Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
|Articles|August 18, 2020
QRM in the Context of Viral Contamination
Author(s)PDA
The ebooklet addresses findings from the Consortium on Adventitious Agent Contamination in Biomanufacturing’s survey of virus contamination experience and mitigating controls and other research, reviews recommended risk management tools to avoid adventitious agent contamination, and provides a framework for a risk management process
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