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Charles River platform offers 40% reduction in cell bank production timeline, over the industry standard of 20 weeks
Charles River Laboratories International, Inc. (NYSE: CRL) has introduced rapid cell banking programs designed to significantly accelerate release timelines, enabling biopharmaceutical and advanced therapy developers to reach critical milestones faster and bring innovative treatments to patients sooner. By combining rapid cell bank and release packages with advanced characterization using Next-Generation Sequencing (NGS), Charles River delivers a comprehensive, end-to-end solution that enhances product quality, safety, and regulatory readiness while reducing overall development timelines.
"By leveraging our long-standing expertise in rapid test methods, we can expedite pre-bank and release testing timelines, enabling clients to establish and characterize cell banks quickly and move their product forward in development," said Matthew Hewitt, Corporate Vice President, Chief Technology Officer, Manufacturing, Charles River. "The integration of rapid cell banking with NGS technologies provides a powerful advantage for developers, helping accelerate critical milestones, de-risk development programs, and ultimately bring innovative therapies to patients faster."
At every stage of the process, Charles River provides deep regulatory rigor and support, helping clients navigate the complexities of biologic and advanced therapy development, align with global regulatory expectations, and efficiently progress programs from early development through commercialization.
This platform offering further advances the Company's commitment to the 3Rs (Replacement, Reduction, Refinement) through its Alternative Methods Advancement Projectâ„¢ (AMAPâ„¢), which develops and implements alternative methods and other innovative strategies to reduce reliance on animal testing while supporting efficient product development.
Established Expertise in Delivering Rapid Test Methods
To accelerate the establishment of cell banks, Charles River offers rapid microbiological methods (RMM) for microbial detection (including Celsis ® ATP-Bioluminescence technology) and rapid mycoplasma detection using real-time PCR. These technologies replace traditional compendial testing with automated, objective results, resulting in faster pre-bank, and release testing timelines.
Leveraging In Vitro Techniques for Next-Generation Sequencing
Following the establishment of cell banks, Charles River can leverage NGS, via our iDTECT ® platform, to provide reliable in vitro characterization services. NGS is revolutionizing how cell banks and advanced therapeutics are characterized and tested, ensuring high-quality products are delivered to patients. NGS has transformed the landscape of genetic analysis and pathogen detection with its scalability, speed, and broad viral detection capabilities.
"Cell bank characterization is a critical foundation for the development of biologic products, and NGS is transforming how the industry approaches safety and quality testing," said Colette Côté, Executive Director & Scientific Advisor, Global Biologics Testing Services , Charles River. "By combining rapid cell banking capabilities with NGS as part of the cell bank characterization package, we help clients accelerate development timelines while generating the comprehensive data needed to support regulatory submissions and build confidence in product quality and safety."
Charles River's CGMP-compliant NGS testing services accelerate development timelines without compromising safety, while meeting stringent global regulatory expectations for accuracy, reliability, and compliance, including GMP requirements and regulatory guidance from the FDA and EMA along with ICH Q5A and Q5B. The Company's acquisition of Pathoquest, a recognized leader in NGS solutions for in vitro characterization and quality control testing of biopharmaceutical products, further strengthens these capabilities. By integrating Pathoquest's expertise and technology platform, Charles River delivers faster, more advanced sequencing-based testing solutions, enabling clients to move efficiently through development while maintaining confidence in product quality, safety, and regulatory readiness.
About the Alternative Methods Advancement Project (AMAP)
The Alternative Methods Advancement Project (AMAP) is a Charles River-led initiative dedicated to developing New Approach Methodologies (NAMs) and exploring innovative scientific and technological solutions aimed at reducing reliance on traditional animal testing. As we enter the next frontier of drug development, AMAP enables strategic, purpose-driven investment to shape a future in which more patients can access the treatments and medicines they need safely, swiftly, and successfully. AMAP is supported by our global, cross-functional Scientific Advisory Board led by Dr. Namandjé N. Bumpus.
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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Charles River Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com
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Chief Communications Officer
781.222.6168
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