SBIR Phase II: Manufacturing and Characterization of a Synthetic Platelet (SynthoPlateTM) Technology

这项小企业创新研究（SBIR）二期项目的更广泛/商业影响旨在推进创伤性损伤后不受控制的出血（出血）治疗技术。创伤引起的不受控制的出血是死亡的一个主要原因，但如果能够迅速实现出血控制，估计有40%是可以预防的。在医院，这种外伤性出血的治疗方法是输血捐献的血液，以帮助凝血止血，但这一来源缺乏及时供应，细菌污染风险高，保质期短（5-7天）。该技术将通过附着在受伤部位和增强个体的凝血机制来快速止血。此外，它还具有大规模制造、可灭菌性、长保质期和易于携带/存储的优点，可按需使用。这个项目将大规模推进纳米技术的工程。SBIR第二期项目将推进纳米合成止血剂的大规模生产。创伤引起的不受控制的出血通常是通过输血供体血液来源的血小板来控制的，这种方法有许多缺点。该项目将推进合成血小板替代纳米技术的发展，其技术目标如下：1)开发和验证脂质肽偶联方法；2)开发和验证脂肽表征方法；3)开发和验证脂质体制造方法；4)批量试验；5)大规模测试一致性。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。

The broader/commercial impact of this Small Business Innovation Research (SBIR) Phase II project aims to advance a technology for the treatment of uncontrolled hemorrhaging (bleeding) after traumatic injury. Uncontrolled hemorrhage from trauma is the a major cause of death, but an estimated 40% are potentially preventable if hemorrhage control can be achieved rapidly. In hospitals, such traumatic bleeding is treated by transfusion of donated blood to assist with clotting to stanch bleeding, but this source suffers from lack of timely availability, high risk of bacterial contamination, and short shelf-life (5-7 days). The proposed technology will rapidly stanch bleeding by adhering to the injury site and amplifying the individual's clotting mechanisms. In addition, it offers advantages of large-scale manufacturing, sterilizability, long shelf life, and easy portability/storage for on-demand use. This project will advance the engineering of this nanotechnology at scale. This SBIR Phase II project will advance the development of a synthetic hemostat nanotechnology for manufacturing at scale. Uncontrolled hemorrhage from trauma is typically managed by transfusion of donor blood-derived platelets, which suffer from many disadvantages. This project will advance the development of a synthetic platelet surrogate nanotechnology with the following technical objectives: 1) Develop and validate lipid-peptide conjugation methods; 2) Develop and validate lipid-peptide characterization methods; 3) Develop and validate liposome manufacture methods; 4) Test at batch scale; 5) Test consistency at scale.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.