Biomanufacturing in low Earth orbit: A paradigm shift.

This perspective article explores the transformative potential of biomanufacturing in low Earth orbit (LEO) for regenerative medicine. Building on key symposia and workshops, it highlights the International Space Station (ISS) National Laboratory's role in advancing tissue engineering through microgravity research. The article discusses breakthroughs in stem cell therapies, disease modeling, and automation, while emphasizing the need for collaboration, investment, and emerging technologies like AI and machine learning. Insights from the scientific community and market analyses point to a rapidly growing sector. Strategic partnerships and policy support will be essential to scale space-based biomanufacturing and unlock new therapeutic possibilities for patients on Earth.