What if the future of regenerative medicine doesn’t lie in high-tech Earth-based labs, but in orbit, where gravity – or a lack of it – changes the ways in which cells behave and react? That’s the premise behind the work of researchers led by the International Space Station (ISS) National Laboratory, in collaboration with experts from Wake Forest Institute for Regenerative Medicine, Axiom Space, Redwire Space, Sierra Space Corp., and UC San Diego Sanford Stem Cell Institute. The research explores biomanufacturing in low Earth orbit (LEO), as outlined in a recent perspective article in Stem Cell Reports. Their findings highlight not only the immense promise of microgravity-facilitated research, but also the daunting technical, ethical, and logistical challenges that must be overcome to bring this vision to life.
The Microgravity Advantage
At the heart of the case for space-based biomanufacturing is the unique environment of microgravity. Free from the Earth’s pull, cells and biomolecules organize themselves differently – sometimes more efficiently – than they do in terrestrial labs. Protein crystals grown in space, for example, are often larger and more structurally perfect, enabling clearer insights for drug development. Similarly, 3D tissue structures form more evenly, leading to potential breakthroughs in organoid science, regenerative therapies, and stem cell engineering.
The ISS National Laboratory has become a crucible for this line of research. Experiments there have shown that microgravity can accelerate tissue maturation, enhance stem cell proliferation, and improve the physiological relevance of disease models. These are not just laboratory curiosities but practical benefits with implications in drug discovery, personalized medicine, and long-duration space missions.
Yet for all the potential, turning these ideas into scalable realities is incredibly challenging. From the building of operational biomanufacturing systems in space, to observing how microgravity changes the way fluids behave, complicating the operation of bioprinters and bioreactors. Bio-inks and cells must be deposited with precision in a weightless environment, where surface tension, not gravity, dominates.
Maintaining ideal cell growth conditions – temperature, nutrient delivery, gas exchange, and waste removal – is even more complex hundreds of kilometers above the Earth. Automated systems with remote telemetry and biosensor integration are being developed, but they must be robust enough to withstand radiation and the extreme environment of space.
Cryopreservation, too, remains limited by hardware constraints. While the ISS’s Minus Eighty-degree Laboratory Freezer provides essential long-term storage, space is tight and power resources are finite. Consequently, many biological materials must be returned to Earth quickly, narrowing the window for downstream analysis and creating bottlenecks in the research pipeline.
DEI – Data, Ethics, Infrastructure (calm down, Donald dear)
Another obstacle is data management. It is not uncommon for the results of space-based experiments to remain unpublished. With cross-sector learning limited in this way, ethical considerations loom large. What does it mean to manipulate human cells in space? Who owns the intellectual property derived from research undertaken beyond the confines of Earth? And how do we regulate therapies produced in an environment beyond national jurisdictions?
There’s no comprehensive model for the infrastructure needed to scale in-space production of tissues, therapeutics, or organoids. From launch logistics to onboard equipment reliability, and the safe reintegration of biological products into Earth’s supply chain, the to-do list is long and complex. Addressing these issues will require scientific ingenuity, strategic policy making, regulatory foresight, and international collaboration.
Despite these challenges, the rewards of success are extraordinary. Take the recent development of the small molecule drug rebecsinib, which inhibits ADAR1, a driver of malignant regeneration and immune evasion in cancers. Organoid models grown in microgravity helped fast-track its mechanism-of-action studies, contributing to FDA clearance (IND153126) for clinical trials set to begin in 2025. It’s a proof-of-concept that LEO-based biomanufacturing can deliver both research insights, and regulatory-grade innovation.
Similarly, efforts such as the NIH-funded “Tissue Chips in Space” program demonstrate how microgravity can yield more physiologically accurate models for studying diseases and testing drugs. These chips form 3D cell aggregates that better mimic real human tissue, improving predictive power and potentially reducing the need for animal testing.
Future applications could include personalized regenerative treatments, space-grown stem cells with enhanced therapeutic potential, and even organ bioprinting for astronauts on deep space missions. The dream is that one day, hospitals may source tissues and therapies manufactured in orbit, created under conditions impossible to replicate on Earth.
Looking Forward
Biomanufacturing in space is a high-risk, high-reward venture that sits at the intersection of space science, biotech, and medicine. It demands multidisciplinary cooperation, continued investment, and careful navigation of both practical and philosophical terrain. Once the challenges are addressed and overcome, biomanufacturing in LEO could usher in a new era for regenerative medicine. It might even transform space into a new kind of laboratory that can look for life on other planets, as well as save lives on Earth.
Enjoy this space-based medicine content? Try some of our previous articles:
Space Biology Awakens
Can the stress of space force fungi to produce novel therapeutics?
Space Age
Assessing the effect of microgravity on the physiology of aging.
The Clinical Cosmos: Exploring Medicine's New Frontier
The unique environment of space and its implications for clinical research.
Bringing Knowledge Back to Earth
A quick tour of just some of the developments in space-based medicine
The Martian Pharmacy
The transportation, storage, and administration of drugs in space: a hypothesis and the case for lyophilization
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