Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay

Presented by

Dr. Ruth Daniels, Janssen & Kevin L. Williams, BIOMÉRIEUX USA, Inc.

About this talk

Title: Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay Presenter: Dr. Ruth Daniels, Janssen This 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 Title: : Addressing LER at the root, with ENDO-RS® sample preparation (demasking) prior to endotoxin assay of choice Presenter: Kevin L. Williams, Senior Scientist Endotoxin - BIOMÉRIEUX 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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