Abstract
Testing of parenteral pharmaceuticals and medical devices for pyrogens (fever-inducing substances)is critical to patient safety. The original rabbit pyrogen test has largely been replaced by different bacterial endotoxin testsbased on Limulus amebocyte lysate (LAL), sourced from the blood equivalent of horseshoe crabs after comparative studies to the rabbit pyrogen test. Since 2004a bacterial endotoxin test based on recombinant factor C (rFC), the endotoxin sensor protein inside of LAL, has been used as an animal-free alternative to LAL. Likewise, numerous studies compared LAL and rFC. Herewe describethe history of pyrogen and bacterial endotoxin testing and summarizethe evidence presented by those studies. We demonstratethat rFC and LAL areequivalent and comparable.
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