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13th February 2024  Content supplied by: Charles River Microbial Solutions

Charles River Announces the First Rapid Animal-free Bacterial Endotoxin Test

Building upon its flagship Endosafe® cartridge technology, Charles River Laboratories has advanced this innovation one step further and combined it with their recombinant cascade reagent (rCR) to launch the Endosafe® Trillium™ rCR cartridge offering. Expanding its robust bacterial endotoxin testing (BET) portfolio with a new animal-free testing solution, this offering, which builds on Charles River’s existing Trillium rCR vial product, enhances testing efficiency and accelerates manufacturing timelines while simultaneously contributing to Charles River's 4Rs imperatives (Replacement, Reduction, Refinement, and Responsibility) and further progressing our client's 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 the 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, whose blood contains LAL, an aqueous extract of blood cells. 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 optimized formulation and composition of three recombinant proteins (recombinant Factor C, recombinant Factor B, and recombinant proclotting enzyme) and a specific concentration of key components. Our extensive data package supporting our proprietary matrix demonstrates assay superiority in accuracy, comparability, and robustness.

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

Gregory Marshall, Vice President and General Manager, Microbial Solutions, Charles River commented "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 utilize 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."

Learn More or use the "Request Information" button below to contact Charles River for details.

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Date Published: 13th February 2024

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