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DATE: February 13, 2019
TIME: 11:00 AM EST
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DURATION: 1 Hour
HOST: Charles River
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Recently, demand for pyrogen detection assays has grown to keep pace with globalization, emerging economies, and the expanding vaccine, medical device, and biologics industries. The FDA-approved standard for bacterial endotoxin testing (BET) is the Limulus Amebocyte Lysate (LAL) assay; however, misleading media coverage and baseless claims that an LAL shortage is imminent have generated a renewed interest in alternative endotoxin assays within the industry. These current methods promise a rapid, specific alternative to the gold standard. What is never discussed though is that not only do these alternatives require extensive validation, but legitimate concerns also exist regarding their specificity, robustness, and reproducibility.
In this webinar we’ll examine published data that illustrates specificity issues with naturally occurring and relevant endotoxins as well as why the ability to detect all environmental Gram-negative bacterial endotoxins is a critical element of safe therapeutics.
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Have a scheduling conflict?
Sign up even if you can't make it; we'll share the recording after.
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Nicola Reid
Senior Endosafe Product Manager
Charles River
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Nicola has over 20 years of experience with bacterial endotoxin testing and pharmaceutical microbiology. She has been involved in all aspects of the endotoxin assay, including the design and development of BET-specific instrumentation and software. Her work has led her to directing workshops and training courses, as well as lecturing internationally on a variety of BET-related topics including LAL methodologies, product validations, 21 CFR Part 11, and BET regulatory affairs.
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©2019 Charles River Laboratories International, Inc.
Charles River Laboratories | 1.877.274.8371 | 251 Ballardvale St. | Wilmington, MA | 01887
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