SBIR Phase I: Magnetic Flow Sorter Channels for Rare Cancer Cell Enrichment

This Small Business Innovation Research (SBIR) Phase I project proposes to develop the technology for the magnetic isolation of rare cancer cells from human blood. Various problems have been encountered in attempts to collect and identify cancer cells. Success will require processing large volumes of cell suspensions, capturing cancer cells with high efficiency, and avoiding morphological and physiological damage during separation. The company's collaborators at Ohio State University and Cleveland Clinic Foundation have established that quadrupole magnetic flow sorting fulfills most of the requirements for successful cancer cell selection. The methods include positive selection of immunomagnetically labeled cancer cells and / or negative selection by removal of undesired cell types. This project will test the latter, higher-yield method and compare it to the former. The Phase I project objectives are (1) to transfer existing magnetic flow channel technology from the Cleveland Clinic Foundation, (2) to determine, through research, the optimum manufacturing processes for high-precision column manufacture using processes eligible for cGMP qualification, and (3) to test, through partners at Ohio State University, the efficacy of such columns. The commercial application of this project is in the area of clinincal research. The proposed project will advance knowledge and understanding within the fields of oncology, cancer biology, metastasis, pathology, hematology and stem cell research by putting a powerful, high-capacity and user-friendly cell separation tool in the hands of investigators and clinicians.