that is PARTICLE SIZE suitable for flexible milling REDUCTION down to ultrafine particles of APIs at R&D, pilot scale and FACILITY ALLOWS small-scale production FOR FULLY volumes.

The contained API particle FLEXIBLE size reduction facility includes OPERATION three mills plus a lump breaker, three material feed options and operator exposure levels of <1 µg/m3.

Manufactured to cGMP design and incorporating full SCADA control, the system is the first size reduction facility of its kind to offer such high levels of ‘complex but not complicated’ operational flexibility that is crucial in today’s fast moving and competitive market.

The system consists of two separate but interconnecting isolator chambers, the milling chamber and the product collection chamber.

Product feed and mill placement is at the rear of the unit. Production operatives work from the front of the unit.

Interchangeable Size Reduction — The milling chamber is engineered for multipowder size reduction, with three separate mills available for use within the system. The interchangeable mills are mounted onto wheeled skids that are wheeled into position for docking. Interlocking seals ensure mills are fully engaged and connected ready for operation and enable the <1 µg/m3 OELs to be achieved.

The system’s originally specified impact mill for fine grinding and the spiral jet mill for finer grinding are supplemented with an additional fluidised opposed jet mill for finest micronising. The microniser was originally part of another system, but was re-engineered to meet the skid mounted requirements of the new size reduction plant.

The grinding chamber also houses an in-line lump breaker for coarse grinding and preconditioning the powder prior to fine size reduction.

Multi-Feed Options — Because of known problems associated with the different handling characteristics of the materials to be processed in the facility, three feed options are incorporated into the system, with the option to switch to the most appropriate; a screw feeder, a rotary valve and manual feed via a small hopper that may be the best solution when small batches are to be processed.

Continuous Tablet Coater Range Reduces Costs and Improves Quality O’Hara has 30 years of experience in the pharmaceutical and healthcare sector.

Combining this experience with its extensive knowledge of continuous coating of healthcare and neutraceutical products, O’Hara recently launched its range of continuous coating technologies for pharmaceuticals.

The Fast Coat Continuous (FCC) series of coaters offer proven technologies, a highly efficient process, increased flexibility, low tablet residence times and dramatic performance improvements, ultimately reducing the manufacturing cost per tablet, whilst improving tablet coat quality.

The FCC also incorporates further reportedly unique benefits such as a rapid batch mode, so the coater can operate in a batch mode, semicontinuous and continuous. This offers exceptional flexibility for manufacturing companies investing in this technology, which will be able to conduct a phased transition to continuous manufacturing and thus reduce operational risks.

O’Hara has overcome issues such as yield losses at process start up and rundown, with the Zero Waste design. This solves a common problem experienced with some other continuous technologies.

The FCC coaters have been

independently proven by the leading coating solution suppliers to be a very stable process that provides shorter product residence times, savings in coating materials and a high quality coating.

With an automated CIP system, product changeovers are quick and highly efficient, with minimal intervention by an operator, taking no longer than conventional coaters. The new, wider FCC range provides throughput capacities from 10 to over 1000 kgs/hour capacity.

S3 Process Ltd +44 845 50 53 53 0 sboswell@s3process.co.uk www.s3process.co.uk

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Product Collection Chamber — Whilst isolator one is for production of small and gramme batches, isolator two is for large batch production, sub-division and dispensary operations. The product is collected using a reverse jet filter.

In-line laser diffraction particle size analysis or manual sampling options are available in this chamber to ensure accurate product specification.

The contained API particle size reduction facility features half suit technology for an enhanced ergonomic and less restricted working environment, with lift platforms providing easy operator accessibility for all procedures. An easy clean construction eliminates dust collection and dead spots and enables handheld lance WIP operations to meet stringent standards.

With operational flexibility in mind, the system is upgradeable to closed loop intelligent system control should this be required in the future.

“Hosokawa Micron engineers have worked closely with the customer to develop this new dimension in flexible API processing with every opportunity taken to deliver a long-term, future proof processing facility. We have been able to use existing equipment and associated performance data to deliver a highly customised processing solution,” said Mike Coffey, Pharma Team Leader, Hosokawa Micron.

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

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP

CASE STUDY Top of the agenda for two new warehouses acquired by the UK’s reportedly largest AIR HANDLING independent generic UNITS HELP KENT pharmaceuticals manufacturer and leading PHARMACEUTICALS wholesaler Kent MEET MHRA Pharmaceuticals, was the GUIDELINES installation of a temperature control solution. The warehouses, located in Measham, Derbyshire, needed to maintain internal operating temperatures of between 18–25˚C in order to maintain product effectiveness, whilst ensuring compliance with MHRA guidelines for the storage of pharmaceutical products.

Kent Pharmaceuticals approached HVAC specialist Jet Environmental to design, manufacture and install a suitable system.

With a long and successful track record of providing energy efficient, cost-effective temperature control solutions to the pharmaceutical industry, JET offers a complete environmental package with bespoke system design, quick installations and ongoing maintenance provision.

Due to the size of buildings, a single JET Air Induction System was installed in both units, using gas fired heating and DX cooling as there was sufficient gas and power available on the site. JET systems feature a series of self-balanced air induction nozzles that direct warm or cool air into the space from roof level. These nozzles are connected via

ductwork to an air handling unit and selected heating/cooling source. A JET system is designed to provide uniform temperatures throughout a building space and captures and re-circulates any waste heat generated in the space from lighting, natural solar gains through roof lights, mechanical handling equipment and people. Both air handling units (AHUs) were mounted externally to the buildings and at ground floor level to save valuable internal floor space.

External summer design conditions were selected at 32˚C DB/21˚C WB to ensure the plant could maintain warehouse conditions, even during extreme conditions. Since both warehouses had been constructed with roof lights, Kent was advised to provide some form of solar protection to prevent excessive heat build up within the space. This provided an added advantage as the size of the AHUs and condensing units could be reduced.

As the JET Air Induction System offers such even temperature around the warehouse, normally a maximum of four temperature sensors (two at high level and two at low level) would be installed to control the plant.

In this case, a total of 14 sensors were fitted (eight in the larger unit and six in the smaller) as a temperature monitoring system was also installed to provide continuous monitoring and recording across both sites.

The installations on both warehouses were completed on schedule. Kent’s Facilities Manager Jason Atkins said: “On taking on both warehouses, we had the opportunity to

address our temperature control requirements and JET responded quickly. They were meticulous in their planning and both installations were trouble free.

“We routinely show off the air induction systems to our customers, which not only is great PR for Kent, but also shows that we are committed to MHRA guidelines and ultimately, patient safety.”

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

Packaging Specialists Co-Launch Carton with PIL Attached The Chrysalis carton is a new packaging solution brought to market by Medica Packaging Ltd and Burgopak Healthcare & Technology.

The solution connects the outer carton and patient information leaflet (PIL) conveniently together. The patient pulls a perforated flap on the carton to expose the patient leaflet, which they can unfold to display the product information.

Once the information has been read, the patient can easily refold the leaflet and return it neatly and simply into the carton.

In a pharmaceutical and healthcare application, the pack encourages compliance from the patient. Important information about the medication is conveniently connected to the carton for the entirety of the product’s lifecycle, whether it is an ethical prescriptive or an OTC drug. The design allows maximum room inside the carton for the product, eliminating unnecessary space and therefore having potential to reduce the overall size of the pack.

Increased legislative demands have resulted in larger leaflets that can be difficult to pack in-line. The Chrysalis Carton offers a robust, streamlined option that runs efficiently and effectively, reducing the incidence of leaflets jamming, poor product insertion and costly equipment downtime. The EPM 12

packs can be specially designed to fit client requirements with a variety of leaflet sizes and panel configurations, while also allowing the supply chain to deal with one single component rather than two separate articles.

Mark Symonds, MD, Burgopak Healthcare & Technology, said: “We are excited about our partnership with Medica Packaging, they have demonstrated their ability to efficiently and cost effectively produce what is a unique carton solution. The product can clearly assist clients’ supply chain, carton and leaflet packaging challenges, while also being a genuine alternative to the limited solutions on the market.”

Burgopak Healthcare & Technology +44 20 7089 1950 tim.bollans@burgopak.com www.burgopak.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Updated 32-Page Earthing and Bonding Handbook Covers Hazardous Area Static Electricity A newly updated and expanded 32-page earthing and bonding applications handbook from Newson Gale provides a wide range of information on controlling static electricity in hazardous areas.

Information sections include a general introduction to the hazards and methods of control of industrial static hazards, 17 illustrated application drawings, a guide to hazardous area equipment selection, a comparison of International, European and North American approval codes, a plant operator’s maintenance guide and a safety checklist.

The extensive general introduction to electrostatic hazards and control includes a review of the source and

nature of static electricity, the harmful effects it imposes in various types of flammable or combustible atmospheres, common means of control, including relevant technical standards, and a discussion of the equipment available for hazardous area applications.

The illustrated arrangements are based on Newson Gale’s range of static earthing and bonding equipment. The applications include those involving drums and containers, mobile vessels and equipment, bulk storage containers, tankers, drums in storage, fluidised bed and drying equipment, rotating vessels, pipes/ducting systems and personnel/footwear. One of the new

inclusions in the handbook is the growing area of mobile/field earthing, including vacuum tanker transfers and trans-loading. Each application is described in some detail and clearly illustrated, along with summarised guidance from the main international technical standards.

The guide to hazardous area equipment approvals and comparison of IECEX, European and North American certification systems covers the main international codes with thumbnail descriptions of each, while the maintenance guide and safety checklist are must reading for even experienced plant operators. The handbook is

available in printed or PDF format and is free on request from Newson Gale.

Newson Gale Ltd +44 115 940 7500 groundit@newson-gale.co.uk www.newson-gale.co.uk

Seal Provides Enhanced Performance for Freeze-Drying Applications

Freeze-drying processes can involve cycling temperatures in the range of 20°C to +130°C, together with solvents and/or water under medium/high pressures. This combination of aggressive working conditions is conducive to the development of thermal stresses in the seals utilised for the freezer operation. These thermal stresses can also result in associated mechanical stresses, leading to premature sealing failures due to cracking and blistering of the seal materials. Dupont Kalrez 6230 perfluoroelastomer (FFKM) parts have been developed to meet such challenging sealing requirements, offering excellent steam cycling resistance up to 260°C. In freeze-drying applications, the Kalrez 6230 parts can also be used in a triclamp seal. This provides an extended performance in the presence of oxidising chemicals over competitive materials, while operating at high pressures and cycling temperatures between -20°C and +121°C. Kalrez 6230 parts are available in the UK from Dichtomatik, an authorised UK distributor for Dupont Kalrez products.

These products have been developed to meet the unique sealing requirements of today’s food and pharmaceutical processes. They are compliant with the FDA’s regulations and with the United States Pharmacopeia Class V1 (USP Class V1). They reduce extractables from sealing materials to trace levels, as well as offer a wide range of enhanced performance and endurance capabilities.

Dichtomatik Ltd +44 1332 524401 kalrez@dichtomatik.co.uk www.dichtomatik-kalrez.co.uk EPM 14

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP University Lecturer Gives Capsule Filling Equipment Seal of Approval A leading lecturer at one of the top universities in the UK has described the Dott. Bonapace capsule filling machine supplied by Isopak as “brilliant and a vital piece of equipment” for the organisation's renowned pharmacy and biomedical science courses.

The University of Central Lancashire’s (UCLan) faculty in Preston checked out the market before choosing Italian manufacturer Dott. Bonapace’s In-Cap automatic capsule filling machine at its state-of-the-art pharmaceutics laboratory facility.

Isopak is the sole UK distributor of Dott. Bonapace’s range of specialised, small-scale equipment for the preparation and packaging of pharmaceutical products, ideal for organisations like UCLan engaged in clinical trial preparation and research.

The In-Cap, which can handle up to 3,000 capsules per hour, is being deployed by the university in its training programmes for the formulation of powders — although it is also suitable for liquid filling — and is proving to be a great hit with students and staff alike.

Lecturer in Pharmaceutics at UCLan Dr. Enosh Mwesigwa said the university prides itself on using the best technology available to improve the learning experience of its students and he has not been surprised by how well the In-Cap has been received: “It is a key component in our arsenal for teaching formulations, helping to show

students how to formulate powder and compound capsules. It is performing brilliantly, is very easy to use and extremely reliable.

“We did look at other machines, but I have worked with Dott. Bonapace equipment before and knew it was of a very high standard. Isopak delivered exactly what was needed in both capacity and cost. The service and training provided on how to use the machine were also very good. I would certainly recommend the equipment to other organisations.”

Dott. Bonapace’s compact In-Cap capsule filler scores highly in the versatility and simplicity of operation stakes, which makes it an ideal choice for use in R&D laboratories, for clinical trials and small batch and specialist productions. It has a low-volume hopper, which allows operation with as little as 50 g of powder, thus cutting wastage.

Isopak has an extensive range of pharmaceutical equipment suitable for a variety of applications. Its capsule fillers and sealers are extremely flexible and can be used for powders, liquid or tablets, which is why they are popular with laboratories, clinics, hospitals, pharmaceutical companies and universities.

