Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay


28th September 2020 | 10:00 am EST | Dr. Ruth Daniels, Senior Scientist - Microbiology Expert at Janssen and Kevin L. Williams, Microbiological Test Development at bioMérieux |WATCH FOR FREE

This webinar presentation will discuss:

• Endotoxin hold time studies to identify LER
• In silico assessment of interfering factors and associated LER mitigation strategies
• Case study: optimization of product-specific LAL assay to overcome LER

Presented by Dr. Ruth Daniels, Senior Scientist – Microbiology Expert at Janssen

Ruth Daniels holds a M.Sc. and Ph.D. degree in Bioscience Engineering from the Catholic University of Leuven (Belgium). After an academic career, she started in 2011 at Genzyme (Sanofi Belgium) as Lead ‘Microbiology Operational Technical Support and Manufacturing Science’. Since 2015 Ruth is Senior Scientist at Janssen within the Analytical Development Microbiology department. She has a broad expertise in the field of endotoxin and pyrogen testing and is involved in multiple Janssen clinical development programs as microbiology expert. Ruth is a member of BPOG Low endotoxin recovery Group and PDA Low endotoxin recovery task force.

And Kevin L. Williams, Microbiological Test Development at bioMérieux

Kevin studied microbiology at the Texas A&M University and has worked in the pharmaceutical field for 35 years. The bulk of his career was spent at Eli Lilly & Company (30 years) developing QC tests for microbial and endotoxin detection. Kevin‘s current role at bioMérieux as Senior Scientist focuses on endotoxin science, including Low Endotoxin Recovery method development. Kevin has also helped setting up a dedicated endotoxin service laboratory in the USA for hold-time studies, LER root cause analysis and endotoxin demasking protocol development. He is the author of: Endotoxins 2nd Edition (Marcel Dekker, 2001), Microbial Contamination Control in Parenteral Manufacturing (CRC Press, 2004) Endotoxins 3rd Edition (Informa Healthcare, 2007).

This follow up presentation is sponsored by bioMérieux

bioMérieux helps our clients unlock greater value from their organizations with expert consultation and a complete line of diagnostic solutions that enable more rapid, confident results. Clients benefit from improved productivity and profitability by minimizing errors and reducing time to result, as well as brand protection and safer and healthier consumer products.


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