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PRESS RELEASE: Charles River Introduces Animal-Free Endotoxin Testing with a Recombinant Cascade Reagent (rCR)

Image created by Dr. Michael J. Miller

For decades, the biopharmaceutical industry has trusted us to listen and react to the unique manufacturing challenges parenteral manufacturers face bringing products to market.

With insights and product feedback fueled by the industry, our optimized Endosafe® bacterial endotoxin testing solutions continue to make mandatory safety testing faster, easier, and more reliable. As we navigate the intricate relationship between nature, science, and human health, we recognize the importance of reducing our impact on the environment and embracing ethical practices in pharmaceutical, vaccine, and medical device development.

As a result of our commitment to innovation, the 3Rs, and sustainability, we’ve refined the next addition of our 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 optimized 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.

In addition to being 100% animal-free, Endosafe Trillium rCR offers a host of benefits that will transform your endotoxin testing program. 

· 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.

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