This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
|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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The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.