Endotoxins Standards and Their Role in Recovery Studies: The Path Forward

Posted on November 8, 2024

Karen Zink McCullough, MMI Associates
Radhakrishna Tirumalai, Ph.D., United States Pharmacopeial Convention
David Hussong, Ph.D., Eagle Analytical Service, (Previously ValSource, LLC)
James Akers, Ph.D., Akers Kennedy Associates
Dennis Guilfoyle, Ph.D., Johnson and Johnson
Robert Mello, Ph.D., Mello PharmAssociates, LLC
Donald Singer, Ecolab Life Sciences and New Beginnings Microbiology, (Previously GSK)

The USP General Chapters – Microbiology Expert Committee (EC) is the steward in the United States of harmonized Chapter <85>, “Bacterial Endotoxins Test”, or BET (USP 2016a). The EC has closely followed the Low Endotoxin Recovery (“LER”) discussion and publications since the interfer...

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