CELLforCURE is a French pharmaceutical group that is authorized to do CAR-T manufacturing at its bioproduction site in Les Ulis (Essonne). CELLforCURE holds two Good Manufacturing Practice (GMP) certificates that allows it to manufacture experimental and commercial cell and gene therapies.
On July 10, 2018, CELLforCURE signed an agreement to manufacture CAR-T products for Novartis. Under the terms of the agreement, CELLforCURE will produce cancer CAR-T therapies (“chimeric antigen receptor T-cells”).
Production is scheduled to begin in 2019 following transfer of Novartis’ CAR-T manufacturing technology to CELLforCURE.
CAR-T Manufacturing CDMO
CELLforCURE is one of more than two dozen contract development and manufacturing organizations (CDMOs) worldwide specializing in the production of novel cell and gene therapies.
As stated by CELLforCURE, “With an annual production capability of several thousands of therapeutics batches, the Les Ulis CELLforCURE facility is the first modular entity in Europe to enable large scale industrial production for ATMPs.” ATMP stands for Advanced Therapy Medicinal Products, a classification created by the European Medicines Agency (EMA) that encompasses gene therapies, somatic cell therapies, and tissue engineered products.
One of the major issues with moving CAR-T therapies from “bench to bedside” has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional drug manufacturing.
In recent years, CAR-T T cells have been explored in numerous clinical trials worldwide and both Novartis (Kymriah) and Kite Pharma (Yescarta) have received CAR T product approvals from the U.S. FDA.
Novartis CAR-T Therapy | Kymriah
Novartis (NYSE:NVS) achieved a world-first when Kymriah became the first CAR-T cell therapy to be approved in the U.S. in August 2017. Kymriah is a treatment for B-cell acute lymphoblastic leukemia that uses autologous (self-derived) T cells. One of its major drawbacks is that it extremely expensive to manufacture, as exhibited by its price tag of $475,000.
Headquartered in Basel, Switzerland, Novartis is a global leader in integrated cancer solutions. It is one of the largest pharmaceutical companies when assessed by market cap or sales.
CAR-T Manufacturing Agreement
Key findings from the Novartis and CELLforCURE CAR-T manufacturing agreement include:
- CAR-T cell therapies will be manufactured at CELLforCURE’s CDMO facility in in France
- The new manufacturing facility will supplement Novartis’ existing manufacturing located in the US and in Europe
- Novartis’ decision to manufacture in France reflects its interest in the country as a high-tech hub with strong research and clinical standards
According to the press announcement, “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.”
To learn more, view the full press release.
What do you think about this agreement between Novartis and CELLforCURE? Was this the CDMO partner you expected Novartis to choose? Comment below.