A–Mab: A Case Study in Bioprocess Development

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30 October 2009

CMC Biotech Working Group

Version 2.1

This is a detailed case study to stimulate discussion around how the core principles contained in Q8(R2), Q9 and Q10 guidelines could be applied to product realisation programs for a biotechnology-derived monoclonal antibody.

Bioprocess

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A–Mab: A Case Study in Bioprocess Development

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