Cell therapies, including Chimeric Antigen Receptor (CAR) T cells, natural killer (NK) cells, and T cell receptor (TCR), have demonstrated promising results for treating hematological cancers. The manufacturing of these cell therapies begins by collecting and enriching an adequate number of desired critical cells from the blood of patients or donors. Raven Biomaterials plans to demonstrate a significant increase in speed and efficiencyand a reduction in cost over current cell separation methodologies used to enrich the desired critical cells incell therapy starting material . Our preliminary data has shown a rapid, efficient [high yield, high purity], andcost-effective cell separation and enrichment methodology to greatly improve cell therapy starting materialquality. Our cell separation methodology enables improved antibody binding, particle dispersion and magneticseparation leveraging the differences in unique physical properties our immunomagnetic particles provides:surface coat for binding, 4x higher density and 20-50x higher magnetic susceptibility than current magneticbead separation particles. In preliminary studies we have demonstrated high recovery > 97% of desired cellswhile rapidly [< 5 minutes] depleting > 99% of unwanted cells [CD4+, CD8+, and CD15+] in small 2-10 mlspecimen volumes using simple magnetics. According to product literature, current competitive cellseparation products only recover 30-70% of the desired cells, require specialized magnetic instruments, andexpose the desired cells to stress that can lower cell functionality. In this proposal, we aim to expand the typesof magnetic particle / antibody combinations to address the needs of cell therapy manufacturers, and tooptimize our cell separation and enrichment performance in larger leukapheresis specimen volumes (apheresisbags). The goal of this Phase I project is to consistently achieve a >98% recovery of a selected cellpopulation with a depletion of >99% of unwanted cells from leukapheresis samples for at least 3 cell types. InPhase II we will further expand our improved cell separation and enrichment with additional magnetic particle /antibody combinations for therapeutic cell types, and we will develop simple equipment to automate the cellenrichment process.
Public Health Relevance Statement: PROJECT NARRATIVE Cell therapies to treat cancers, including Chimeric Antigen Receptors (CAR) T, NK (natural killer), and T cell receptors (TCR), have demonstrated promising results, but current manufacturing costs are unsustainably high. The goal of this project is to develop more rapid, efficient, and cost-effective cell separation products with higher depletion of unwanted cell types and higher recovery of desired cells from leukapheresis samples (apheresis bag) utilizing unique immunomagnetic particles. Successful commercialization of our technology will decrease the time and cost to manufacture cell therapeutics for cancer immunotherapy treatments.
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