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Strategies for Testing Host Cell Protein

Summary: The FDA requires that host cell proteins (HCPs) be reduced to low levels because they can affect the safety and efficacy of a drug. Pharmaceutical Technology recently spoke with Catalent Biologics’ Michael Sadick, PhD, Principal Scientist, and Todd Stone, PhD, Senior Manager, to learn more about HCP testing and gain insight into the tools that Catalent Biologics uses to monitor HCPs, with the goal of removing them from the biologic.

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