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European Biopharmaceutical Review

Strategic Process Development to Complement Commercial and Regulatory Requirements

Commercial Pressures

The need to take products through to the market rapidly is driven by patent expiry and the loss of time on the market at peak sales. The need to recoup costs in an increasingly price-conscious market also drives cost containment during the development of the product. There is still a need to meet the standards set out by the regulatory authorities. The approach to the optimal route to the market differs between small and large companies. A large profitable organisation is more likely to focus on speed to market, but may not have the co-ordinated infrastructure to direct early development towards this aim. A small company will be concerned with rapid progression into Phase I and II trials and compromises are inevitable. In either case, the early phase process may not be applicable to large-scale or commercial manufacture.The rapid development of a process for use in Phase I or II can lead to considerable, lengthy re-development of the process when facing the requirements of process validation for Phase III.


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By Mark Wilson, Senior Development Leader of Downstream and Formulation at Xenova

Mark Wilson is Senior Development Leader of Downstream and Formulation at Xenova in Cambridge, UK. Since gaining a BSc and PhD at the University of Kent in genetically engineered interferons, Mark has worked in biotech process development for 14 years.
He spent five years at Delta Biotechnology, working on the recombinant albumin process. He subsequently moved to Cantab Pharmaceuticals to work on process development, technology transfer and manufacture of several biotech products from therapeutic proteins to live virus vaccines. This work has continued following Cantab's merger with Xenova. Mark has given presentations on biotech process development at a number of international conferences.

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