As part of its £2bn Life Sciences Sector Plan, the UK government has taken a global lead in announcing new measures to support the emerging area of in-orbit manufacturing. The development of biological drugs in microgravity creates a unique environment in which to observe and enhance their formation and behaviour with the potential to improve drug solubility, stability and crystallisation. The possibility of enhancing the overall quality of complex medicines and treatment options has led the UK government to name in-orbit manufacturing as a priority capability area for national growth and leadership.
The new package of measures aims to confirm the regulatory position and clarify industry guidance in preparation for a transition from experimental in-orbit research to regulated medicines manufacturing. The measures were announced at Space-Comm Expo at ExCel London and will involve case studies outlining clear regulatory routes, updated regulatory guidance, strengthened supply-chain engagement and regulatory sandboxes that facilitate the controlled testing of developing technologies.
As part of this, a new regulatory roadmap will tie in with the Medicines and Healthcare products Regulatory Agency (MHRA)’s existing framework for decentralised manufacturing, which was launched in 2025 and is already working to establish a regulatory model for drug development in atypical environments. A “Re-entry Regulatory Sandbox” is also being prepared by the Civil Aviation Authority, focusing on the licensing involved in returning manufactured products to Earth. The new measures are underpinned by the combined support of the UK Space Agency, the MHRA, the Regulatory Innovation Office within the Department for Science Innovation and Technology and the Civil Aviation Authority.
These developments are part of wider UK investment in this field. The UK Space Agency is supporting a range of projects, including a feasibility study for BioOrbit – a start-up exploring crystallising biologic drugs in space with the long-term aim of enabling at-home cancer treatment. Additionally, infrastructure designed to underpin medicine manufacture in space has received extra funding, with grants allocated to companies like Biologic Technologies for its development of a “Space Biocomputer”.
The UK is increasingly positioning itself as a global leader in this field and, taken together, these initiatives signal an exciting shift in its life sciences sector. Harnessing groundbreaking technologies to facilitate research in micro-gravity environments has the potential to advance complex medicines and, ultimately, to improve patient outcomes back on Earth.
