Rockville, MD, March 26, 2024 —The USP Microbiology Expert Committee will vote on the proposed chapter to approve endotoxin testing using non-animal derived regents between June 21st and July 1st, this year. If approved by the committee, USP anticipates it will be published for early adoption in November 2024 and in USP-NF in May 2025.
The proposed Chapter <86> provides additional techniques for bacterial endotoxin testing using non-animal derived reagents. The new 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.
USP Media Contact:
Nazila Fathi
Nazila.fathi@USP.org
(301) 816-8547
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