An Approach to Microbiological Testing of Raw Materials Used in the Manufacture of Biological Drug Substances Utilising a Microbial Attributes and Assessment System

Introduction Pfizer, Andover is a low bioburden biopharmaceutical drug substance manufacturing site, and the QC Microbiology Laboratory performs both bioburden (total count) and endotoxin testing on raw materials used in the manufacture of biologically active drug substances. The QC Microbiology gro...

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