July 26, 2024
Recombinant Factor C Methods for Endotoxin Testing: Towards Sustainable Development and Reliable Supply Chain
On July 26, 2024, the United States Pharmacopeia Microbiology Expert Committee voted in favor of adopting new Chapter <86>, which endorses the use of non-animal derived reagents for Endotoxin testing. Chapter <86> provides additional techniques for bacterial endotoxin testing using non-animal derived reagents and information for manufacturers of new and existing biopharmaceuticals on how to incorporate them into their quality testing – in line with the USP’s commitment to expand the use of animal-free methods and materials.