The company said its nAAVigation platform can streamline the pathway to GMP AAV vector manufacturing without the need for significant process development. The technology, it continued, builds on Charles River’s viral vector CDMO capabilities with established processes for AAV production and purification, and testing expertise.
nAAVigation utilizes an optimized single-use upstream approach coupled with robust downstream purification processes, enabling client AAV programs to scale up to 500L in suspension, explained the provider.
The platform is based on a high-productivity HEK293 suspension cell line, which is amenable to clients’ scale-up and serotype needs, it added.
“The significant turnaround time reduction for viral vector therapy developers utilizing nAAVigation combined with Charles River’s established development process, standard, on-hand materials, templated documents, and in-house analytics will enhance our clients’ experiences,” said Professor Daniel Smith, executive director, global cell and gene therapy (CGT) portfolio, Charles River.
The company, which looks to provide end-to-end support and supply chain simplification for advanced therapy (ATMP) developers, has been expanding its CGT services, with it acquiring Vigene Biosciences, Cobra Biologics, and Cognate Bioservices in 2021. Its CGT targeted portfolio spans viral vector, plasmid DNA, and cell therapy production.
“The launch of the nAAVigation Vector Platform process is the latest in a series of portfolio enhancements aimed at supporting our cell and gene therapy clients from early target identification through clinical-stage manufacturing. By increasing speed and efficiency for viral vector production, nAAVigation will help accomplish our ultimate goal of delivering safe, effective therapies to patients faster,” added Kerstin Dolph, corporate senior vice president, Biologics Solutions, Charles River.
In August this year, Charles River received EMA approval for commercial production of allogenic cell therapy drug product in Memphis.
That CGNP CDMO facility manufactures clinical as well as commercial cell and gene-modified therapies.
The regulatory approval - in the form of Good Manufacturing Practice (GMP) certification - to commercially produce allogeneic cell therapy drug products for distribution in Europe, from the European Medicines Agency (EMA) means its Memphis site can now manufacture and ship drug products intended for EU distribution.
The approval came after a review of the site by the Italian inspectorate, Agenzia Italiana del Farmaco (AIFA), performed on the EMA’s behalf.