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European Biopharmaceutical Review

Biopharmaceutical Characterisation - Considering Key Questions

In the race to bring new biotech derived products to market, researchers face many obstacles along the road from discovery to commercial success. So, any new analytical techniques which can help smooth the path, particularly through the regulatory approval stages, are always welcome. One such breakthrough has been the use of mass spectrometry (MS) to provide information about the primary protein and carbohydrate structure of biomolecules. MS techniques are now being applied routinely to the characterisation of products ranging in size and complexity from small synthetic peptides to conjugated antibody molecules. However, with the bewildering array of modern analytical instruments available, it is sometimes difficult to choose the most suitable strategies to use for a particular characterisation problem, or indeed decide if or when these studies should be performed. This article intends to address some of the frequently asked questions about biopharmaceutical characterisation using mass spectrometry.

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By Dr Fiona M Greer, Director, Biochemical Services at M-Scan Ltd

Following a PhD in Protein Biochemistry from Aberdeen University, Fiona Greer 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.

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Dr Fiona M Greer
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