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European Biopharmaceutical Review

ebr
Summer 2005
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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In her Editor's Letter, Dr Helen Tayton-Martin takes a look at the articles in this issue  
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BioBusiness, Finance & Communication
Dr Alexandra Goll, General Partner at Techno Venture Management, investigates new hurdles faced by biotech companies, in Life Science Venture Investing in Europe: Playing by New Rules  
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The potential to improve efficiency alongside compliance is explained by Trevor Williams, Software Solutions Manager EMEA at Hitachi Data Systems, in US FDA Data Regulations: A Wealth of Challenges but a Valuable Route towards Accountability  
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In The Unlikely European Biotech Poker Game - Good Hands, but No Bets! Catherine Pichereau, Finance Practice Leader at Bionest Partners, charts the trials and tribulations involved in the pursuit of IPOs  
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Dr Joachim Bender, Senior Consultant and Dr Lucio AA van Rooijen, Managing Director at van Rooijen & Partners Ltd, assert the importance of balancing internal and external expertise in Management Challenges in Biotech  
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Science and Innovation
In Tissue Engineering - Realising the Commercial Potential, Dr Stephen Blatcher, Principal Consultant at PA Consulting Group and Dr Will West, Chief Operating Officer at CellCentric Ltd, suggest a dual approach to curtail the commercial risks of this groundbreaking field  
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Professor RJ Mayer, Professor of Molecular Cell Biology in the School of Biomedical Sciences at the University of Nottingham Medical School, outlines a new way of looking at the life process, in The Nobel Prize for Chemistry 2004 - Ubiquitin: The Everywhere Protein Receives the Ultimate Accolade!  
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Technological Issues in Novel Therapeutic Protein Development are examined by Dr Nicolas Mouz, CSO and Co-founder, Dr Vincent Monchois, Chief Technical Development Officer, and Dr Sebastian Mouz, Chief Production Officer at Protein Expert  
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Hopes for the discovery of novel disease markers are underlined in Understanding and Treating Psychiatric and Neurological Disorders: The Benefits of Cerebrospinal Fluid Analysis, by Dr Christoph W Turck, Research Group Leader, Molecular, Cellular and Clinical Proteomics at the Max Planck Institute of Psychiatry, Munich, Germany  
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Vitaly Buckin, Head of the Laboratory of Physical Chemistry of Biocolloids and Elizabeth Craig, Research Student in the Department of Chemistry, University College Dublin, discuss New Applications of High Resolution Ultrasonic Spectroscopy for Real-Time Analysis of Enzymatic Proteolysis  
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Discovery Technology
Henry Hepburne-Scott, Head of Marketing, Protein Arrays at Procognia Ltd, surveys the dawning of a new era in biological research, in Protein Function Arrays - An Emerging Tool in Proteomics - Complexity Beyond the Gene  
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Enhanced speed and dexterity will be the hallmarks of future synthesis and screening processes, asserts Richard Gray, Commercial Director at Syrris Ltd, in Flow Reactors for Drug Discovery  
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In Web Services in Bioinformatics, Dr Thure Etzold, CEO and Dr Christof Gunzler, Senior Scientific Consultant at Lion Bioscience, follow the evolution of cross-application communication  
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Jason Smith, Technical and Marketing Writer, Protein Expression & Proteomics Department at Qiagen GmbH, argues the importance of standardisation in the collation and interpretation of data, in Setting the Proteomic Standard  
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BioDevelopment
Tackling the issue of inter-individual variability, Patrick Keenan, Medical Director at PRA International, explores Pharmacogenetics: The Future of Antidepressant Drug Development  
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The greater purity, consistency and safety of recombinant excipients is discussed in Formulation of Biotherapeutics - Avoiding Human and Animal Derived Excipients, by Dr Steve Berezenko, Research Director at Delta Biotechnology Ltd  
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Andy Lewis, Research and Technology Director and Mike Driver, Director of Licensing at Biocompatibles UK Ltd, outline the clinical advantages of amalgamating therapeutic and physical functions, in The Benefits of Drug-Device Combinations: An Open and Shut Case  
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Histologically Defined Specific Tissue Damage Biomarkers in Drug Development can do much to reduce costs, argues Martin Shaw, Marketing Manager at Biotrin International  
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Previously beset by scepticism, the value of a test for vCJD is gaining increasing recognition. Dr Stuart Wilson, Founder and Scientific Director of Microsens Biotechnologies, gives us the lowdown, in Human Prion Disease - Technological Developments Towards Blood Screening and the Prospect of Therapy  
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BioManufacturing
Ryan Scanlon, Manager of Marketing & Business Development at Cambrex Biopharmaceuticals, considers the impact of a growing trend, in Biosimilars and Contract Manufacturing  
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A practical guide for monitoring glycosylation is provided by Dr Daryl Fernandes, Founder and CEO of Ludger Ltd, in Demonstrating Comparability of Antibody Glycosylation during Biomanufacturing  
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By Dr Phil Ball, Analytical Development Consultant at Eden Biodesign, puts new analytical techniques under the microscope, in The Power of Proteomics in Biopharmaceutical Drug Development  
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Is dispensing with convention the way forward for manufacturing? Dr Suzanne S Farid, Lecturer and Professor Nigel J Titchener-Hooker, Co-Director at The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London investigate, in Considering Disposables for the Manufacture of Early Phase Biopharmaceutical Candidates  
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Preview
A look ahead to BioPartnering Europe 2005, now in its 13th year  
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The Lisbon strategy will be a key topic at CORDIA, the International Biotechnology Convention, as previewed in Six Months to Save Lisbon - What is the Role of Biotechnology?  
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
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Characterisation of Biopharmaceutical Proteins

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Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. Consequently, in line with regulatory guidance, there will be a commensurate need to provide full characterisation of such biopharmaceuticals. The purpose of this article is to describe the array of the more common techniques used in biopharmaceutical characterisation (typically of protein or polypeptide). For full characterisation of a protein, the protein�s primary, secondary and tertiary structure as well as its physiochemical properties should be assessed.
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