Charles River Modernizes Endosafe® Endotoxin Testing Cartridge Manufacturing with Fully Automated Production Suite

A fully automated Endosafe cartridge suite delivers higher capacity, better quality controls and extensive traceability for Charles River’s endotoxin testing products.

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Enhanced automation delivers improved traceability and capacity, while increasing manufacturing efficiency

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) has successfully implemented its Endosafe^® Cartridge Technology Automated Manufacturing Suite, a significant advancement in bacterial endotoxin testing cartridge production that expands in-process inspection and digital traceability, strengthens manufacturing controls and increases production capacity.

Reaching full operational capacity in Q3 2026, the automated suite is a major investment in advanced manufacturing technologies, designed to strengthen product quality and support the growing demands of customers worldwide. This technology was designed to streamline and optimize testing by consolidating all the essential components into a single disposable cartridge, to provide real-time, quantitative endotoxin analysis.

“Bringing the automated cartridge manufacturing suite to full operation is an important milestone in our commitment to continuous improvement and operational excellence,” said Daniel Fernandes, Senior Site Director, Microbial Solutions, Charles River. “Automation and advanced inspection technologies give us greater visibility into manufacturing performance while strengthening process control and traceability.”

Delivering Measurable Operational Improvements
Since its inception, the Endosafe^® Cartridge Technology Automated Manufacturing Suite has delivered measurable improvements across quality, manufacturing efficiency, and operational performance.

Since becoming fully operational in July of 2026, key outcomes include:

• 2% reduction in scrap rates compared to manual cartridge production, resulting in reduced waste.
• 13% reduction in invalid cartridge rates, resulting in improved product consistency.
• 14% greater production capacity across Trillium™ and LAL cartridges, to meet growing customer demand.
• 87% improvement in labor productivity and manufacturing efficiency, enabling higher throughput with fewer production resources while reducing the risk of human error.

Benefits of Automation
The implementation of automated manufacturing processes has improved precision and clarity, enabling enhanced quality, more efficient resource use, faster innovation, and industry modernization.

"Automation is helping us do more than improve quality. It allows us to optimize how we deploy our talent," said Matt Hewitt, Corporate Vice President, Chief Technology Officer Manufacturing, Charles River. "By reducing the manual effort required to manufacture cartridges, we have been able to redirect skilled employees to higher-value initiatives that contribute to continuous improvement and long-term growth."

• Advancing Quality Through Automated Inspections: A key feature of the new automated suite is its ability to inspect every cartridge, unlike traditional sampling methods. It performs full inspections across critical quality parameters, including cartridge thickness, reagent fill via imaging, package seal integrity, and digital traceability. This ensures a controlled manufacturing environment and greater confidence in product quality and consistency.
• Improving Supply Chain Quality: The automation initiative has improved Charles River’s manufacturing by switching to automated flat-tray packaging, reducing manual handling and enhancing material consistency. These changes have positively impacted both automated and manual processes by increasing raw material quality.
• Greater Efficiency and Scalability: The automated suite delivers substantial operational efficiencies. The system enables Charles River to maintain production volumes while reducing the labor resources required to manufacture cartridges. This increased productivity supports long-term scalability and positions the company to meet future demand while maintaining rigorous quality standards.
• Enhanced Traceability for Continuous Improvement: Each cartridge has a unique ID, enabling traceability throughout its lifecycle. This allows manufacturing teams to review data like inspection images, measurements, and packaging results. Enhanced visibility supports faster investigations, improvements, and optimization. Customer feedback combined with manufacturing data offers insights to refine inspection and manufacturing performance.
• Commitment to Continuous Innovation: The automated cartridge manufacturing suite reflects Charles River’s ongoing commitment to innovation, quality, and customer success. By combining advanced automation, comprehensive inspection capabilities, and enhanced process intelligence, the company is establishing a stronger foundation for future growth and continuous product improvement.

“We view this as more than a manufacturing upgrade,” said Hewitt. “It is a platform for continuous learning and innovation that will help us deliver even greater quality, consistency, and value to our customers in the years ahead.”

About Charles River Laboratories
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/20260908778943/en/

Charles River Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com

Charles River Media Contact:
Amy Cianciaruso
Corporate Senior Vice President,
Chief Communications Officer
781.222.6168
amy.cianciaruso@crl.com

Source: Charles River Laboratories International, Inc.

Key Terms

bacterial endotoxin testing technical

A laboratory procedure that detects and measures bacterial endotoxins—heat-stable toxins (lipopolysaccharides) released from the cell walls of certain bacteria—commonly in injectable drugs, vaccines, medical devices, and manufacturing water. Think of it like a smoke detector for invisible bacterial toxins: regulators require it to confirm products are free of contamination that can cause severe fever or shock, and results affect product release, regulatory approval, recalls, and manufacturing continuity.

reagent fill technical

Reagent fill is the amount or process of loading chemical or biological solutions into test kits, cartridges, vials, or instruments used for laboratory assays and diagnostics. Think of it like filling ink into a printer cartridge: the correct volume and composition ensure each test runs reliably and consistently. It matters to investors because fill accuracy affects product yield, manufacturing costs, quality control, regulatory compliance, and the consistency of revenue from consumable sales.

package seal integrity technical

Package seal integrity is the measurable ability of a product’s outer closure—foil, cap, heat seal, or adhesive—to stay intact and prevent leaks, contamination, moisture, or air from entering during storage and transport. It matters to investors because compromised seals can degrade product safety and shelf life, trigger regulatory actions or recalls, interrupt sales and supply chains, and therefore affect a company’s reputation, costs, and revenue. Think of it like the seal on an envelope keeping the contents safe until opened.

digital traceability technical

Digital traceability is the ability to record and follow the origin, movement and changes of a product, data point or transaction through digital records, like a permanent breadcrumb or package-tracking history. For investors it matters because clear digital trails reduce risk, expose fraud or quality problems sooner, help prove regulatory or sustainability claims, and can improve efficiency and brand trust—factors that affect a company’s costs, liabilities and long-term value.