R43CA265589

Improving yield of cellular therapeutics using unique dense magnetic microparticles - Project summary

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 efficiency and a reduction in cost over current cell separation methodologies used to enrich the desired critical cells in cell therapy starting material. Our preliminary data has shown a rapid, efficient [high yield, high purity], and cost-effective cell separation and enrichment methodology to greatly improve cell therapy starting material quality.

Our cell separation methodology enables improved antibody binding, particle dispersion, and magnetic separation leveraging the differences in unique physical properties our immunomagnetic particles provide: surface coat for binding, 4x higher density, and 20-50x higher magnetic susceptibility than current magnetic bead separation particles.

In preliminary studies, we have demonstrated high recovery (>97%) of desired cells while rapidly (<5 minutes) depleting (>99%) of unwanted cells [CD4+, CD8+, and CD15+] in small 2-10 mL specimen volumes using simple magnetics. According to product literature, current competitive cell separation products only recover 30-70% of the desired cells, require specialized magnetic instruments, and expose the desired cells to stress that can lower cell functionality.

In this proposal, we aim to expand the types of magnetic particle/antibody combinations to address the needs of cell therapy manufacturers and to optimize our cell separation and enrichment performance in larger leukapheresis specimen volumes (apheresis bags). The goal of this Phase I project is to consistently achieve a >98% recovery of a selected cell population with a depletion of >99% of unwanted cells from leukapheresis samples for at least 3 cell types.

In Phase 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 cell enrichment process.

Raven Biomaterials

NOT APPLICABLE

93.395 - Cancer Treatment Research

National Cancer Institute (NCI) [HHS - NIH]

Bethlehem, Pennsylvania 180154731 United States

Single Zip Code

PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) (PA-21-259)

Amendment Since initial award the End Date has been extended from 04/30/23 to 02/29/24.