An Approach to Microbiological Testing of Raw Materials Used in the Manufacture of Biological Drug Substances Utilising a Microbial Attributes and Assessment System
Posted on September 2, 2015
By: Kim Bowers, Manager, QC Microbiology
Pfizer
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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Related Topics and Keywords
Assessment System, Biological Drug Substances, biopharmaceutical manufacturing, buffers, cryoprotectants, culture media, cytokines, enzymes, EU guidelines for Good Manufacturing Practice Annex 2, feeder cells, growth factors, JP, Kim Bowers, low bioburden biopharmaceutical, Manufacture of Biological Drug Substances, Microbial Attributes, Microbiological Testing of Raw Materials, o Harmonised EP, Pfizer, QC Microbiology Laboratory, reagents, Serum, USP
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