September 21, 2022
Rockville, MD–USP dismissed all members of the Microbiology Expert Committee. This action was taken due to fundamental issues with the dynamic of this group that resulted in an inability to work collaboratively and productively, impeding the standards-setting process.
This committee is responsible for evaluating alternatives to certain animal-based products, including the introduction of synthetic alternatives to Limulus amebocyte lysate (LAL) and Tachypleus amebocyte lysate (TAL) – reagents used for bacterial endotoxins testing.
USP is furthering innovation, including alternative methods for endotoxin testing, and is ready to collaborate with companies who adopt these methods to collect more real-world evidence, accelerate scientific knowledge and broaden the adoption of animal-free reagents and methods.
USP will continue to support manufacturers by offering access to guidelines and specifications for proper use of alternative methods. Evaluating options for endotoxin testing will be a top priority for the new committee, which will be ready to convene in early 2023.
USP is currently recruiting the Chair and members for this committee. For more information please visit: https://callforcandidates.usp.org/