rFC Endotoxin Detection: Accurate, Modern, Sustainable

Change can be difficult, especially in an industry governed by complex regulations and cautious innovation cycles. Many pharmaceutical and biopharmaceutical companies hesitate to move away from traditional endotoxin testing methods like LAL (Limulus Amebocyte Lysate), due to the data required to switch and the risk of regulatory delay. The Eurofins BioPharma Product Testing (BPT) network of laboratories is utilising Recombinant Factor C (rFC) testing—a synthetic, sustainable, and highly specific method for endotoxin detection.

rFC testing is now recognised in global pharmacopeias (Ph. Eur. 2.6.32, USP <86>, JP <4.01>) and is aligned with the latest USP updates effective May 2025. Unlike the traditional LAL test, rFC does not require horseshoe crab blood—eliminating the ethical and environmental concerns surrounding this resource-intensive practice.

With rFC, you also avoid the need for additional reagents and buffers, streamlining your testing process while ensuring reproducibility. The method provides high specificity to endotoxin, reducing the likelihood of interference from glucans or other non-endotoxin contaminants, and helping avoid costly false positives. At Eurofins BPT, we recognise that adoption of new methods requires trust, data, and support. Our laboratories offer: 

• Comprehensive validation support and regulatory expertise
• Expertly trained scientists with deep knowledge in rFC performance
• Fast, reliable turnaround and transparent reporting
• Global laboratory network and GMP-compliant facilities
• Reduced reliance on animal-derived resources—supporting your ESG goals 

We’ll work closely with you to ease the transition from LAL to rFC, equipping you with the scientific data, documentation, and confidence needed to support regulatory submissions. Whether you’re developing new biologics or seeking efficiencies in established production lines, our rFC method helps futureproof your quality strategy while aligning with sustainability objectives.