Charles River is expanding rapid cell banking solutions to assist biopharmaceutical developers with shortening development timelines. The company speeds up cell bank production by combining fast testing with advanced in vitro methods. These capabilities can cut cell bank production timelines by 40% That’s approximately 20 weeks, which is the industry standard now.
Charles River Laboratories International, Inc. (NYSE: CRL) has announced the launch of rapid cell banking programs. These programs are intended to accelerate release timelines for biopharmaceutical and advanced therapy developers. The result is that developers are able to reach key milestones more quickly. They can also get innovative treatments to patients more quickly.
The company combines rapid cell bank and release packages with Next-Generation Sequencing (NGS). This approach creates a comprehensive, end-to-end solution for developers. It also supports product quality, safety, and regulatory readiness throughout development.
“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.”
“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.”
Rapid Testing Supports Faster Cell Banking
Charles River offers regulatory support throughout the cell banking process. The company helps clients understand the complex nature of developing biologics and advanced therapies. It is also in line with global regulatory expectations. Charles River also provides programs the ability to move seamlessly from early development through to commercialization. It helps developers stay compliant with regulations and allows them to keep up with their development cadence.
The platform also supports the 3Rs commitment of the Company. The principles are Replacement, Reduction and Refinement. Charles River supports these initiatives through its Alternative Methods Advancement Project™ (AMAP™). AMAP™ develops and adopts alternative methods and innovative development strategies. The aim of these methods is to reduce reliance on animal testing. At the same time they help in the efficient development of products.
Rapid Microbiological Methods Improve Testing
Charles River brings proven rapid test method expertise to cell banking programs. The company provides rapid microbiological methods (RMM) for detecting microbes. These capabilities include Celsis® ATP-Bioluminescence technology. Charles River also provides rapid detection of Mycoplasma using real-time PCR. These technologies allow for faster and more objective testing.
Traditional compendial testing can have longer timelines for processing. Conversely, automated rapid procedures are more efficient to produce objective results. This reduces the time developers spend on pre-bank and release testing. These capabilities accelerate the development of cell banks. They also give developers timely information about testing in critical development stages.
NGS Advances In Vitro Cell Bank Characterization
After establishing cell banks, Charles River can apply NGS for characterization. The company uses its iDTECT® platform for reliable in vitro characterization services. NGS is changing approaches to cell bank characterization and advanced therapy testing. The technology offers scalability, speed, and broad viral detection capabilities.
Consequently, NGS supports more comprehensive genetic analysis and pathogen detection. It also helps developers generate important information about product quality and safety.
“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.”
GMP-Compliant NGS Supports Regulatory Readiness
CGMP-compliant NGS testing services from Charles River are available to support biopharmaceutical development. These services help to speed up development without sacrificing safety or testing quality. The services also meet strict international standards of accuracy, reliability and compliance. This includes GMP requirements and regulatory guidance from FDA and EMA.
The testing approach also meets the requirements of ICH Q5A and Q5B. So developers are able to have a full set of characterization data for regulatory processes. Charles River also improved its NGS offerings through its purchase of Pathoquest. Pathoquest is known for its expertise in NGS solutions and in vitro characterization.
The capabilities allow for quality control testing of biopharmaceutical products. The integration further augments the Charles River platform with sequencing-based testing expertise. This allows Charles River to offer advanced testing solutions to development programs. These capabilities enable clients to accelerate their development efforts.
At the same time, developers are able to continue to focus on product quality and safety. The integrated platform also supports improved regulatory preparedness throughout the product lifecycle. Charles River’s fast cell banking and NGS capabilities address overall key development needs. The approach links rapid testing, in vitro characterization and regulatory support.
This integrated model can help developers shorten timelines and generate critical testing data. It also helps speed up the journey of innovative therapies to commercialization and to patients.
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News Source: Businesswire.com
