Kymriah Manufacturing
In 2012, Novartis acquired a specialized facility from the former Dendreon for $43 million. Dendreon went bankrupt trying to establish its once-promising prostate cancer vaccine Provenge.
Dendreon’s Morris Plains, New Jersey, facility is a 173,100 square foot state-of-the-art IMF.
In July 2018, before EU approval, Novartis announced that it had signed an agreement with CellforCure, a French CDMO, to produce CAR-T cell therapies. Manufacturing at Cell for Cure’s site in Les Ulis, a city southwest of Paris, would mimic the processes Novartis has in place at its Morris Plains, New Jersey hub.
In August 2018, when Kymriah get approved in EU, Norvartis said it will spend CHF90 million over three years on an existing building at a production site in Stein, Switzerland. Novartis expects to initially have 260 positions and create up to 450 new jobs by 2021.
New manufacturing capacities are keys to scale up revenue and Novartis acknowledged existing production problems with out-of-spec doses.
In September 2018, Novartis paid $40 million for a 9% stake in Cellular Biomedicine Group (CBMG), a Shanghai-based firm which will manufacture CAR-T cell therapy Kymriah for the China market and license select proprietary technology to Novartis for global use.
In December 2018, Novartis went further to acquire CellforCure from LFB including the cell and gene manufacturing facility located in Les Ulis and the related adjacent land.
The Switzerland facility completed the first clinical production batch in September 2019 and inaugurated at the end of November.
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.