The Recombinant Factor C (rFC) assay represents a revolutionary milestone in bacterial endotoxin testing (BET). For decades, the industry relied on the Limulus Amebocyte Lysate (LAL) derived from horseshoe crab blood. The rFC assay is a biotechnologically engineered, animal-free alternative that utilizes a genetically cloned version of the primary endotoxin-sensing protein found in horseshoe crabs. Our Recombinant Factor C (rFC) Assay Kits helps you obtain high-accuracy endotoxin quantification and future-proof your supply chain through advanced recombinant DNA technology and high-sensitivity fluorogenic detection. These kits are specifically designed for the detection of gram-negative bacterial lipopolysaccharides (LPS) in parenteral drugs, biologics, and medical devices.
Regulatory bodies worldwide are actively endorsing the transition to recombinant reagents to enhance supply security and protect biodiversity.
European Pharmacopoeia (Ph. Eur.): The rFC assay is formally listed as a compendial method in Chapter 2.6.32, allowing it to be used as a standalone test for the release of injectable products.
United States Pharmacopeia (USP): Under General Notices and Chapter <85>, the rFC method is recognized as a suitable alternative, provided that product-specific validation (under USP <1225> or ICH Q2) is performed to demonstrate equivalence to traditional methods.
Global Acceptance: Major manufacturers at global sites have successfully validated rFC for drug substances and pharmaceutical-grade water, meeting the stringent requirements for manufacturing.
The rFC assay operates through a streamlined, single-step enzymatic process that mimics the natural immune response of the horseshoe crab. The resulting signal is directly proportional to the endotoxin concentration, allowing for precise quantification down to 0.005 EU/mL.
Creative Biolabs offers a comprehensive suite of rFC products. Our kits are available in 96-test formats and bulk configurations to meet the demands of large-scale manufacturing and clinical trials. Transitioning to the Creative Biolabs rFC Assay Kit offers significant analytical and operational advantages over traditional LAL-based methods:
Our rFC reagent lacks Factor G, meaning it is entirely insensitive to (1→3)-beta-D-glucans, which frequently cause false-positive results in traditional assays.
While traditional methods can struggle with recovery, our rFC technology consistently achieves nearly 100% spike recovery in both environmental dust and pharmaceutical formulations.
Our kits have been stress-tested against the most challenging matrices, including autogenous vaccines with aluminum adjuvants and drug substances leached from cellulosic filters.
Creative Biolabs provides pre-written validation protocols that align with ICH and European Pharmacopoeia standards, significantly reducing your internal method development time.
Creative Biolabs is your trusted partner in the transition to sustainable, high-precision endotoxin detection. Our Recombinant Factor C (rFC) Assay Kits provide the reliability of a synthetic reagent with the validation support required for global regulatory compliance. By choosing Creative Biolabs, you secure your supply chain, protect natural ecosystems, and ensure the highest level of patient safety. Contact us to discuss your specific project requirements.
Yes. Global pharmacopoeias and agencies accept rFC as a compendial or alternative method. We provide the necessary documentation to support its inclusion in your BLA or IND filings.
Creative Biolabs includes specialized unblocking buffers in our kits. These are specifically formulated to release endotoxins that may be bound to proteins or surfactants, ensuring accurate quantification in complex biologics.
You will need a standard fluorescence microplate reader capable of 380 nm excitation and 440 nm emission. Our technical team can assist with calibrating your equipment for optimal sensitivity.
rFC is highly accurate for environmental matrices, with spike recoveries of nearly 100% in house dust and bioaerosol monitoring.
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