SBIR Phase II: Scalable Manufacturing of Supramolecular Polymers for Regenerative Medicine

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to develop a synthetic bone graft that enables safer, simpler, and lower-cost spinal fusion surgery. The success of this technology would reinforce the United States’ competitive advantage and leadership position in the $12B global spinal implant market. The bone graft implant consists of a novel nanotechnology which introduces a new approach for regenerative medicine. This technology requires the development of new manufacturing methods, as standard approaches are not sufficient for larger scale production. This project directly addresses the manufacturing challenges in producing this implant, and the knowledge generated can accelerate the clinical development of other similar therapies. This project will serve as a model for other novel forms of matter requiring unique manufacturing and processing methods. Since the technology used in the implant has deep roots in academic research, this project also serves as a model for academia-industry collaboration. The proposed project will develop methods for manufacturing a new spine implant technology at large scales, which will enable its translation to clinical trials. First, the active ingredient in the implant, which has novel chemical properties, will be manufactured at large scales in conditions appropriate for use in human patients. The active ingredient is a supramolecular polymer held together by non-covalent bonds, which are sensitive to manufacturing and processing steps, akin to protein misfolding. Spectroscopic and microscopy techniques will be used to ensure that the correct structures and function are maintained as manufacturing is scaled up. Second, the active ingredient will be combined with other supporting materials to create a formulation that surgeons can easily handle and place into the spine. Manufacturing methods will be developed to address the challenge of processing and freeze-drying viscous solutions at large scale. Furthermore, the biocompatibility of the spine implants will be established to ensure the manufacturing methods are safe for human use. The final deliverable of this project is a packaged and sterilized implant, manufactured at scale and under conditions appropriate for clinical use in humans. 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.