STTR Phase I: Affinity Chromatographic Cell Sorting (AFFICS) System for Simultaneous Multiple Cell Separation

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) project will be the development of a cell sorting system to allow separation of two or more cell types to be used in cell therapies for treatment of cancer and other diseases. Purification of specific cell populations from complex materials such as blood is a critical component of cell therapy manufacturing. However, since most protocols for clinical-grade cell purification rely on binding of magnetic particles to cells, promising cell therapies face the risk of transplanting residual and potentially toxic magnetic particles to human subjects. The steps currently required to eliminate this risk add complexity, time and cost to cell therapy manufacturing, limiting the wide-scale usefulness of promising new cell therapies. This project will develop a novel cell separation technology, free of magnetic particles, that can be readily scaled to levels required to enable clinical-scale manufacturing of highly pure and highly viable cell-based therapeutics. The aim is to perform multi-target cell sorting while simultaneously leaving cells free from contaminating tags. This STTR Phase I project proposes to develop a novel affinity chromatographic cell sorting (AFFICS) system, based on proprietary dissolvable hydrogel microbeads, for efficient simultaneous separation of two and more cell types directly from heterogeneous cell environments without requiring magnetic or fluorescent tagging of cells. To achieve this, the objectives are to 1) Design a column-based affinity chromatographic system with functionalized dissolvable hydrogel microbeads for single surface marker-based cell isolation from complex cell suspensions, leading to cell capture and target cell populations with >85% purity and viability. 2) Develop tandem connection of multiple columns for sequential cell separation based on two or more surface markers on a large scale. 3) Optimize the rapid release mechanism required for efficient simultaneous separation of two and more cell subpopulations while maintaining cell phenotype and viability. The proposed system will provide multi-target cell sorting at clinical scale while simultaneously leaving cells free of residual magnetic or fluorescent affinity tags.