Collaboration to support in-orbit pharmaceuticals manufacturing
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, with guidance, regulatory sandboxes, case studies and supply chain engagement.
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The announcement came on the second day of Space-Comm Expo, at ExCeL London, one of Europe’s biggest space industry events.
The unique environment of microgravity, impossible to replicate on Earth, can improve how biologic drugs form, behave and work within the human body and have the potential to improve outcomes for people with cancer, rare diseases and other conditions by enhancing the quality, stability and performance of complex medicines.
To help turn these advances into real world treatments, UK companies developing medicines in space will now benefit from a coordinated package of measures announced today to support the rapid growth of in-orbit manufacturing. The measures will provide industry with greater regulatory clarity and a clearer pathway from research in orbit to patient access on Earth. As set out in the UK Government’s £2 billion Life Sciences Sector Plan, these innovations could expand treatment options and improve outcomes across the health system.
Space Minister Liz Lloyd said: "The UK is taking medical breakthroughs from orbit to patient – tackling the practical barriers that have held back commercial in-orbit manufacturing, from regulatory uncertainty to supply chain gaps."
Lord David Willetts, Chair of the UK Space Agency and Regulatory Innovation Office, said: "In-orbit manufacturing of pharmaceuticals represents a significant opportunity for the UK, combining the growth potential of our space sector with the promise of better treatments for patients.
"The UK Space Agency is committed to supporting the companies pioneering this work, from microgravity platform providers to biotech and pharmaceutical firms. Setting out a clear adoption pathway with well-defined regulatory requirements gives investors and entrepreneurs the confidence they need to bring these innovations to market. The UK is open for business in space-enabled pharmaceuticals, with the ambition and capability to lead globally."
Dr Paul Bate, CEO of the UK Space Agency, said: "Our investment in innovative projects is matched by focused work through our Unlocking Space Portfolio to connect space companies with the pharmaceutical sector and public health partners. We want to ensure that promising microgravity research doesn’t stall at the experimental stage but progresses towards treatments that improve people’s lives.
"This is about turning the UK’s strengths in space and life sciences into a competitive advantage that delivers for patients and for growth."
Rosemary Whitbread, Head of Space Regulation Policy at the UK Civil Aviation Authority, said: "Space manufacturing unlocks cutting?edge products that simply can’t be made here on Earth.
"As the UK space regulator, we play a key role in enabling these groundbreaking innovations, which have the potential to deliver real health benefits and drive economic growth.
"We are confident that in?space manufacturing can be licensed under the UK’s current rules, as long as companies go through the normal approval steps, ensuring that these ideas and innovations take shape, safely, securely and sustainably."
Lawrence Tallon, CEO at the Medicines and Healthcare products Regulatory Agency said:??"The UK is well placed to enable safe, cutting-edge innovation in space-enabled biomanufacturing. Our existing medicines regulations already support advanced and novel manufacturing approaches, including those that take advantage of microgravity.??
"Through joint case studies and early scientific and regulatory advice, the MHRA is helping to shape a clear pathway from in-orbit manufacture to patient access – supporting innovation while?maintaining?the highest standards of safety,?quality?and patient protection.??
"I encourage developers to engage with us early, through our Scientific and Regulatory Advice services and the MHRA Innovation Accelerator, so we can help them navigate regulatory expectations and bring safe, effective space-enabled medicines closer to patients."
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.
Dr Katie King, CEO of BioOrbit said: "BioOrbit is pioneering the future of medicine in space, unlocking advanced therapies that directly benefit UK patients and support the NHS.
"The UK Government’s commitment today sends a clear signal: Britain isn’t watching from the sidelines, we’re leading it. BioOrbit is proud to be driving that mission – from orbit to patient, faster than anyone thought possible."
The microgravity advantage
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.?
In-orbit manufacturing of pharmaceuticals offers transformative potential across multiple domains, from precision medicines for oncology and rare diseases to drug stability for remote and crisis-affected populations.?This reinforces the UK’s commitment to enabling innovation in pharmaceutical manufacturing. This includes supporting the development of novel modalities that could enhance drug quality, improve supply chain resilience and unlock new therapeutic possibilities for patients. As this sector evolves, the UK remains focused on ensuring the highest standards of safety, quality and regulatory compliance, creating a clear and supportive pathway for innovators while safeguarding public health.
