Charles River adds animal-free endotoxin testing to Endosafe solution

Published: 2-Aug-2023

The global microbial expert has added Endosafe Trillium to its portfolio, a robust recombinant cascade reagent (rCR) assay designed for a sustainable progress

With insights and product feedback fueled by the industry, Charles River has optimised its Endosafe (registered trademark) bacterial endotoxin testing solution to continue to make mandatory safety testing faster, easier, and more reliable.

"As we navigate the intricate relationship between nature, science, and human health, we recognise the importance of reducing our impact on the environment and embracing ethical practices in pharmaceutical, vaccine, and medical device development," the company stated.

The company has refined the next addition to its Endosafe bacterial endotoxin detection portfolio by introducing Endosafe Trillium, a robust recombinant cascade reagent (rCR) assay designed for sustainable progress.

Trillium detects and quantifies natural environmental endotoxins as well as endotoxin standards (RSE & CSE) by simulating the natural LAL enzymatic cascade through an optimised formulation and composition of three critical recombinant proteins (Recombinant Factor C, Recombinant Factor B, and Recombinant pro-clotting enzyme). This proprietary matrix demonstrates assay superiority in accuracy, comparability, and robustness compared to other recombinant endotoxin detection technologies, and has been proven to ensure its equivalency to LAL.

Trillium detects and quantifies natural environmental endotoxins as well as endotoxin standards (RSE & CSE) by simulating the natural LAL enzymatic cascade through an optimised formulation and composition of three critical recombinant proteins 

As an optimised kinetic chromogenic reagent curated to simulate the natural LAL reaction, the formulation and composition of Trillium includes the three critical biological proteins (recombinant Factor C, recombinant Factor B, and recombinant pro-clotting enzyme) and a specific concentration of key components.

In addition to being 100% animal-free, Endosafe Trillium rCR offers benefits for an endotoxin testing programme:

  • A kinetic chromogenic method, it is compatible with existing incubating absorbance plate readers
  • 3-Factor enzymatic cascade simulates the same cascade reaction as traditional LAL
  • Eliminates the potential for 1,3-β-D-glucans, reducing the risk of false positives
  • Quantitative range: 0.001 to 100EU/mL
  • Primary validation package includes protocols, summary report, and implementation support

"We are dedicated to constantly identifying technologies that reduce animal use while ensuring patient safety," the company added.

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