On June 25, 2024 Charles River Laboratories International, Inc. (NYSE: CRL) and the Gates Institute at the University of Colorado Anschutz Medical Campus reported a lentiviral vector contract development and manufacturing organization (CDMO) agreement (Press release, Charles River Laboratories, JUN 25, 2024, View Source [SID1234644543]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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