Science With Purpose: Advancing Sustainability In Biopharma

Switching away from LAL-based endotoxin testing remains a sticking point for many pharmaceutical and biopharmaceutical organizations, even as more sustainable, pharmacopeia-recognized alternatives become available. Recombinant Factor C (rFC) testing addresses several of the practical limitations that have historically reinforced the status quo: it requires no horseshoe crab blood, involves fewer reagents and buffers, and delivers high specificity to endotoxin that reduces interference from glucans and other non-endotoxin contaminants.

Recognition across Ph. Eur. 2.6.32, USP <86>, and JP <4.01>, along with alignment to USP updates effective May 2025, has strengthened the regulatory standing of rFC considerably. For organizations weighing the transition, the regulatory data requirements and risk of delay remain real concerns. Explore how rFC testing addresses those barriers in practice.