Charles River Launches Rep/Cap Plasmids to Streamline Adeno-Associated Viral Vector Manufacturing

Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its off-the-shelf Rep/Cap plasmid offering, designed to streamline adeno-associated virus (AAV)-based gene therapy programs.

Following the previously announced launch of its lentiviral packaging and AAV Helper plasmid products, the addition of AAV Rep/Cap (RC2, 5, 6, 8, 9) supplements a comprehensive range of contract development and manufacturing organization (CDMO) products and services, reducing manufacturing effort by up to 66%. The ready-to-use plasmid products are produced and released according to batch production records, with CMC guidance and a Certificate of Analysis (COA) to support Investigational New Drug (IND) and Clinical Trial Application (CTA) filing.

Using standard off-the-shelf plasmids, such as Helper and Rep/Cap plasmid required for AAV production, gene therapy developers leverage the advantages of being immediately available, reducing development costs, risks, and timelines, subsequently simplifying supply chains. Charles River’s Rep/Cap has been used successfully to support the production of a range of AAV serotypes carrying various therapeutic transgenes at multiple development and GMP production scales.

Advanced Therapies Week Launch

Charles River will officially launch the off-the-shelf Rep/Cap plasmid offering during Advanced Therapies Week, January 16-19, at the Miami Beach Convention Center.

Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services, will present: How to Expedite your Gene Therapy Program: Platform Manufacturing Approaches. Join Dr. Baghirzade in the Gene Therapy Manufacturing Track as part of the Regulatory Alignment for Gene Therapy Manufacturing session to learn how to:

• Ensure alignment with phase-appropriate plasmid DNA, AAV, and lentiviral vector (LVV) manufacturing best practices
• Adopt an established platform approach for speed and predictability
• Jump-start production with off-the-shelf products

Matthew Hewitt, B.A. PhD, Vice President, Technical Officer CGT & Biologics, and a wealth of expert speakers will explore: The Future of Cell and Gene Therapy Manufacturing, Development, and Commercialization.

• Development of Cell and Gene Therapies: Preclinical CRO perspective
• Delivering Next Generation CGT Manufacturing Solutions
• A Decentralized CDMO Manufacturing Strategy for Future Readiness
• Market Access and Reimbursements

Plasmid DNA and Viral Vector CDMO Services