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Using Lean Practices to Reduce Cost and Lead Time for the Autologous CAR-T Cell Manufacturing Process Open Access

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Immune and cell therapies have started to play important roles in cancer treatment. Among different cell therapy methods, Chimeric Antigen Receptors T-cell (CAR-T cell) therapy is the first and only autologous cell therapy that the FDA has approved for cancer treatment so far. CAR-T therapy is a highly customized and novel treatment method that re-engineers a patient’s own T-cells to equip the cells with the ability to recognize and attack tumor cells, provoking lesser immune response issues. However, the disadvantage of the autologous CAR-T cell therapy is that each patient’s CAR-T cells have to be produced individually to avoid immune response. Hence, the production cost of CAR-T cells is high, and the lead time is long. The newly-invented CliniMACS Prodigy cell automatic processor was developed around 2014 and significantly reduced traditional manual operations in the CAR-T production process. Although Prodigy reduced the number of manual steps and lowered the chance of contamination, it did not reduce the production cost and the lead time remains long. In this study, we introduced Lean principles to the CAR-T production process. We used two Lean tools—Root Cause Analysis (RCA) and Value Stream Mapping (VSM)—to analyze current production process and determine sources of process waste. The simulation results showed that the manufacturing time can be shortened by 11.46% (42.61 hours) by reducing QC test time and production preparation time. For the production cost analysis, our cost of goods (COG) analysis result showed that, after shortening lead time and increase Prodigy system from one to two units to increase productivity, manufacturers could save up to 13.47% of the cost for the process.

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