Isopak Ltd +44 1780 410093 mail@isopak.co.uk www.isopak.co.uk

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Astellas Implements MES at Second European Site The MES will be fully integrated with the SAP ERP system, the shop floor equipment and process control systems.

Astellas intends to roll out the MES to all production processes in a phased approach.

Astellas is the second largest pharmaceutical group in Japan with three European production sites.

Werum’s PAS-X is already installed in the Astellas site in Meppel, the Netherlands.

Astellas Ireland Co. Ltd. has decided to implement Werum’s PAS-X MES at its production facility in Killorglin, County Kerry, Ireland. The MES will introduce

efficient and state-of-the-art paperless electronic batch recording functionality, supporting compliant, efficient and lean production processes.

Extra Low Profile Sanitary Sifter Significantly Reduces Height Requirements

Werum Software & Systems AG +49 4131 8900-689 dirk.ebbecke@werum.com www.werum.com / www.pas-x.com The new Ultra Sanitary Sifter model K30-1FT-SS from Kason minimises height requirements while increasing screening capacity, it was announced

by President Henry Alamzad.

An extra low profile version of the company’s Vibroscreen Flo-Thru design, the sifter employs two unbalanced-weight gyratory motors mounted on opposing exterior sidewalls of the unit, instead of one motor positioned beneath the screening chamber, reducing overall height significantly.

On-size particles pass rapidly through the 762 mm diameter screen in a vertical straight-through discharge path at higher rates than with circular screeners having a centrally mounted gyratory motor and horizontal discharge paths. Oversize material exits through a side discharge spout.

All material contact surfaces and the floor stand are stainless steel with continuous welds polished to cGMP, 3A, USDA and FDA standards. Quickrelease clamps allow rapid removal of screens and tool-free disassembly of frames for thorough wash down of components (including the motors), as well as rapid interior access for inspection and screen changes.

Intended to scalp oversize particles through a screen mesh as fine as 38 µm (400 mesh) from dry bulk materials or solids-laden slurries, the screener is offered in diameters from 457 to 2134 mm and can be furnished with a dusttight cover.

The company also manufactures other circular vibratory screeners, as well as centrifugal separators and circular fluid bed dryers, coolers and moisturisers.

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

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Catalytic Aeration Drastically Reduces Isolator Decontamination Cycles

With the use of catalytic aeration, M+P — part of Optima Pharma (Schwäbisch Hall) — is able to reduce the duration of the aeration phase in isolators by more than 50%. The aeration phase is the most time-consuming process in the decontamination of isolators used for pharmaceutical filling and closing equipment. Decontamination with VHP (Vaporous Hydrogen Pyroxide) regularly takes place prior to production. Existing M+P isolators can also benefit from this with a simple upgrade.

Isolators are considered to be the safest method for guaranteeing a sterile filling environment in pharmaceutical production. Decontamination of isolators with vaporous H2O2 takes place in three process steps, which begins with the conditioning of the temperature and humidity. Next follows the sterilisation phase, in which a vaporised H2O2 fog kills off any viable microbes. Even in low concentrations, H2O2 can be detrimental to pharmaceutical products, so the final phase, aeration with fresh air, must be complete. Without the use of catalytic aeration and depending on the allowable residual concentrations (usually <1 ppm–10 ppb; largely dependent on the product), the average time required for aeration is between 3 and 12 hours. Using catalytic aeration, the aeration phase can be shortened by more than 50%.

The construction and decontamination process of M+P isolators allows the use of catalytic aeration. The microbial killrate of the H2O2 during decontamination is not influenced by the catalytic converter. The time advantage of catalytic aeration is of particular benefit; the smaller the residual concentration to be achieved, the better the efficiency. A further advantage is that the catalytic converters are also effective during the production phase. As experience has shown, H2O2 diffuses into plastic parts such as format parts during the VHP phase and adsorbs over time. Even after the aeration phase and during production, an increase in the residual H2O2 concentration can occur. This increase in concentration is only slowly flushed out with time. The catalytic aeration employed by M+P is effective during the production phase and prevents increases in residual H2O2 concentration because the isolator continuously re-circulates air through the catalytic converter.

A pilot project at a pharmaceutical company is being used to demonstrate catalytic aeration in practice. For over two years, M+P has performed tests with catalytic conversion on a research isolator. The efficiency of the catalytic converters remained at 100% and degeneration is not expected.

High-Speed Tablet and Capsule Counting Machine at 400 Bpm

Cremer has introduced the new counting system CF-622. Featuring a versatile modular design and advanced patented inline motion filling system, it maximises production speeds within a space-saving footprint. It will handle a wide range of tablets, caplets, hard and

softgel capsules, as well as a wide variety of container sizes with fast and easy changeovers.

The number of counting-heads on the CF-622 can vary from 3 to 10 modules with typical output ranging from 120 to 400 containers per minute. With the required number of modules, the machine is easy to set to a specific and repeatable output.

The CF-622’s advancements include full servo control of all motions, easier operation with fewer parameters, and improved system efficiency, which also makes it easier to validate the machine.

Product and bottle changeovers can be accomplished on the CF-622 by loading a different recipe and with only a

OPTIMA packaging group GmbH +49 791 506 1410 sabine.gauger@optima-ger.com www.optima-ger.com EPM 17

limited number of change parts by one operator in les then 10 minutes. The format parts are container dedicated and include all variations within the machine, preventing any manual adjustment.

An integrated bottle sampling system makes it possible to sample containers on the fly, without interrupting the production process.

The CF-622 also includes central dust extraction, bottle verification sensors and reject tracks, touchscreen HMI and antistatic bar.

Cremer Speciaalmachines B.V. +31 252 41 90 38 pd.wassenaar@cremer.com www.cremer.com

Dixon Purefill Ltd, UK +44 1744 892 555 sales@dixonpurefill.co.uk www.dixonpurefill.co.uk

Tablet Presses — Multi-Station/Rotary

Tablet Presses Training

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I Holland Ltd, UK +44 115 972 6153 sales@iholland.co.uk www.iholland.co.uk IMA S.p.A. and IMA Kilian, Italy +39 051 6514111 behrensm@ima.it www.ima.it KORSCH, Germany +49 30 435 76 0 berlin@korsch.de www.korsch.de Natoli Engineering Company, Inc., US +1 636 926 8900 sales@natoli.com www.natoli.com

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Weigh Module Provides 100% In-Process Weight Control for Tablets High-performance tablet pressing machines have an output of up to 100 parts per second. Obtaining 100% weight control of such an output is a challenge because of the required speed and vibrations resulting from the mechanical pressing of the tablets. Such a high throughput is only possible if distances between individual process steps are optimised and the weighing equipment is fast and insensitive to vibrations.

Mettler Toledo offers the ultra-compact WMC weigh module, with a width of only 25 mm. Readability ranges from 0.01 to 1 mg. The weigh module can be allocated in arrays of various devices for parallel weighing of lots of tablets.

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GEA Pharma Systems - Courtoy, Belgium +32 2 363 83 00 courtoy@gea.com www.gea-ps.com

Yener Kalıp San ve Tic Ltd Sti, Turkey +90 212 270 22 45 export@yenerkalip.com www.yenerkalip.com

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Adept Engineers, India +91 22 26858479 anand@adeptexport.com www.adeptexport.com

Laboratory and Manufacturing

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single weigh module. This facilitates service and offers flexibility for the machine builder. The short weighing time per tablet — as quickly as 0.3 seconds — enables the checkweighing process to keep the pace of the tablet press. Sophisticated filter algorithms ensure the measuring of correct and repeatable results, despite vibrations from the machine.

Mettler Toledo has the expertise needed to consult machine builders in designing very fast checkweighing solutions for large amounts of tablets.

The factory-trained service technicians are globally available to support machine manufacturers wherever their machines are installed.

Mettler Toledo +41 44 944 25 68 eugen.schibli@mt.com www.mt.com/wmc EPM 18

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Metal detectors, press setup kits, ultrasonic cleaning systems, microscopes and magnifiers, H-1 lubricants, storage systems, lab furniture and equipment, and more.

SHOWCASE DRYING Freeze Dryer for Aseptic Small-Scale Production of High Value Products

Article Demonstrates How Controlled Nucleation Temperature Impacts Product Resistance

Telstar has extended its range of freeze dryers with the development of a cGMP unit suited to clinical and small production scale batches of high-value pharmaceutical products under aseptic conditions. The Telstar Lyotris freeze dryer is suitable for the freeze drying of high potency products that require containment in addition to those for biological, biotechnology and biopharmaceutical applications. The Lyotris is scaled to enable its use for the development of new products, clinical trials and small production batches.

Designed using in-house technology, the Lyotris freeze dryer combines industrial equipment specification and performance and small-batch flexibility in a compact envelope.

The Telstar Lyotris freeze dryer has a 1 m2 loading surface and capacity for approximately 1,600 10R-type vials or 30 l of bulk product. It has been specially designed for aseptic production in vials or in bulk and its reportedly novel fascia and door design provides easy isolator integration. The standard version includes the components required for automatic cleaning (CIP) and steam sterilisation (SIP) processes and filter integrity testing (WIT). The unit offers critical component redundancy for elements such as the vacuum pumps, compressors and the heat transfer fluid pump. The equipment also incorporates an advanced SCADA system, which includes Telstar’s patented DPE system,

SP Scientific has written a technical article that describes research undertaken to understand the impact of controlled nucleation temperature on freeze drying product resistance. The researchers demonstrate how SMART Freeze Dryer technology is able to simplify and accelerate the determination of product resistance during controlled nucleation freeze drying experiments.

SMART Freeze Dryer technology is a reportedly unique control software tool, proven to enable development scientists to accelerate and streamline the arduous task of developing and optimising freeze drying cycles.

According to the company, based upon unique control algorithms developed by some of the world’s leading lyophilisation experts, SMART Freeze Dryer technology enhances freeze drying cycle development in several important ways. Traditional cycle development relies on the experience and intuition of the development scientist, along with a trial and error approach. This often requires weeks of development time, and multiple test cycles can consume scarce and valuable active ingredients. SMART technology enables the developer to generate the right cycle on the first attempt.

The authors of the technical article demonstrate how SMART Freeze Dryer technology is able, in conjunction with ControLyo On-Demand Nucleation

providing advanced real-time information on the freeze drying process. The Telstar Lyotris freeze dryer can be supplied on two separate skids to facilitate transport through facilities and installation flexibility.

This solution is a response to the everincreasing demand from the pharmaceutical market for high-value medicines aimed at specific population groups and requiring small-scale production under aseptic conditions. It is particularly suitable for products for biopharmaceutical and biotechnology applications such as personalised drugs and pharmacogenomic treatments, vaccines, antibodies and other advanced drugs and therapies that require stabilisation.

TELSTAR +34 93 736 16 00 marketing@telstar.eu www.telstar.eu

Vacuum Mixer Dryer Achieves Even Mixing With the AMT series, amixon presents a new generation of vacuum mixer dryers.

A key feature that differentiates the AMT range from previous models is its conical floor, which allows complete and automatic self-discharging to be achieved with free-flowing material. A further benefit is that even mixing is achieved in the cone. This is the result of a patented, helical ribbon mixing tool, which creates a three-dimensional movement of the mixing-goods. The helical spring gathers the mixing materials at the periphery of the mixing chamber and transports them upwards.

Once it reaches the top, the mixture flows downwards in the centre of the container. The mixing effect essentially takes place at the interfaces between the two macro-currents.

Not only the mixer itself, but also the helical ribbon, mixing arms and mixing shaft are completely heated. Drying is extremely fast, gentle and even. The patented mixing tool is only fixed and driven at the top. The tanks are vacuum and pressure proof, which means that pressure-dependent reactions can also be managed. For example, an inert carrier gas can be used for subsequent drying.

The AMT vacuum mixer dryer reactor is suitable for drying powders, suspensions, pastes and dough. Cutting rotors can accelerate the mixing and drying process and at the same time carry out de-agglomeration; as a further option, the tanks can be provided with a heated inspection door without dead space.

According to amixon, the AMT series fulfills the highest hygiene requirements and complies with FDA regulations, EHEDG requirements and the 3a sanitary standards.

Each amixon vacuum mixer dryer and reactor is individually adapted to the respective customer’s requirements and process parameters. The processes within the drying procedure can be determined at the amixon test centres in Paderborn, Germany, Memphis, the US, Osaka, Japan, and Bangkok, Thailand, where all the relevant parameters are recorded in real time. amixon GmbH +49 5251 688888 0 info@amixon.de www.amixon.com

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technology, to instantly link product related properties such as product resistance to important process performance attributes. ControLyo and SMART technologies are exclusively available on the SP Scientific Lyostar 3 R&D freeze dryer.

A copy of the technical article is available from the SP Scientific website.

SP Scientific Inc. +1 845 255 5000 shireen.scott@spscientific.com www.spscientific.com

Corporate News & Events

Tabletting Machines and Accessories Provider Opens Competence Centre in Brazil This April, Fette Compacting, a subsidiary of the LMT Group, opened a competence centre for tabletting technology in Brazil. Based in Campinas, not far from São Paulo, the company is offering its customers a reportedly unique range of products and services for the South American market — from servicing and training to extensive compression trials.

