• HQ pDNA will be used to produce GMP lentivirus for ex vivo gene therapy

WILMINGTON, Mass. / Aug 24, 2023 / Business Wire / Charles River Laboratories International, Inc. (NYSE: CRL), today announced a High Quality (HQ) plasmid manufacturing collaboration with Fondazione Telethon. The rare disease organization will leverage Charles River’s market leading cell and gene contract development and manufacturing organization (CDMO) expertise in High Quality (HQ) plasmid DNA production, and Good Manufacturing Practice- (GMP) compliant plasmid DNA batches to manufacture HQ plasmid DNA for Fondazione Telethon’s lentivirus production that will be used in ex vivo cell and gene therapy.

Fondazione Telethon is a non-profit organization and an internationally recognized biomedical research foundation focused on advancing biomedical research to cure rare genetic diseases. Founded in 1990, the Fondazione Telethon supports and finances scientific research of excellence for the study and treatment of genetic diseases. These efforts focus on developing effective therapies against these serious pathologies.

A Robust Manufacturing Collaboration

Through this collaboration, Fondazione Telethon will have access to established manufacturing platforms and multiple Charles River CDMO centers of excellence, leveraging a comprehensive range of services including, but not limited to, GMP cell banking and HQ and GMP-grade plasmid DNA manufacturing.

Plasmid DNA Manufacturing Services

Charles River’s plasmid DNA production, specifically HQ plasmid production, combines key features of GMP manufacturing leading to rapid turnaround times and accelerated clinical application. Plasmid DNA is a critical starting material for many cell and gene therapies with a demand that continues to outstrip supply. In response, Charles River recently announced the opening of a state-of-the-art HQ plasmid manufacturing center of excellence to address the supply shortages and support the growing needs of the cell and gene therapy field.

Approved Quotes

• “We are thrilled to work with Fondazione Telethon to produce HQ plasmid DNA for Fondazione Telethon’s lentivirus for ex vivo gene therapy. Charles River has had decades of success developing, producing, and reliably delivering plasmid DNA, which provides confidence customers are in safe hands.” - Kerstin Dolph, Corporate Senior Vice President, Biologics 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.