In 2013 the efficacy of the LAL test was called into question, when Chen and Vinther presented data where known concentrations of LPS where added to undiluted samples of final product, which the LAL reagent failed to detect. This phenomenon was described as Low Endotoxin Recovery or LER. This presentation will set out to review the scientific data surrounding the topic of Low Endotoxin Recovery. It will address the structure of LPS and Naturally Occurring Endotoxin (NOE), and present data describing the differences between the two in the presence of an LER inducing matrix. It will include data from different endotoxin detection methods and explore how each reacts with respect to LER. It will also examine how microorganisms adapt to their environment and the impact this has on LER.
Alan Hoffmeister is the Senior Global Technology Manager for Charles River, Microbial Solutions Division, specializing in the Bacterial Endotoxins Test. Alan’s experience with the Bacterial Endotoxins Test (BET) dates to 1988, since when he has been actively involved in all aspects of the assay. Alan has directed workshops and training courses and lectured internationally on a variety of BET topics including, amongst others, LAL Methodologies, Product Validations, Interference Matrices, Data Integrity and BET Regulatory Affairs. He has also contributed to the development of BET protocols, technical guides and fact sheets.