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Reliable and Sustainable Bacterial Endotoxin Testing

July 15, 2020

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.

           

Watch the Webinar Replay

WRITTEN BY

Dr. Johannes REICH

General Manager
Microcoat Biotechnologie GmbH

Dr Johannes Reich is General Manager at Microcoat Biotechnologie in Germany where he is responsible for Endotoxin and Pyrogen test services. Johannes actively engages with the regulatory and scientific community through participation in dedicated working groups, presentations and publications in peer-reviewed journals.  He has published in respected journals on endotoxin assays and Low Endotoxin Recovery (masking), and is internationally known for his expertise concerning the phenomenon of low endotoxin recovery in biopharmaceuticals.  Johannes received his PhD in Chemistry from the University Regensburg in Germany.