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

SBIR 第一阶段：用于再生医学的超分子聚合物的可扩展制造

• 批准号: 2151711
• 负责人: Charlotte Chen
• 金额: $ 25.29万
• 依托单位: AMPHIX BIO, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2151711&HistoricalAwards=false
• 关键词: SBIR; Phase; Scalable; Manufacturing; Supramolecular

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.

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响和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，以治疗背部和颈部疼痛。与从患者的供体部位获取骨骼相比，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、现成的植入物，只需要一个手术部位，并且提供了一致的临床结果。然而，围绕这些治疗方法的安全性问题限制了其仅用于脊柱腰椎区域的批准，重组蛋白的高制造成本可能使其难以广泛采用。该项目推进了一项技术，该技术比目前在脊柱手术中使用的生物制剂更安全，更便宜。这个小型企业创新研究（SBIR）第一阶段项目开发了肽类两亲分子（PA）分子的大规模制造方法，这些分子可以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剂量，这在临床前大型动物模型中得到了证明。虽然前景广阔，但大规模制造超分子聚合物也面临挑战，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分子将使用工业兼容的方法来合成，以提高可扩展性。该奖项反映了美国国家科学基金会的法定使命，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。