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rFC Troubleshooting

Resolve matrix interference with CellMade’s rFC troubleshooting services. We specialize in EndoLISA® solid-phase assays and advanced pre-treatments to neutralize inhibition in complex biologics, ensuring Ph. Eur. 2.6.32 and USP <86> compliance.

CellMade’s rFC troubleshooting services are engineered to resolve complex matrix interference that can compromise endotoxin detection in high-protein biologics and viscous formulations. Utilizing a science-led approach in accordance with Ph. Eur. 2.6.32 and USP <86>, we identify the root cause of inhibition or enhancement through rigorous Positive Product Control (PPC) recovery analysis. For samples that remain recalcitrant to standard dilution, we implement advanced pre-treatment protocols—including pH adjustment and cation-chelating buffers—or deploy the EndoLISA® solid-phase assay, which effectively "washes away" interfering components while preserving endotoxin recovery. This specialized technical support ensures that your recombinant methods remain robust and defensible, transforming challenging Out-of-Specification (OOS) investigations into validated, routine QC success.