SBIR Phase II: Scale-up Manufacturing of Nitric Oxide Nanotechnology for Healthcare Infections

SBIR 第二阶段：用于医疗感染的一氧化氮纳米技术的放大生产

• 批准号: 1127380
• 负责人: Nathan Stasko
• 金额: $ 50万
• 依托单位: Novan, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-11-01 至 2013-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1127380&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Scale; up

This Small Business Innovation Research (SBIR) Phase II project aims to develop the process and engineering controls necessary to scale up the manufacturing of a nitric-oxide-releasing active pharmaceutical ingredient (API). One of the applications is a wound-healing product for diabetic foot ulcers. This project will focus on 1) optimizing the process parameters required to scale production of a nitric-oxide-releasing API to reproducible 1 kg batches, and 2) implementing the analytical methodologies to meet the requirements of the Chemistry, Manufacturing and Control (CMC) sections of an Investigational New Drug (IND) application. The expected outcome is a manufacturing process capable of producing large batches of the API that are suitable for an IND submission of a wound-healing product for diabetic foot ulcers or other nitric-oxide-releasing drug. The broader/commercial impacts of this project will be the potential to provide a new standard of care for the treatment of diabetic foot ulcers. Currently, there are no products that address both wound healing and infection in diabetic foot ulcers. Infection is particularly problematic in diabetic foot ulcers due to the lack of normal skin barrier function, long duration of wound exposure to the external environment (months to years), poor blood circulation to the extremities that limits the migration of inflammatory cells to the site of infection, and the recent understanding of biofilm formation which protects bacteria from topically applied antimicrobials and systemically administered antibiotics. Nitric-oxide-releasing wound-healing therapeutics have the potential of addressing both infection and healing in diabetic foot ulcers.

这个小型企业创新研究（SBIR）第二阶段项目旨在开发必要的工艺和工程控制，以扩大一氧化氮释放活性药物成分（API）的生产规模。其中一个应用是用于糖尿病足溃疡的伤口愈合产品。该项目将侧重于：1)优化工艺参数，以将一氧化氮释放API的生产规模扩大到可重复的1公斤批次；2)实施分析方法，以满足研究新药（IND）申请的化学、制造和控制（CMC）部分的要求。预期结果是能够生产大批量API的生产工艺，适用于糖尿病足溃疡伤口愈合产品或其他一氧化氮释放药物的IND提交。该项目的更广泛/商业影响将有可能为糖尿病足溃疡的治疗提供新的护理标准。目前，还没有一种产品可以同时解决糖尿病足溃疡的伤口愈合和感染问题。由于缺乏正常的皮肤屏障功能，伤口暴露于外部环境的时间长（数月至数年），四肢血液循环不良，限制了炎症细胞向感染部位的迁移，以及最近对生物膜形成的理解，生物膜形成可以保护细菌免受局部应用抗菌剂和全身使用抗生素的影响，因此糖尿病足溃疡的感染尤其成问题。一氧化氮释放创面愈合疗法具有解决糖尿病足溃疡感染和愈合的潜力。