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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Autumn 2003
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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Industry Insight 
In her Editor's Letter, Dr Patricia Lobo reviews the articles in this issue of PMPS  
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Formulations, Ingredients and Excipients
In Isomalt as Excipient in Pharmaceuticals, Ines Kranczoch, Manager of Special Projects and Pharma Projects, Technical Services at Palatinit GmbH, and Tillmann T Dörr, Product Manager at Südzucker, argue that isomalt is highly suitable for a wide range of pharmaceutical applications  
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Advances in combinatorial chemistry techniques have increased the number of compounds for evaluation as drug candidates. Jack Stevens, Associate Foundation Scientist, Pam Mims, Director of Product Support and Services and Neil Coles, Marketing and Business Development Liaison at Fresenius Kabi Clayton Inc, discuss Lipid Emulsions as Drug Delivery Systems  
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Michael Hite, Lead Research Associate, Stephen Turner, Director of Product Development and Cathy Federici, Research Associate; Members of the Research and Product Development Group at SCOLR® Inc, review Oral Delivery of Poorly Soluble Drugs, Part 2: Formulation Strategies for Solid Dosage Forms and Novel Delivery Systems for Controlled Release  
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STERILE MANUFACTURING
In Environmental Monitoring Practices and Regulations for the Sterile Manufacturer, Anne Booth, Quality GMP and Sterilisation Specialist at Booth Scientific, explains why pharmaceutical manufacturing requires environments where airborne particles can be controlled  
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Diana Raine, Business Manager for Cryogenics in Europe at Air Products, identifies why new EU legislation is forcing the industry to look closer at abatement technologies to ensure compliance, in Cryogenics Leads the Way in Emissions Control  
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A much misunderstood process, cleaning validation can be relatively straightforward if tackled correctly. Phil Smith, Marketing Manager at STERIS - Life Sciences Group, makes the case, in Cleaning Validation - Dismissing Your Fears  
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In Maintaining a Spore-Free Environment in the Cleanroom, Suzanne Stubbs, Quality Manager at Shield Medicare Ltd, focuses on two key issues - creating and maintaining a spore-free environment and preventing spore contamination that may result from the use of disinfectants  
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Fries Holger, Production Manager for Pharmaceutical Products at Braun GmbH, reviews the production and environmental requirements to satisfy sterile manufacturing standards, in Production of Blow Fill Seal Container Closure Systems for Pharmaceutical Application  
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Drug Delivery
In Emerging Novel Liquid Delivery Systems, Ola Nerbrink, Principal Scientist at Novo Nordisk A/S, gives an overview of current novel liquid inhalation technologies  
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Dr Graham Kerr, Head of R&D at Products of Technology Ltd and Dr Vic Young, Process Development Manager at Encap Drug Delivery, investigate the varied types and uses of process gases, in High Purity Gas Generation for use in Drug Delivery Preparation and Pharmaceutical Manufacturing  
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Traditionally restricted to treating the common cold and nasal allergies, nasal delivery is enjoying something of a renaissance. Per Gisle Djupesland, Head of R&D and Co-Founder of OptiNose AS, puts the question Who Nose How Far Nasal Delivery Can Go?

