Reliable and Sustainable Bacterial Endotoxin Testing

PRESENTATION OVERVIEW

This webinar will introduce the concept and relevance of bacterial endotoxin, along with a review of established detection methods. Dr Reich will discuss the emergence of recombinant Factor C (rFC) as a consistent and sustainable basis for endotoxin testing, the principles of its use, and performance of endotoxin tests based on rFC in comparison with tests based on limulus amoebocyte lysate (LAL). He will also review the rapidly evolving regulatory environment concerned with endotoxin testing, taking a global perspective. Low Endotoxin Recovery (masking) is now a phenomenon recognized by regulatory authorities in relation to the nature and formulation of biopharmaceuticals. Dr Reich will draw on his extensive expertise in this field to provide commentary on how it can be detected and addressed.

The webinar will conclude with a Question & Answer session to address matters of specific interest.