Charles River Launches Endosafe Nexus 200, Emphasizes Critical Importance of Smart Automation for Endotoxin Detection

Next generation robotic endotoxin testing system boosts manufacturing productivity in the lab

WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) launches the Endosafe^® Nexus 200™, expanding its robust endotoxin testing portfolio. The Nexus 200 is the next evolution of Charles River’s data integrity compliant, fully robotic instrument, capable of processing both undiluted or complex, serial dilutions for water, in-process, and final product testing via Endosafe Limulus Amebocyte Lysate (LAL) cartridge technology in a fully enclosed system. Powered by Endosafe EndoScan-V version 6.1, the system allows for data to be exported into a Laboratory Information Management System (LIMS) integration and provides improved traceability, security, and data management on an integrated touch screen.

Automation through robotics represents an evolution of bacterial endotoxin testing and streamlines quality control (QC) processes. Smart automation can improve overall process efficiency, including:

• Minimizing variation, time, and resources of performing laboratory investigations.
• Improving workflow of quality control operations, which can reduce product lead times by 60-70 percent, enabling real-time product releases.
• Avoiding the cost and time needed to train individuals to perform repetitive tasks to allocate to more high-priority tasks, such as interpreting data, analyzing trends, and proactively addressing risks.
• Reducing the risk for human error in testing processes by implementing automation, leading to greater confidence in product quality and setting a standard of excellence in line with the new revisions to Annex 1.

Unlocking the Benefits of Endosafe LAL Cartridge Technology
Nexus 200 combines technology, innovation, and control to optimize and streamline testing by combining the Endosafe LAL cartridge technology, the Endosafe^® nexgen-MCS™ multi-cartridge system, and the Hamilton Microlab^® Nimbus platforms for a low-maintenance, high-precision walkaway platform. Charles River’s FDA-licensed LAL cartridge is designed to optimize the standard LAL test. All necessary components are included in the self-contained disposable cartridge, including precise amounts of LAL reagent, chromogenic substrate, and control standard endotoxin (CSE). Cartridges are manufactured in accordance with rigid QC procedures and have been approved by the FDA for in-process and final product release testing.

Approved Quotes

• “As pharmaceutical manufacturing becomes more efficient, the demand for reliable, compliant, and high-throughput automated bacterial endotoxin solutions increases. Since the launch of Endosafe Nexus in 2014, these demands have inspired our Research and Product Development team to reimagine robotic endotoxin testing with the Endosafe Nexus 200. We are proud of this advancement of our testing portfolio.” –Birgit Girshick, Corporate Executive Vice President & Chief Operating Officer, Charles River
• “As we move towards future-proofing the micro QC lab, priorities continue to be driven by the need to accommodate increasing sample volumes, data integrity compliance, and evolving regulations, all while focusing on efficiency, quality, and patient safety.” –Gregory Marshall, Vice President and General Manager, Microbial Solutions, Charles River

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.

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