Ep. 8 Nature’s Safety Test: Horseshoe Crabs and the Future of Endotoxin Testing
Description
For decades, the biopharma industry has relied on horseshoe crab blood to detect dangerous bacterial endotoxins. But with growing ethical, environmental, and scientific concerns, the tides are shifting.
We explore the history of pyrogen testing, from rabbit injections to the LAL test, and unpack the science behind these methods. Then, we turn our focus to the emerging recombinant technologies that promise greater specificity, consistency, and sustainability; all without relying on animal sources.
Most importantly, we break down the new U.S. Pharmacopeia <86>, a major regulatory milestone that officially recognizes recombinant endotoxin tests as compendial methods. What does this mean for manufacturers? For regulators? And for the horseshoe crabs?
If you're in biotech, pharma, or medical devices, or just curious about how injectable drugs are kept safe, this is an episode you won't want to miss.
Featured Article: Barriers to the Use of Recombinant Bacterial Endotoxins Test Methods in Parenteral Drug, Vaccine and Device Safety Testing (https://journals.sagepub.com/doi/10.1177/02611929231204782)
United States
