High efficiency microfluidic device for large scale engineered cell therapy manufacturing

The goal of this project is to demonstrate the feasibility of a gentle and high-yield microfluidic device for the enrichment and capture of CD3+ T cells, for use in manufacturing autologous and allogenic engineered cell therapies. Despite impressive clinical results CAR-T and other engineered cell therapies, manufacturing these products is time consuming and costly. The ideal solution is one that could process whole blood, including target cell enrichment and genetic engineering, with minimal human intervention. Indee. Inc. previously developed Hydropore™, a microfluidic technology that has been optimized for the delivery of genes and constructs to immune cells (e.g., T-cells). Hydropore™ is a reliable and rapid alternative to current transfection approaches that yields tens to hundreds of millions of high-quality engineered cells negligible impact on cell viability and function. However, immune cells must be isolated and enriched from whole blood prior to transfection, a cumbersome, multistep process that introduces variability in the final cell product. Therefore, the Phase I objective is to develop a microfluidic device that is similarly optimized for T cell isolation and enrichment. Studies will focus on (1) the design and qualification of prototype device that is compatible with the Hydropore instrument, (2) device optimization to maximize the viability and yield of isolated cells, and (3) demonstrating the performance of the optimized T cell capture device in improving the quality and yield of engineered T cells. The success of this project will demonstrate the feasibility of a high-yield T cell enrichment device that will not only improve the source material for cellular immunotherapies but also make the manufacturing process more robust and reliable, and ultimately providing more potent and cost-effective therapies that will benefit more patients.