Charles River Laboratories International, Inc. 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.