US-based Charles River Laboratories International has rolled out the Endosafe Trillium recombinant cascade reagent (rCR) cartridge, based on the company’s Endosafe cartridge technology.
Endosafe Trillium rCR cartridge is a rapid animal-free bacterial endotoxin testing solution that expands the company’s bacterial endotoxin testing (BET) portfolio.
Pre-loaded with all the reagents required to perform an endotoxin test, the rCR cartridges are designed to deliver rapid, quantitative results.
The new animal-free test eliminates the need for the preparation of multiple reagents and reduces the opportunity for technician error, said Charles River.
It has been developed based on the company’s existing Trillium rCR vial product to enhance testing efficiency and advance the manufacturing timelines.
In addition, the product is fully integrated with its existing suite of Endosafe cartridge instrumentation and software, said the company.
Charles River corporate executive vice president and chief operating officer Birgit Girshick said: “The launch of Charles River’s Endosafe Trillium cartridge revolutionizes 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.”
Traditionally, endotoxin testing is primarily performed using the Atlantic horseshoe crab, whose blood contains limulus amebocyte lysate (LAL), an aqueous extract of blood cells.
LAL has been a key component in the testing of implantable medical devices and injectable pharmaceutical products to ensure the absence of endotoxins.
Charles River’s Trillium rCR formulation within the cartridge technology is designed to detect and quantify the natural environmental endotoxins.
The test simulates the LAL enzymatic cascade through an optimised formulation and composition of three recombinant proteins and a specific concentration of key components.
Charles River microbial solutions vice president and general manager Gregory Marshall 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 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.”
Charles River has developed its Trillium cartridge in a data-driven process to provide a high-quality recombinant technology product and ensure patient safety.
The company used samples from a wide group of product types, where different 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, said the company.
DePuy Synthes microbiology laboratory supervisor and Blackpool STEM lead Greg White said: “Using the Endosafe Trillium rCR cartridges alongside our routine testing was straightforward for our technicians, as the test method remains identical, and the results are reported the same way.
“We were pleased with the technology implementation, quality of data, and onboarding as it was simple and seamless, which is ideal when introducing such an impactful change in the microbiology lab.
“We look forward to moving to Endosafe Trillium rCR cartridges for routine testing later in the year as part of our environmental sustainability efforts.”