At the opening ceremony, Fette Compacting also celebrated the 10th anniversary of its Brazilian subsidiary and presented the newly developed FE55 tablet press on the South American continent for the first time.

Fette Compacting’s presence in South America is strategically important for the company, as MD Olaf J. Müller explained: “Brazil is the world’s sixth largest economy. In addition, the entire continent is currently on a remarkable growth course. The new competence centre places us at the very heart of one of the world’s most dynamic regions.

Sales of tablets have doubled in Brazil between 2007 and today alone.”

Fette Compacting’s invitation was accepted by more than 100 high-ranking

guests, including the Mayor of Campinas, Pedro Sarafim, and representatives of numerous South American pharmaceutical firms. They were welcomed by Franziska Eichel, the representative of the family that owns the LMT Group, who was also accompanied to the event by her sister Angelika Bengel. In her welcoming address, Eichel emphasised how closely Fette Compacting’s success story is bound up with development in South America: “Since the foundation of our subsidiary in Brazil, the countries of the region have made significant advances, from which we have also benefited.

Today, we achieve more than 10% of our turnover with customers in South America and the future prospects are very promising.”

Fette Compacting’s positive expectations are closely associated with the new competence centre, underlined Dr. Michael Heinrich, Chairman of the Management of the LMT Group: “Campinas is our fourth competence centre for tabletting technology. As a result, we now have unique facilities in all pharmaceutical industry growth

Testing Equipment Provider Expands Worldwide Distribution Network

Building on its reputation as a leading manufacturer of inhaler testing equipment and as a major provider of test equipment for other pharmaceutical dosage forms, including tablets, capsules, powders, suppositories and transdermals, Copley Scientific has appointed new partners in Turkey, Brazil and China.

“Copley Scientific aims to provide the very highest levels of localised service to all its customers, around the world,” said Sales Director Mark Copley, “so we’re delighted to have identified strong distribution partners for these three important territories. The economies of Turkey, Brazil and China are flourishing, with high levels of pharmaceutical research activity taking place. These new relationships will enable us to enhance our technical and sales support specifically tailored to growing local

India and the US, as well as the Fette Compacting Academy in Schwarzenbek, near Hamburg, Germany.

Fette Compacting GmbH +49 4151 12498 tablet@fette-compacting.com www.fette-compacting.com

Life Science Products and Services Provider Announces Replacement Head of Process Solutions Business

requirements, and provide customers in these regions with the best possible service.”

BLG Chemical Technologies, based in Istanbul, has more than 15 years of experience in the sales and service of analytical and industrial equipment and will be Copley Scientific’s distribution partner in Turkey. Joint activities in the region have already got off to a highly successful start with much interest shown in a shared exhibition stand at the recent ‘Supergenerics: innovative, enhanced and affordable medicines’ conference in Istanbul.

In Brazil, Copley Scientific will work with Flowscience from Cotia, São Paulo, a company dedicated to providing technological solutions to pharmaceutical researchers across industry and academia.

Finally, located in Nanjing, 190 miles northwest of Shanghai, Copley Scientific now has a dedicated Chinese sales and technical support representative.

Copley Scientific has offices in the UK and in Switzerland and already has a reciprocal partnership in place with aerosol particle science expert MSP Corporation, in North America.

Copley Scientific Ltd +44 115 961 6229 m.copley@copleyscientific.co.uk www.copleyscientific.com

markets, which allow us to deliver our complete range of services directly to our customers on the spot. That means we can continue developing our rapidly growing service business.”

In addition to the new centre in Brazil, Fette Compacting also operates identically equipped centres in China,

Merck Millipore, the Life Science division of Merck, has announced that Andrew Bulpin, Head of Global Pharmaceutical Chemicals Solutions Sales at Merck Millipore, has been appointed Head of the company’s Process Solutions Business Unit. He assumed leadership in May and is based at the company’s US headquarters in Massachusetts.

Bulpin succeeds Jean-Paul Mangeolle, who is retiring from the company after 28 years of distinguished service.

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“Andrew brings a wealth of leadership experience and an in-depth understanding of the life science markets,” noted Robert Yates, President of Merck Millipore. "With a continued focus on helping biopharmaceutical and pharmaceutical manufacturers advance their molecules to market, Andrew has an unprecedented opportunity to evolve the Process Solutions business."

Bulpin joined Millipore Corporation in 2006 as VP for the Upstream Processing Business Unit and, in January 2012, assumed leadership of the Services and Solutions Business. Following the company's acquisition by Merck, he was appointed to his current position.

Prior to Merck Millipore, Bulpin worked at Serologicals Corporation in a number of sales and marketing roles both in the US and Europe. He holds a Ph.D. in organic chemistry from the Université de Caen, France, an MBA from the University of Strathclyde, Scotland, and a BSc from the University of Sussex, UK. Bulpin also worked as a Post-Doctoral Research Fellow at the Australian National University, Australia.

Merck Millipore +1 781 533 5197 janice.paquette@merckgroup.com www.merckmillipore.com

LABORATORY PRODUCTS & EQUIPMENT

Stability Testing System with Superior Control for Improved Analysis Chemical stability, forced degradation and stress testing are just some of the applications for the Amebis Stability Testing and Monitoring System (STAMS).

This highly flexible, low-cost tool with 21 CFR Part 11 compliant software is for any laboratory or research facility involved in drug discovery, analytical chemistry, QC, formulation development and finished product analysis.

The system uses the very latest wireless technology to provide highly accurate and flexible stability testing solutions. Any condition between 0–80⁰C/5–95% RH can be generated for routine or investigative studies with full data logging of the humidity and temperature readings for each sample. It can also be used to monitor and map environmental conditions in existing stability cabinets and rooms.

Amebis Ltd +353 1 8240123 info@amebisltd.com www.amebisltd.com

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SPECIAL FOCUS

Four Additional Models Extend Reputable Lab Mills Line

The FRITSCH premium line has been extended with four high-tech laboratory mills for various applications. Functionally designed down to the smallest detail, with new features and the latest technology, the new mills offer high performance and maximum safety.

Features of the Planetary Mono Mill PULVERISETTE 6 are: high-speed grinding with doubled drive power

and extremely high centrifugal acceleration; automatic motor-controlled grinding bowl imbalance compensation; advanced ServoLOCK grinding bowl tensioning; touchscreen colour display; and tightly sealed grinding bowls, even under overpressure and outside the mill.

Features of the Variable Speed Rotor Mill PULVERISETTE 14 are: threefold drive power for high throughput and grinding performance; clean design for easy cleaning; low noise level; and optimised cooling.

Features of the Jaw Crusher PULVERISETTE 1 are: extra strong with up to 3 kW drive power; extra

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robust for tough demands; easy zero-point and gap width adjustment; clean design for easy cleaning (fixed crushing jaw removable and movable crushing plate easy to exchange); and optimal sound insulation.

Features of the Disk Mill PULVERISETTE 13 are: easy milling gap width adjustment; TFT Display with membrane keyboard; large, removable funnel; and optimal grinding disk adjustment.

FRITSCH laboratory mills are used worldwide for the most diverse applications in sample preparation.

The brand PULVERISETTE is an international synonym for fast sizereduction, easy handling, consistent reproducibility and long, reliable service life — even under continuous, heavy duty usage.

FRITSCH GmbH +49 67 84 70 146 koehler@fritsch.de www.fritsch.de

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Partnership Boosts ELN Parallel Synthesis Capabilities IDBS, a global provider of innovative data management, analytics and modelling solutions, has announced the addition of new functionality to its ChemBook electronic laboratory notebook (ELN). Extending its partnership with ChemAxon, a leading provider of cheminformatics software for the life sciences industry, IDBS has added the Reactor engine, known as the Parallel Synthesis add-on, to support the workflows of chemists, synthesising libraries of compounds in a parallel fashion.

ChemAxon’s Reactor is a highperformance library enumeration engine that produces synthetically relevant virtual libraries, giving users a highly efficient, automated workflow that saves time and improves upon best practices in the laboratory. Chemists can define a generic reaction, a set of reactant structures and combine the two to enumerate and iteratively tune a set of product compounds and discrete reactions on a high throughput scale.

This intelligent processing removes tedious recording and drawing out of chemical reactions multiple times.

“Intelligent and flexible enumeration of chemical reactions for compound library design and combinatorial chemistry is an essential capability within an ELN environment. In choosing our Reactor, IDBS is bringing leading edge performance and usability to ChemBook clients,” said Alex Drijver, CEO of ChemAxon. “We look forward to bringing more functionality and performance as we continue to expand our relationship with IDBS.” ChemAxon’s Reactor enables users to create virtual compound libraries that can be generated under extensive manual control. Users can draw and edit reactants directly, run and tune reactions to achieve real-world products. This

Flash Chromatography Product Offers Full PDA Spectral Scanning

approach is particularly advantageous for enumerating small, focused libraries and the IDBS ChemBook user interface ensures that all IP is captured and stored in-house.

“Our winning formula is to provide researchers with innovative tools that enable them to be more effective within an enterprise-wide, scalable data management framework. We empower them and their organisations to benefit from the value of all their research data,” said Neil Kipling, CEO and Founder of IDBS. “Adding the Parallel Synthesis tool to ChemBook provides chemists with what we believe to be the leading technology in the field and further extends our broad ELN capability.”

ChemBook is part of IDBS’ EWorkBook Suite, a flexible and configurable science-neutral ELN used across enterprises from basic research through to manufacturing. Released with the new version of ChemBook this month, the Parallel Synthesis add-on is an optional capability for users.

Biotage has introduced Isolera Spektra, which expands its flash chromatography product line’s scope of application by increasing efficiency with significant solvent and time saving capabilities, as well as enabling purity assessment technology.

The new full PDA spectral scanning capability with λ-All detection and baseline correction generates real time PDA spectral data for eluting compounds. This provides compound detection at any wavelength, enabling chemists to see how pure their eluting compounds are both in real time and post-purification. Post-purification spectral analysis can also be conducted in 2D and 3D displays for improved visibility of impurities and eliminating the need for post-flash TLC purity testing.

The new proprietary TLC-to-Step gradient feature (patent-pending) instantly converts TLC separation data into an efficient step gradient and suggests a sample load for up to six compounds. Chemists can target one or more compounds for isolation, dramatically reducing solvent requirements and purification time compared with linear gradients. Used in conjunction with Biotage SNAP Ultra cartridges, with their 2–3X loading capacity and flow rate advantage, researchers can routinely achieve total processing times and ultra-low solvent consumption volumes, which were previously not possible with other flash instruments.

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Biotage +46 18 56 57 10 www.biotage.com

SPECIAL FOCUS

Combined High Shear Granulator and Single Pot Processor Range Transforms Any Product Type into Dry Granules

IDBS +44 1483 595 000 www.idbs.com

Research Grade FT-IR Spectrometer Boasts One-Touch Operation

The Thermo Scientific Nicolet iS50 FT-IR spectrometer is reportedly the first research grade FT-IR to be equipped with one-touch operation. The simple FTIR bench is highly adaptable and is designed to utilise purpose-built accessories and integrated analytic software capabilities, making the Nicolet iS50 a comprehensive materials analysis platform. The ATR, Raman and NIR modules make the Nicolet iS50 a multispectral range system, allowing users to acquire spectra from the farinfrared to the visible.

“Isolera Spektra is a revolutionary enhancement in flash purification. It transforms 1D flash purification into 3D purification systems that can target a specific compound for isolation and characterise collected fractions for purity and spectral properties,” said Bob Bickler, Senior Product Manager, Biotage. “This technology can have a huge positive impact on the amount of time that researchers need to invest in compound purification as well as the solvents they consume. These system improvements, combined with high efficiency columns, will quickly pay for themselves in any lab.”

In addition to the flexibility of the Nicolet iS50, the one button technology creates a highly streamlined system that provides fast, accurate analysis, while eliminating manual operational errors.

An integrated diamond ATR allows users to obtain IR spectra almost instantly. An in-sample-compartment FT-Raman feature includes a video microstage for point-and-shoot Raman spectroscopy with no fluorescence. The iS50 also features a new dual-purpose fibre-optic and integrating sphere module that enables collection of NIR spectra from a broad range of bulk samples.

The breadth of its functionality, coupled with the one-button efficiency, makes the Nicolet iS50 an ideal instrument for laboratories worldwide. It gives scientists working in diverse fields, from pharmaceutical formulation to art conservation, the ability to answer questions efficiently with confidence.

Thermo Fisher Scientific Inc. +1 608 276 6114 amy.knock@thermofisher.com www.thermoscientific.com/iS50.

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Developed in 1984 as a contained solution for the processing of highly active pharmaceutical products, the ROTO technology has reportedly become the benchmark for high shear granulation and drying for both R&D and production.

The ROTO range of machines includes the laboratory unit ROTO CUBE LAB, available in two models, suitable for small batch production and R&D applications: 12 and 30 l capacity.

The ROTO CUBE LAB is a high shear granulator and single pot processor for the complete wet granulation and drying process of any type of product, from the loading of raw materials to the discharge of dry granules. The process is carried out in a single, contained bowl, thus reducing risk of contamination and increasing protection for the operators. This technology is an optimal solution in case it needs to be used in a high containment process.

The ROTO CUBE design allows for optimisation of the room layout. The product bowl is located in the processing area and installed through the wall. Utilities can be located in a technical area, minimising the process area.

