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

The broader impact/ commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to create a safe and effective therapeutic for spinal fusion surgeries. Over 500,000 people undergo spinal fusion surgery in the U.S. every year to treat debilitating back and neck pain. Compared to harvesting bone from a donor site on the patient, spinal biologics are popular among surgeons because they offer a synthetic, off-the-shelf implant requiring a single surgical site and offering consistent clinical outcomes. However, safety concerns surrounding these therapeutics have limited its approval for use only to the lumbar region of the spine, and high manufacturing costs of recombinant proteins can be prohibitive for widespread adoption. This project advances a technology that is safer and less expensive than the currently used biologics in spinal surgeries.This Small Business Innovation Research (SBIR) Phase I project develops large-scale manufacturing methods for peptide amphiphile (PA) molecules, which self-assemble into supramolecular polymers that can reduce the dose of the biological necessary to achieve successful spinal fusion as demonstrated in preclinical large animal models. While highly promising, manufacturing supramolecular polymers at large scale presents challenges because supramolecular self-assembly is highly sensitive to processing steps and conditions. The project goal is to develop a scalable manufacturing method that results in PA assemblies with efficacy equivalent to PA assemblies produced in the research laboratory setting. To achieve this, PA molecules will be synthesized using industry-compatible methods to improve the scalability.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.