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Charles River’s off-the-shelf rep/cap plasmids are intended to simplify gene therapy supply chains.
Charles River Laboratories International announced the launch of its off-the-shelf replication/capsid (rep/cap) plasmids for the manufacture of adeno-associated virus (AAV) vectors during Advanced Therapies Week, held Jan. 16–19, 2024 in Miami Beach, Fla. These plasmids are designed to streamline AAV-based gene therapy programs, according to a company press release.
The addition of AAV rep/cap (RC2, 5, 6, 8, 9) follows a previously announced launch of the company’s lentiviral packaging and AAV helper plasmid products. According to Charles River, the ready-to-use plasmid products are produced and released according to batch production records. The products include chemistry, manufacturing, and controls guidance and a certificate of analysis to support investigational new drug and clinical trial application filing.
Standard off-the-shelf plasmids, such as helper and rep/cap plasmids required for AAV production, are immediately available, which can lower development costs, risks, and timelines for gene therapy developers, according to the press release. Charles River’s rep/cap plasmids have been used to support the production of AAV serotypes carrying various therapeutic transgenes at multiple development and good manufacturing practice production scales.
“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,” said Kerstin Dolph, senior vice-president, Manufacturing, Charles River, in the release.