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.
- Nicola Reid, Senior Endosafe Product Manager, Charles River