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Charles River Launches Rep/Cap Plasmids

Designed to streamline adeno-associated virus (AAV)-based gene therapy programs.

By: Anthony Vecchione

Charles River Laboratories has launched 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, and aims to reduce 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.

According to the company, 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. Charles River’s Rep/Cap has been used to support the production of a range of AAV serotypes carrying various therapeutic transgenes at multiple development and GMP production scales.

“The launch of Charles River’s off-the-shelf Rep/Cap offering is the latest in a series of portfolio enhancements designed to streamline adeno-associated virus (AAV)-based gene therapy programs,” said  Kerstin Dolph, Senior Vice President, Manufacturing, Charles River. “The reduction in production time and improved efficacy of the supply chain will help accomplish our ultimate goal of delivering safe, effective therapies to patients, faster.”

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