Charles River will officially launch the Rep/Cap plasmid offering during Advanced Therapies Week at the Miami Beach Convention Center, with a presentation by Dr. Ramin Baghirzade on platform manufacturing approaches for expediting gene therapy programs.
Charles River Laboratories International, Inc., Charles River, has unveiled its off-the-shelf Rep/Cap plasmid offering, aimed at simplifying adeno-associated virus (AAV)-based gene therapy programs. This addition to their product line complements lentiviral packaging and AAV Helper plasmid products, 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 Certification of Analysis (COA) to support IND and Clinical Trial Application CTA filing. By utilizing standard off-the-shelf plasmids, gene therapy developers can capitalize on immediate availability, thereby cutting down on development costs, risks, and timelines, and simplifying supply chains.
Kerstin Dolph, Senior Vice President, Manufacturing, Charles River stated:
“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. 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.”
Charles River will officially launch the Rep/Cap plasmid offering during Advanced Therapies Week at the Miami Beach Convention Center, with a presentation by Dr. Ramin Baghirzade on platform manufacturing approaches for expediting gene therapy programs. The Rep/Cap plasmids have demonstrated success in supporting AAV serotypes carrying various therapeutic transgenes across different production scales.
The expansion of Charles River’s cell and gene therapy portfolio, marked by acquisitions and capacity expansions, aims to meet the increasing global demand for plasmid DNA, viral vector, and cell therapy services. This addition of Rep/Cap plasmids enhances their industry-leading “concept-to-cure” solution for advanced therapies.
Andrew Frazer, PhD, Associate Director, Scientific Solutions, Gene Therapy CDMO Services, Charles River commented:
“Gene therapy clients leveraging the Rep/Cap offering, combined with Charles River’s established CDMO capabilities and phase-appropriate approach, can expect reduced development costs, risks, and timelines while ensuring the highest quality product.”
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