Charles River Laboratories International, Inc. and the Gates Institute at the University of Colorado Anschutz Medical Campus 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 An Schutz 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.