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FAST, ACCURATE, AND SUSTAINABLE QUALITY CONTROL

Endotoxin Testing

Our endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.  They’re more efficient, more flexible, and less wasteful. In other words, they’re better for your lab and better for our planet.

New Technologies for Confident Decision-Making

With 100% endotoxin specificity, lot-to-lot consistency, and more streamlined workflows, our range of ENDONEXT™ solutions gives you confidence in your in-process control and product release decisions. Based on Recombinant Horseshoe Crab Factor C (rFC), ENDONEXT technology eliminates the need to harvest horseshoe crab blood and makes your laboratory more efficient, so you can optimize testing costs along the way.

Product List

  • ENDONEXT™

    Better for your lab. Better for the planet.

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

    Low Endotoxin Recovery

    The phenomenon of Low Endotoxin Recovery (LER) has gained renewed attention in the scientific community in recent years as the FDA now requires that all new Biological License Applications are able to successfully unmask when LER occurs. ENDOXPERTS™ is our solution for unmasking LER, which helps you meet 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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Resources

THE EFFECT OF Β-GLUCANS ON LAL ACTIVITY IN PRE-TREATMENT WATER

The efficacy of recombinant Factor C (rFC) for bacterial endotoxin testing (BET) has been proven with multiple peer-reviewed papers comparing rFC with LAL. Non peer-reviewed data has been circulating looking at the Limulus amebocyte lysate (LAL) and rFC reactivity of pre-treatment deionized water.

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OVERCOMING LER: TOOLS TO DETECT MASKED ENDOTOXIN

The phenomenon of low endotoxin recovery (LER) has gained renewed attention in the scientific community in recent years, as the FDA requires that all new BLAs are able to successfully unmask endotoxin if LER occurs. In this webinar, endotoxin experts demystify LER and discuss a “toolbox” for effective endotoxin detection.

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THE TRUTH AND FALLACIES OF RECOMBINANT ENDOTOXIN ASSAYS

The comparability and equivalence of recombinant Factor C (rFC) to LAL has been proven with over 10 peer-reviewed studies by government and pharmaceutical facilities. Some articles and papers with limited scientific proof have been recently published, attempting to raise doubt with users and authorities regarding the use of these recombinant methods.

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