• New option for cryopreserved leukopaks supports demand of gene-modified cell therapy development and manufacturing

WILMINGTON, Mass. / Nov 16, 2023 / Business Wire / Charles River Laboratories International, Inc. (NYSE: CRL) today announced the expansion of its CliniPrime™ suite of Good Manufacturing Practice (GMP)-compliant offerings with the launch of CliniPrime Cryopreserved Leukopaks for cell therapy development and manufacturing. All CliniPrime products meet regulatory guidelines for clinical trial development and commercial manufacturing of advanced therapies.

As advances in gene-modified cell therapies continue, there is a growing need for reliable and consistent sources of GMP-compliant, donor-derived, cellular starting material. Cryopreserved leukopaks play a critical role in the research and development continuum and have become an ideal option for many cell therapy developers. Cryopreservation shortly after leukopak collection maximizes cellular viability, product consistency, and long-term availability. These factors can help simplify logistics and mitigate risk throughout the supply chain of donor-derived cellular starting materials.

The launch of CliniPrime Cryopreserved Leukopaks completes an already robust portfolio of GMP-compliant leukopaks from Charles River. CliniPrime leverages Charles River’s established production processes to provide advanced therapy programs with a high-quality product offering that supports both clinical trial development and commercialization, while reducing client resource investment and risk.

Charles River provides cellular products and services, creating collaborative relationships with clients as they progress their programs through the development cycle.

Approved Quotes

• “The new CliniPrime Cryopreserved Leukopak offering provides a solution to a growing industry need for reliable and consistent sources of cellular starting material. Clients can rely on Charles River leukopaks as they develop potentially life-saving modalities of treatment.” – Birgit Girshick, Executive Vice President and Chief Operating Officer, Charles River
• “The addition of the cryopreserved leukopak rounds out the CliniPrime suite of GMP-compliant offerings. Clients now have rapid access to fresh or cryopreserved leukopaks to meet any specific program needs.” – Steve Phagoo, Executive Director, Global Cell 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.