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Assessment of Recombinant Factor C for Endotoxin Testing

‐ Jun 26, 2023 4:30pm

The Agency has a vested interest in understanding the specific failure modes and performance challenges of commercially available Rapid Microbiological Methods (RMMs) in comparison to conventional compendial methods in the manufacturing process of biologics drug products to confirm that the recombinant technologies are comparable to providing sterility assurance of drug sterility for patient use. The use of a recombinant Factor C (rFC) endotoxin test was recently approved in two CDER BLAs and rFC tests are currently used to test more than 20 clinical products under IND development. In this study we propose to investigate several commercially available rFC kits for endotoxin detection for risk assessment in biologic manufacturing.


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