SBIR TOPIC 445- ADVANCED MANUFACTURING TO SPEED AVAILABILITY OF EMERGING AUTOLOGOUS CELL-BASED THERAPIES

Current practice of T cell therapy drug manufacturing involves collection, shipment of the blood to a manufacturing site, manufacturing of the drug in a cleanroom environment by a trained technologists, analytical assays for drug release, and the final shipment of frozen product back to the treatment site. The cost and time involved in manufacturing process, analytical assays, and a regulatory approval create a huge

bottleneck to rapid translation of early phase, innovative products. Our long-term objective is to develop a device (EM01) that can implement a point of care walk-away operation to significantly simplify the cost, time, and a regulatory approval of the cell therapy manufacturing. EM01 will be designed to eliminate cryopreservation and shipping of incoming material and final product, to operate in a non-cleanroom environment by minimally trained personnel, and to integrate automated analytical assay system.

Specific to this proposal, we will build a prototype integrated cell culture chamber and flow guide with in-chamber cell isolation and for in-process monitoring of glucose, oxygen, cell density, transgene expression, and microbial assays. Cell products manufactured from the prototype will then be benchmarked against the CAR T products manufactured following a clinical protocol using CliniMACS Prodigy system.