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

这一创新-技术转化伙伴关系(PFI-TT)项目的更广泛影响/商业潜力是缓解涉及大容量肠外解决方案(LVPS)的药物短缺，如电解质替代、静脉输液和透析液。在过去的二十年里，美国的毒品短缺已经成为一个令人不快的现实，对公共卫生和国家安全产生了影响。在最近对719名卫生系统药剂师的调查中，所有药剂师都报告在前一年经历过药物短缺，其中52%的短缺涉及LVPS。81%的受访者表示，主要的缓解策略是囤积可用供应。目前缓解药物短缺的战略大多侧重于反应和恢复，而不是准备。迫切需要一种可确保长期复原力的替代药物供应。除了短缺之外，这项技术还有可能在灾难情况下、在军事/战争地区、在低资源环境中或在需要模块化解决方案且没有洁净室的其他环境中产生重要的解决方案。该项目还将为首席研究生提供机会，参加学生推介比赛、价值主张设计课程、领导力研讨会，以及与团队的商业化和监管专家定期签到。拟议的项目是一项技术创新，在医院和药店的看护点附近产生注射用水(WFI)，将WFI与浓缩物混合，并在内置环境污染控制内执行无菌、无热原包装，消除了在洁净室设施中使用的需要。大多数LVPS的体积都超过了95%的注射用水(WFI)，因此拟议的创新显著降低了与在世界各地运输“水”相关的成本和能源。这项PFI-TT奖将使第一个全系统概念验证原型得以实施，能够按需、医院/药房规模(100 L/小时)生产左肺泡灌洗液，并验证该系统在非洁净室环境中满足成分和微生物稳定性要求的能力。该项目的目标包括最终确定初级水处理机组的设计，以满足法规并降低生物污染的风险，并展示全系统的可行性，以满足生产率、成分和微生物稳定性的成功标准。可行性将通过整合和验证生产一个具有代表性的LVPS的所有三个模块来证明，Dianel PD-2含有2.5%Dextrose，这是一种经过140多次客户发现访谈后挑选出来的常见腹膜透析处方。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.