Variability, Limits, and Other Considerations for the Next Generation...

Presented by

Karen Zink McCullough, at MMI Associates and Kevin L. Williams, at bioMérieux

About this talk

Full title: Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing The Limulus Amebocyte Lysate (LAL) test has been the “gold standard” test for endotoxins since the 1980s.  In 2023, we find ourselves at an exciting crossroads.  We are thinking “outside of the box” with respect to using recombinant and cellular based technologies that promise to make improvements to the existing lysate-based methods.  But as technology evolves, should we also be evolving in our thinking regarding assay capability/variability?  Given the clear benefits of the LAL test in process control and the statistically irrelevant final sample size for drug product testing, should we consider parametric release?  How do we think about setting appropriate endotoxin limits for complex or combination drugs or drugs used in infusions?  Is 20EU/device an appropriate limit for all medical devices?  Given ongoing research into microorganism adaptation and microbiome, what is the appropriate role of the current purified E. coli calibration standard? Can we be content with 2023 technologies that are mired in 1980s thinking?  This webinar describes the events and thinking that got us here and poses some food for thought moving forward.

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