rFC Implementation

CellMade’s implementation of rFC-based methods follows a rigorous, three-phased path designed to ensure sensitivity and reproducibility while transitioning to animal-free endotoxin testing. Phase I focuses on matrix screening and identifying the Maximum Valid Dilution (MVD) to ensure Positive Product Control (PPC) recovery falls within the compendial 50–200% range. For recalcitrant matrices like high-protein biologics, Phase II offers advanced troubleshooting, including specialized pre-treatments and the EndoLISA® solid-phase assay to eliminate inhibitory components. With the 2025 harmonization of Ph. Eur. 2.6.32 and USP <86>, the regulatory burden is significantly streamlined; rFC is now a standalone compendial method, removing the need for LAL equivalency testing. CellMade facilitates this transition through Product-Specific Verification across three independent batches, providing a fast, compliant, and science-led route to global market access.