Novartis will manufacture Kymriah and other CAR-T cell therapies and gene therapies at the new factory
Aerial shot of Novartis Stein manufacturing facility for cell and gene therapies. Photo: courtesy of Novartis AG.
Novartis has officially inaugurated a new $90m cell and gene therapies manufacturing facility in Stein in the Swiss canton Aargau.
Apart from housing manufacturing areas for chimeric antigen receptor T cell (CAR-T cell therapies), the new manufacturing facility also hosts the production of difficult-to-manufacture solid dosage forms like tablets and capsules, said the Swiss drugmaker.
The first clinical production of a cell and gene therapy badge was completed by the pharma major at the facility in September.
Novartis technical operations global head and executive committee member Steffen Lang said: “Our site in Stein is vital for new launches of solid and liquid drugs.
“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.”
According to Novartis, production of cell and gene therapies is different from conventional drug production as they need the manufacturing of a personal dose for each patient. For this reason, patients who already had gone through different therapies have a small amount of their own blood cells taken, which are sent to Stein.
Novartis Stein plant for cell and gene therapies project manager Dorothea Ledergerber said that the facility enriches part of the white blood cells, the T cells, and modify them genetically so that they can identify and fight the cancer cells in the patient’s blood.
The modified cells are then sent back to hospital and administered to the patient through infusion.
Ledergerber said: “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.”
Novartis Stein facility to manufacture Kymriah
The Stein facility will manufacture the CAR-T cell therapy Kymriah (tisagenlecleucel) among other cell and gene therapies.
Kymriah was approved in August 2017 by the US Food and Drug Administration (FDA) for certain pediatric and young adult patients with a type of acute lymphoblastic leukemia (ALL). The Novartis’ candidate at that time became the first gene therapy to be approved in the US.
Subsequently, Kymriah was approved in the European Union for the treatment of B-cell acute lymphoblastic leukemia. The CAR-T cell therapy also got a FDA approval for a second indication for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).