Novartis signed an agreement with CELLforCURE to produce innovative cancer treatments known as CAR-T therapies (chimeric antigen receptor T-cells) at the bioproduction site based in Les Ulis (Essonne). Production could start in 2019 following transfer of Novartis innovative manufacturing technology to CELLforCURE.
The choice to invest in France reflects Novartis’ long-term commitment to the country, in recognition of its attractiveness: its vibrant business environment, high academic standards and the renowned expertise of its scientific community. Over the period between 2015-2019, Novartis has invested over 900 million euros ranging from the expansion of its cutting-edge biotechnology centre in Huningue (Alsace), the construction of a new head office building in Rueil-Malmaison (Ile-de-France), as well as innovative research and development projects.
The decision to manufacture innovative CAR-T therapies in commercial and clinical phases in France delivers on the Group’s global supply strategy. These therapies are fully in line with Novartis’ strategic gene therapy pipeline bringing transformative innovation in areas of high unmet medical needs.
CELLforCURE is a LFB group company specializing in innovative therapy drugs. CELLforCURE’s industrial platform located in Les Ulis (Essonne-France) is one of the first and largest in Europe for the production of cell and gene therapy drugs. Established as a pharmaceutical company since 2013, CELLforCURE, operates a CDMO (Contract Development and Manufacturing Organization). The company obtained two Good Manufacturing Practice (GMP) certificates from ANSM in 2016 for the production of innovative experimental and commercial therapy drugs.
CELLforCURE will be responsible for producing CAR-T therapies which are considered the embodiment of personalized medicine. Unlike traditional treatments each dose is tailored individually to, and manufactured for, each patient using their own blood cells.
The manufacturing process used by CELLforCURE in France will be the same pioneering technology and sophisticated process developed by Novartis on its Morris Plain site (USA).
To produce CAR-T cells, a patients’ T-cells (white blood cells called lymphocytes) are collected using a specialized procedure known as “leukapheresis” and then frozen in a process called cryopreservation. The cells will then be transferred to the Les Ulis site where experts will modify the cells so that they can recognize specific receptors that are part of cancer cells. Following safety and quality testing, the patient’s cells will be infused back into the hospitalized patient. In responding patients, the reprogrammed cells multiply to identify and destroy tumor cells which were previously unrecognizable for the immune system.