Recombinant Factor C (rFC) Endotoxin Test: Complete Guide for Pharmaceutical Microbiology and GMP Compliance
Recombinant Factor C (rFC) Endotoxin Test – Complete Guide for Pharmaceutical Microbiology and GMP Compliance Endotoxin testing is a critical quality control requirement in the pharmaceutical industry, particularly for parenteral products, water systems, medical devices, and biologics . Traditionally, the Limulus Amebocyte Lysate (LAL) test has been used for bacterial endotoxin detection. However, with increasing ethical, sustainability, and regulatory focus, the Recombinant Factor C (rFC) assay has emerged as a modern, animal-free alternative. This article provides a complete, GMP-oriented explanation of Recombinant Factor C (rFC) , including its principle, procedure, validation requirements, regulatory acceptance, advantages, limitations, and comparison with the LAL test. What Is Recombinant Factor C (rFC)? Recombinant Factor C (rFC) is a laboratory-produced, genetically engineered version of Factor C , the endotoxin-sensitive enzyme found in horseshoe...