The product bowl can tilt during the vacuum drying phase to provide a gentle treatment of granules and preserve them from breakage.

Moreover, the gas stripping system (GA.ST.) — by injecting an inert gas through the product mass — enhances evaporation rate.

The machine guarantees a reliable monitoring and control of all the process parameters, including accurate detection of the process end-point.

A complete range of machines for production purposes, up to 3,000 l (bowl geometrical capacity) is also available.

IMA S.p.A IMA Active Division +39 051 6514111 mktg.soliddose@ima.it www.ima-pharma.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP White Paper Sheds Light on Flow Chemistry’s Strengths

Mettler Toledo has announced that a new white paper entitled ‘Enhanced Development and Control of Continuous Processes: A Review of Modern Technologies’ is joining the company’s

extensive collection of thoughtleadership resources.

The paper reviews flow chemistry’s revolutionary role in pharmaceutical and fine chemistry environments, including

Portable NIR Instrumentation Line Boasts Fast and Non-Destructive Materials Analysis

its ability to enhance product quality, increase yield, elucidate synthetic route and improve reaction safety, all while reducing cycle time, which is critical to reducing development costs and capturing market share in today’s competitive manufacturing arena.

The paper explores mid-infrared (IR) spectroscopy as a convenient and nondestructive method for real-time inline flow chemistry monitoring, because it allows real-time datagathering on the formation of products and reactive intermediates. This instantaneous feedback on how changing a parameter such as flow rate or reaction temperature affects a reaction enables faster, safer and more cost-effective process optimisation.

The intensity of IR energy absorbed at a particular wavelength is defined by Beer’s law to be proportional to concentration, making it possible to track the relative concentration of individual reaction components using

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mid-IR-enabled technology. Employing this type of technology not only results in improved reaction understanding, it also allows researchers to overcome what used to be significant optimisation issues, such as making a controlled addition of reagent stoichiometries to a product stream using output data from a prior reaction stage when performing multi-step synthesis.

The paper describes specific instances where mid-IR technology and flow chemistry principles were applied to monitor product streams/dispersion effects in continuous flow reactors and allowed successful third-stream reagent addition, helping to eliminate poor reaction control and the waste it produces.

For a copy of the white paper, visit www.mt.com/flowchemwp.

Mettler-Toledo AutoChem, Inc. +1 410 910 8486 patricia.hicks@mt.com www.mt.com

SPECIAL FOCUS

Continuous Granulation and Drying Goes Lab-Scale

Analytik has announced the release of the LabSpec 4 line of portable nearinfrared (NIR) spectrometers from ASD Inc., for rapid, non-destructive materials analysis in qualitative and quantitative applications.

The new LabSpec 4 line of NIR instruments is portable and precise. This advanced new line features an improved optical design, providing a faster speed of analysis while yielding the best possible analytical results on a wide range of materials, including solids, powders and liquids. Additionally, wireless capabilities are now standard for more flexible use and a new ruggedised cable ensures superior fibre optics performance.

Improvements to the LabSpec 4 line provide the user with higher quality measurements that identify and quantify materials in real time with minimal sample preparation. The non-destructive measurements result in minimised sample waste and users enjoy the ability to measure multiple properties simultaneously.

ASD has released three models of the LabSpec 4 analytical instrumentation.

The Hi-Res model (6 nm) produces exceptional high-resolution spectral data while maintaining an outstanding signalto-noise ratio. This instrument is ideal for the measurement of materials that have

sharp, well-defined spectra features such as polymers, petrochemicals, industrial chemicals and pharmaceutical active ingredients. The LabSpec 4 Hi-Res model produces faster, more precise analytical results for more accurate characterisation of incoming raw materials and in-process or finished products.

This is complemented by a ‘standard’ resolution system, providing an ideal balance between spectral resolution and noise performance. The LabSpec 4 Standard-Res (10 nm) analyser can be used for measurement in food and feed products, forestry products and raw materials identification.

Both the Hi-Res and Standard-Res instruments are available as ‘i’ models — models with an internal light source useful in measuring liquids, slurries, small sample sizes as well as other application that may require analysis using fibre optic sample probes.

Finally, the LabSpec 4 is also available as a benchtop instrument; the LabSpec 4 Bench (10 nm) provides the same level of performance as the StandardRes model, with the benefits of a stationary, space-saving design.

Analytik Ltd +44 870 991 4044 tom.greenwell@analytik.co.uk www.analytik.co.uk EPM 23

Three years ago, GEA Pharma Systems introduced ConsiGma, a high-shear granulation and drying concept capable of producing pharmaceutical granules continuously, without startup and shutdown waste. This concept enabled the use of the same system for development and production work without the need for scale-up, as the determining factor for batch size is running time and not the size of the equipment. Batch sizes ranging from a couple of kilogrammes up to several tonnes could be produced.

In early research and formulation development however, the availability of the active ingredient is often very limited and there is a need for process equipment that is capable of producing only a couple of hundred grammes to develop new drug formulas.

In response to this need, GEA Pharma Systems developed ConsiGma-1, the laboratory-scale version of the ConsiGma concept.

This system consists of a patented continuous high-shear granulator

equipped with all necessary auxiliaries to allow the development of the granulation process. A small dryer, equal to one drying segment of the ConsiGma production dryer and capable of handling 0.5 to 1.5 kg of granules, can be added to the laboratory machine, creating a reportedly unique combination with integrated controls for the development of continuous processes.

ConsiGma-1 is capable of running batches of a couple of hundred grammes up to 5 kg (or more if necessary), with less than 10 g of product held up in the process and less than 80 g of product losses.

Because of the fast processing times, minimal retention times and flexibility of the system, it is ideal for developing the formula and process parameters using Design of Experiments.

GEA Pharma Systems Collette +32 3 350 1258 tomas.vermeire@geagroup.com www.geapharmasystems.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP MPI Research Invests in Additional Nanolitre-Scale Immunoassay Platform

Gyros has announced that MPI Research has become the first CRO in North America to secure a second Gyrolab xP workstation, a nanolitre-scale immunoassay platform.

Data from immunoassays underpin many critical decisions within complex workflows for the development of biopharmaceuticals. The automated, precise, nanolitre-scale immunoassay

Expansion of Microbiological Culture Media Portfolio Prompts Release of Revised Technical Manual

platform from Gyros enables projectspecific biomarker, pharmacokinetic (PK), immunogenicity assays and impurity tests to be developed quickly, and to easily transfer the running of established assays. Since installing its first Gyrolab xP workstation in April 2011, MPI Research has developed more than 25 novel assays using the platform. The ability to work with nanolitre volumes maximises the number of assays that can be performed on samples that are often scarce.

Roger Hayes, PhD, VP and GM of Laboratory Sciences at MPI Research, commented: “Part of our mission is to exceed expectations, which means investing in innovative technology that can make a real difference to the way we work. We have seen great success both scientifically and commercially with the Gyrolab workstation, and look forward to building on this with additional platforms.”

Erik Walldén, CEO, Gyros, added: “We are very pleased that MPI Research has seen success with the Gyrolab platform.

With the growing trend for outsourcing to CROs, we are also seeing these companies increasing their capacity for our technology.”

Gyros AB +46 18 56 63 00 support.europe@gyros.com www.gyros.com

With the continuing expansion of its microbiological culture media portfolio, Lab M has revised the associated technical manual, which is now fully available. The Spring 2012 edition will reflect the fresh new branding brought in during 2011 when the company launched its information-rich ‘gateway to microbiology’ e-commerce website.

Offering detailed specifications for all Lab M products — including dehydrated culture media, Harlequin chromogenic media, anaerobe isolation media,

supplements and additives — this latest edition of the Lab M technical manual is available to download from the company’s website.

Lab M’s MD Ian Morris said: “Lab M is undergoing an exciting period of further growth and development, and the company’s product portfolio is moving forward all the time. We have been revisiting all our supporting documentation and this has given us the opportunity to advance the look and feel of our materials to reflect our ever widening global perspective, as well as ensuring they remain as useful and easy-to-use as possible.”

Lab M’s ongoing success in both domestic and export markets is driving the company forward into a period of rapid growth and transformation. Fully integrated research, development, quality assurance and manufacturing enable Lab M to provide a range of precise, rapid and dependable methodology for the detection, isolation and identification of micro-organisms.

Lab M Ltd +44 161 797 5729 info@labm.com www.labm.com

Droplet System for Encapsulation of Single Cells or Beads Dolomite has successfully developed a droplet system for the encapsulation of single cells or beads into droplets, which benefits a wide range of applications, including single cell analysis, high throughput screening and droplet PCR. The system represents a major breakthrough in microfluidics by providing users with the tools required to perform assays on individual cells in picolitre volume environments. This reportedly novel technology was demonstrated by feeding 2.8 µm diameter magnetic beads into monodisperse 100 µm diameter droplets at a ratio of one bead per droplet with minimal bead losses.

Featuring Dolomite’s standard microfluidic components, the new system allows users to load single cells or beads into droplets. The Mitos PPump allows stirring of the input fluid reservoir to provide an even distribution

of beads and delivers a pulseless and stable flow for excellent control of droplet volumes. Reliable and leak-free connections are made from pump to tube to chip using Dolomite’s Multiflux linear connectors.

Droplets are isolated in an inert fluorocarbon carrier stream to prevent cross-contamination and are stabilised with Pico-Surf, a biocompatible surfactant designed specifically for generating and stabilising pico-droplets.

The Dolomite Centre Ltd +44 1763 242491 www.dolomite-microfluidics.com

Multi-Media Cooling System Significantly Reduces Sterilising Time Astell Scientific has introduced the CYCLON COOLING system, which can cut sterilising and cooling times of large bottled loads such as culture media by up to 60%. This is a major benefit in microbiology laboratories where large quantities of culture media need to be processed quickly. A reduction in cycle time means that more loads can be processed during normal working hours, improving efficiency and reducing costs.

Shorter cycle times also mean reduced water and power consumption, so CYCLON COOLING can help to reduce environmental footprints.

Designed and developed by Astell’s in-house technical department, CYCLON COOLING is now available as an integral feature on all units fitted with air ballast and jacket cooling. It can also be offered EPM 24

as a retrofit on existing Astell autoclaves.

CYCLON COOLING is fully programmable using Astell’s unique LOGI colour touchscreen control system so that operating parameters can be set during validation to suit the types of fluid being processed.

Astell Scientific Ltd +44 20 8309 2024 sales@astell.com www.astell.com

SHOWCASE LIQUID HANDLING Manual Repeater Pipette Offers Flexible Solution for Repeated Liquid Dispensing Steps Over Wide Range of Volumes Mettler Toledo has announced the release of its Rainin AutoRep S manual repeater pipette. This new, lightweight, positive displacement repeater pipette gives laboratory researchers and technicians a simple, robust solution for applications that involve tedious, repetitious pipetting of liquid samples.

“The new AutoRep S represents a significant advancement in repeater pipette technology,” said Rainin Product Manager Brian Perry, Ph.D. “In addition to offering the highest precision and accuracy, the AutoRep S is 25% lighter than its predecessor, the AutoRep M. It features many enhancements to improve ergonomics and ease of operation — an important consideration for people who work with large sample

sets that require multiple, repetitive pipetting steps.”

The AutoRep S can dispense 59 different liquid volumes, ranging from 2 to 5 µl. A convenient filling lever on the front of the instrument simplifies aspirating liquids and the dispensing lever is conveniently placed for thumbaction control. Its extended finger hook, narrow shape and ergonomic grip work together to make the AutoRep S easy to hold over long periods and let it rest comfortably in either hand.

The stroke-setting wheel makes selecting application-specific sample dispense volumes and iterations for specific application requirements fast and easy. An ejection key further streamlines workflow by quickly ejecting

spent syringes, eliminating the need to manually detach them. Reference tables attach to the back of the instrument to aid in selecting the appropriate syringe size and stroke setting for a particular application.

The AutoRep S works with syringes from many manufacturers. Rainin’s Encode family of disposable syringes now includes 1 and 10 ml syringes, giving users an exceptionally broad selection of pipetting formats and dispense volumes. The syringes are available both sterile and non-sterile.

Rainin Instrument, LLC +1 510 564 1809 brian.perry@rainin.com www.mt.com

Low Dead Volume Reservoir Saves on Reagent Costs INTEGRA has introduced a 10 ml disposable multichannel reagent reservoir, the low dead volume (650 µl) of which generates significant savings on reagent usage. One side of the 10 ml reagent reservoir is moulded into a pour-back spout to help control liquid flow, allowing users to neatly and easily return excess fluid to a source container.

INTEGRA multichannel reagent reservoirs, now available in 10, 25 and 100 ml, are cleverly designed to nest within one another without sticking.

INTEGRA reagent reservoirs come in compact, space-saving packages.

Packaging options include portable, standalone sleeves (ideal for laboratory

benches or hoods) and individually sealed bags for sterile applications.

INTEGRA reagent reservoirs are both economically and environmentally friendly because users can reuse the reservoir base and dispose of the reservoir inserts.

