Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay


28th June 2018 | 10 EST | Dr. Ruth Daniels, Janssen & Kevin L. Williams, 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, 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.

 

 

Sponsored by BIOMÉRIEUX

Presented by Kevin L. Williams, Senior Scientist Endotoxin – 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).

 

Addressing LER at the root, with ENDO-RS® sample preparation (demasking) prior to endotoxin assay of choice

Scientific studies have demonstrated that biologics typically containing protein in high concentrations and non-ionic surfactants, are likely to change the aggregate state of endotoxin in such a way that it is no longer accessible for detection with Factor C-based endotoxin detection methods (LAL and rFC). The ENDO-RS® endotoxin recovery method developed by Hyglos – a bioMérieux company, is a unique toolbox of dedicated reagents for demasking (recovering) endotoxin prior to detection, also for conventional LAL. This presentation covers the mechanism of LER, regulatory requirements, work principle of ENDO-RS, the demasking services of bioMérieux, as well as method application data.

 


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