SBIR Phase I: Microparticle reagents for clonal selection of producer cell lines

The broader impact /commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of an easily distributed and adopted approach to find cells used to manufacture antibodies. Many of the antibodies used today for diagnostics and therapies are produced using cell lines. Selection of the cells that produce the most antibodies in a stable manner is required to bring new diagnostic and therapeutic products to market faster and with lower costs. However, the tools and approaches used to identify and pick cells today are extremely slow and/or expensive, often requiring costly custom equipment. The goal of this project is to develop a product that enables a user to identify individual cells that produce the most antibodies with equipment already present in their labs. This would enable more small pharmaceutical companies, biotechnology companies, and research labs to develop stable cell lines for antibody production and could have immediate impact in enabling distributed development and production of antibodies during pandemics, such as COVID-19. This Small Business Innovation Research (SBIR) Phase I project aims to develop a reagent-based workflow to perform single-cell antibody secretion assays that is user-friendly and easily distributed. The ability to analyze and select out single cells based on secretions is critical for the rapid development of monoclonal antibody therapies. A key challenge is the screening of producer cell lines for productivity, which can take months and require significant time and effort. Existing systems that try and address this problem require specialized expertise or commercial equipment that is not widely available, so the number of cells that can be analyzed remains small. This project focuses on developing a microparticle, reagent-based product that can isolate single cells, concentrate and analyze their secreted products, and sort individual cells based on secretions in high-throughput using standard flow cytometers. The key technical objectives of this project are to: develop microparticle product formulations optimal for standard cells used to produce high quantities of antibodies, compare the system performance to current approaches, and use the system to create a cell line producing high amounts of a potential SARS-CoV-2 therapeutic. 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.