Abstract
There are medical treatment vulnerabilities in longer-duration space missions present in the current International Space Station crew health care system with risks, arising from spaceflight-accelerated pharmaceutical degradation and resupply lag times. Bioregenerative life support systems may be a way to close this risk gap by leveraging in situ resource utilization (ISRU) to perform pharmaceutical synthesis and purification. Recent literature has begun to consider biological ISRU using microbes and plants as the basis for pharmaceutical life support technologies. However, there has not yet been a rigorous analysis of the processing and quality systems required to implement biologically produced pharmaceuticals for human medical treatment. In this work, we use the equivalent system mass (ESM) metric to evaluate pharmaceutical purification processing strategies for longer-duration space exploration missions. Monoclonal antibodies, representing a diverse therapeutic platform capable of treating multiple space-relevant disease states, were selected as the target products for this analysis. We investigate the ESM resource costs (mass, volume, power, cooling, and crew time) of an affinity-based capture step for monoclonal antibody purification as a test case within a manned Mars mission architecture. We compare six technologies (three biotic capture methods and three abiotic capture methods), optimize scheduling to minimize ESM for each technology, and perform scenario analysis to consider a range of input stream compositions and pharmaceutical demand. We also compare the base case ESM to scenarios of alternative mission configuration, equipment models, and technology reusability. Throughout the analyses, we identify key areas for development of pharmaceutical life support technology and improvement of the ESM framework for assessment of bioregenerative life support technologies.
Highlights
The Need for a Pharmaceutical Foundry in SpaceSurveying missions to Mars, like the InSight lander1 (Overview | Mission–NASA’s InSight Mars Lander) launched in 2018 and Perseverance rover2 in 2020, directly support the objectives of NASA’s long-term Mars Exploration Program3: an effort to explore the potential for life on Mars and prepare for human exploration of Mars
The maturation of the program requires redefining the risks to human health as mission architectures transition from the current “Earth Reliant” paradigm used on the International Space Station (ISS) to the cislunar space “Proving Grounds” and to deep-space “Earth Independent” mission architectures, as defined in NASA’s report titled, “Journey to Mars: Pioneering Steps in Space Exploration.”4
Construction of a detailed pharmaceutical production reference mission architecture (RMA) is hindered by uncertainty in the number and identity of monoclonal antibody (mAb) therapy products that would be included within mission scope, the decay rate of mAb therapy stores in the mission environments, and a reasonable basis for building robustness to unanticipated disease states
Summary
The Need for a Pharmaceutical Foundry in SpaceSurveying missions to Mars, like the InSight lander (Overview | Mission–NASA’s InSight Mars Lander) launched in 2018 and Perseverance rover in 2020, directly support the objectives of NASA’s long-term Mars Exploration Program: an effort to explore the potential for life on Mars and prepare for human exploration of Mars. A recent review highlights the current understanding of the primary hazards and health risks posed by deep space exploration as well as the six types of countermeasures: protective shielding, biological and environmental temporal monitoring, specialized workout equipment, cognition and psychological evaluations, autonomous health support, and personalized medicine (Afshinnekoo et al, 2020). Of these countermeasures, it could be argued that medicine is the most crucial and least advanced toward mitigating space health hazards.
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