Free webinars of Associates of Cape Cod, Inc.:
- Dec, 2020 – Sustainability In Bacterial Endotoxin Testing; A Holistic Approach to Conservation and Recombinant Technology
- Sep, 2020 – Current Bacterial Endotoxins Test (BET) and its Intended Use
- Apr, 2020 – Recombinant chromogenic assay as an alternate method for the Bacterial Endotoxins Test (BET)
- Nov, 2019 – The status of recombinant reagents used for Bacterial Endotoxin Testing (BET)
Sustainability In Bacterial Endotoxin Testing; A Holistic Approach to Conservation and Recombinant Technology
Current Bacterial Endotoxins Test (BET) and its Intended Use
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.
Recombinant Chromogenic Assay as an Alternate Method for The Bacterial Endotoxins Test (BET)
The Status of Recombinant Reagents Used for Bacterial Endotoxin Testing (BET)
There has been a lot of discussion associated with the potential for use of synthetic (non-animal based) reagents for bacterial endotoxin testing. This free webinar provides an overview of the current status of the recombinant reagents on the global market. It will also lay out the recent proposed changes to USP <85>.