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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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4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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