The transparent polystyrene design allows the crisp graduations on the inside of the reservoir base to be clearly seen, enabling accurate fluid measurement and reduced reagent waste. For maximum fluid recovery, INTEGRA reagent reservoirs feature a full-length, extra deep trough that is more easily accessible for pipette tips.

INTEGRA also offers SBS footprint 100

and 300 ml reagent reservoirs. Ninetysix individual pyramidal indentations allow for maximum liquid recovery when using the VIAFLO 96 - 96 channel electronic pipettor or other instruments.

INTEGRA’s SBS footprint reservoirs are also economically and environmentally friendly because users can reuse the reservoir base and dispose of the reservoir inserts.

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

System Bridges Gap Between Nanolitre and Microlitre Liquid Handling TTP Labtech’s new mosquito HV, launched at SLAS 2012, has been developed to allow scientists to accurately handle low volume serial dilutions and assay plate preparations, across the 500 nl to 5 µl range. In addition, the mosquito HV can rapidly perform serial dilutions in the 2–8 µl final volume range, and can stamp from a mother plate directly to assay plates as part of the same protocol, saving valuable laboratory time. mosquito HV is one of three brand new products to be launched by the innovative laboratory instrumentation manufacturer. mosquito HV retains all of the reportedlyunique features of TTP Labtech’s mosquito range of nanolitre liquid handlers, including its proprietary positive displacement pipetting technology for rapid, accurate dispensing of sample volumes,

regardless of viscosity. The mosquito HV’s larger disposable micropipettes ensure zero cross-contamination and reach right to the bottom of wells, minimising dead volume to under 50 nl per well. mosquito HV also offers outstanding accuracy, to within 2% of target volume. It is available in an HTS format for screening and an X1 format for hit picking applications.

Building on the success of the mosquito liquid handling portfolio, mosquito HV offers further flexibility in the low volume range for highly accurate sample dispensing and handling for a wide range of chemical and biological-based applications beyond serial dilutions and plate reformatting. These include compound and small molecule screening, cell or bead based assays, enzyme kinetics assays, ELISAs, molecular biology

applications such as PCR, RNAi screening and SNP genotyping. mosquito’s extremely accurate and precise pipetting and mixing capabilities ensure good quality, repeatable data, with c.v.’s of below 2.5% throughout its volume range, whilst minimising run times and reagent wastage.

Joby Jenkins, Product Manager for the mosquito product range, commented: “It is exciting to be able to launch mosquito HV, which has come about as a result of a number of requests for a higher volume version of our renowned mosquito HTS.” TTP Labtech Ltd +44 1763 262626 sales@ttplabtech.com www.ttplabtech.com/new

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Corporate News & Events

The Royal Society of Chemistry to Host Conference at LAB INNOVATIONS

LAB INNOVATIONS is proud to announce its partnership with the Royal Society of Chemistry for the upcoming event on 7 and 8 November, at Birmingham NEC, UK. The Royal Society of Chemistry will be running a programme of talks from industrial researchers, academics, spinout researchers and technical sales managers. These scientific sessions will deliver exceptional talks on the latest developments and applications around life sciences, chemical industries and environmental science core to the exhibition visitors.

The two-day programme will address a range of practical issues through workshops and walk-in sessions ranging from health and safety obligations to information on continuing a career and getting the most out of continual professional development (CPD).

As a supporter of LAB INNOVATIONS, The Royal Society of Chemistry will also help promote the event to its members and to the industry. Jennifer A. Dougan, Programme Manager in Analytical Sciences from the Royal Society of Chemistry, commented: “The RSC is delighted to be working closely with easyFairs on the LAB INNOVATIONS show. We will be delivering a programme of valuable content that will

Automated Lab Equipment Provider Launches Impressive Number of Products Following Company Growth

be of benefit to all delegates. We are looking forward to supporting the chemical sciences by providing a forum to find out about new technologies and developments through scientific sessions and professional workshops.”

LAB INNOVATIONS is reportedly the UK’s only tradeshow dedicated to laboratory technology and consumables, analytical and biotech equipment for the chemical industries, life sciences, food and beverage and environmental sciences. This two-day event brings together the manufacturers, distributors and suppliers with end-users and senior decision-makers from the leading industrial, educational and research laboratories.

LAB INNOVATIONS provides an invaluable platform for visitors to not only source new products and suppliers, but also touch, feel and test the latest product developments, and build their skills and knowledge through a programme of vital seminars. The latest techniques and products will be presented in a live demo area, helping visitors improve their knowledge and processes. easyFairs UK Ltd +44 20 88 43 88 00 uk@easyfairs.com www.easyFairs.com/labinnovations

TTP Labtech has strengthened its inhouse team and commitment to product development following a successful 2011, which saw revenue increase by 5%. Having invested heavily in R&D in 2011, with 100% of resources focused solely on product development, TTP Labtech has launched an impressive number of products this year alone, with more launches planned for later in 2012.

Utilising a commercial-focused yet still consultative approach, which involves listening carefully to customers and developing products that closely meet their needs, TTP Labtech has further built on its strong reputation as an innovative yet approachable industry partner. With a sales increase of 16% in products, 14% in consumables and 7% in sales across Asia, TTP Labtech expects this growth trend to continue throughout 2012.

An established leader within the liquid handling, cell based screening and sample management fields, TTP Labtech has continued to develop reportedly innovative solutions within these arenas, while also extending its product offering to include new application areas, including PCR (mosquito HV), biobanking (arktic) and analytical chemistry (aequus).

Following the recent launch of its new microlitre flow calorimeter for highthroughput enzyme screening, chipCAL, TTP Labtech has also entered the food industry market for the first time, illustrating the company’s commitment to further expansion during 2012.

To support company growth, TTP Labtech has expanded its in-house team of scientists, engineers and automation experts, with a series of promotions and

new appointments to drive the company forward. The most significant of these is the promotion of Jas Sanghera, former Commercial Manager, to MD. He commented: “I am delighted to be taking on the role of Managing Director, as it will enable me to strengthen our marketing and sales activities, while maintaining responsibility for the products. One of the factors that sets TTP Labtech apart is our reputation for robustness, reliability and customer service.”

Providing the company with a solid marketing position, Barbara Bengyel has been appointed as Marketing Manager, while Andrew Goulter has been employed as Distributor Network Manager to expand and support product distribution. Finally, following the division of the products into two main product lines, automation and instrumentation, Joby Jenkins has been promoted to Global Sales Manager for Automation and David Sharp has been appointed as Global Sales Manager for Instrumentation.

According to TTP Labtech, the newly appointed members will complement the current team and help to maintain the company’s stance as a natural innovator in the creation, development, design and manufacture of instrumentation, providing novel, high calibre solutions for the biotechnology and pharmaceutical industries, and academia.

TTP Labtech Ltd +44 1763 262626 sales@ttplabtech.com www.ttplabtech.com

Registration Open for Workshop on Portable and Handheld Molecular Spectroscopy

Analytik, a leading supplier of innovative analytical solutions to the UK and Ireland, has announced the first UK workshop at its new premises in Swavesey, Cambridge, UK. Run in partnership with Agilent Technologies, a leading analytical instrument company,

the free-to-attend meeting will focus on portable and handheld molecular spectroscopy.

Molecular spectroscopy techniques are extremely well suited to being applied as portable or handheld instruments. Their simplicity, speed,

selectivity and ability to operate without sample preparation make them ideal to be used outside of the laboratory in more challenging environments. By bringing the analyser to the sample and making measurements when and where they are required, the full benefits of molecular spectroscopy can be realised.

Since becoming a channel partner for Agilent Technologies and incorporating the company’s handheld and portable FTIR products into its spectroscopy portfolio, Analytik is now able to deliver the three core vibrational spectroscopy techniques, FTIR (Mid-IR), NIR and Raman, as portable solutions.

In order to keep customers up to date with the latest innovations in mobile spectroscopy and the powerful potential applications available, Analytik, working in collaboration with Agilent, is running a

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‘Portable and Handheld Molecular Spectroscopy Workshop’ on Tuesday 17 July, at Analytik’s premises in Swavesey.

Product specialists from both Agilent and Analytik will be available for consultation at the workshop. The day will consist of a mix of presentations and product demonstrations, and will give delegates the opportunity for practical hands-on sessions using the FTIR, NIR and Raman instruments. Delegates are encouraged to bring along their own samples to measure and experience the ease of using these tools first hand.

With spaces limited, please contact Analytik to register as soon as possible.

Analytik Ltd +44 870 991 4044 tom.greenwell@analytik.co.uk www.analytik.co.uk

INGREDIENTS & CONTRACT SERVICES

Commercial Supply of Improved Hyaluronic Acid Begins from Q7 cGMP Facility in China Novozymes Biopharma, part of Novozymes A/S, has announced the first shipment of the company’s Bacillus-derived hyaluronic acid (HA), Hyasis, from its newly inaugurated manufacturing facility in China, which represents an investment of more than DKK 350 million. The first commercial products using Hyasis as a raw material are expected to reach the market in Q2 of this year.

“Shipment of the first commercial hyaluronic acid material from our new Q7 GMP facility marks an important milestone on our journey to becoming a leading producer of high quality HA. With our new patented process, based on the safe bacteria Bacillus subtilis, the market will have access to a new improved source of HA that is fully compliant with the highest pharmaceutical standards and developed with customers’ specific needs in mind,” said Thomas Videbæk, EVP of Novozymes A/S. Hyasis has been specifically designed to fill a gap in the market for biomedical and pharmaceutical manufacturers looking for Q7 regulatory compliant ingredients with superior performance benefits.

According to Novozymes, its focus on improving processes for its customers has resulted in a HA that offers a wealth

of innovative advantages over competitive sources.

Superior heat stability permits autoclaving without significant loss of product viscosity, and tight control of molecular weight during production allows for excellent control in formulations.

Novozymes’ Hyasis also offers its customers exceptional batchto-batch consistency in production at large-scale, and its reported capability of dissolving five times faster than other sources can reduce processing times by up to 50%.

A critical component in the development of an improved biomedical grade HA has been the construction of the new manufacturing facility designed exclusively for Hyasis.

Located in Tianjin, China, the facility employs a patented water-based process to manufacture Hyasis to Q7 cGMP standards. Working with raw materials that are already Q7 compliant can help medical device and

pharmaceutical drug manufacturers to reduce testing time, minimise documentation requirements, save on manufacturing costs and take products to market faster.

First customers have been testing the product for some time with good results and Hyasis is now being sold to medical device and pharmaceutical customers.

Novozymes Biopharma +45 4446 2274 retr@novozymes.com www.novozymes.com / www.hyasis.com

APIs & Formulated Products Supplier Appoints Chairman One of the fastest growing businesses in the UK, Aesica Pharmaceuticals, the pharmaceutical contract manufacturer backed by Silverfleet Capital, the European private equity firm, has appointed David Greensmith as NonExecutive Chairman.

Greensmith has highly relevant experience from operating in the chemical and pharmaceutical markets, as well as through holding a number of private equity backed non-executive chairmanship positions. Greensmith’s previous executive roles include MD of Fujifilm Imaging Colorants and COO of Avecia Group.

Greensmith’s appointment comes on the back of news that Aesica Chief Executive Robert Hardy has been named CEO of the Year for the North East region in the BVCA (British Venture Capital Association) Management Team Awards.

Headquartered in the North East, Aesica exemplifies a UK manufacturing

success story. Over the last four years, turnover has quadrupled in size from €25 million in 2005 to a forecast of €180 million this year. In the last 12 months alone, the business has doubled its employee numbers to approximately 1,300.

Adrian Yurkwich, the partner at Silverfleet Capital with responsibility for healthcare, who is on the board as a Non-Executive Director, commented: “David joins at an exciting time for the business. We have recently strengthened links with the US market after the site at Queenborough in Kent passed its first US FDA inspection. This is a particularly significant development for Aesica and will help it to boost credibility in the US market at a time when the company is expanding its presence outside of Europe.

“David has excellent experience as a chairman of private equity backed businesses and understands the dynamics of the pharmaceutical

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manufacturing sector well. We look forward to working with him.”

Greensmith commented: ”Aesica is an excellent business with a first rate management team who have achieved impressive growth. We expect to continue to deliver strong growth and further strengthen our international footprint.”

Dr. Robert Hardy, CEO of Aesica, added: “We’re delighted that David has joined the Aesica team. His insights will put us in an even stronger position to achieve our vision of becoming the number one supplier of APIs and formulated products to the pharmaceutical industry. We have already made significant strides towards this goal and will continue our focus on organic growth and strategic acquisitions.”

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

INGREDIENTS & CONTRACT SERVICES ROUNDUP Gelcap Makes Paracetamol Line Extension Possible in France When Sanofi was looking to expand its popular paracetamol brand in France, the company turned to Capsugel, a leading worldwide provider of reportedly innovative dosage forms and solutions, for support.

A dosage form that would mask the tablets’ strong taste was required, so Capsugel recommended its proprietary Press-Fit gelcap technology, which enrobes a caplet with a high-gloss gelatin cover, not only helping to mask taste, but also making the caplet easier to swallow than its original tablet form. Also, since Press-Fit gelcaps are available in a wide range of colours, they were able to use the brand’s signature colours for the new line extension and enhance its brand recognition with patients.