 
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Christopher Searcy, Vice President of Corporate Development at Nektar Therapeutics, explores Drug Delivery: An Evolving Concept  
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MANUFACTURING
In Generics Boards Surfing the New Wave in Contract Manufacturing Services, Dr Patricia Lobo, Associate Director at Technomark Consulting Services Limited and Editor of PMPS, reflects on the rapidly rising sales of unbranded medicines and considers what the future holds for the owners of expiring patents for branded products  
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Ernie Benway, Welder Training Specialist at Swagelok Company, addresses traceability issues for materials and procedures used for construction and maintenance of bioprocessing systems, in New Orbital Welding Documentation Method Improves Accuracy for Inspections and Leads to Lower Cost per Weld  
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CLINICAL TRIALS FOCUS
The introduction of new EC legislation and a range of new pack innovations spells fundamental change for the clinical trials process. Pat Hobbs, Clinical Trials Technical Manager at Brecon Pharmaceuticals Ltd, examines the issues, in Complex Pack Assembly - Clinical Trials  
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Paul O'Connor, Head of Quality at Clinical Trial Services, examines The Impact of the EU Clinical Trials Directive on the Supply Chain  
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PMPS talks to Jill Warr, Quality Manager and QP at BlisTech UK, in Knowledge Sharing in the Clinical Trials Industry - Annex 13  
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The years when Russia was a 'blind-spot' on the clinical trials world map are now far away, as Sergei Varshavsky, MD, PhD, Chairman and CEO, Anna Ravdel, MBA, Director of Marketing and BusinessDevelopment, Pyotr Platonov, MD, PhD, Scientific Director, Svetlana Timofeeva, MD, PhD, Head of Moscow Representative Office and Nadia Nurutdinov, Account Manager at Evidence Clinical and Pharmaceutical Research, explain, in Handling Clinical Trial Materials in Russia  
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LOGISTICS
At every point in the cold chain, records have to be maintained to provide evidence of compliance with labelled storage conditions. In Temperature-Controlled Distribution of Vaccines and High-Value Medicine, Tanja Leys, Marketing and Quality Manager at Dirk Raes NV, explains why this is so important  
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In Total Supply Chain Solutions for the Life Sciences Industry, PMPS talks to Clive Bryant, Global Business Development Manager for the life sciences industry sector at DHL, about the services and benefits DHL has to offer  
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Robert Kayum, Application Support Manager at Envirotainer, highlights the importance of ensuring that a temperature-sensitive medicinal product reaches the end-user without compromising integrity, in Future Cold Chain Technology For The 21st Century: The 'Blue Sky' Idea  
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In Preventative Medicine - How Advances in Technology can Protect the Integrity of the Supply Chain, Bulent Osman, Sales Director at XKO, reviews key strategies ensuring traceability, compliance, due diligence and risk mitigation  
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PACKING & PACKAGING
Bruce Drew, Managing Director at Aquasol Ltd, looks into some innovative advances in pharmaceutical packaging, in Water-Soluble Packaging - An Exciting Future  
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Many pharmaceutical manufacturers who opt to conduct packaging operations in-house are confronted with a 'catch 22' situation. Guy Malchi, Associate Partner of the Life Science Sector at Tefen Operations Management Consulting, searches for answers, in Beating the Bottleneck in Contract Packaging  
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In Colours as Registered Trademarks, Sara Elwyn Jones, Associate at Taylor Wessing, explores how pharmaceutical companies are using the power of branding to capture the hearts and minds of the public
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PREVIEWS & REVIEWS
In Direct Contact, Direct Sales and Direct Leads in Pharma Chemicals and R&D, Joanne Glover at PMPS, outlines what to expect from the upcoming CPhI and ICSE conference  
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Charles Horth, Life Science Consulting Editor at Cytops, reports from Outsourced Development and Production; Speed in Development Plus Strength in Manufacturing Equals Success in Bio/Pharma: Bio/PharDOS and Bio/PharMOS 2004  
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In Quality: A Strategic Element in the Success of a Company, 17th May, 2003 in Portofino Vetta, Italy, Lucia Giardino, Contract Manufacturing Manager at Dompй Spa, regales the conference highlights  
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Edited by
Randice Altschul
Chief Executive Officer at Pop Test and Palisades Therapeutics

Published quarterly in
February, May,
August, and November

News and Press Releases

Datwyler celebrates official opening of its new production plant with First Line standard in Middletown, Del

• The new facility in Middletown, Del., is Datwyler’s third facility with First Line standard which will be catering to the markets in North and South America • Approximately 120 jobs will be created, with the majority staffed from the local community • With the Middletown facility, Datwyler will be able to increase its global First Line production by 50 percent by 2020 • First Line is specially designed to manufacture biotech and pharmaceutical elastomer components in a fully integrated good manufacturing practice (GMP) environment
More info >>

White Papers

Value-Added Processing and Quality By Design Principles Help Meet High-Quality Demands

West Pharmaceutical Services, Inc.

The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs in an effort to provide a product that meets the requirements of payers along with facilitating profitability in order to continue adequate business reinvestment.
More info >>

Industry Events

SMi Presents the 11th Adaptive Designs in Clinical Trials Conference 2019

1-2 April 2019, Holiday Inn Kensington Forum, London

SMi Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st – 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new FDA draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.
More info >>

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