
NSF Org: |
TI Translational Impacts |
Recipient: |
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Initial Amendment Date: | February 7, 2023 |
Latest Amendment Date: | February 7, 2023 |
Award Number: | 2234509 |
Award Instrument: | Standard Grant |
Program Manager: |
Samir M. Iqbal
smiqbal@nsf.gov (703)292-7529 TI Translational Impacts TIP Directorate for Technology, Innovation, and Partnerships |
Start Date: | February 15, 2023 |
End Date: | March 31, 2025 (Estimated) |
Total Intended Award Amount: | $249,884.00 |
Total Awarded Amount to Date: | $249,884.00 |
Funds Obligated to Date: |
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History of Investigator: |
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Recipient Sponsored Research Office: |
2221 UNIVERSITY AVE SE STE 100 MINNEAPOLIS MN US 55414-3074 (612)624-5599 |
Sponsor Congressional District: |
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Primary Place of Performance: |
200 OAK ST SE # 224 MINNEAPOLIS MN US 55455-2009 |
Primary Place of
Performance Congressional District: |
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Unique Entity Identifier (UEI): |
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Parent UEI: |
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NSF Program(s): | PFI-Partnrships for Innovation |
Primary Program Source: |
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Program Reference Code(s): |
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Program Element Code(s): |
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Award Agency Code: | 4900 |
Fund Agency Code: | 4900 |
Assistance Listing Number(s): | 47.084 |
ABSTRACT
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.
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