“The Press-Fit gelcap size that was

required for the new caplet was not something we already had available for order. It would be the largest Press-Fit capsule ever manufactured by Capsugel, so we conducted a complete development project to make it a possibility for the line extension,” said Dominique Cadé, Director of Polymer Science at Capsugel.

Capsugel’s consumer studies show that when it comes to dosage forms, consumers significantly prefer gelcoats and capsules over tablets, and Press-Fit gelcaps offer a simple solution for OTC and pharmaceutical products to offer a line extension in a preferred form.

“Capsugel’s Press-Fit gelcaps offer a fast and simple alternative for customers like Sanofi looking to extend their product offerings. Consumers and

Industry Leaders Launch Company Focused on R&D of Drug Delivery Systems to Meet Needs of Patients and Specialist Physicians

Leading figures from across the pharmaceutical industry have joined forces to launch Adeptio Pharmaceuticals, an organisation that combines the experience and expertise available to a large pharmaceutical company with the agility of a small specialist pharmaceutical company.

Adeptio Pharmaceuticals is a wellfunded, privately owned company, with an industry renowned Board of Directors that includes industry icons such as: Henry Wendt lll CBE, former Chairman of SmithKline Beecham plc and founder and former Chairman of Global Healthcare Partners; Handel Evans, cofounder and former Chairman of Marketing Services Inc. and co-founder and Senior Executive of IMS International Inc.; and Mark Evans, former CEO of Cambridge Laboratories.

Other Non-Board Investors include individuals such as Bernard Taylor, cofounder and former Executive Chairman of Medeva plc, who also brings a lifetime of experience within the pharmaceutical industry. CEO Ian Montague (pictured) has over 20 years experience in the pharmaceutical industry with companies such as Abbott Laboratories and Roche Pharmaceuticals, most recently holding the position of Business Unit Director for Northern Europe at Valeant Pharmaceuticals Ltd. Focused on the R&D of drug delivery systems designed and developed to meet the needs of patients and specialist physicians, Adeptio Pharmaceuticals brings its team’s wealth of experience to address long-term treatment challenges.

Capsugel +33 3 89205846 catherine.lehmann@capsugel.com www.capsugel.com

Dry Powder Analysis Service Launched at Respiratory Drug Delivery 2012

The company targets established niche and specialist therapeutic markets by designing and developing innovative products based on already established APIs to address long-term treatment challenges. The Board possesses indepth and wide-ranging knowledge in a variety of sectors, including neurology, wound care and OTC dermatology, and has extensive experience of managing drug development teams, while the Management team has a strong background in all aspects of managing a product life span, including strategic pipeline development and regulatory affairs (MHRA, FDA and Orphan Drug), and has a record of having successfully launched many products in the EU, US and globally. In addition, the team brings extensive experience in the areas of operations, finance and international marketing.

Montague commented: “Adeptio Pharmaceuticals has ambitious plans and the first projects are already in progress and running to schedule.

Several other opportunities are currently being evaluated by the Management team and we anticipate initiating at least one of these in 2012.

“Adeptio Pharmaceuticals has the ability to accelerate product time-tomarket launch. We aim to reduce the inherent risks of product development and secure long-term protection of intellectual property, thus creating and adding value through the R&D process.

“Our Management team has the depth and breadth of experience required to manage a product from pre-clinical development through to market and all have a proven track record of this. It is this combination of Board and Management know-how that gives Adeptio Pharmaceuticals the strongest possible foundation. We are taking the vast experience of these two elements to create a forward thinking, groundbreaking company. The industry leaders we have on board give us an incredibly strong starting point and we look forward to helping shape the future of the pharmaceutical industry.”

Adeptio Pharmaceuticals Ltd +44 207 400 3388 info@adeptioltd.com www.adeptioltd.com

patients already perceive capsules and gelcoats to be easierto-swallow than tablets, so enhancing an existing caplet with Press-Fit gelcaps gives manufacturers a simple way to offer a valueadded line extension and differentiate their brand,” said Erasmo Schutzer, Chief Marketing Officer for Capsugel.

Melbourn Scientific is to extend its portfolio of formulation and analysis services for inhaled product and device development. This follows the introduction of the Freeman Technology FT4 Powder Rheometer, which provides characterisation of powders in order to predict performance.

Derek Solomon, Operations Director at Melbourn Scientific, said: “A key challenge of developing pharmaceuticals for inhalation is creating a formulation that offers both good pharmacologic activity and desirable pharmaceutical properties — fluidity, dispersion, delivery and deposition.

“It is becoming more widely understood that powder properties can vary widely with different formulations and this can impact the performance of a DPI. Use of specialist equipment, such as the FT4, makes it possible to characterise the powder and optimise the formulation.”

Particle size determines where product is deposited in the lungs, but it is just one of many factors that can impact on the flow properties of a powder.

Most DPI formulations consist of a micronised drug blended with larger carrier particles. When the DPI is actuated, the formulation is fluidised and enters the patient’s airways. The inspiratory airflow carries the drug deep into the lungs while the larger carrier

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particles impact the oropharyngeal surfaces. If the cohesive forces in the powder are too strong, the shear of the airflow may not be sufficient to separate the drug from the carrier.

Melbourn Scientific provides support for early stage product development and device development, with teams of formulators and analysts working closely together in teams. Investment in the FT4 means that modifications to formulation can be made and the impacts realised with great precision.

Freeman Technology Operations Manager Jamie Clayton commented: “The FT4 provides an innovative and patented approach to powder testing that quantifies dynamic properties (flow energy, stability, aeration) bulk properties (permeability, compressibility) and shear properties. For the first time, this allows sensitive and reliable characterisation of powders with respect to a given process, which helps improve quality control and performance from development through to manufacture.”

The company anticipates that this further investment in leading-edge technology will be a valuable addition to its suite of services.

Melbourn Scientific +44 1763 261648 info@melbournscientific.com www.melbournscientific.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP CDMO Secures Triple-Digit Million Euro Credit Facility

As part of its business growth strategy, Vetter has announced that a triple-digit million euro syndicated loan has been arranged with a consortium of renowned banks led by Deutsche Bank AG, the Landesbank Baden-Württemberg, and Commerzbank AG at the end of march.

The five-year credit facility will secure Vetter’s plans for additional investments in its facilities and production capacities.

Thanks to this syndicated loan, Vetter will manage to set a course for continued success and expand its role in the international pharmaceutical and biotechnology market.

Over the past several years, Vetter has seen constant growth in customer demand, resulting in the need for expanded production capacity. In response, Vetter created its new production site Ravensburg Vetter South and the company’s clinical development

Paper Demonstrates Improved Delivery and Co-localisation of Respiratory Medicines in Lung Via ‘Smart’ Combination Particles

site in Chicago, Vetter’s first US facility.

This growth has also led to the continuing need for additional employees. As such, Vetter has created over 300 new jobs in the last year alone.

To continue organic growth, Vetter sought the announced credit facility for further investments in new filling capacity, as well as modernising and expanding existing facilities.

“This syndicated loan allows for continuous investment in our company and keeps us strategically well positioned for the future,” said Max Horn, MD at Vetter. “Therefore, combined with our own financial strength, this multimillion credit facility, from renowned business banks, gives us the financial basis we need. We always seek to use most innovative technologies and processes available within the industry.

To do so means that we must continue to adapt our facilities to meet the markets ever-increasing capacity and quality requirements. Such expansion not only provides our customers with security of supply, but also safeguards jobs for our employees. With this syndicated loan, we have secured our position as a key strategic partner for the development and filling of drugs for our clients now and in the future.”

Vetter Pharma International GmbH +49 751 3700 0 info@vetter-pharma.com www.vetter-pharma.com

University Graduates Receive Recognition for Excellence in Academic Research and Creative Drug Delivery Solutions

Catalent Pharma Solutions announced the winners of the company’s Global Academic Competition for Life Science Leaders of Tomorrow, a programme that aimed to identify the world’s premiere scientific talent and innovative research at university level, while rewarding academic excellence. Graduate students from St. John’s University and Purdue University received first-place and runner-up awards.

Sponsored by Catalent Pharma Solutions and with St. John’s University as the academic lead for the programme, the competition was open to university students enrolled in graduate programs in pharmaceutical science, industrial pharmacy, drug delivery, drug development or related disciplines. Participants were asked to submit either an original research article focusing on challenges in drug development and/or drug delivery, or a research proposal that clearly described an original, innovative research project in drug development/delivery. Among the schools invited to participate were Purdue University, US, the University of Mississippi, US, Rutgers University, US, the University of Maryland, US, Ohio State University, US, University of Bristol, UK, and the Chatenay Malabry Pharmacy School, France.

The first-place prize for best Research Article was awarded to Zhen Ye of St. John’s University for her paper titled: ‘The Development and Scale-up of Biodegradable Polymeric Nanoparticles for the Non-Steroidal Anti-inflammatory Drug Ibuprofen’. Pulkit Khatri of St. John’s University took first place for best Research Proposal on the ‘Construction of Recombinant Lactococus Lactis for Oral Delivery of Glucagon Like Peptide-1 Fused to Cell Penetrating Peptide for the Treatment of Type-2 Diabetes’. Runnerup Trung Xuan Nguyen from Purdue University won for his proposal titled: ‘The Design, Synthesis and Biological Evaluation of Indenoisoquinolines as Potent Dual Topoisomerase 1, TyrosylDNA Phosphodiesterase 1 inhibitors’.

The first-place winners of the competition received a $5,000 cash prize and an opportunity to intern at Catalent Pharma Solutions. Their awards were presented at a special ceremony on 14 May, at Catalent’s facility in Somerset, New Jersey, US, where they met with Catalent executives as they toured the facility.

Catalent +1 732 537 6407 media@catalent.com www.catalent.com

Prosonix has published a review paper describing how its reportedly novel particle engineering led approach to respiratory medicines is enabling the development of ‘smart’ excipient-free, drug-only Multi-component Particles (MCPs) that offer the potential of more effective inhaled combination therapies.

Since their introduction, inhaled combination therapies have improved the management of major respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD).

There is compelling evidence that combination therapies act synergistically to reduce inflammation and constriction of the airways, preventing disease progression, offering symptomatic relief and improving quality of life by providing treatment for complications and exacerbations. Drug combinations form the basis of several blockbuster respiratory medicines such as GlaxoSmithKline’s Advair/Seretide and AstraZeneca’s Symbicort. Both of these products are based on combinations of an inhaled corticosteroid (ICS) plus a long-acting beta-agonist (LABA).

Combinations of a LABA with a longacting muscarinic antagonist (LAMA) and triple ICS/LABA/LAMA combinations are also being developed.

In the new review, published in the Spring 2012 issue of European Respiratory Disease1, the authors highlight the advantages of combining two or more APIs in exact and consistent ratios in a single, excipient-free, drugonly particle (known as Multi-component Particles or MCPs) compared with mixed powder formulations. This is particularly beneficial when there is a synergistic action between the APIs, which ideally should be delivered and deposited together at the targeted site of action in the lung.

Going into more depth, the authors describe the use of Prosonix’s ultrasonic particle engineering approach to creating MCPs comprising equivalent

ratios of fluticasone propionate (FP) and salmeterol xinafoate (SX) as in Advair/Seretide, and of budesonide (BDS) and formoterol fumarate dehydrate (FFD) as in Symbicort. These MCPs were found to retain the ratio of APIs of the originator products in both formulation and delivered dose via pMDI. Co-association of respiratory APIs in the form of MCPs was consistent throughout the process chain of manufacturing, formulation and delivered dose, offering the promise of achieving true synergy, optimal therapeutic efficacy and reduced dosing.

In developing respiratory MCPs, Prosonix believes it is overcoming the main challenge faced by the companies developing combination products of maintaining consistent ratio of the APIs during formulation and upon redispersion and deposition in the lung.

The excipient-free, drug-only nature of the MCPs is particularly advantageous.

The majority of combination products on the market and in development are based on dry powder blends of APIs, which once aerosolised and inhaled are co-deposited randomly and therefore reduce the opportunity for a synergistic effect. Furthermore, current manufacturing methods — primarily jet milling large particles into smaller particles — change the chemical and physical stability of the particles. As a result, this creates little, if any, coassociation among the actives.

Advair® and Seretide® are registered trademarks of GlaxoSmithKline, and Symbicort® is a registered trademark of AstraZeneca.

1/ Parikh, D., et al., Improved Localised Lung Delivery using Smart Combination Respiratory Medicines. (2012) European Resp. Disease, vol. 8 (issue 1), 40–45.

Prosonix Ltd +44 1865 784250 www.prosonix.co.uk

Clinical Technology for Investigating Drug Absorption Receives Final Patent Approval Quotient Clinical, part of Quotient Bioresearch (Quotient), has received approval of the final patent for its Enterion technology. This completes a portfolio of eight granted patents across North America and Europe, with a lifetime extending through to 2020.

The Enterion capsule has been developed to investigate the absorption of drugs from the gastrointestinal (GI) tract. It is a remote-controlled device that is capable of precisely delivering pharmaceutically relevant drug formulations (both liquids and solids) to specific sites within the GI tract. The information gained from these studies provides formulation scientists and clinical development teams with invaluable insights in order to guide the development of optimised drug products for oral administration.

