TOPIC 397 - FUNCTIONALLY CLOSED PURIFICATION AND ELUTION OF UNTOUCHED T CELLS USING CLEAVABLE MAGNETIC BEADS WITH RATCHETING CYTOMETRY

The goal of this effort is to develop a functionally closed, high throughput magnetic cell purification system which can achieve 1) purification of T cell populations directly from a leukopak biomatrix via positive selection and 2) cleavage of bead-cell bonds resulting in untouched T cells for cell therapy production. We believe that a functionally closed system that can achieve high purity positive selection of target cell populations will improve potency and repeatability of the final therapeutic cell batches as well as enable therapeutic production using more nuanced and delicate cell types. In Phase I we will perform separations using Ferrologix existing T cell purification cartridge and commercially available cleavable magnetic beads. Leukopak/apheresis specimens will be first tagged with anti-CD3 cleavable magnetic beads, separated with Ferrologix ratcheting cytoemtry cartridge, incubated within the cartridge with bead cleaving agents, and T cell elution off chip while the beads remain trapped in the cartridge. Ferrologix untouched T cell workflow will be compared in split sample fashion with two other cleavable bead workflows from Miltenyi and StemCell Technologies. Workflows will be compared on the basis of processing time, purity, viability, and successful cleavage of magnetic beads.