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European Biopharmaceutical Review

Post-Translational Modifications of Biopharmaceuticals - A Challenge for Analytical Characterisation

The list of biopharmaceuticals produced by recombinant DNA technology, transgenics and synthetic manufacture continues to grow to encompass therapeutic and diagnostic agents ranging from antibodies to vaccines. Regardless of the method of production, all these products present the biotechnology community with complex challenges in manufacture and, ultimately, analytical characterisation. Recognising the importance of this topic, a recent international conference was held on 'The Impact of Post-Translational and Chemical Modifications on Protein Therapeutics' (1). At this meeting of leading scientists from academia and industry, a keynote address was given by Dr Keith Weber, Deputy Director, Division of Monoclonal Antibodies, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research (CBER), FDA. Dr Weber presented the current CBER perspective on post-translational and chemical modifications, emphasising above all that CBER's primary concerns are "safety, purity, potency and strength of bioproducts".


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By Dr Fiona Greer and Dr Andrew Reason of M-Scan Ltd (UK) and Dr Mark Rogers of M-Scan Inc (US)
Dr Fiona Greer, Dr Andrew Reason and Dr Mark Rogers are principals of M-Scan (Mass Spectrometry Consultants and Analysts). Together, they have over 45 years' experience in the analysis of proteins and carbohydrates using mass spectrometry.
Following a PhD in Protein Biochemistry from Aberdeen University, Fiona joined M-Scan in 1984 to develop analytical services using the then new techniques of biopolymer mass spectrometry. She is Director of Biochemistry and VP of M-Scan Ltd, M-Scan SA and M-Scan Inc, and is also responsible for QA at all three laboratories.
Andrew received his PhD in Biochemistry from Imperial College, University of London in 1992 and joined M-Scan in 1994. He is Managing Director of M-Scan Ltd, Wokingham, UK.
Mark received his PhD in Biochemistry from the University of Westminster, London and has been with M-Scan for 13 years. He is currently Vice President of M-Scan Inc, Pennsylvania, US.

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Dr Fiona Greer
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Dr Andrew Reason
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Dr Mark Rogers
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