Endotoxin Control Strategies for Parenteral Drug Product Manufacturing
Posted on February 21, 2018
Robert Simler
Associate Director, Engineering and Technology
Biogen, Cambridge, MA, USA
Brian M. Thome
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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Related Topics and Keywords
0.22 µm membrane, autoclave or filtration, biogen, Brian M. Thome, Cambridge, Endotoxin Control Strategies, final drug product, gram-negative bacteria, high dosing volumes, MA, manufacturing process, Membrane, Parenteral Drug Product Manufacturing, patients with low body weights, pyrogenicity, Robert Simler, Switzerland, terminal sterilization, therapeutics, USA, Zug
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