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

SBIR 第二阶段：合成血小板 (SynthoPlateTM) 技术的制造和表征

• 批准号: 1951301
• 负责人: Michael Bruckman
• 金额: $ 74.93万
• 依托单位: Haima Therapeutics, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-15 至 2022-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1951301&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Manufacturing; Characterization

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.

这项小型企业创新研究（SBIR）II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）的技术。创伤引起的不受控制的出血是死亡的主要原因，但如果可以迅速实现出血，则估计有40％可以预防。在医院中，这种创伤性出血是通过输血来治疗的，可以帮助凝结出凝结出血，但是这种来源遭受了缺乏及时可用性，细菌污染的高风险和短暂的货架寿命（5-7天）。提出的技术将通过粘附在伤害部位并扩大个人的凝血机制来迅速出血。 此外，它还提供了大规模制造，无菌性，较长的保质期以及可按需使用的便携性/存储空间的优势。该项目将大规模推进该纳米技术的工程。 这个SBIR II期项目将推动开发用于大规模制造的合成止血纳米技术。 创伤产生的不受控制的出血通常由供体血液衍生的血小板的输血来管理，这些血小板患有许多缺点。该项目将推进具有以下技术目标的合成血小板替代纳米技术的开发：1）开发和验证脂质肽共轭方法； 2）开发和验证脂质肽表征方法； 3）开发和验证脂质体制造方法； 4）批量测试； 5）测试一致性。该奖项反映了NSF的法定任务，并通过使用基金会的知识分子优点和更广泛的影响评估标准来评估值得支持。