Novartis Gets EMA Approval for Two European Commercial CAR-T Manufacturing Sites

The European Medicines Agency (EMA) has approved two of Novartis’ sites in Europe for the commercial manufacture of chimeric antigen receptor T-cell (CAR-T) cell therapies. The sites are located in Les Ulis, France, and Stein, Switzerland, and will now support the supply of CAR-T cell therapy for patients in both commercial and clinical settings. The approval expands the commercial capacity that already exists in Novartis’ global network, the company announced in a July 24, 2020 press release.

With the addition of these two commercial sites, Novartis has significantly increased its geographical CAR-T cell therapy manufacturing footprint. The company has a comprehensive, flexible, and regionalized manufacturing network that includes Novartis-owned facilities as well as contract manufacturing organization facilities. The company currently has a total of seven sites on four continents: North America (United States), Europe (Germany, France, Switzerland), Asia (China, Japan), and Australia.

“I am very excited that with our growing capacity and capabilities, we will have the opportunity to serve many more commercial and clinical patients around the world. Every site approval brings us closer to our patients, while also supporting our ambition to bring additional CAR-T cell products to the market,” said Steffen Lang, global head of Novartis Technical Operations, and member of the Novartis executive committee, in the press release.