Charles River introduces the first rapid animal-free bacterial endotoxin test

Published: 2-Feb-2024

Charles River has expanded its robust bacterial endotoxin testing (BET) portfolio with a new animal-free testing solution

Charles River, a US-based microbial solutions company, has expanded its endotoxin testing (BET) portfolio with a new animal-free testing solution.

This new offering builds on Charles River’s existing Trillium rCR vial product and enhances testing efficiency.

The manufacturing timeline is also accelerated while simultaneously contributing to Charles River's 4Rs imperatives (Replacement, Reduction, Refinement, and Responsibility), further progressing its clients' goals on sustainability and animal welfare.

Designed to deliver rapid, quantitative results, the rCR cartridges are pre-loaded with all the reagents required to perform an endotoxin test, eliminating need for preparation of multiple reagents, and reducing the opportunity for technician error. 

Additionally, the product is fully aligned and integrated with Charles River’s existing suite of Endosafe cartridge instrumentation and software, allowing for current limulus amebocyte lysate (LAL) cartridge clients to transition seamlessly.

Historically, endotoxin testing has relied on the Atlantic horseshoe crab

Historically, endotoxin testing has relied on the Atlantic horseshoe crab, whose blood contains LAL, an aqueous extract of blood cells. 

Gregory Marshall, VP and General Manager, Microbial Solutions of Charles River, said: “We are proud to support our clients’ wide range of BET needs with this first-ever animal-free cartridge. In conjunction with our LAL-based cartridges, which utilises 95% less horseshoe crab raw material required for a traditional bacterial endotoxin test, the Trillium cartridge builds on our portfolio to provide our clients with robust animal-free and animal-reduced offerings.”

LAL is the critical component of the testing of implantable medical devices and injectable pharmaceutical products to ensure the absence of endotoxins that can cause pyrogenic responses and symptoms of septic shock. 

The Trillium rCR formulation within the cartridge technology detects and quantifies natural environmental endotoxins by simulating the LAL enzymatic cascade through an optimised formulation and composition of three recombinant proteins (recombinant Factor C, recombinant Factor B, and recombinant proclotting enzyme) and a specific concentration of key components. 

Charles River continues to apply the highest scientific standards when offering new and innovative products in its BET portfolio.

Our LAL-based cartridges utilises 95% less horseshoe crab raw material required for a traditional bacterial endotoxin test

The Trillium cartridge was developed following a data-driven decision-making process to create a product that ultimately will provide the highest quality results among recombinant technologies and ensure patient safety. 

Samples representing a wide group of product types from global geographies were tested through a beta study of existing cartridge clients.

The results for these samples showed equivalency within that data set, supporting the claim of equivalency to LAL.

Birgit Girshick, Corporate Executive VP and Chief Operating Officer of Charles River, said: ”The launch of Charles River’s Endosafe [trademarked] Trillium [trademarked] cartridge revolutionises the way the industry approaches endotoxin testing while strengthening our united commitment to sustainability initiatives. This year, as we celebrate the 20th anniversary of the original Endosafe LAL reagent cartridge technology, we are excited to bring a new animal-free option to clients that leverages innovative technology, while continuing to offer our LAL-based offerings for clients whose work requires them.” 

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