Article: The Critical Role Of Bioprocessing Contracts
Defining Your Rights, Obligations, and Liabilities
Simon Portman
Any company developing a biopharmaceutical manufacturing process has a much more complex and critical role than its counterparts in other industries, including those working in the conventional (small molecule) pharmaceutical sector. This is largely because the basic building block for a biopharmaceutical is live material, and for full use to be made of that building block, additional technical obstacles have to be overcome and regulatory requirements met. Bioprocess development is therefore a specialization that many companies do not possess in-house. They are very likely to outsource either the development of an original process or a scaled-up version of it so that commercial volumes can be manufactured efficiently, effectively, and economically.
Reprinted with permission from BioProcess International 4(2): pp 24-26 (February 2006)
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