Endotoxin Control Strategies for Parenteral Drug Product Manufacturing
Posted on June 23, 2026
Robert Simler, Associate Vice President, Process Development, Amgen
(previously Associate Director, Engineering and Technology, Biogen, Cambridge, MA, USA)
Brian M. Thome, Head of Injectable Development, Galderma
(previously Senior Engineer III, Parenteral Manufacturing Sciences, Biogen, Zug, Switzerland)
Introduction Control of bacterial endotoxins, gram-negative bacteria that can cause pyrogenicity, is critical in the manufacture of pharmaceutical drug products intended for parenteral administration. Unlike bioburden, which can be readily eliminated by terminal sterilization via autoclave or filtra...
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