The Medicines and Healthcare products Regulatory Agency (MHRA) is working with the UK Space Agency (UKSA) to develop the manufacturing of drugs in space.
The medicines regulator has set out its support for the in-orbit manufacturing (IOM) of drugs along with UKSA, the Regulatory Innovation Office (RIO) and the Civil Aviation Authority (CAA).
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The four bodies said IOM offers a “transformative opportunity” to produce materials and products in space that offer “superior quality and performance compared to those manufactured on Earth”.
IOM is one area of research within the in-orbit servicing, assembly and manufacturing (ISAM) market, which has been identified by the government “as a priority capability area for UK leadership, growth, and national security”.
World first
UKSA is funding three IOM feasibility studies, with the MHRA working on the ‘PHARM’ study to showcase what the regulatory requirements for the IOM of drugs are and whether existing regulations for manufacturing completed on Earth will apply to space-made drugs.
The ‘PHARM’ study is an “end-to-end mission to manufacture drugs in microgravity”, and £250,000 has been awarded to UK start-up BioOrbit, which is leading the study and working with the regulatory bodies so the “mission can be readily commercialised”.
BioOrbit describes itself as “aiming to be the go-to pharmaceuticals factory in microgravity”, and its chief executive Dr Katie King said space made pharmaceuticals “will have a dramatic impact on all of our lives”.
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“BioOrbit’s PHARM study ensures that we can produce drugs in space under the same regulation as drugs made on Earth – which will be a world first,” she said.
UKSA chief executive Dr Paul Bate said these studies “demonstrate the government’s ambition to drive forward one of the most exciting frontiers of space technology”.
The MHRA confirmed to C+D that outside the UK, no national medicines regulator has a dedicated pathway for in-orbit medicines manufacturing.
Which drugs?
The study involves designing a scalable IOM system to crystallise biologic drugs for cancer treatments in microgravity.
Microgravity allows for the formation of “more perfect, reproducible protein crystals for drug formulations” which “cannot be achieved on Earth”.
The MHRA told C+D that protein crystals in microgravity will grow with “improved solubility, stability and higher purity formulation”.
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It added that complex proteins that are “very difficult, if not impossible to crystallise in terrestrial conditions” can “more easily be crystallised” in microgravity.
It means there is more precise drug formulation for protein-based drugs like insulin and ones used in vaccines, with the hope these space made drugs may be “more robust and effective” for patients on Earth.
Is this expensive to achieve?
The MHRA explained that orbital drug manufacturing missions send small, self-contained crystallisation payloads into space rather than entire production lines.
Space missions can use “fully autonomous spacecraft” which do not rely on crewed missions, meaning human intervention is not needed for IOM.
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Aerospace companies are providing more regular, low-cost rideshare launch opportunities to allow for the IOM of drugs.
The MHRA said these developments in space infrastructure are “key enablers” that makes “microgravity manufacturing a viable option”.
Community pharmacy
Even though there has been several successful proof of concept missions that demonstrate drug crystallisation can be carried out in orbit, the MHRA confirmed no drugs are yet manufactured in space “at commercial scale” as the sector is still “at an early stage”.
So, how likely, and how soon, will patients be able to grab a box of paracetamol from a community pharmacy that’s been manufactured in space?
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The MHRA said the current focus will be to scale “high-value, hard to manufacture formulations” and not every day over the counter (OTC) products.
But the statement by the four bodies said that IOM of drugs has the potential to be used from “precision medicines for oncology and rare diseases” to “drug stability for remote and crisis-affected populations”.
Collaboration
Along with producing a regulatory case study with UKSA on BioOrbit’s study, the MHRA will facilitate scientific and regulator advice meetings with developers.
It will also continue to develop industry and academic engagement through the MHRA Innovation Accelerator to ensure there is guidance for emerging space-enabled biomanufacturing technologies.
Space Minister Liz Lloyd said space “isn’t just about exploration” but it’s about “innovation that improves everyday lives here on Earth”.
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“These pioneering studies show how British ingenuity is pushing the boundaries of what’s possible - leveraging space conditions to innovate the development of life-saving medicines.
“By investing in in-orbit manufacturing, we’re backing the jobs and industries of tomorrow while cementing the UK’s position as a global leader in the space economy,” she said.
Current regulations
The MHRA said the existing regulatory frameworks used on Earth should allow for drugs to be manufactured in microgravity.
But it will work with manufacturers to understand challenges that may occur in-orbit and “collaboratively identify solutions that address our primary requirements for safe, efficacious and high-quality medicinal products”.
In June, the UK’s first in-orbit manufacturing platform was launched in Space Forge’s ForgeStar 1 mission which has “set a precedent and framework for licensing in-orbit manufacturing activities”.
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The mission was “a British breakthrough in in-orbit manufacturing technology” as it fired up its miniature furnace and generated plasma in orbit.
Following the 2024 Space Regulatory Review, spaceflight licence applicants will need to demonstrate how they will ensure the risks associated with their activities are as low as reasonably practicable, including for the “re-entry and safe landing of platforms with the manufactured products” on board.
The CAA is also exploring how to streamline spaceflight licensing processes to support “larger-scale, higher cadence” operations.
R&D
UKSA is engaging with the NHS and biopharma supply chain to “drive growth and development of the in-orbit pharmaceuticals sector”.
It is completing a literature review of the International Space Station’s (ISS) experiments on pharmaceuticals and biologics to “identify the UK’s competitive advantage and capabilities for future focused development”.
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And it is organising the inaugural UK-Swiss Dialogue in June 2026 so space and pharma experts and decisionmakers can work together “advance microgravity for biopharma R&D”.
The government is supporting the development of IOM by giving £8 million to Cardiff-based Space Forge for a National Microgravity Research Centre, as well as investing £2.2m in IOM technologies through the National Space Innovation Programme (NSIP).
It comes as C+D exclusively spoke to Dr Li Shean Toh, the “queen of space pharmacy”, who explained what this area of research is all about and how it can evolve “medicines development from Earth to space, and space to Earth”.
