Regulators set out support for in-orbit pharmaceutical manufacturing

UK regulators have pledged collaborative support for the development of pharmaceuticals manufactured in space, including the development of a regulatory framework intended to give industry the confidence to invest in the sector.

In a joint statement published on 5 March 2026, the UK Space Agency, Medicines and Healthcare products Regulatory Agency (MHRA), Regulatory Innovation Office and Civil Aviation Authority (CAA) said they would produce a coordinated effort to provide a “supportive regulatory environment” for space, biopharma and pharmaceutical companies through guidance, regulatory sandboxes, case studies and supply chain engagement.

The support centres on in-orbit manufacturing (IOM) — the production of materials and products in space — and its potential to produce medicines of superior quality compared with those produced on Earth, the statement said.

It also noted the advantages of microgravity for biologics and protein-based drugs, including monoclonal antibodies, vaccines and insulin, as the low-gravity environment can improve drug solubility, purity, crystallisation and stability, which may support more effective delivery and lower manufacturing risk and cost.

The UK Space Agency has already provided three IOM feasibility studies, including a £250,000 feasibility study for BioOrbit — a start-up that is designing a scalable IOM system to crystallise biologic drugs for cancer treatments — which ran until March 2026 and included specific work to clarify whether existing regulations for terrestrial manufacturing would also apply to manufacturing of pharmaceuticals in-orbit for patient use. 

The statement also revealed that the UK Space Agency and MHRA are now working together to produce principles-based case studies that map out the regulatory pathway for space, biotech and pharmaceutical companies interested in IOM.

The UK’s modern legislative frameworks for human medicines and spaceflight activities together offer “a unique opportunity to demonstrate a clear end-to-end regulatory pathway for UK in-space manufactured pharma products”, with the goal of promoting inward investment, it said.

Commenting on the statement, Phil Williams, professor of biophysics at the University of Nottingham, said: “This collaboration is central to be able to utilise the unique properties of the space environment to research into and manufacture pharmaceuticals in a way that cannot be done on Earth. The well-cited example, and which lies at the heart of much interest and opportunity, is that of forming crystals.

“This collaboration between the UK Space Agency, MHRA, DSIT [Department for Science, Innovation and Technology], and the CAA positions the UK at the forefront of this opportunity, creating not only the technical ability, but also leading the way in regulation, quality control and compliance. There are many areas to this in which the UK is leading, and can develop further, such as in skills development with the University of Nottingham’s unique PhD programme in astropharmacy a prime example.

“The ability to manufacture pharmaceuticals and formulate them in ways that are hitherto impossible, or at least prohibitively expensive in time, resource and money, will have huge impact on patients. The start-up BioOrbit, for example, are looking to harness the microgravity environment of low-earth orbit to grow crystals of antibodies that can be delivered to a patient as a simple subcutaneous injection, which currently require intravenous infusion over many hours in hospital.

“Space offers the environment to research into new treatments that are also difficult to do on Earth. The microgravity environment allows larger 3D cultures and organelles to be grown and studied without the problems of the interactions with container walls, for example. Biological systems generally age quicker in space, so research into natural process that necessarily require a long time, such as in ageing, can be accelerated, deriving benefit to patients earlier,” he added.

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