Roche will access an adeno-associated virus (AAV) vector manufacturing platform for its gene therapy portfolio in a deal CEVEC says validates its ELEVECTA technology.

The deal, financials of which have not been disclosed, will see Swiss pharma giant Roche use CEVEC’s ELEVECTA Technology for AAV vector manufacturing across its gene therapy portfolio, including products being developed by its acquisition Spark therapeutics.

ELEVECTA, launched in April this year, is a platform that allows for the large-scale production of AAV vectors from one cell line in consistent quality. The technology can be implemented in bioprocess development and large-scale GMP manufacturing facilities running standard suspension bioreactor equipment used for monoclonal antibody and recombinant protein production.

Th deal is “quite a big milestone deal for CEVEC and its ELEVECTA technology, not just in terms of financials but even more importantly regarding reputation,” a spokesperson from the German biotech firm told this publication.

“The deal validates the technology as the technology of choice for AAV-based viral vector production for gene therapy applications. In addition, to have a company like Roche being seriously interested in your technology is a signal to the industry and a big marketing advantage.”

According to CEVEC, ELEVECTA overcomes volume concerns – a major bottleneck in the production of AAV vectors – as it is based on a stable human suspension cell line, which enables full scalability in all types and formats of suspension bioreactors, from laboratory to commercial scale without the need for cGMP plasmids, special transfection reagents and difficult-to-scale-up transfection protocols.

While this is the first deal with a big pharma firm, several other drug developers including Rzgomics, Evox Therapeutics, Cellgenix, and Xell already have deals in place with CEVEC for its CAP technology, which forms the basis of the ELEVECTA platform.

After a fundraiser in May 2019, the firm told Bioprocess Insider its CAP GT-based platform can overcome scale and reproducibility issues as the producer cells “permanently carry the AAV blueprint with assembly instructions, which greatly simplifies the production process.”

CEO Nicole Faust said at the time: “CEVEC is the first and only company to offer a solution that makes the production of AAV vectors as easy as the production of monoclonal antibodies.”