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

该创新-技术转化合作伙伴关系（PFI-TT）项目的更广泛影响/商业潜力是缓解涉及大容量肠外溶液（LVPS）的药物短缺，如电解质置换液、静脉输液和透析液。在过去二十年中，美国的药品短缺已成为一个不受欢迎的现实，对公共卫生和国家安全产生了影响。在最近对719名卫生系统药剂师进行的一项调查中，所有人都报告在前一年经历了药物短缺，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的供应。目前缓解药物短缺的战略主要侧重于反应和恢复，而不是准备。迫切需要为LVPS提供替代药物供应，以确保长期的弹性。除了短缺之外，该技术还有潜力在灾难情况下，军事/战区，低资源环境或其他需要模块化解决方案且无洁净室的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参加学生演讲比赛、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的机会。拟议的项目是一项技术创新，可在医院和药店的护理点附近生产注射用水（WFI），将WFI与浓缩物混合，并进行无菌、无菌和无菌操作。无热原包装，内置环境污染控制，无需在洁净室设施中使用。大多数LVPS的注射用水（WFI）体积含量超过95%，因此拟议的创新大大降低了与全球运输“水”相关的成本和能源。该PFI-TT合同将使第一个完整的系统概念验证原型得以实施，能够按需，医院/制药规模（100 L/h）生产LVPS，并验证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一级水处理机组的设计，以满足法规要求，降低生物污染的风险，并证明整个系统的可行性，以满足生产率，成分和微生物稳定性成功标准。可行性将通过集成和验证所有三个模块生产一个代表性的LVPS，Dianeal PD-2与2.5%葡萄糖，一个常见的腹膜透析处方后选择140+客户发现采访。这个奖项反映了NSF的法定使命，并已被认为是值得支持的评估使用基金会的知识价值和更广泛的影响审查标准。

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.