- Bioproduction laboratories at French contract manufacturer Cell for Cure could soon be crafting Novartis' cancer cell therapies for clinical and potential commercial use, pending a technology transfer that's planned for 2019.
- 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, which currently produces Kymriah for sale in the U.S.
- In CAR-T therapy, patient T cells are extracted from the body and shipped to a central manufacturing center, where they are genetically engineered to target a specific protein found on the surface of tumor cells. The souped-up T cells are then expanded and re-infused into the patient. Due to the complexity of the process, establishing strong manufacturing supply is seen as critical to the technology's success.
Novartis is awaiting approval by the European Commission for its CAR-T cell therapy Kymriah (tisagenlecleucel), which is already OK'd in the U.S. for adult lymphoblastic leukemia and B-cell lymphoma.
Currently, manufacturing of the bespoke cell treatment is handled in Morris Plains and at the Leipzig, Germany-based Fraunhofer Institut, which is dedicated to supporting clinical trials.
Adding in Cell for Cure would give Novartis additional capacity and help it manage the supply challenges involved with shipping live patient cells from hospitals to production hubs and back again — a journey that can span hundreds or even thousands of miles depending on where a patient is treated.
In the near term, however, manufacturing support will be largely run from the Morris Plains site, as production won't be set up at Cell for Cure's site until 2019 at the earliest. A decision from European regulators on Kymriah's approval is expected sometime in August, a Novartis spokesperson said.
The pharma already has experience supplying Kymriah across international borders through its pivotal clinical studies ELIANA and JULIET, which involved sites in the U.S., Europe, Canada, Australia and Japan.
Novartis rival Gilead Sciences, however, is also awaiting European Commission approval in Europe for its competing CAR-T product Yescarta (axicabtagene ciloleucel), after the European Medicines Agency recommended market authorization for both therapies in late June. The Commission typically takes the advice of the EMA.
In May, Gilead leased a nearly 120,000 square foot site in The Netherlands to produce Yescarta, complementing its other site in El Segundo, California.
Both companies aim to turn around a finished CAR-T product in two to three weeks after cells are extracted from a patient, although Gilead is seen as having an edge in speed.