Wilmington, Mass. — Charles River Laboratories International has introduced rapid cell banking programs designed to shorten release timelines for biopharmaceutical and advanced therapy developers.
The company said the platform can reduce cell bank production timelines by about 40% compared with the industry standard of roughly 20 weeks.
The offering combines rapid cell bank and release testing with advanced characterization using next-generation sequencing, or NGS. Charles River said the integrated approach is designed to support product quality, safety and regulatory readiness while helping developers move programs forward more quickly.
“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.”
Charles River said its rapid testing capabilities include rapid microbiological methods for microbial detection, including Celsis ATP-Bioluminescence technology, as well as rapid mycoplasma detection using real-time PCR.
These methods are intended to replace traditional compendial testing in some applications with automated testing designed to deliver faster results.
Following establishment of the cell bank, Charles River can use its iDTECT platform to provide in vitro characterization services using NGS. The company said NGS can support broad viral detection, genetic analysis and pathogen testing for cell banks and advanced therapeutics.
“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 said its CGMP-compliant NGS testing services are designed to meet global regulatory expectations, including requirements and guidance from the FDA, EMA and ICH.
The company’s NGS capabilities have also been expanded through its acquisition of Pathoquest, which specializes in sequencing-based in vitro characterization and quality control testing for biopharmaceutical products.
The rapid cell banking platform also supports Charles River’s Alternative Methods Advancement Project, or AMAP, which focuses on developing new approach methodologies and other techniques intended to reduce reliance on animal testing.
