Therapy with chimeric antigen receptor-modified T cells (CAR-T) is an established and accepted standard of care for relapsed refractory B cell malignancies (1, 2). Access to CAR-T cell therapy is prohibitively expensive, has significant logistic challenges with centralized manufacturing, and remains difficult to access even in developed countries (3). In a resource-constrained environment and a health care delivery system with a very high out-of-pocket expense, such as in India (4), for high-end therapy, access to CAR-T cells is for all practical purposes, not a considered option.
The currently established industry and profit-driven commercial process of centralized manufacturing of the CAR-T cells is financially unviable and is unlikely to make this technology accessible to most of our patients. An alternative to centralized industry-driven manufacturing is a decentralized, distributive or point of care manufacturing process at academic / tertiary care centers using a closed GMP compliant CliniMACS Prodigy (Miltenyi Biotec, Germany) system. Early phase clinical trials with this approach have been completed in USA and Europe (5). The costing structures in India and countries with similar economies (low and upper middle-income countries – L/UMIC) are however different, with a relatively higher purchasing power parity and a lower cost of skilled manpower which would make this approach an attractive option to consider.
