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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Autumn 2004

At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. PMPS provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of pharmaceuticals, take a look below at the range of articles featured in this issue of PMPS

   
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PMPS Editor, Patricia Lobo, takes a look at articles in this issue  
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Formulations, Ingredients and Excipients
Dr Kristiina Ylihonko, Chief Executive and Co-founder of Galilaeus, investigates methods that develop pharmaceuticals from microbes, in Biosynthetic Control: Improving Production of Pharmaceuticals  
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In Development Manufacturing of Oncolytic APIs: Challenges and Opportunities, Angelo Bedeschi, Head of the Active Pharmaceutical Ingredients Group at Nerviano Medical Science, reviews the issues faced by process development groups during the formulation of APIs  
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Jussi Holopainen, CEO and President of Pharmatory Ltd, argues that it is critical to make R&D more efficient, in The Pharma Business Model and Process R&D

 
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Manufacturing
In Leveraging Next Generation Six Sigma: Addressing Challenges in the Pharmaceutical Industry, Philip Samuel, Senior Vice President of Operations and Lisa Modesitt,Director of Operations at Six Sigma Academy, consider the case for choosing Six Sigma  
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Cleanliness is a prerequisite for successful drug production, contend Bettina Gierszewski, Product Manager, and Dr Bjoern-Thoralf Erxleben, Product Manager at Shimadzu Deutschland GmbH, in Cleaning Validation in the Pharmaceutical Industry – Two Analytical Methods  
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In Fittings and Valve Selection: Enhanced Cleanliness and Drainability, Michael Bridge, Sanitary Projects Manager at Swagelok Company, outlines methods to better cleanliness and drainability in biopharmaceutical manufacturing  
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Andy Matthews, Business Manager at Metrohm UK Ltd, presents the latest regulatory developments in FDA 21 CFR Part 11 – The Continuing Story for the Laboratory

 
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Dosage Forms
Graham Buckton, Chief Executive Officer of Pharmaterials Ltd, discusses the significance of powders and the advances that have occurred, in the Physical Characteristics of Powders  
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Can further improvements be made to reach optimum performance for the capsule manufacturing process? Alan S Holmes, Sales Manager at Raupack, explores the challenges in Capsule Filling: Aiming for the Future  
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David Edwards, Director of XcelodoseTM Business Unit at Meridica, deliberates ways to reduce the expensive and time-consuming business of drug development – the so-called ‘Holy Grail’ of the pharmaceutical industry – in Accelerating Drug Development with Precision Dosing Techniques  
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In Liquid Fill Capsule Technology – Untapped Versatility, Dr Victor Young, Process Development Manager at Encap Drug Delivery, reviews the advantages of this technology within the pharmaceutical industry  
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Drug Delivery
What should be taken into account when selecting oral dosage forms for drug delivery? Michael Hite, Formulator and Technical Writer at Scolr Pharma, Inc offers his perspective, in Logical Drug Delivery: Biopharmaceutical and Economic Considerations of Drug Delivery System Selection  
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In Water for Injection (WFI) – Today’s Requirements for Pharmaceutical Water of the Highest Quality, Helmut Sommer, Sales Manager at Christ Water Technology Group, recommends factors that should be accounted for when selecting the right technology  
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Packing, Packaging and Labelling
In Something ‘Smart’ in your Medicine Cabinet,Tom Grinnan,Vice President of Business Development at MeadWestvaco Healthcare Packaging,welcomes the advent of technology and packaging solutions that monitor patient compliance  
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The use of oxygen absorbers in the packaging of pharmaceuticals is gaining momentum. In Current Status and Future Prospect of Applications of Oxygen Absorbers in the Fields of Pharmaceuticals, Diagnostics and Medical Appliances,Yoshihisa Sakakibara, General Manager, Planning and Development, Oxygen Absorbers Division at Mitsubishi Gas Chemical Company Inc, contrasts this new technology with more conventional methods  
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LASER CODING AND MARKING
In An Introduction to Product Coding using Laser Technology, Janine Lettau, Head of Sales and Marketing, Linx Xymark, at Linx Printing Technologies plc, charts the benefits available  
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Clinical Trial Supplies
The design of packaging in clinical trials is imperative to a successful outcome, asserts Dr Sue Miles,Director of Clinical Trials Services at Brecon Pharmaceuticals Ltd, in Clinical Trial Supplies – Planning the Perfect Packaging  
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The administration of drugs to combat long-term illness is seriously affected by the issue of patient compliance. In Compliance: Enhancing Drug Treatment, Christian Husegaard, Head of Sales and Marketing at Bang and Olufsen Medicom, guides us through the latest developments in monitoring adherence to drug regimes  
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LOGISTICS
Jжrgen Bertals, Product Development Manager at Envirotainer, offers advice on how to manage the risks involved in transporting temperature-sensitive cargo, in Development of New Cold Chain Solutions for Air Cargo  
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Logistical service suppliers have in the past been guilty of assuming wrongly that money is no object for the pharmaceutical industry. In Uniting Quality and Cost Control in the Pharmaceutical Supply Chain, Sanjay Tiwari,Director of the Pharmaceutical Logistics Unit at KLM Cargo, looks at ways of ensuring quality at a reasonable price  
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In From Chain Reaction to Chain Protection, Rob Cassab, Head of Supply Chain Management at Bovis Lend Lease, examines the so-called ‘Three Pillars’ of supply chain management  
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The continuing growth of the biotechnology industry will bring about an increasing number of thermally unstable products. In The Convergence of Cold Chain Monitoring Systems and RFID Technologies, Robert Wood,Operations Manager at Sensitech, presents the means of managing demand and security in the supply chain  
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CPhI FOCUS: PREVIEW AND INTERVIEWS
Discover the details for CPhI Worldwide/ICSE in Belgium this December, now in its 15th year  
Thomas Eldered and Kenth Berg of Recipharm, the contract manufacturing division of Recip AB, the largest pharmaceutical company in Scandinavia, talk to PMPS Editor, Patricia Lobo in A Swedish Recipe for Pharma: New Developments at Recipharm  
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PMPS Editor Patrica Lobo was there to witness the opening of the packaging facility at Recipharm and tells us all about it in Recipharm’s Right Royal Reception  
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Developments are afoot for Capsugel since the acquisition of Warner Lambert by Pfizer. PMPS talks to Catherine Lehmann and Sven Stegemann about what this means for their company  
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Dr Albert Strube of The Cognis Group, leaders in speciality chemicals, talks to PMPS  
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Previews
Vision in Business give you the opportunity to see what is in store at the Clinical Trials Summit, to be held in January 2005  
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Dr Volker Pfeufer,Director of Marketing at Alltec, supports the use of laser marking to maximise the efficiency of the production line in Laser Marking of Cosmetic,Pharmaceutical and Medical Packages  
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Consultant Editor
Bruce Horton,
Partner in charge of
Accenture’s European
Health & Life Sciences
Supply Chain
Published quarterly in
February, May,
August and November

Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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News and Press Releases

Dr James Thomson to lead new Stem Cell and Regenerative Medicine Center within the new Morgridge Center for Discovery on UW-Madison campus

By Tom Still MADISON – There’s no one alive today who was around to witness the birth of Wisconsin’s dairy and cranberry industries in the late 1800s, or its rise as a manufacturing power in roughly the same era. But a new page in Wisconsin’s history of commerce is being written in our time – the emergence of stem-cell medicine. Recent events have solidified Wisconsin’s edge as a global leader in stem-cell research and the breakthroughs in human health it will produce (continued):
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