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Recombinant Factor C: Advanced Endotoxin Testing

Endotoxin Testing

In the competitive pharma industry, effective quality control programs are essential to ensure product safety and compliance. Traditional endotoxin testing methods can be time-consuming, prone to errors, and involve practices that may not align with your company's sustainability initiatives.

Our advanced endotoxin detection solutions, based on the recombinant Factor C technology (rFC), are specifically designed to meet your need for quick, accurate, agile, and environmentally friendly testing. By adopting our rFC-based solutions, you can improve your lab efficiency, ensure product safety, and support your sustainability vision.

Innovative Endotoxin Testing Technologies for Confident Decision-Making

What all successful laboratories have in common is the ability to combine efficient data management and cost optimization without compromising quality. For confident in-process and product release decisions, they need advanced and agile tools supporting streamlined workflows.

Our ENDONEXT™ technology, based on recombinant Horseshoe Crab Factor C (rFC), offers:

  • 100% endotoxin specificity, ensuring accurate results
  • lot-to-lot consistency for greater laboratory efficiency and reliability
  • competitive testing costs, optimizing your budget without compromising quality
  • environmental sustainability, as ENDONEXT™ does not require harvesting horseshoe crab blood, thereby reducing your laboratory's environmental impact 

Learn more on how you can take a major step toward robust solutions that will support you in delivering both breakthrough products and achieving your sustainability goals.

   

Our Endotoxin Offering

  • ENDONEXT™

    The Evolution of Endotoxin Testing

    ENDONEXT™ endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.

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  • ENDONEXT™ Automated with Tecan

    We have paired our ENDONEXT® rFC-based endotoxin testing solutions with the Tecan Fluent® automation platform. 

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  • ENDOXPERTS™ Services

    Comprehensive Endotoxin Services with a Special Focus on Low Endotoxin Recovery (LER)

    ENDOXPERTS™ Endotoxin Services by bioMérieux provide routine testing and feasibility studies as well as specialized services for analytical issues such as LER. Our work for leading pharmaceutical companies has resulted in validated methods for LER, fulfilling regulatory requirements. 

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  • ENDOZYME® II GO STRIPS

    Flexible Endotoxin Testing

    Laboratories don’t always need to test all 20 samples to fill a full plate—that’s why ENDOZYME® II GO STRIPS are designed with flexibility in mind: the flexibility to use only what you need, when you need it.

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  • Feasibility Study

    Quickly Confirm Your Product Compatibility and Method

    A feasibility study is probably the single most important consideration when it comes to changing your method of application. Saving you time, resources, and energy, it’s a vital aspect of ensuring compatibility.
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Partner With bioMérieux For Sustainable Endotoxin Testing

Our endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control — will you join us? Fill out the short form below to request more information from our team.

endotoxin testing

Revolutionize Your Endotoxin Testing

Embark on a 6-part journey designed to challenge the traditional norms in endotoxin detection.

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endotoxin testing

Celebrating Innovation With Professor Ding: A Pioneer In Sustainable Endotoxin Testing

Professor Jeak Ling Ding is a world-renowned pioneer in the field of molecular biotechnology. We spoke with Professor Ding to learn more about her career defining breakthrough to genetically engineer recombinant Factor C, and the importance of creating a sustainable and ethical alternative to replace traditional methods of endotoxin testing. 

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The Hunt for the Missing Endotoxin

This white paper reviews the causes contributing to low endotoxin recovery (LER), the impact it creates, as well as solutions which can rectify the issues it results in. We also discuss the advantages and disadvantages of developing your de-masking protocols in-house, and how you can use the ENDO-RS® de-masking tool kit to make the process easier from beginning to end. Following this, we outline the pros and cons of outsourcing your de-masking project, what you should look for in a third-party company, and why you can and should trust bioMérieux with your de-masking protocol development.
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horseshoe crab

WHITE PAPER

Adoption of rFC for Bacterial Endotoxin Testing

Both pharmaceutical companies and regulators have the same goal — ensuring continuous supply of safe drugs and therapies. Global pharmaceutical companies depend upon robust global supply chains to fulfil their endotoxin testing requirements to ensure patient safety. rFC is a safe, sustainable endotoxin testing solution that could mitigate many of the adverse trends impacting global supply chain consistency.

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WHITEPAPER

Low Endotoxin Recovery Case Studies

This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference.
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bacteria

WHITEPAPER

Waste in Endotoxin Detection Assays: LAL vs rFC

From traditional to alternate endotoxin testing methods used for product release testing, there is an opportunity to waste less reagent and generate cost savings. Given that Limulus Amoebocyte Lysate (LAL) is packaged in vials (2.6 or 5.2mL) and reconstituted as needed, there is inevitable waste compared to using recombinant Factor C (rFC).
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