TOPIC 397 - MICROFLUIDIC VORTEX SHEDDING: A LOW-COST, HIGH EFFICIENCY METHOD FOR GENETIC MODIFICATION TO SUPPORT CELL ENGINEERING FOR CELL-BASED IMMUNOTHERAPIES

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The objective of this contract proposal is to refine and commercialize Hydropore, a low cost, high efficiency method to support manufacture of cell-based cancer immunotherapies. Meeting this objective will result in a technology that will modernize cell therapy development from early stage through clincical studies, thereby expediting the delivery of treatments to patients in need. In Phase 1 the Hydropore technology demonstrated feasability in improving the manufacturing processes of CAR-T cells. In Phase II the proposal plans to (1) scale-out Hydropore performance to optimize the efficiency of constructing gene-edited CAR-T cells, (2) scale-up Hydropore capacity with the development of a large scale Hydropore consumbable device, with >5 x 10^8 cell processing capability, and (3) validate the Hydropore platform and process analytics. Processed cells will be rigorously evaluated through established approaches, including flow cytometery, in vitro assays, and in vivo (mouse) efficacy studies. Quality control parameters will also be established. The final deliverable is defined as (1) Hydropore instrumentation and devices capable of robustly processing >5 x 10^8 T cells for large volume cell therapy applications and (2) Standard Operating Procedures for manufacturing Hydropore instruments and consumables.