Charles River Introduces the First Rapid Animal-Free Bacterial Endotoxin Test

Rhea-AI Summary

Charles River Laboratories International, Inc. (NYSE: CRL) has launched the Endosafe® Trillium™ rCR cartridge offering, an animal-free testing solution that enhances testing efficiency and accelerates manufacturing timelines. This innovation builds upon the company's flagship Endosafe® cartridge technology and their recombinant cascade reagent (rCR) to bolster commitments to sustainability and animal welfare.

Insights

Market Research Analyst

The introduction of the Endosafe® Trillium™ recombinant cascade reagent (rCR) cartridges by Charles River Laboratories represents a strategic move within the biotechnology and pharmaceutical services industry. This development aligns with the increasing market demand for sustainable and ethical laboratory practices. The shift towards animal-free testing solutions not only addresses ethical concerns but also regulatory trends that favor alternatives to traditional methods involving animal-derived components.

From a market perspective, this innovation could potentially expand Charles River's customer base to organizations prioritizing sustainability and animal welfare in their operations. Additionally, the enhanced efficiency and accelerated manufacturing timelines promised by the new product could improve client throughput and satisfaction, leading to potential increases in company revenue and market share. However, it is essential to monitor the adoption rate of the new cartridges and the operational impact on Charles River's financials in subsequent quarters to assess the long-term viability of this investment.

Biotechnology Industry Analyst

Bacterial endotoxin testing (BET) is a critical quality control measure in the pharmaceutical and medical device industries, ensuring that injectable therapeutics and implantable devices are free of bacterial contamination that could lead to serious infections. The Endosafe® Trillium™ rCR cartridge's animal-free testing solution is significant as it leverages recombinant technology, potentially offering a more consistent and reliable alternative to traditional Limulus Amebocyte Lysate (LAL) testing, which relies on blood extracted from horseshoe crabs.

By utilizing recombinant technology, Charles River Laboratories is not only adhering to ethical standards but also mitigating the risk of supply chain disruptions associated with horseshoe crab populations. This move may set a new industry standard, prompting competitors to innovate similarly. The long-term implications for the industry include a probable shift in regulatory guidelines and a transformation in how endotoxin testing is conducted globally.

Sustainability Analyst

The launch of the Endosafe® Trillium™ rCR cartridges is indicative of the broader industry trend towards sustainable and responsible research practices. By providing an alternative to traditional methods, Charles River Laboratories is positioning itself as a leader in the sustainability aspect of laboratory operations. This could enhance the company's reputation and align with the values of stakeholders increasingly concerned with corporate social responsibility.

While the immediate financial implications may be limited to R&D and marketing expenses, the long-term benefits could include stronger relationships with clients who value sustainability, potentially leading to increased customer loyalty and a competitive edge. The true measure of success for this initiative will be its adoption across the industry and its influence on shaping future regulatory standards and practices.

Endosafe^® Trillium™ recombinant cascade reagent (rCR) cartridges provide an alternative option to bolster commitments to sustainability and animal welfare

WILMINGTON, Mass.--(BUSINESS WIRE)-- 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 20^th 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.

View source 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

Source: Charles River Laboratories International, Inc.

FAQ

What is the ticker symbol for Charles River Laboratories International, Inc.?

The ticker symbol for Charles River Laboratories International, Inc. is CRL.

What is the Endosafe® Trillium™ rCR cartridge offering?

The Endosafe® Trillium™ rCR cartridge offering is an animal-free testing solution that enhances testing efficiency and accelerates manufacturing timelines.

How does the Endosafe® Trillium™ rCR cartridge contribute to sustainability and animal welfare?

The Endosafe® Trillium™ rCR cartridge offering bolsters commitments to sustainability and animal welfare by providing an alternative option to traditional testing methods.

What technology does the Endosafe® Trillium™ rCR cartridge build upon?

The Endosafe® Trillium™ rCR cartridge offering builds upon Charles River Laboratories International, Inc.'s flagship Endosafe® cartridge technology and their recombinant cascade reagent (rCR).