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EMA plans guidance on process validation of biotechnology-derived active substances

This article was originally published in SRA

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Executive Summary

The European Medicines Agency is seeking stakeholder feedback on its plan to develop guidance on the process validation of biotechnology-derived active substances1. The agency's proposal is outlined in a concept paper, on which comments will be accepted until 31 August.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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