Manufacturing Biz #6 - Magazine - Page 38
New programme to help UK
commitment to advancing spaceenabled manufacturing
A
number of key groups have come
together to support 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.
In-Orbit Manufacturing (IOM) is one
subset of the wider In-Orbit Servicing,
Assembly, and Manufacturing (ISAM)
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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.
M A N U FA C T U R I N G B I Z M A G A Z I N E A P R I L 2 0 2 6
“Microgravity conditions can
improve drug solubility, purity,
crystallisation and stability,
supporting more effective
delivery and potentially lowering
manufacturing risk and cost.”
The microgravity advantage
The unique properties of the microgravity
environment enable more precise drug