July 9, 2024
Rockville, MD —The USP Microbiology Expert Committee concluded voting early this week on the proposed chapter related to endotoxin testing using non-animal derived regents. USP will announce the results of the vote on July 26, and, if approved by the committee, USP anticipates it will be published for early adoption in November 2024.
The proposed Chapter <86> provides additional techniques for bacterial endotoxin testing using non-animal derived reagents. The proposed chapter includes methods using both recombinant cascade (rCR) and recombinant Factor C (rFC) reagents and provides information for manufacturers of new and existing biopharmaceuticals on how to incorporate them into their quality testing. Endotoxin testing is a critical step in ensuring the quality and safety of many sterile biopharmaceutical products.
The proposed addition of Chapter <86> to the US Pharmacopeia is in keeping with USP’s commitment to expanding the use of animal-free methods and materials. A previous version of this press release was issued on June 28, 2024.
A previous version of this press release was issued on June 28, 2024. This release incorporates updates and revisions.
USP Media Contact:
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