Recombinant Factor C Assay Service

Creative Biolabs provides a one-stop service for recombinant factor C assays.

Principle of rFC Assay Advantages Validation Timeline FAQ Related Services
Pipetting for Recombinant Factor C (rFC) Biological Testing. (Creative Biolabs Authorized)

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!

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 Process of Recombinant Factor C Cascade. (Creative Biolabs Original)Fig.1 The Novel Single-Step Activation of Recombinant Factor C Assay.

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

  • Uses recombinant technology for precise endotoxin detection.
  • Avoids Factor G interference, reducing false positives.

High Specificity

  • High specificity, avoiding interference from β-glucans and contaminants.
  • Prevents false positives for reliable results.

Sensitive & Accurate

  • Detects as low as 0.001 EU/mL, ideal for ultra-sensitive applications.
  • Offers a broad linear range and consistent accuracy.

Eco-Friendly & Sustainable

  • Fully synthetic, reducing reliance on horseshoe crabs.
  • Environmentally sustainable and ethically compliant.

Consistent & Stable

  • Provides consistent batch quality through synthetic production.
  • Suitable for high-throughput and large-scale testing.

Regulatory Approval

  • Approved by the regulatory authorities and included in global pharmacopeias.
  • 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.

Validation Timeline

A possible validation timeline is outlined below. The test with the rFC method is performed in the step of validation of the alternative method.

Fig.2 Timetable of rFC Assay. (Creative Biolabs Original) Fig.2 Validation Timeline.

Creative Biolabs has experience in bacterial endotoxin testing for clients in the medical device industry. With a proven effective and compliant process, we provide the highest quality testing and fast turnaround time. For more detailed information, please feel free to contact us or directly send us an inquiry.

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.

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