• Lentiviral vector CDMO collaboration to support advanced cell therapies for hematological cancers

ROCKVILLE, Md. / Jun 25, 2024 / Business Wire / Charles River Laboratories International, Inc. (NYSE: CRL) and the Gates Institute at the University of Colorado Anschutz Medical Campus today announced a lentiviral vector contract development and manufacturing organization (CDMO) agreement. Gates Institute will leverage Charles River’s premier cell and gene therapy CDMO expertise to develop Good Manufacturing Practice (GMP)-grade lentiviral vectors (LVVs) for use in novel chimeric antigen receptor (CAR) T-cell therapies for hematological cancers.

The Gates Institute mission at the University of Colorado Anschutz Medical Campus is to develop and deliver advanced therapies in cell and gene therapy. The Institute brings together researchers, clinicians, and a GMP biomanufacturing facility for first-in-human clinical trials. Through this strategic collaboration, Gates Institute will have access to Charles River’s established manufacturing platforms and dedicated viral vector CDMO center of excellence, utilizing a range of services including process development evaluation of Gates Institute’s LVV backbone, phase-appropriate research grade and High –Quality (HQ) plasmid DNA production, and GMP LVV manufacturing. Materials produced within the collaboration will support an upcoming Investigational New Drug (IND) application for Phase I clinical trials.

Plasmid DNA and Viral Vector Manufacturing Services

With over 20 years of plasmid DNA and viral vector CDMO expertise and validated platform processes including eXpDNA™ and Lentivation™ with a proven track record, Charles River has standardized protocols and high-yield, optimized methods to accelerate speed to clinical and commercial manufacturing by reducing process development time and costs while ensuring premium quality production.

In recent years, Charles River has significantly broadened its cell and gene therapy portfolio with several acquisition integrations and expansions to simplify complex supply chains and meet the growing demand for plasmid DNA, viral vector, and cell therapy services. Combined with the company’s legacy testing capabilities, Charles River offers a premier “concept to cure” advanced therapies solution.

To learn more about LVV design, manufacturing, and regulation, join Charles River for a roundtable webinar to examine key trends, address manufacturing challenges, and overcome quality control and regulatory hurdles: https://bit.ly/3Ttijzz

Approved Quotes

• “The cell therapy ecosystem that Gates Institute has created is exciting and we look forward to helping them advance the development of CAR-T therapies for hematological cancers. Our complementary strengths and concept to cure capabilities are well positioned to help move the science forward into the clinic and beyond for oncology patients.” – Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River
• “We value this new partnership with Charles River, an industry leader in biopharmaceutical services. In the near term, this collaboration will accelerate the Gates Institute CAR-T programs with their plasmid and lentiviral vector production. Looking ahead to our long-term collaboration, we remain committed to advancing patient impact more broadly.” – Terry Fry, MD, Executive Director, Gates Institute

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.

About Gates Institute

Gates Institute is a premier cell therapy translational research institute with biomanufacturing capabilities delivering first-in-human therapies. Based at the University of Colorado Anschutz Medical Campus, we are part of a rich biomedical ecosystem. We bring together and support researchers and clinicians who specialize in regenerative, cell and gene therapies, accelerating their discoveries from concepts to cures.