OBJECTIVES: Chimeric Antigen Receptor (CAR) T cell therapies represent a novel promising approach to cancer immunotherapy and have been licensed for the treatment of rare late stage blood cancers. The pricing of commercially available products at approximately 300,000 euros per patient treated (in Germany, 2020) has raised concerns about affordability and sustainability. Further, the centralized production process requires long-distance transportation of human cells. We analyzed the cost of decentralized T cell production in the non-profit setting of an academic cancer research center (DKFZ) in Germany.

METHODS: We identified work steps and main activities in the local production process, and determined the associated fixed costs and variable costs (in 2018 Euros). We used scenario analyses to estimate (1) the impact of production upscaling and (2) the impact of likely technological improvements.

RESULTS: Main cost components were personnel and technician salaries, expenditure on equipment, a clean room facility, and production materials. For the clean room facility with one automated cell manufacturing platform, annual fixed costs were €438,098. The variable cost per production was estimated at €34,798. At maximum capacity of one machine, total cost per product was close to €60,000. (1) If three machines were installed in one clean room facility, per production total cost could be as low as €45,000. (2) If plasmid-based vectors were used as a substitute for currently applied lentiviral vectors, per production total cost could be further reduced to €33,000.

CONCLUSIONS: Abstracting from potential issues related to intellectual property rights, decentralized T cell production might be a more efficient alternative to the commercially available centralized production mode. We anticipate production costs to further decrease in the future with increased standardization of processes, economies of scale and scope, and learning curve effects. This expectation is commensurate with the early life cycle stage of this new technology