Current regulatory framework
Existing medicines regulations are applied to established and novel medicines available to patients and also to potential treatments currently in development. Building on the MHRA’s experience in developing innovative and proportionate regulatory pathways, including the MHRA’s world-first framework for decentralised and modular manufacturing launched in 2025, the Agency works closely with developers and partners to ensure that existing and future regulations remain fit for purpose for medicines manufactured using advanced and novel manufacturing approaches. This includes manufacturing that may take place in microgravity or other unique environments, where modular manufacturing and atypical distribution practices may occur. This approach enables innovation, providing regulatory clarity and confidence to innovators exploring cutting-edge biomanufacturing methods.
BioOrbit’s in-orbit demonstrator feasibility study, funded by the UK Space Agency and running until March 2026, includes specific work to clarify the relevant regulatory requirements for pharmaceutical manufacturing in-orbit. This collaborative work between the UK Space Agency, MHRA and BioOrbit will deliver clarity to space biotech companies on whether existing regulations for terrestrial manufacturing will also apply to manufacturing of pharmaceuticals in-orbit for patient use.
Alongside this, the UK has a flexible and outcome-focused approach to regulating spaceflight activities, which can accommodate the licensing of novel activities such as operating in-space manufacturing platforms.
A recent example of a demonstration mission is Space Forge’s ForgeStar 1, the UK’s first in-orbit manufacturing platform, which was licensed by the Civil Aviation Authority (CAA) and launched in June 2025. This mission, which has since successfully fired up its miniature furnace and generated plasma in orbit, is a British breakthrough in in-orbit manufacturing technology and has helped set a precedent and framework for licensing in-orbit manufacturing activities.
In addition to this, the UK has established itself as a frontrunner in licensing other novel emerging technologies, including Astroscale UK’s ELSA-D, a world first commercial space debris removal demonstration mission launched in 2021. The UK has established a track record of blazing a trail in licensing novel and emerging ISAM missions in line with its ambitions to continue leadership in these technologies.
While the UK’s existing spaceflight legislation under the Space Industry Act 2018 and Outer Space Act 1986 has already provided a flexible framework for licensing such missions, the UK government is working to provide additional clarity to support the predicted growth of manufacturing activities in the emerging in-orbit economy. In line with the recommendations of the Space Regulatory Review 2024 we are therefore developing new guidance products and regulatory sandboxes to support innovators and investors by providing clarity and transparency on the steps to licensing UK operated in-orbit manufacturing platforms.
This will be in line with the UK’s non-prescriptive, outcome-focussed approach where spaceflight licence applicants demonstrate what steps they propose to take to ensure that the risks associated with their planned activities are as low as reasonably practicable, including for the re-entry and safe landing of platforms with the manufactured products on board. To support this activity, the Government is launching a Re-entry Regulatory Sandbox. This sandbox will aim to support re-entry activities, such as IOM, and builds on the learnings from the recent Rendezvous & Proximity regulatory sandbox.
The CAA and government are also exploring opportunities to streamline spaceflight licensing processes, in particular to support progression to larger-scale, higher cadence operations.
The UK’s modern legislative frameworks for human medicines and spaceflight activities represent a unique opportunity to demonstrate a clear end-to-end regulatory pathway for UK in-space manufactured pharma products. To promote investment into the UK and support innovators seeking to seize this opportunity, the UK Space Agency and MHRA are collaborating to produce principles-based case studies which illustrate the regulatory pathway to be followed by space, biotech and pharmaceutical companies.
Potential applicants for UK operated In-Orbit Manufacturing platforms are encouraged to engage with the CAA as early as possible to discuss proposed missions by contacting the CAA at commercialspaceflight@caa.co.uk. Further information on the licensing process can be found here - Space licensing in the UK.
Government initiatives
Alongside providing regulatory clarity through the production of joint case studies with the MHRA, the UK Space Agency is leading a wide range of initiatives to drive growth and development of the in-orbit pharmaceuticals sector. This work contributes directly to the ambitions of the Life Sciences Sector Plan and the Modern Industrial Strategy 2025 to support economic growth and strengthen health outcomes for the United Kingdom. These actions are intended to provide coordinated support and clarity to the supply chain on the adoption pathway.
Read the joint statement from the UK Space Agency, MHRA, RIO and CAA.