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

这项小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是为脊柱融合手术创造一种安全有效的治疗方法。在美国，每年有超过50万人接受脊柱融合手术，以治疗衰弱的背部和颈部疼痛。与从患者的供体部位获取骨相比，脊柱生物制剂在外科医生中很受欢迎，因为它们提供了一种合成的现成植入物，需要单个手术部位并提供一致的临床结果。然而，围绕这些治疗剂的安全性问题限制了其仅用于脊柱的腰椎区域的批准，并且重组蛋白的高制造成本可能阻碍广泛采用。该项目推进了一项比目前脊柱手术中使用的生物制剂更安全、更便宜的技术。这一小型企业创新研究（SBIR）I期项目开发了肽两亲物（PA）分子的大规模制造方法，该分子自组装成超分子聚合物，可以减少实现成功脊柱融合所需的生物制剂剂量，临床前大型动物模型证明了这一点。虽然非常有前途，但大规模制造超分子聚合物存在挑战，因为超分子自组装对加工步骤和条件高度敏感。该项目的目标是开发一种可扩展的制造方法，使PA组件的功效与研究实验室环境中生产的PA组件相当。为了实现这一目标，PA分子将使用与行业兼容的方法合成，以提高可扩展性。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.