Challenge
To design and develop a capability that can manufacture pharmaceuticals or biologics in less than 24 hours. This machine should (1) have the capability of reconfiguration within a couple hours and with minimal human intervention to change the drug to be manufactured and (2) use precursors that do not require refrigeration and themselves have a shelf life of more than 3 years. Mass, power and volume requirements should be reduced as much as possible, however they are not required to be mission feasible for this solicitation.
TRISH is soliciting proposals that develop or test capabilities to manufacture medications in real time during deep space exploration missions.
Background
Most currently commercially-available medications, whether prescription or over-the-counter (OTC), have shelf lives of 24 months or less. In contrast, NASA exploration missions may last three years and will not have the capability to re-stock medications by re-supply vehicles, which is the current practice onboard the International Space Station (ISS). Given pre-launch preparations that can require a year or more, there is a need for mission medications to be safe and effective for at least four to five years. Currently, only about 10% of the ISS medical kit meets even a three-year shelf life requirement.
Even if the shelf life could be sufficiently extended, it will be impractical to carry along a pharmacy of prescription, OTC medications and biologics. During planned deep space exploration missions all supplies for the entire mission duration must be carried from Earth, the mass and volume storage capability for a medication kit will be very limited. Moreover, it is unlikely that refrigeration will be available for medication storage. As a result, we expect the capability to manufacture therapeutics on-demand—using platforms such as 3D printing, precision compounding, bioreactors or lyophilized cell extracts—will be required.
Should a medical condition arise during a mission, these platforms should be able to produce pharmaceuticals ready for administration in under 24 hours. For this purpose, miniaturized, flexible platforms for end-to-end manufacturing of pharmaceuticals will likely be required in order to solve these unique logistical and technological challenges.
This call for proposals seeks to develop miniaturized device platforms and techniques that can produce multiple NASA-relevant active pharmaceutical ingredients (APIs) and biologics (ISS MED KIT LINK) in response to specific deep spaceflight medical conditions as they arise. The proposals should aim to develop and demonstrate the capability to manufacture multiple APIs of varying chemical complexity using precursors that do not require refrigeration and have a shelf life of more than 3 years.
The ultimate vision for these technologies would be the development of a flexible system that is capable of producing different pharmaceuticals, that is highly adaptable, and that is capable to consistently produce pharmaceuticals within 24 hours and without need for cold storage.
These technologies will provide a path to enable deep space missions where astronauts have self-sufficient and reliable medical capabilities for their own health needs.
Examples of projects that COULD be considered:
- Proposals that develop platforms for manufacturing different dose levels of different FDA-approved APIs and biologics included in the NASA spaceflight medications of interest list (in addition, certain biologics such as G-CSF, GM-CSF and EPO are of interest for acute radiation syndrome countermeasures).
- Proposals that aim to reduce mass, power, and volume of existing devices.
Examples of projects that WILL NOT be considered:
- Proposals that do not demonstrate high purity, efficacy, and potency in short timeframes (<24 hours).
- Proposals that do not promise to manufacture at least 3 medications of high priority for deep space exploration.
- Proposals that rely on precursors or ingredients with less than 3 years of shelf life stability or that require refrigeration.