French CDMO to Make Kymriah as Part of Novartis CAR-T Strategy

Novartis has selected France-based CELLforCURE as a CAR-T therapy manufacturing partner fresh from receiving European Medicines Agency (EMA) recommendation for Kymriah (tisagenlecleucel).

Kymriah became the first chimeric antigen receptor (CAR) T cell therapy to receive approval in the US last August. Last month, marketing authorization holder Novartis came one step closer to bringing the therapy to Europe after receiving positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

In the wake of this recommendation, the Swiss Biopharma has revealed it will transfer manufacturing technology from its production site in Morris Plain, New Jersey to a facility in Essonne, France run by third-party manufacturer CELLforCURE.

Manufacturing Process:

A patient’s T-cells (white blood cells called lymphocytes) are collected by leukapheresis and then frozen. The cryopreserved cells will then be transferred to the Les Ulis site where they will be modified so that they recognize specific receptors that are part of cancer cells. The patient’s reprogrammed cells will then be infused back into the hospitalized patient where they multiply to identify and destroy tumor cells previously unrecognizable by the immune system.

Part of the LFB group company, CELLforCURE will be responsible for producing Novartis CAR-T therapies. According to a Novartis spokesperson, the tech transfer with the contract development and manufacturing organization (CDMO) is being started now and production at the site in Les Ulis (Essonne) facility could start in 2019.

“Kymriah is not a conventional therapy or medicine,” the spokesperson told BioProcess Insider. “Due to its unique manufacturing process, we have invested heavily to ensure safety and quality of the cell transport and manufacturing is maintained at all times. Our primary goal has been, and will always be, to produce a quality product and successfully deliver it to patients in need.”

Financial details have not been divulged.

Outsourcing vs In-House

Novartis acquired the New Jersey facility from Dendreon in 2012 to make the then unapproved candidate. We asked the drugmaker why the firm has opted to use a CDMO in Europe for CAR-Ts rather than invest in its own facilities or acquire a plant as it did in the US.

“Novartis is actively pursuing options for additional manufacturing capacity through external partnerships, as well as internal manufacturing sites,” we were told.

“[CELLforCURE’s] 3600 m2 facility received the authorization from the French regulatory agency (ANSM) for the handling and manufacturing of GMO gene therapy products.

“The decision to manufacture commercial and clinical products in France delivers on the Company’s global supply and regulatory strategy. It helps to offer an additional manufacturing capacity in Europe, as part of Novartis plan to expand availability of supply.”

The firm also has facilities in Leipzig, Germany, used in CAR-T clinical trials which is also intended to be used for commercial manufacturing.

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