Charles River Introduces the First Rapid Animal-Free Bacterial Endotoxin Test
29 Enero 2024 - 7:00AM
Business Wire
Endosafe® Trillium™ recombinant cascade reagent
(rCR) cartridges provide an alternative option to bolster
commitments to sustainability and animal welfare
Building upon its flagship Endosafe® cartridge technology,
Charles River Laboratories International, Inc. (NYSE: CRL) 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 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, 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.
Approved Quotes
- “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.” – Birgit Girshick,
Corporate Executive Vice President & Chief Operating Officer,
Charles River.
- “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.” – Gregory
Marshall, Vice President and General Manager, Microbial Solutions,
Charles River.
- “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.” – Greg White, Microbiology
Laboratory Supervisor & Blackpool STEM Lead, DePuy Synthes
International.
About Charles River Charles River provides essential
products and services to help pharmaceutical and biotechnology
companies, government agencies and leading academic institutions
around the globe accelerate their research and drug development
efforts. Our dedicated employees are focused on providing clients
with exactly what they need to improve and expedite the discovery,
early-stage development, and safe manufacture of new therapies for
the patients who need them. To learn more about our unique
portfolio and breadth of services, visit www.criver.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20240129294361/en/
Investor Contact: Todd Spencer Corporate Vice President,
Investor Relations 781.222.6455 todd.spencer@crl.com
Media Contact: Amy Cianciaruso Corporate Vice President,
Chief Communications Officer 781.222.6168
amy.cianciaruso@crl.com
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