PFI-TT: Decentralized, On-Demand Production of Dialysis Solutions and Similar Medical Fluids

PFI-TT：透析溶液和类似医用液体的分散式按需生产

• 批准号: 2234509
• 负责人: Natasha Wright
• 金额: $ 24.99万
• 依托单位: University of Minnesota-Twin Cities
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2234509&HistoricalAwards=false
• 关键词: PFI; TT; Decentralized; Demand; Production

The broader impact/commercial potential of this Partnerships for Innovation - Technology Translation (PFI-TT) project is the mitigation of drug shortages involving Large Volume Parenteral Solutions (LVPS), such as electrolyte replacement, intravenous fluid, and dialysis solutions. Over the past two decades, the United States drug shortages have become an unwelcome reality with public health and national security implications. In a recent survey of 719 health system pharmacists, all reported experiencing drug shortages in the preceding year with 52% of the shortages involving LVPS. The main mitigation strategy, reported by 81% of the respondents, was the hoarding of available supply. Current strategies to mitigate drug shortages are mostly focused on reaction and recovery rather than preparedness. There is a critical need for an alternative pharmaceutical supply for LVPS that ensures long-term resilience. Beyond shortages, the technology has the potential to generate vital solutions in disaster situations, in military/war zones, in low-resource settings, or other settings where a modular solution is needed and clean rooms are not available. The project will also provide opportunities for the lead graduate student to participate in student pitch competitions, a value proposition design course, leadership seminars, and regular check-ins with the team’s commercialization and regulatory experts.The proposed project is a technological innovation that generates water-for-injection (WFI) near the point of care, in hospitals and pharmacies, mixes the WFI with concentrates and performs aseptic, pyrogen-free packaging within built-in environmental contamination controls, eliminating the need for use in a cleanroom facility. Most LVPS are over 95% water for injection (WFI) by volume, so the proposed innovation significantly reduces the cost and energy associated with shipping ‘water’ around the world. This PFI-TT award will enable the implementation of the first full system proof-of-concept prototype, capable of on-demand, hospital/pharmacy-scale (100 L/h) production of LVPS and validation of the system’s ability to meet composition and microbiological stability requirements in a non-clean room environment. The aims of the project include finalizing the design of the primary water treatment train to meet regulations and to reduce risk of biological contamination and demonstrating full-system feasibility to meet production rate, composition, and microbiological stability success criteria. Feasibility will be demonstrated by integrating and validating all three modules in the production of one representative LVPS, Dianeal PD-2 with 2.5% Dextrose, a common peritoneal dialysis prescription selected following 140+ customer discovery interviews.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.

这种伙伴关系对创新 - 技术翻译（PFI -TT）项目的更广泛的影响/商业潜力是缓解涉及大量肠胃外溶液（LVP）的药物短缺，例如电解质替代，静脉输液液和透析解决方案。在过去的二十年中，对公共卫生和国家安全的影响，美国的毒品短缺已成为不受欢迎的现实。在最近对719名卫生系统药剂师的调查中，所有据报道，上一年的药物短缺，涉及LVP的短缺的52％。 81％的受访者报告的主要缓解策略是可用供应的ho积。当前减轻药物短缺的策略主要集中在反应和恢复而不是准备上。对于确保长期弹性的LVP的替代药物供应迫切需要。除短缺外，该技术还可以在灾难情况，军事/战区，低资源环境或其他需要模块化解决方案且无法提供清洁室的设置中生成重要解决方案。该项目还将为主要研究生提供机会参加学生的音调比赛，价值提议设计课程，领导力的半身和与团队的商业化和监管专家的常规签入。拟议的项目是一项技术创新，可在护理上，构建室内和药房的内部范围内，将水面注入（WFI）带入室内，并与环境组合在一起，并将其组合起来。污染控件，消除了在洁净室设施中使用的需求。大多数LVP按数量进行注入（WFI）超过95％，因此拟议的创新大大降低了与世界各地“水”相关的成本和能量。该PFI-TT奖将使能够实施第一个完整的概念验证原型，该原型能够按需，医院/药房规模（100 l/h）生产LVP，并验证该系统在非客房环境中满足组合物和微生物稳定性需求的能力。该项目的目的包括最终确定主要水处理火车​​的设计，以符合法规，并降低生物污染的风险，并证明满足生产率，组成和微生物稳定性成功标准的全系统可行性。 Feasibility will be demonstrated by integrating and validating all three modules in the production of one representative LVPS, Dianeal PD-2 with 2.5% Dextrose, a common peritoneal dialysis prescription selected following 140+ customer discovery interviews.This award reflects NSF's statutory mission and has been deemed precious of support through evaluation using the Foundation's Intellectual merit and broader impacts review criteria.