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ENDONEXT™ Endotoxin Detection Assays


Based on Recombinant Horseshoe Crab Factor C (rFC), the ENDONEXT range of assays by bioMérieux is the future of endotoxin testing systems. With improved specificity, better consistency, and a more efficient workflow, ENDONEXT technology also completely eliminates the need to harvest horseshoe crabs for their blood—ushering in a new era of smarter, more sustainable pharmaceutical quality control.

All ENDONEXT assays follow BET methodology and are validated according to standard pharmacopoeia criteria. rFC is included both in the European Pharmacopoeia chapter Ph. Eur. 5.1.10 as well as in the U.S. FDA Guidance for Industry: Pyrogen and Endotoxins Testing. The U.S. FDA recently also approved rFC for product release testing of Galcanezumab (Eli Lilly).

The ENDONEXT assay range:

ENDOZYME® II GO

NEW 2018: The rapid GO version of ENDOZYME II featuring GOPLATE™—a microplate pre-filled with required standard curve and positive product control concentrations (PPC).

  • Eliminates manual preparation of standard dilutions and PPCs
  • Over 50% reduction in handling time compared to conventional microplate assays
  • Significantly reduces risk of error
  • Ideal for in-process control of water and raw materials as well as product release testing
  • Easy automation

ENDOZYME® II

ENDOZYME II is the enhanced second generation of ENDOZYME, a flexible and easy-to-use endotoxin detection assay offering state-of-the-art test performance.

  • Test sensitivity down to 0.001 EU/mL
  • Flexible assay time depending on required sensitivity
  • Excellent lot-to-lot reproducibility
  • Particularly suited for final product testing, formulation and research

ENDOLISA®

With its unique built-in sample preparation step, the ENDOLISA assay revolutionizes endotoxin testing of complex samples.

  • ELISA-like format features 96-well plate pre-coated with a specific endotoxin-binding phage protein
  • Overcomes limits of traditional methods such as inhibition and enhancement
  • Unprecedented tolerance of organic solvents, detergents, and chaotropic agents
  • Low to no dilution of samples

With more than 50 years’ experience in microbiological diagnostics, bioMérieux, Inc. helps you unlock greater value from your organizations with expert consultation and a complete line of diagnostic solutions that enable more rapid, confident results. You benefit from improved productivity and profitability by minimizing errors and reducing time to result, as well as brand protection and safer and healthier consumer products.

Click here to learn more about bioMérieux solutions.


    

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Date Published: 4th March 2019

Source article link: bioMérieux (Industry)


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