Recombinant Factor C Assay Service
Recombinant Factor C (rFC) is a growing appeal for endotoxin detection. Combined with horseshoe crab’s endotoxin-sensitive protein, Creative Biolabs provides a recombinant factor C (rFC) assay to detect the presence or absence of endotoxin in various test samples with precise quantification. Our rFC endotoxin detection service offers superior specificity by eliminating G-factor interference, ensuring accurate and reliable results. Trust Creative Biolabs for efficient, eco-friendly, and compliant endotoxin testing solutions tailored to your pharmaceutical and biological research needs!
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Principle of rFC Assay
The rFC assay is the evolution of the Limulus Amebocyte Lysate (LAL) assay and includes the rFC enzyme cloned from the horseshoe crab. The rFC is an endotoxin-sensitive synthetic protein that is cloned from factor C DNA. In this assay, when endotoxin binds to rFC, the activated synthetic rFC molecules that cleave a fluorescein substrate, amino-methylcoumarin result in the generation of a fluorogenic compound. The difference in fluorescence is proportional to endotoxin concentrations in the sample and the fluorescence is measured using 380/440 nm excitation/emission in the absence and presence of endotoxins.
Fig.1 The Novel Single-Step Activation of Recombinant Factor C Assay.
Comprehensive Workflow for Method Suitability and Release Testing
Our comprehensive, flow-chart-ready workflow ensures accurate method transfer and validation, minimizing time-to-release and regulatory risk. This detailed process is critical for demonstrating that the rFC method is non-inferior to traditional testing, a key step for successful regulatory filing.
Contact Creative Biolabs now for a detailed consultation and to initiate your rFC assay validation protocol.
Publication
This study validates the rFC assay for endotoxin quantification in veterinary autogenous vaccines. Testing 200 batches of E. coli and Pasteurella spp. vaccines, the rFC method demonstrated significant correlation and comparable performance to the traditional kinetic chromogenic LAL (KCA) assay while meeting all validation criteria. The findings support rFC as a reliable, specific, and animal-free alternative for routine quality control, advancing the 3Rs principle in veterinary vaccine safety testing.
Fig.2 Quantitative comparison of mean endotoxin concentrations.1
Advantages of Our Recombinant Factor C (rFC) Assay
Creative Biolabs provides the advanced recombinant Factor C (rFC) method as an improved alternative to the classic LAL assay. Unlike LAL, which uses horseshoe crab blood and can produce false positives due to G-factor interference, our rFC approach has superior specificity and accuracy.
Precise Detection
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Uses recombinant technology for precise endotoxin detection.
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Avoids Factor G interference, reducing false positives.
High Specificity
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High specificity, avoiding interference from β-glucans and contaminants.
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Prevents false positives for reliable results.
Sensitive & Accurate
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Detects as low as 0.001 EU/mL, ideal for ultra-sensitive applications.
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Offers a broad linear range and consistent accuracy.
Eco-Friendly & Sustainable
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Fully synthetic, reducing reliance on horseshoe crabs.
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Environmentally sustainable and ethically compliant.
Consistent & Stable
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Provides consistent batch quality through synthetic production.
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Suitable for high-throughput and large-scale testing.
Regulatory Approval
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Approved by the regulatory authorities and included in global pharmacopeias.
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Meets regulatory needs for various pharmaceutical products.
With improved sensitivity, a broader detection range, and consistent performance across batches, our rFC service provides reliable results you can trust. Additionally, it supports sustainability by eliminating the need for animal-based materials. Recognized by the regulatory authorities, our rFC solution is ideal for high-throughput testing. Choose Creative Biolabs for precise, eco-friendly endotoxin detection.
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FAQs
How does rFC differ from the traditional Limulus Amebocyte Lysate (LAL) assay?
Unlike the LAL assay, which relies on horseshoe crab blood cells, rFC is entirely animal-free, supporting sustainability and reducing the impact on endangered horseshoe crab populations. The rFC method also avoids interference from the G-factor, which can cause false positives in the LAL assay. This increases the specificity and reliability of rFC, providing more consistent and accurate results across various applications.
What equipment is required for rFC testing?
Performing rFC testing requires a fluorescence microplate reader capable of detecting at an excitation wavelength of 380 nm and an emission wavelength of 440 nm. The assay is usually conducted at 37°C ± 1°C to maintain optimal reaction conditions. The reader must be compatible with 96- or 384-well plates for high-throughput applications.
Is the rFC method internationally recognized?
Yes, the rFC method has gained significant recognition worldwide. It has been approved to be an alternative to
the LAL assay for endotoxin testing in pharmaceutical, and it has been included in the European Pharmacopoeia since 2015. Its acceptance by regulatory bodies demonstrates its reliability and alignment with international quality standards.
Can rFC be used with all sample types?
Yes, the rFC method works well with a wide variety of sample types, including those containing substances like β-glucan, which can interfere with the LAL assay. Its high specificity ensures accurate results, even for complex samples such as biological drugs, medical devices, and injectable solutions. If you are not sure about your sample type, please feel free to send us an inquiry now!
What is the future outlook for rFC?
The rFC method is expected to become the standard for endotoxin testing, especially as regulatory agencies continue to support animal-free alternatives. As production technology advances and rFC becomes more accessible, it is likely to fully replace
the LAL assay. Its combination of high accuracy, sustainability, and compliance makes it an ideal solution for future pharmaceutical testing needs.
Customer Review
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High Specificity
Using Creative Biolabs' rFC endotoxin testing assay in our research has significantly improved the reliability of our raw material qualification. We eliminated the false positives previously caused by filter-derived β-glucans, saving us weeks of retesting and investigation. – Dr. Je*Sn
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Regulatory Advantage
Switching to the rFC assay was crucial. The method's superior quantitative accuracy allowed us to meet the rigorous EP compliance requirements seamlessly. This is a robust, future-proof solution. – Prof. Aa*Lg
Related Services
To fully support your product development and quality control needs, Creative Biolabs offers several complementary services that integrate seamlessly with your rFC testing program:
Contamination Testing
Creative Biolabs offers comprehensive contamination testing (mycoplasma, bacterial, and viral assays) from pre-clinical to CMC batch release. Our expertise helps identify contamination sources and design customized testing solutions for enhanced product safety.
Learn More →
In Vitro Cell Culture Service
Creative Biolabs provides comprehensive cell culture services (primary, tumor, iPS cells, hybridomas), including stringent quality control (authentication, sterility, viral testing). We also specialize in mammalian cell culture for therapeutic protein and mAb production.
Learn More →
Contact Us
Creative Biolabs is committed to providing pharmaceutical manufacturers with the most advanced, compliant, and sustainable endotoxin testing solutions available. By choosing our rFC endotoxin testing assay, you are investing in unmatched specificity, consistency, and a clear path to global regulatory compliance. Secure your product's safety and streamline your quality control today.
Contact Our Team for More Information and to Discuss Your Project
Reference
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.Di Paolo, Antonella, et al. "Recombinant Factor C as an In Vitro Assay for the Residual Pathogenicity Evaluation of Veterinary Autogenous Vaccines." Veterinary Sciences 11.12 (2024): 673. Distributed under Open Access license CC BY 4.0, without modification. https://doi.org/10.3390/vetsci11120673
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