The use of novel chimeric antigen receptor (CAR)-modified T-cells as a highly effective treatment for various types of cancer continues to expand. To receive a CAR T-cell treatment, cancer patients must first undergo leukapheresis, a highly specialized, expensive procedure during which 10-15 liters of patient’s blood are continuously recirculated, over several hours, through an apheresis machine to extract a sample enriched with patient’s T-cells. Because the leukapheresis sample also contains large quantities of unwanted cells that may interfere with the subsequent CAR T-cell manufacturing process, the sample is further processed via density gradient centrifugation to remove the unwanted ...

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The use of novel chimeric antigen receptor (CAR)-modified T-cells as a highly effective treatment for various types of cancer continues to expand. To receive a CAR T-cell treatment, cancer patients must first undergo leukapheresis, a highly specialized, expensive procedure during which 10-15 liters of patient’s blood are continuously recirculated, over several hours, through an apheresis machine to extract a sample enriched with patient’s T-cells. Because the leukapheresis sample also contains large quantities of unwanted cells that may interfere with the subsequent CAR T-cell manufacturing process, the sample is further processed via density gradient centrifugation to remove the unwanted cells. This current approach to obtaining patient T-cells by leukapheresis / density gradient centrifugation is a very complex, expensive process that takes many hours of highly skilled labor and requires the use of specialized automated cell processors to complete. The goal of this high-impact / high-risk project is to develop and validate a novel high-throughput microfluidic device for extracting T-cells with high efficiency, minimal cell damage, and in numbers sufficient for manufacturing a therapeutic dose of CAR T-cell therapy directly from whole blood (WB). Using this technology, most cancer patients receiving CAR T-cell therapies could avoid leukapheresis by instead donating ~300 mL of WB via venipuncture, a simple 15 min procedure that does not require any specialized equipment. Because of the equipment-free, scalable, closed-system design, the proposed high-throughput microfluidic device could be easily integrated into the exiting workflow to replace the most laborious initial steps in the CAR T-cell manufacturing process. Reduced complexity, increased speed and lower cost of manufacturing will ultimately lead to making novel CAR T-cell therapies accessible to more cancer patients in Texas and worldwide.

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