SBIR Phase I: A New Approach for Isolating Leukocyte Sub-populations to Enable Efficient Manufacturing of Cellular Therapies

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be to develop a microfluidic device for cell therapy manufacturing. Advantages in terms of cost and quality of the cell products produced by the proposed technology should benefit clinical researchers and cell therapeutics. Further, by providing an efficient, standardized, and scalable approach to the manufacturing process, the translation of lab-scale discoveries to curative therapies that are widely-available should be significantly accelerated. On a fundamental level, this project will enhance technological understanding of how to apply microfluidic technology concepts to clinically-relevant applications (requiring macroscopic flowrates) in a practical manner, while also establishing a new medical device sector centered on a suite of easily implemented cell separation devices for use in cellular therapies and related fields. The intellectual merit of this SBIR Phase I project is to employ a cell separation approach to create a high-throughput proof-of-concept prototype to help simplify and streamline the manufacture of cellular therapies. To accomplish this objective, a two-stage microfluidic module will be designed to achieve isolation of separate lymphocyte- and monocyte-rich subpopulations from blood samples, while removing undesirable red blood cells and platelets, at levels sufficient for successful culture growth. In addition, the plan is to fabricate a full-scale prototype system of parallelized lymphocyte/monocyte isolation modules to achieve a volumetric throughput capable of processing 200mL of peripheral blood-, buffy coat-, or mononuclear cell (MNC) leukapheresis-derived product within ~30 minutes. Once developed, this technology will overcome many drawbacks that plague current cell isolation approaches including high per unit cost, laborious/time-consuming workflow, and potential to compromise sterility. This device will require no expensive or complex equipment on-site to drive the separation/concentration of the cells of interest. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.