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European Biopharmaceutical Review

ebr
Winter 2009
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EBR 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 of biopharmaceuticals, take a look below at the range of articles featured in this issue of EBR
   
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BioFinance and Management
Independent consultant Emile Bellott looks at the changing biotech landscape in light of the global financial crisis and considers the likely implications for the global pharmaceutical/biotech industry  
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Mark B Hassenplug and Kai Gindner at Ernst & Young examine ways in which pharmaceutical companies can maintain standards in supply chain management  
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BioBusiness Development
Pharma and biotech companies often manage scientific assets and equipment on their own. Bob Moore at GE Healthcare discusses why and how outsourcing scientific asset services can help to improve effectiveness in the lab  
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Catherine D’Arcy at PA Consulting Group describes the requirement for greater efficiency and effectiveness in R&D operations and how working closely with a global pharmaceutical company has prompted a review of key functions  
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Richard Barratt at Barratt Legal examines the proliferation of outsourcing operational practices in the industry, and tells us how to get the best out of it  
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BioResearch and Innovation
Mats Hellström and Björn Frendéus at BioInvent International examine the developments that are occurring in monoclonal antibody drugs, and discuss their future in the fight against cancer  
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Birgit Jehn at QIAGEN GmbH gives an overview on HLA-Typing or pre-therapeutic testing in AIDS patients  
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Discovery Technology
David Bunton and Lee Rankin at Biopta Ltd and Alistair Corbett at Glasgow Caledonian University discuss opioid receptors as drug targets in gastrointestinal disorders  
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Graham Lappin at Xceleron argues that microdosing can provide important information about a drug’s behaviour before Phase I, thereby reducing the likelihood of costly failures at a later stage  
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BioDevelopment and Regulatory
Ulrich Braumann at Bruker BioSpin and Herbert Thiele at Bruker Daltonik analyse structure verification of small molecules using integrated MS spectrometry and NMR spectroscopy  
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Josep Prous at Thomson Reuters introduces biomarkers, identifying them as a crucial factor in the evolution of drug research and development  
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LABALisette Oversteegen at Datamonitor discusses combination product market trends in the respiratory drug sector  
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BioFormulation and Manufacturing
R Keith Williams at The Clinical Biotechnology Centre, Bristol Institute for Transfusion Sciences, NHS Blood and Transplant and Angela Osborne of eXmoor pharma concepts ltd discuss small-scale biomanufacturing for clinical trials, cell and gene therapies in the UK market  
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Kate Westwell and Gina Wenham at Eden Biodesign explain how implementing the quality cycle can deliver product value  
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BioRegional
Jacques Lhomel of Biocitech tells how one of Europe’s high-profile life science parks has boosted resources for life sciences R&D  
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
Published quarterly in
January, April,
July, and October

News and Press Releases

PCI Announces Expansion of its Industry-Leading Cold Chain Infrastructure with Dedicated Minus 40 degrees C Facility

Philadelphia, USA – August 29, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, Clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce the completion of a purpose built -40°C storage and distribution facility at its North American Clinical Services Center of Excellence.
More info >>

White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
More info >>

Industry Events

PDA Universe of Pre-Filled Syringes and Injection Devices

8 October - 9 November 2018, Loews Royal Pacific, Orlando, FL

At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices,industry and regulatory experts will share experiences, new developments, regulatory considerations, challenges, and industry trends and best practices. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing, or marketing of pre-filled syringes and injection devices.
More info >>

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