Current Bacterial Endotoxins Test (BET) and its Intended Use


24th September 2020 | 10:00 am EST | Karen Zink McCullough, Owner, Principal Consultant at MMI Associates |BOOK FREE SEAT FOR THIS WEBINAR

The Bacterial Endotoxins Test is not a test for pyrogens (fever causing agents). It is not a test for the presence of Gram negative bacteria. Based on extensive comparisons of endotoxins activity in the BET and fever rabbits executed in the 1970s and 1980s, we may say that the BET is a test for levels of Gram negative bacterial endotoxins activity that may be predictive of a fever in mammals.

The various methodologies that are described in the harmonized in the harmonized chapter use the primary Reference Endotoxin Standard (RSE) or secondary Control Standard Endotoxin (CSE) to prepare assay standards, perform suitability testing as instructed in the chapter and inoculate positive product controls. These standards are relatively pure preparations of lipopolysaccharide. However, the utility of the compendial assay for non-compendial applications is limited. Our discussion will focus on the compendial uses of these BET assays.

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates

Karen Zink McCullough is the principal consultant at MMI Associates, a firm focusing on GMP and Microbiology in the drug, biologics, cell therapy and medical device industries, with a speciality in the Bacterial Endotoxins Test (BET). Ms. McCullough was the first to publish on the use of the BET as a replacement for the rabbit pyrogen test for small volume parenterals. She has published over 50 articles and book chapters, and is the editor of the book, “The Bacterial Endotoxins Test:  A Practical Guide.”   She is a well respected international speaker on GMP and the BET. Ms. McCullough is chairperson of the LAL Users’ Group, is a United States Representative to Working Group 2, TC 209 for the revision of ISO 14698, and is a member of the United States Pharmacopeia Expert Committee on Microbiological General Chapters. She holds a Bachelor’s degree in Bacteriology from Rutgers University, and a Master’s degree in Molecular Biology from the University of Oregon.


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