Current Bacterial Endotoxins Test (BET) and its Intended Use

Presented by

Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services

About this talk

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services 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.

Related topics:

More from this channel

Upcoming talks (15)
On-demand talks (242)
Subscribers (24674)
BioPharma Webinars aims to keep its 30,000 readers abreast of all developments in the areas of Drug Development, Drug Delivery, Manufacturing, Quality Assurance, Outsourcing and Regulatory Affairs, with only the highest quality articles, written by the most respected authors, associated with only end-user companies. This ensures that the information will always be guaranteed to remain timely, informative and above all totally unbiased.