Joint Statement from the UK Space Agency, the Medicines and Healthcare products Regulatory Agency, the Regulatory Innovation Office and the Civil Aviation Authority

UK Space Agency, MHRA, RIO and CAA set out support for in-orbit manufacturing of pharmaceuticals

The UK Space Agency, the Medicines and Healthcare products Regulatory Agency (MHRA), the Regulatory Innovation Office (RIO) within the Department for Science, Innovation and Technology (DSIT) and the Civil Aviation Authority (CAA) are working collaboratively to provide a supportive regulatory environment to space, biopharma and pharmaceutical companies through collaborative work on guidance, regulatory sandboxes, case studies and supply chain engagement. 

The UK is committed to advancing its leadership in space-enabled manufacturing. In-Orbit Manufacturing (IOM) is one subset of the wider In-Orbit Servicing, Assembly, and Manufacturing (ISAM) market. It represents a transformative opportunity to produce materials and products in space that offer superior quality and performance compared to those manufactured on Earth. 

The UK Space Agency is providing funding for three in-orbit manufacturing feasibility studies including a £250,000 feasibility study for BioOrbit, a pioneering start-up that is designing a scalable in-orbit manufacturing system to crystallise biologic drugs for cancer treatments. This study, funded through the UK Space Agency’s Unlocking Space Portfolio, will involve collaborative work between MHRA, the UK Space Agency and BioOrbit to provide clarity on the regulatory pathway for in-orbit manufacturing of pharmaceuticals. 

The unique properties of the microgravity environment enable more precise drug formulation, particularly for biologics and protein-based drugs such as monoclonal antibodies, vaccines, or insulin. Microgravity conditions can improve drug solubility, purity, crystallisation and stability supporting more effective delivery and potentially lowering manufacturing risk and cost.