SBIR Phase I: Automated System for Point of Care Manufacture of Tumor Infiltrating Lymphocytes Cell Therapies

The broader/commercial impact of this Small Business Innovation Research (SBIR) Phase I project is to expand access to personalized cancer therapies by enabling cell therapy manufacturing at the point of care. This approach could significantly improve outcomes for cancer patients by reducing wait times, improving the consistency of therapy, and lowering treatment costs. Decentralizing cell manufacturing makes these advanced therapies more accessible, not only in premium locations but also in regions with limited access to centralized cleanroom facilities. In addition to improving health outcomes, the project will reduce the cost of cell therapy logistics by eliminating the need to ship live or frozen cells across long distances. The system's built-in analytics and imaging capabilities will contribute to better scientific understanding of cell growth and help train future generations of scientists and technicians in advanced biomanufacturing. This project supports economic growth, technological advancement, and the development of a more resilient healthcare system. The proposed project addresses critical limitations in current cell therapy manufacturing by developing an intelligent, single-use bioreactor system designed to automate the expansion of therapeutic cells in an aseptically closed environment. The system supports the full process from small initial volumes to large-scale expansion without the need for multiple containers or manual cell transfers. The project will focus on three technical goals: (1) manufacturing and verifying Alpha prototypes of the disposable bioreactor, (2) developing and testing bioreactor nests to support parallelization and scalability, and (3) validating the complete Alpha system with real cell cultures and benchmarking against existing commercial systems. These innovations aim to reduce cleanroom dependency and manual labor while enabling decentralized, reproducible, and high-quality manufacturing of cell therapies. 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.