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Relying on Data:
A Comparison
of BET Methods
 

 
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WEBINAR DETAILS

 
 
 

DATE: February 13, 2019

TIME: 11:00 AM EST

 

DURATION: 1 Hour

HOST: Charles River

 
     
 

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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PRESENTER INFORMATION

 
 
 
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Nicola Reid

Senior Endosafe Product Manager
Charles River

 

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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