SBIR Phase I: Medical Device to Isolate and Purify Therapeutic Antibodies from Recovered Donors (COVID-19)

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is in managing pathogenic outbreaks. This project will purify therapeutic antibodies from recovered patients’ blood for therapeutic use in other critically ill patients in a novel and safe process. This technology can be used even as viral mutation takes place. The device based on this technology will be portable and can be deployed easily and swiftly to remote areas to save lives. This is a platform technology and will not only be useful as a potential COVID-19 treatment but also for future pathogenic outbreaks or to give antidotes for various poisons. The proposed project will address issues associated with convalescent sera used for COVID-19 treatment. This approach is not widely used as the first line of defense due to potential risks for both donors and recipients. In addition, one donor can provide only a limited amount of convalescent sera to treat only one recipient. Currently no methods exist to isolate immunoglobulins directly from whole blood and generate multiple doses from a single donor. One of the key challenges is the development of a suitable magnetic chromatography media that is coated with Protein A, has paramagnetic properties, and high binding capacity for immunoglobulins. This project will generate media using core paramagnetic particles. Media will be used to perform studies with rabbit and human blood to assess its suitability. A prototype separation chamber will be developed for separation of magnetic beads from other materials. This project will also explore systems engineering for single-use disposable components and automated operation. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.