SBIR-STTR Award

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.

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.