Since its invention, Enterion has been

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used in over 120 clinical studies that have involved the dosing of over four thousand Enterion capsules to healthy volunteers at Quotient’s clinical facility in Nottingham, UK. Mark Egerton, MD, Quotient Clinical, said: “Approval of this final patent represents a key milestone in our Enterion programme. The technology has been in routine use for several years and reinforces our commitment to deliver innovative solutions for our customers. It is gratifying that Enterion has been deployed in development programmes for many of the breakthrough medicines in the industry’s pipeline today.”

Quotient Clinical +44 115 974 9000 clinical@quotientbioresearch.com www.quotientbioresearch.com/clinical

INGREDIENTS & CONTRACT SERVICES ROUNDUP Clinical Trial Laboratory in Japan to Expand Covance Inc., a leading provider of drug development services, and BML, Inc., a leading Japanese laboratory testing company, have announced the expansion of the Covance-BML Clinical Trial Laboratory (CB Trial Lab) in Kawagoe City, Saitama Prefecture, to enhance the capacity and capabilities in the region. The companies, which opened the laboratory together in 2010 as part of a five-year agreement, will launch several new expansion-related services this month.

“The expansion of the CB Trial Lab speaks to both the success of our affiliation with BML and the growing drug development relationships we have built with our clients in Japan and across the Asia-Pacific region,” said Jonathan Koch, Global General Manager, Covance Central Laboratory Services.

“This investment is an important step in growing our relationship with Covance and allows us to offer clients a wider range of services in an increasingly competitive marketplace,” said Kazuta Fukuda, President, BML.

The laboratory expansion includes increasing the size of the original facility by 50%, while adding new testing platforms, equipment and additional sample storage space. Specifically, new laboratory testing platforms have been added to enhance the capacity of the CB Trial Lab to manage the growing demand for in-country testing services.

These new service offerings in the areas of immunoassay, flow cytometry and protein chemistry will speed results to physicians conducting clinical trials for these critical testing parameters.

The CB Trial Laboratory is accredited by the College of American Pathologists (CAP), and maintains CDC lipid certification as well as National Glycohemoglobin Standardization Program (NGSP) Level 1 certification.

REGULATORY AFFAIRS

Covance Inc. +1 609 419 2060 laurene.isip@covance.com www.covance.com

Pharma Development and Manufacturing Services Provider Strengthens Finance Team with Senior Appointment

Penn Pharma has announced the appointment of a new Director of Finance, Craig Collingwood has joined Penn at an integral point, playing an essential role in the company’s growth strategy.

Collingwood’s appointment follows a recent £14 million investment announcement from the global pharma company in its South Wales, UK, facility to expand its specialist high containment offer.

As a qualified chartered accountant, Collingwood brings more than 12 years experience, having worked for KPMG, Cardinal Health, and Catalent Pharma Solutions as Group Finance Director, where he managed a number of international group businesses. His most recent experience comes from working

Regulatory Affairs (RA) is a comparatively new profession, which has developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

It may take anything up to 15 years to develop and launch a new pharmaceutical product and many problems may arise in the process of scientific development and because of a changing regulatory environment. RA professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. As a matter of fact, all these activities have been incorporated in the term ‘Regulatory Science’, which better describes the impact and the role of professionals involved.

Consequently, choosing a regulatory partner is not easy nor a simple matter of the best offer. Inadequate reporting of data may prevent a timely positive evaluation of a marketing application. A new drug may have cost many millions of pounds, Euros or dollars to develop and even a three-month delay in bringing it to the market has considerable financial considerations.

So, a few tips follow that may be of help in the choice of the right partner.

When choosing a professional consultant or employee, graduation in a scientific discipline — commonly life sciences or pharmacy — is highly desirable, although increasingly biotechnology-based degrees are also valuable. However, a specialist first degree is often not enough. Continuing education is essential and organisations such as TOPRA offer an MSc in Regulatory Affairs for those who wish to gain a formal professional qualification in the discipline.

Communication skills are also very important. Analysing issues and presenting both written and oral evidence before a panel of experts such as scientists, pharmacists, doctors and lawyers who run the government agencies requires considerable understanding of both legal and scientific matters. An attention to detail is therefore a pre-requisite.

When choosing a contract organisation or third-party consultancy, it is wise to look for a wide range of experience based on working daily with both the industry and the authorities, plus a custom-tailored, flexible service that will meet your specific needs and budget. Working on a global scale and in multiple languages and scenarios may give a wider perspective, even to the most local needs, and also add value for money.

Your RA partner should be considered as a trusted doctor for medicines.

Whatever the need is, before outsourcing such a crucial activity, or part of a project, one should evaluate based on the same criteria as when choosing the right surgeon, paediatrician, intern or dentist — according to the level of trust, experience, empathy and track record of success.

CHOOSING THE RIGHT REGULATORY AFFAIRS PARTNER

as an independent consultant within the pharma industry for his own company.

Speaking on his appointment, Collingwood said: “The future plans and growth targets at Penn really appealed to me, I am excited to have joined the team at such a significant point in the company’s development. Finance is particularly important in this transitional period, so I can really use my skills to ensure strong cash management during the investment in our high containment operations.”

The construction of the new approx.

1394 m2 development and commercial manufacturing unit for tablets and capsules has already commenced and it is designed to meet the highest international quality standards. The new facility will enable the team at Penn to further build upon its established 15 years expertise in the manufacture of highly potent drugs for the worldwide market.

Chief Executive Dr. Richard Yarwood said: “Craig is a significant hire for Penn Pharma, as we needed to recruit someone with outstanding pharma finance knowledge coupled with experience in being part of a company undergoing rapid growth and change.

We are delighted to welcome Craig to the board and are sure that this appointment will be key to the continued success of the Penn brand.”

Penn Pharma has a wealth of experience in successfully providing an integrated range of services for the development, manufacture and distribution of medicinal products to the global pharmaceutical market.

Penn Pharma +44 1495 711 222 enquiries@pennpharm.com www.pennpharm.com

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Dr. Paolo Biffignandi paolo@elc-group.com

Dr. Paolo Biffignandi, MD, PhD, QPPV, FTOPRA, former President of The Organisation for Professionals in Regulatory Affairs (TOPRA), is an advisory board member of the pan-European pharmaceutical regulatory affairs organisation ELC Group.

He is a renowned physician who graduated in Medicine with PhDs in Endocrinology and Pharmacology. Dr. Biffignandi started his highly successful career in the pharmaceutical industry after a period at the University of Torino, Italy, and in 1989 he became an independent consultant in medical and regulatory affairs.

He is the author of more than 160 scientific articles and co-author of three books on European Regulatory Affairs and a member of several scientific societies, including DIA, RAPS and TOPRA. From 2003, he was a member of the Board of Directors of TOPRA, of which he was President in 2009–10. In 2009, he was appointed Fellow of The Royal Society of Medicine, in the UK.

SHOWCASE PACKAGING SERVICES Pharma Packaging and Filling Area Extends Established Facility in Pfreimd Gerresheimer Medical Plastic Systems continues to expand its range of services in order to meet customer demand for complete solutions. In addition to injection moulding, assembly, packaging and finishing, the service portfolio now increasingly includes pharmaceutical product assembly and packaging. In fact, the Gerresheimer Regensburg GmbH facility in Pfreimd, Germany, now also has a pharmaceutical packaging and assembly area.

The area was designed in accordance with the modern, flexible zone concept.

It is comprised of three cleanrooms, classified and validated in accordance with GMP Class D (ISO 8), ranging in size between 70 and 90 m2. “When producing different products, the production areas must be physically separate,” Armin Henning, Director of Production Sites in Europe, explained about the concept. The packaging and assembly area therefore consists of modular production cells, which are separated from each other through pressure cascades. The rooms are equipped with assembly, filling and test equipment that complies with the guidelines of the German Pharmaceuticals Act. Compliance with the quality standards is guaranteed through regular audits by the government of Upper Bavaria. The pharmaceutical filling process is supervised by a qualified person, a pharmacist with 25 years of experience in the area of the production of pharmaceutical products.

Additional Clinical and Commercial Packing Capability for Range of Dosage Forms

Gerresheimer Medical Plastic Systems has 10 years of experience in the filling and packaging of active ingredients in various application systems. During 2001, clinical test samples and stability batches of a dry powder inhaler were being filled. This filling permit was limited to the handling of clinical test samples. It included the production of powder mixtures, as well as the assembling, packaging and labelling of dosing devices that came with the powder mixtures. In 2007, this filling permit was expanded to also include the loading and packaging of applicators with implants. In 2011, Gerresheimer Medical Plastic Systems obtained a manufacturing permit as required by the German Pharmaceuticals Act, which entitles the company to package and assemble in accordance to that act.

The facility of Gerresheimer Regensburg in Pfreimd now features a new pharmaceutical packaging and filling area.

Gerresheimer AG +49 211 6181 246 m.stolzenwald@gerresheimer.com www.gerresheimer.com

Following the recent announcement from Penn Pharma on a new £14 million high containment facility for the production of tablets and capsules containing highly potent actives, the specialist provider of pharmaceutical development and manufacturing services has announced additional investment in its packing capacity and capabilities.

The established international pharma services company has installed a number of new packing lines and equipment to support an increased demand for packing and labelling a range of dosage types for both clinical and commercial needs. Penn has also re-modelled its existing facilities, adding additional rooms for assembly of clinical trials kits, several new flexible secondary packing rooms and a new label production suite to further strengthen its European operation in Tredegar, South Wales, UK.

Flexible Options in Final Assembly and Secondary Packaging Vetter’s state-of-the-art secondary packaging facility offers customers the option of one-stop shopping in the drug production process. As a leading, independent, international specialist in aseptic fill and finish, the company offers a comprehensive range of options for final assembly and packaging of pharmaceutical and biotech products: fully automated secondary packaging; packaging for high standards of cosmetic integrity; and assembly of pens, auto-injectors and safety devices.

Vetter Secondary Packaging provides:

• semi- and fully-automated secondary packaging; • labelling, blistering, cartoning with package insert and case packing; • assembly of pens, auto-injectors and safety devices; • and high standards of cosmetic integrity.

Vetter Pharma International GmbH +49 751 3700 0 info@vetter-pharma.com www.vetter-pharma.com

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Chief Executive Dr. Richard Yarwood said: “We are pleased to be in a position to continue to invest in the existing operations whilst the new high containment unit is under construction.

These new facilities have been designed to meet all current GMP requirements across our broad range of licences.

“The new equipment and expanded facilities will provide the business with the capacity to deliver larger contracts for clinical and commercial supplies, including several projects recently won for EU commercial distribution.”

Penn has installed three additional labellers, including one with the capability to automatically label vials and ampoules. All the new labelling equipment features comprehensive security features, including missing overprint presence detection sensors and pharmacode reading systems.

Penn’s clients can now benefit from the addition of three new tablet counters, which have high-speed infrared sensors for high accuracy counting of tablets and capsules, including transparent soft gelatin capsules.

Blister packing capacity is being increased through the installation of a Klockner CP11 blister machine. The unit is capable of running up to 28 cycles per minute and is being modified to provide cold form capability. The new machine is extremely flexible and will provide short lead times for new pack formats.

Yarwood added: “2012 is proving to be a year of rapid change and growth at Penn. We are pleased to be able expand our resources through these targeted investments at a time when the demand for our services continues to grow.”

Penn Pharmaceutical Services Ltd +44 1495 711 222 enquiries@pennpharm.com www.pennpharm.com

SHOWCASE CONTRACT RESEARCH Global CRO Comes Highly Recommended in ISR Report

Worldwide Clinical Trials Inc. (WCT) has received strong ratings and recommendations across all areas of one of the industry’s leading reports into sector standards.

The ‘2012 CRO Quality Benchmarking Report’ has been published by Industry Standard Research (ISR), a top market research firm, and provides a quantitative assessment of the delivery strengths and weaknesses of 25 CROs. Sponsors’ selection drivers, outsourcing volume and provider preferences were also measured.

Based on interviews with 125 industry professionals spanning 72 pharmaceutical and biotechnology companies, the companies were assessed across 21 service categories considered to be influential in provider selection, loyalty and operational performance.

Key highlights of the Worldwide Clinical Trials (WCT) performance include: • WCT was one of only two CROs demonstrating no weakness across the 21 attributes analysed.

• WCT was rated ‘Better than Most’ or displaying ‘Clear Leadership’ in the sector in: project manager quality, team chemistry, timely communication, delivery of clean data and meeting first patient in timeline.

• WCT was ranked in the top two positions for ‘Service Provider Loyalty’,

‘Overall Satisfaction with Service Providers’, ‘Willingness to Recommend Service Providers’ and ‘Likelihood to Use Service Providers Again’.

• WCT was recommended to be shortlisted for companies that require ‘Operational Independence’, ‘Low Cost/Value’ and ‘Global Footprint’ as essential requirements in their CRO selection criteria.

• ISR’s report summed up WCT by saying: “Our data would suggest that if Worldwide Clinical Trials is not on your radar as a potential CRO partner, you should consider some due diligence on them, as they were the only CRO with a strong preference profile that also had a favourable price perception.”

