bioMérieux – Endotoxin Testing (rFC) – Decoding the future of endotoxin testing

By biomérieux On Jul 11, 2025

After 50 years of LAL testing, the pharmaceutical industry is transitioning to recombinant Factor C (rFC) methods. USP Chapter <86> (November 2024) eliminates the biggest barrier—method validation—making adoption faster and easier than ever.

It is now important to switch to recombinant methods than ever before!

Why?

Sustainability: Eliminate dependence on horseshoe crab blood while protecting coastal ecosystems and ensuring ethical manufacturing practices.

Simplified validation: Rely on manufacturer validation packages instead of extensive in-house method validation. Same sample suitability requirements as LAL.

Supply chain security: Unlimited, reproducible supply with enhanced stability and functionality that animal-derived materials cannot match.

Industry leaders have already converted globally!

So, are you ready to future-proof your endotoxin testing?

Download our comprehensive white paper to learn how USP Chapter <86> can transform your quality control program!!

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