Place of care manufacturing of chimeric antigen receptor cells: Opportunities and challenges.

ABSTRACT

The landscape of therapeutic options for B cell malignancies has fundamentally changed with regulatory and marketing approval of chimeric antigen receptor (CAR)-engineered T cell products. The cell types used for CAR-T production, the length of time of manufacture, the stimulation matrix, and the nature of the gene vector used to transduce human T cells all are significant variables that require adequate quality control before infusion. Having approved products available to clinicians using a centralized production paradigm has not stopped innovation in investigator-initiated trials. Moreover, the high costs of the commercial products have been a significant wake-up call to those concerned about rising costs in health care, and the ability of developing nations, and nations with managed care systems to support these costs. Place-of-care manufacturing is a clear alternative to the approved products created in a centralized manufacturing approach. It is supported by continued technological innovation and the willingness of clinicians to develop new ways to decrease costs and make these curative therapies equitably available.