Looking Back At USP <86>: Key Changes And Their Impact On Biological Reactivity Testing

By Jillian Miller, Microbiology Manager at Pace® Life Sciences

The introduction of USP <86>, Bacterial Endotoxins Test Using Recombinant Reagents, marks a significant step in the industry's shift toward animal-free testing technologies. Effective May 1, 2025, the chapter establishes a compendial framework for recombinant endotoxin testing methods, including recombinant Factor C (rFC) and recombinant Cascade Reagents (rCR), while maintaining USP <85> as an acceptable alternative. These technologies offer manufacturers opportunities to reduce reliance on horseshoe crab-derived materials, strengthen supply chain resilience, and support broader sustainability initiatives without compromising product quality or patient safety.

Organizations considering adoption should evaluate method validation requirements, comparability studies, change control processes, and potential regulatory filing impacts. Early planning can help streamline implementation and reduce regulatory risk while positioning quality control programs for future innovation.