OBJECTIVES: Chimeric Antigen Receptor (CAR) T cell therapy is a promising immunotherapy for rare cancers with high acquisition costs, which has raised affordability and sustainability concerns. Furthermore, the current centralized production paradigm for the T cells is less than satisfactory for a number of technical reasons. Objective: Our study provides a cost estimation for an alternative production mode, decentralized T cell production, in the non-profit setting at the University of Heidelberg and the German Cancer Research Center (DKFZ) in Heidelberg, Germany.

METHODS: We first identified the work steps and main activities in the production process. Then we determined the fixed cost and variable cost. Main cost components included personnel and technician salaries, expenditure on equipment, a clean room, as well as production materials. All costs were calculated in 2018 euros.

RESULTS: For a clean room with one CliniMACS® Prodigy machine, annual fixed costs summed up to approximately €438,000 ($490,000). The variable cost per production was roughly €35,000 ($39,000). At the maximum capacity of one machine, total cost per product would be close to €60,000 ($67,000). As shown in our scenario analysis, if three machines were to be installed in one clean room, per production cost could be as low as €45,000 (roughly $50,000). Furthermore, if a cheaper alternative to lentivirus was used, per production total cost could be further reduced to approximately €33,000 (roughly $37,000).

CONCLUSIONS: Abstracting from intellectual property rights, decentralized T cell production might be a less-costly and more efficient alternative to the current centralized production mode that is characterized by a high acquisition cost.