New cell and gene manufacture in Stein offers hope for patients around the globe.

Nov 28, 2019

In the presence of Federal Councillor Alain Berset and other distinguished guests, Novartis inaugurated a new manufacturing facility for cell and gene therapies at Stein, Switzerland on November 28th.

“Our site in Stein is vital for new launches of solid and liquid drugs,” said Steffen Lang, Global Head of Novartis Technical Operations and member of the Novartis Executive Committee. "The construction of the new manufacturing facility is another investment in the production of breakthrough cell-based therapies that can potentially change the lives of patients.”

In addition to manufacturing areas for novel CAR-T cell therapies, the new building also hosts the production of innovative, difficult-to-manufacture solid dosage forms such as tablets and capsules. In September 2019, the first clinical production of a cell and gene therapy batch was successfully completed. 

Unlike conventional drug production, cell and gene therapy asks for the manufacture of a personal dose for each patient. For this purpose, patients who have already undergone various therapies have a small amount of their own blood cells taken, which are then sent to Stein. "Here we enrich part of the white blood cells, the T cells, and genetically modify them so that they can recognize and fight the cancer cells in the patient's blood," says Dorothea Ledergerber, project manager of the Stein plant for cell and gene therapies. The altered cells are then sent back to hospital and administered to the patient by infusion. Novartis is doing pioneering work here: "We have the unique opportunity to offer patients for whom there have been no other therapeutic options a totally new perspective by using these novel CAR-T cell therapies," says Dorothea Ledergerber.