Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
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DOI: 10.5731/pdajpst.2019.011379
Abstract: Prefilled syringes (PFS) are a container and delivery device of choice for storing and administering therapeutic protein products to patients. Addressing concerns and regulatory expectations related to the risk to biologic drug product quality and… read more here.
Keywords: leachables program; biotechnology; program; program evaluations ... See more keywords