Angelico Carta, M.D., President, WCT, said: “We are very proud of WCT’s

performance in this major market research study. We pride ourselves on our operational intelligence and clearly, as the report underscores, our clients are recognising WCT for the very attributes needed to develop and run clinical trials successfully.”

He added: “WCT has long been known for being loyal to our customers and it is fulfilling to have independent confirmation that our clients are equally loyal and supportive of WCT for several excellent reasons. Knowing that a client will continue to use WCT, is satisfied and would recommend us speaks to what we value most, client satisfaction.”

Worldwide Clinical Trials +44 207 121 61 61 lisa.bance@wwctrials.com www.wwctrials.com

Struggling Pharma Companies to Outsource Clinical Trial Research

Falling revenue in some healthcare sectors means companies are making huge efforts to reduce R&D expenditure and increase profitability, and are outsourcing clinical trial activities to CROs in order to achieve this, according to a new report by healthcare intelligence company GBI Research.

The new report suggests that the R&D productivity of top pharmaceutical companies has declined over recent years, as a result of increasingly stringent FDA regulations concerning the approval of new drugs. This will significantly affect pharmaceutical companies’ revenue generation and will only encourage further use of CROs in future.

R&D expenditure for the 10 largest pharmaceutical companies increased at a compound annual growth rate (CAGR) of 8.3% throughout 2004–2010, while revenue turnover during this time came to only 6.5%. A slower growth rate in turnover against growth in R&D expenditure indicates that many companies struggled to maintain their level of returns on R&D expenditure. In

addition, many patents are set to expire in 2012–2018, which will further reduce revenue and erode profits.

As a result, companies are making huge efforts to reduce R&D expenditure and increase profitability. Outsourcing clinical trial activities to CROs, particularly in the developing nations, is rapidly gaining acceptance in the industry.

According to clinicaltrials.gov, by November 2011, 43.9% of clinical trials had been carried out in the US, while 22.9% had been carried out in Europe, and 11.6% had been carried out in Asia.

The rest had been carried out in Canada, Mexico, Australia, the Middle East and Africa, accounting for a total of 21.4%.

In 2009, the CRO industry recorded revenue of £11.8 billion, showing an

estimated increase of only 6% from 2008 due to the global economic crisis, which caused many pharmaceutical companies to reduce their R&D expenditure.

However, funds have begun flowing back into R&D and the expected expiry of several patents may force financially struggling pharmaceutical companies to outsource clinical trials. GBI Research therefore estimates that the CRO industry will grow at a CAGR of 12.8% to £34.7 billion by 2018.

GBI Research +44 1204 543 533 pr@gbiresearch.com www.gbiresearch.com

Partnership to Demonstrate Benefits of Spray Drying Technology in Screening for Poorly Soluble Drugs Molecular Profiles, a leading specialist contract research and manufacturing organisation, has entered into a strategic collaboration with GEA Process Engineering, the company behind the world-recognised GEA Niro spray drying technology. Using the GEA Niro DRYNETICS, single particle spray drying approach, the collaboration will assess early screening of poorly water soluble drugs and polymer compositions for the improvement in solubility. This partnership further highlights Molecular Profiles’ comprehensive materials characterisation capabilities for supporting formulation development strategies through an expert assessment and understanding of the link between structure, function and stability.

Developed with the aim to ensure the improved screening of drug candidates earlier on in the development process, Molecular Profiles and GEA Process

Engineering are working to develop a unique way of preparing solid dispersions of drugs and polymers. The purpose is to understand the viability of the potential drug delivery platform at single particle scale by comparing with batch produced spray dried approaches.

GEA Process Engineering is a world leader in process engineering, process equipment and plant engineering, specialising in the manufacture of products in powder, granular or agglomerate form in the food, chemical and pharmaceutical industries. With 79 years experience in supplying spray drying solutions to the pharmaceutical industry, the Danish company has gained a wealth of data in this industry.

The benefits of using the GEA Niro technology for this application are the ability to assess the stability of drugs in polymer systems where only an

extremely limited amount of API is available and where multiple polymer types/drug loadings are required to be screened for developability.

Claire Madden-Smith, Commercial Director at Molecular Profiles, commented: “We are pleased to have partnered with GEA Process Engineering on this project, which enables us to collaboratively bring an innovative research approach to formulation development.”

Jesper Jensen, Research Engineer, GEA Process Engineering, commented: “The combined efforts of GEA Process Engineering and Molecular Profiles will rigorously test new approaches in spray drying formulations and we’re looking forward to being able to offer improved processes and efficiencies for formulation development.”

The collaboration highlights Molecular

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Profiles’ ability to characterise the physicochemical properties of ‘single’ particle spray dried materials and compare with conventional spray dried material prepared at bulk scale.

Griseofulvin-PEG6000 solid dispersion samples at 2.5% and 20% loading are analysed using X-ray photoelectron spectroscopy (XPS), atomic force microscopy (AFM), confocal Raman microscopy, FT Raman/FTIR, powder Xray diffraction (PXRD), differential scanning calorimetry (DSC) and scanning electron microscopy (SEM) to compare surface vs. bulk properties and determine equivalence of the materials produced using the two processes.

Molecular Profiles +44 115 8718888 info@molprofiles.co.uk www.molprofiles.co.uk

Events

SHOWCASE

Mediplas Announces Partnership with Medilink UK

CONTRACT RESEARCH Rapid News Communications, organiser of the newly launched Mediplas 2012, has announced that Medilink UK is a supporting partner for this year’s show.

To be held at The NEC, Birmingham, 25–26 September, Mediplas is an event that focuses on the highly specialised area of manufacturing plastic parts for the medical industry. The exhibition, which will cover all areas of the medical plastics supply chain, differentiates itself from general plastics shows, as it brings to the forefront aspects and considerations of medical device manufacturing that do not feature in production for other industries. It is also different from existing medical device events because it specialises in plastics — the new material of choice as biocompatible plastics and polymer compounds continue to replace metal and ceramics in the medical industry.

Medilink UK is a leader in developing business networks for medical and healthcare companies. It works with members to increase their viability in the market and grow their medical business through technology and knowledge transfer from universities and the NHS and achieves this by bridging the gap between those who innovate and those who manufacture.

Medilink West Midlands’ Connectivity Director Chris Dyke, who will also be presenting at the Mediplas conference,

CRO and Pharma Company Enter Agreement to Enhance Early Stage Drug Development Services

Harlan Laboratories Contract Research Services (CRS) and global, specialty-driven pharmaceutical company Ipsen have strengthened their collaboration with a new business agreement.

Under the terms of the agreement, the two companies have entered into a three-year programme on the development of early preclinical stage drug candidates with exclusivity in some specific areas.

As a result, Harlan Laboratories has consolidated its standing in the early stage of the drug development process and has established itself as a leader in preclinical drug development.

Harlan Laboratories CRS is one of the world’s leading contract research organisations for the pharmaceutical, agrochemical and chemical industries. The company offers a wide range of pharmaceutical services with particular expertise in inhalation, infusion, reproductive toxicology, neurotoxicology, immunology, genetic toxicology, oncology and CNS. The company’s specialised Pharma ADME (Absorption, Distribution, Metabolism and Excretion) department is primarily based at its site in Barcelona and staffed by scientists with in-depth experience and expertise in pharmacokinetics, in

vitro and in vivo ADME and population pharmacokinetics. These capabilities are supported by Harlan’s Swiss facility. This combined expertise makes the company a key player in the pharmaceutical field, providing the full range of studies associated with drug pharmacokinetics and ADME, involving cold and radiolabelled drugs.

“This new agreement with Ipsen is in line with our strategy to satisfy the needs of the pharmaceutical industry in the preclinical arena and underlines our willingness to be close to our customers, helping them to make their drug candidates successful,” commented Dr. Ciriaco Maraschiello, Head of Global General Toxicology, Harlan Laboratories CRS. “We are delighted to be working with Ipsen and believe this collaboration will offer clients an unrivalled level of expertise and support in the early development of new drug formulations. This is a very important agreement that highlights our commitment to the pharma sector and reinforces our presence in the drug discovery segment of the drug development process.”

said: “The medical plastics supply chain is a dynamic, growing market, and there are plenty of innovative firms that are paving the way for new processes, materials and products for patient treatment. It’s great to see a new show this year that recognises the unique challenges and opportunities this sector faces, and Medilink is delighted to work with Mediplas to raise awareness of the event. I’m also looking forward to bringing our expertise to the show, both as an exhibitor and as a speaker.”

Delighted to be welcoming Medlink on board, Duncan Wood, COO at Rapid News Communications, commented: “It is great to have the support of Medilink on our launch event. We value their contribution and support and look forward to delivering a successful event in partnership with the medical plastics community.”

Further support for Mediplas 2012 comes from Med-Tech Innovation, the magazine and website for the UK and Irish medical device research, design and manufacturing community. Both Medilink UK and Med-Tech Innovation will be co-exhibiting on the show floor.

Another key media partner is Medical Plastics News, the essential source of technology breakthroughs and industry intelligence for manufacturers of plastic medical devices and components.

Rapid News Communications Group +44 1829 770037 events@rapidnews.com www.rapidnews.com

EFCG to Hold 5th Annual Dinner During CPhI WW

The Board of the European Fine Chemicals Group (EFCG) announces that the 5th EFCG Annual Dinner will be held on 10 October, at The Westin Palace, in Madrid.

Guy Villax, CEO of Hovione, Portugal, and Chairman of the Annual Dinner Organising Committee, reported that: “As this is our 5th annual dinner, we are announcing the event earlier than usual to encourage a wider fine chemicals industry participation to celebrate the occasion and to remind everyone that it really does offer a costeffective alternative to a private event during CPhI. Bookings are already ahead of previous years as regular hosts firmly view the dinner as a wellestablished, must-attend, annual European networking event.”

Facilities for a cocktail reception before dinner and dinner for 300+

Harlan Laboratories Ltd +44 1332 792896 crs.uk@harlan.com www.harlan.com

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guests have been booked from 7 pm onwards, with post-dinner networking available until midnight.

Dr. Rudolf Hanko, CEO of Siegfried Ltd and Member of the Organising Committee, said: “I am delighted to announce that Marc Herlant, Partner and MD of the Boston Consulting Group (BCG) in Brussels has agreed to be the keynote speaker at this year’s dinner. Mr. Herlant leads both BCG’s Healthcare and Operations Practices and supports several of the leading and largest Biopharma companies in their manufacturing operations.”

The dinner has been specially created to bring together top management from the European fine chemicals industry to celebrate Europe’s excellence in chemistry, technology and high compliance standards, with their counterparts in the worldwide innovator industries in a comfortable, first class location.

For further information, for early booking discounts and for a 12-month free EFCG membership option, contact GKV Touristik at efcg@gkv-touristik.de.

European Fine Chemicals Group +32 2 676 7244 abo@cefic.org http://efcg.cefic.org

EPM CLASSIFIEDS CLEANROOMS EQUIPMENT & SERVICES CONTAINMENT

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

To advertise here, please contact Rob Anderton: Tel: +44 (0)1829 770037 Email: rob@rapidnews.com

INGREDIENTS

MIXING & BLENDING EQUIPMENT AND SERVICES

Piramal Healthcare Ltd

Müller GmbH

Tel: +44 (0) 1670 562 400 Email: enquiriespharmasolutions@piramal.com Web: www.piramalpharmasolutions.com

CONTAMINATION CONTROL WET GRANULATION EQUIPMENT

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

PACKAGING & BOTTLING EQUIPMENT AND SERVICES

Gerhard Schubert GmbH

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

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

INDUSTRIAL SERVICES DESIGN & INSTALLATION

CHEMICAL CLEANING

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

FURNITURE

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

COATING EQUIPMENT & SERVICES

Glatt GmbH

LABORATORY & R&D PRODUCTS AND SERVICES

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

Weiler Engineering Inc

ASSET SALES & AUCTIONEERS

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

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

PURIFICATION & FILTRATION PRODUCTS AND SERVICES

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

OYSTAR Manesty

ENVIRONMENTAL/STABILITY ROOM

Tel: +44 (0)151 547 8000 Email: sales@oystar.manesty.com Web: www.oystar.manesty.com

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

CONTRACT STERILISATION & TESTING PARTICLE SIZE ANALYSIS

QUALITY & COMPLIANCE SOFTWARE

EXCIPIENTS HPMC FILM COATING

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

TABLET PRESS SUPPLIERS

WEIGHING

Mettler Toledo GRINDING AND GRANULATION EQUIPMENT & SERVICES

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

DIOSNA Dierks & Söhne GmbH Tel: +49 (0) 541 331 040 Email: info@diosna.de Web: www.diosna.de

MANUFACTURING ANCILLARIES PUMPS

Fristam Pumpen F. Stamp KG HOSOKAWA ALPINE Aktiengesellschaft Tel: +49 (0) 821 5906-0 Email: pharma@alpine.hosokawa.com Web: www.alpinehosokawa.com

Tel: +49 (0) 40 725 56 0 Email: info@fristam.de Web: www.fristam.de Peristaltic pumps accurately transfer fluid through a sterile and fully validated tube from source to delivery.

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

Web: www.wmpg.co.uk FINE GRINDING

MATERIAL/POWDER HANDLING

BE HERE FOR A YEAR Call Rob on 01829 770037 or email rob@rapidnews.com

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