Key Summary
- The UK is supporting research to make medicines in space using microgravity.
- Space manufacturing could improve drugs for cancer, rare diseases and other conditions.
- Agencies including the UK Space Agency and Medicines and Healthcare products Regulatory Agency will guide development and regulation.
The UK government has announced that it would support the development of space-manufactured drugs to convert the recent microgravity-based research to provide effective treatments for people with cancer, rare diseases and other conditions.
Microgravity in space can improve how biologic drugs form, behave and work within the human body. They can improve drug solubility, purity, crystallisation and stability supporting more effective delivery and potentially lowering manufacturing risk and cost.
The government has announced that it will provide a coordinated package of measures to provide industry with greater regulatory clarity and a clearer pathway from research in space to patient access on Earth.
The package includes regulatory guidance, case studies, a regulatory sandbox and strengthened supply-chain engagement.
The government agencies involved in the programme is led by UK Space Agency (UKSA), with support from 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).
The UK is committed to promote space-enabled manufacturing and In-Orbit Manufacturing (IOM) is one subset of the wider In-Orbit Servicing, Assembly, and Manufacturing (ISAM) market.
It enables the industry to produce materials and products in space that offer superior quality and performance compared to those manufactured on Earth.
“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,” said Rosemary Whitbread, head of Space Regulation Policy at the UK CAA.
The UKSA is funding three feasibility studies of IOM and one of them is BioOrbit, which explores a scalable system for crystallising biologic drugs in space to enable at-home cancer treatments.
The project is funded via the UKSA’s Unlocking Space Portfolio along and the MHRA is providing regulatory guidance.
The announcement was made during the Space-Comm Expo, at ExCeL London on Thursday (5).
