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Kevin Williams
Articles
The Immune Context in Microbiological Testing
The control of biologics microbiological impurities, contaminants, and mimetics is evolving.
The Emerging View of Endotoxin as an IIRMI
The recognition that microbial artifacts are capable of modulating the mammalian immune system is an emerging view of biologic drug contamination control testing.
Endotoxin Test Concerns of Biologics: The Role of Endotoxin as a Quality Indicator in Biologic Manufacturing Processes
Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.