SBIR Phase II: 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 II project will offer an improved and simpler alternative to existing equipment currently used at several stages of cell therapy manufacturing. An efficient, standardized, and scalable approach to manufacturing will accelerate the translation of lab-scale discoveries to curative, widely available therapies. This project will also enhance understanding of applications of microfluidic technology concepts to clinically relevant applications (requiring high volumetric throughput) in a practical manner. The proposed technology will offer a passive (pump-, equipment-, and even electricity-free), high-throughput, continuous-flow platform that is easily kept sterile, readily used with no formal training, and inherently scalable, thus leading to a new low-risk and inexpensive technique. This Small Business Innovation Research (SBIR) Phase II project proposes to employ a revolutionary cell separation approach for a high-throughput prototype device to help simplify and streamline the manufacture of cellular therapies. The proposed project will optimize the technology for a scaled production process relying only on passive gravity-driven flow to operate. The performance of prototype devices will be measured with respect to enrichment of lymphocytes versus removal of red cells, platelets, monocytes, and granulocytes from an initial blood sample. Retention of 75% or more of lymphocytes from the initial sample, processed at a rate of 5 mL/min or higher, is expected. Further, the degree to which the isolated T-lymphocytes expand in culture and are transduced with standard cellular therapy vectors will be measured and compared to conventionally-isolated cells. 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.