NASA EPSCoR: Personalized Medication System for Deep Space Missions

The mismatch between mission duration (>3 yrs.) and drug product shelf life (≤3 yrs.) represents a major challenge for NASA’s Evolvable Mars Campaign. The current practice is to predict and stockpile every drug that might be needed during space missions. One can think of reformulating drugs to increase their shelf life until re-supply is logistically possible, but as mission duration is expected to extend over progressively longer periods, other alternatives need to be explored. Point-of-use drug manufacturing is able to reconcile the need to produce unanticipated drugs and circumvent shelf life issues, with the need to sustain the crew’s health and independence from Earth’s drug supply during long-term deep space missions. Yet, current practices in pharmaceutical manufacturing (large-scale) are incompatible with the flexible manufacturing needs for small patient populations (mission crews) and the limited resources (time, space, energy, personnel) available in space. The goal of the proposed research program is to deliver a Personalized Medication System for Deep Space Missions that will produce two model drugs, naproxen (dosed ≤1.5 g/day) and warfarin (dosed ≤10 mg/day). The research will develop several state-of-the-art µL to mL-scale unit operations for flow synthesis, purification, filtration, drying, and formulation using process intensification (Objective 1), which can be integrated in a plug-and-play approach to accommodate the manufacturing needs of the model drugs and future target drugs in space (Objective 2). The solid dosage formulations for both active pharmaceutical ingredients (APIs) demand similar requirements in terms of process analytical technologies and US Pharmacopeia to test for product compliance (yield, purity, solid-form, dose, stability), which will be tested in Objective 3. The model APIs were selected to demonstrate the system’s capability to produce a wide range of doses as the required daily dose of the drugs varies (mg to g/day). Particularly, the production of flexible doses for warfarin, the most commonly prescribed oral anticoagulant and poster child of personalized medication will demonstrate the feasibility to reduce risks for drug-related adverse events (Objective 3). Human space flights represent a scenario where therapy failure or adverse side effects need to be prevented at all costs. A recent study indicated that ~30% of the drugs available on the ISS need individual dose adjustments. In the long term, the science advanced by this proof-of-concept system could be employed to manufacture additional drugs of NASA’s interest (e.g. amoxicillin, cetirizine, promethazine, zaleplon). The system would also allow the crew to reprocess stockpiled and partially degraded APIs within its purification and formulation capabilities, and thus, will contribute to in situ resource utilization (ISRU) in space. The proposed research brings together past efforts in small-scale (mL-scale) crystallization and pharmacogenetic analysis of warfarin for the formulation of personalized medication at the point-of-use. Ultimately, the realization of the objectives will establish a program that stimulates competitive research and strong partnerships between the jurisdiction and NASA in technology areas that span across multiple NASA Technology Areas (TA 6 & 12). The proposed research is poised to improve current practices in pharmaceutical manufacturing resulting in overall benefits for the general US population (personalized medication, orphan drugs, cancer, HIV/AIDS, clinical trials, customized fixed-dose combinations), which represents the broader vision of NASA’s Technology Roadmaps. The research program, which includes the development of the necessary human capital in STEM, is expected to have an impact on the pharmaceutical industry valued over $1 trillion. This sector represents one of the key economic engines for the US, specifically, Puerto Rico, as a major hub for the bio-pharmaceutical industry.

This is a mature technology (TRL 7+) — the realistic path in is usually NASA's Technology Transfer Program: licensing an existing NASA patent, or a Space Act Agreement to use NASA facilities/expertise directly. NASA also runs a startup licensing program with no upfront fee for companies formed to commercialize a specific NASA technology.

None of these are guaranteed paths for this specific project — TechPort itself doesn't have an "apply" button. Reaching out to the contact(s) above with a specific question is usually the fastest way to find out what's actually open.