Charles River Leverages Expertise in Rapid and In Vitro Methods to Reduce Cell Banking Timelines

Charles River introduces a rapid, NGS-enabled cell banking platform that shortens timelines and supports in vitro alternatives to traditional testing.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Charles River platform offers 40% reduction in cell bank production timeline, over the industry standard of 20 weeks

WILMINGTON, Mass.--(BUSINESS WIRE)--

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 Project™ (AMAP™), 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260916131517/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

next-generation sequencing technical

Next-generation sequencing is a set of laboratory techniques that read large amounts of DNA or RNA quickly and cheaply by processing millions of short genetic fragments in parallel, rather than one at a time. For investors, it matters because faster, lower-cost genetic data powers drug discovery, diagnostic tests and personalized medicine, creating scalable revenue opportunities and competitive advantages for companies that own the technology or services.

rapid microbiological methods technical

Methods, technologies, or tests that detect, count, or identify bacteria, fungi, viruses, or other microorganisms much faster than traditional culture-based lab tests; examples include molecular assays, rapid biochemical tests, and automated instruments. They matter to investors because they can shorten drug or medical-device production hold times, speed product release, reduce recall risk, and affect regulatory approval or compliance costs—similar to using a fast scanner instead of waiting for a slow manual count.

real-time pcr technical

Real-time PCR is a laboratory method that copies and measures specific genetic material (DNA or RNA) as the reaction happens, giving immediate numerical results rather than only an end-point yes/no. For investors, it matters because it underpins fast, sensitive medical tests and research tools; performance, regulatory acceptance, and manufacturing capacity for real-time PCR systems can directly affect demand, revenue potential, and competitive position in the diagnostics and biotech markets.

cgmp regulatory

cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

in vitro technical

In vitro describes laboratory tests performed on cells, tissues, or biological molecules outside a living body—literally “in glass,” such as in test tubes or dishes. For investors, in vitro results are an early sign that a drug or technology has a desired effect under controlled conditions, but they don’t guarantee it will work or be safe in animals or people; think of them as a prototype tested on a bench rather than in real-world use.