Novartis Tests Global Manufacturing Process For CAR-T Therapy

27 Sep 2016

Rather than wait for regulatory approval prior to commercial-scale manufacturing, Novartis is proving out its global commercial manufacturing process for a CAR-T cell therapy in a Phase II clinical trial as questions remain on how to translate the manufacturing process from the research laboratory to the factory.

ATLANTA - A multi-center Phase II clinical trial Novartis AG is sponsoring will show whether the Swiss drug maker can scale up a personalized leukemia treatment for global manufacturing.

A commercial-scale clinical trial may be unusual, but so are many aspects of manufacturing a chimeric antigen receptor T cell...