The Future of Endotoxin Testing: USP Chapter <86> and the Shift to Recombinant Methods

For the past 50 years, the Limulus amebocyte lysate (LAL) test has served as the foundation of drug and medical device manufacturing endotoxin control. Now, however, the United States Pharmacopeia (USP) has recognized the need to transition to recombinant methods. They provide advantages in sustainability, conservation, and supply chain assurance to the evolving industry. The picture painted here is derived from the newly published USP Chapter <86> and “FAQ” document (Nov. 1, 2024).  

Chapter <86> “contains additional techniques” to the Bacterial Endotoxins Test (BET) <85> offering manufacturers the option to adopt recombinant Factor C (rFC) or recombinant cascade reagents (rCR) to detect or quantify endotoxins. These recombinant solutions provide a significant leap forward by eliminating reliance on animal-derived products and aligning with global efforts to reduce the risks associated with supply chain interruptions.