Manufacturing Biz #6 - Magazine - Page 39
“In-Orbit Manufacturing represents a
transformative opportunity to produce
materials and products in space that offer
superior quality and performance compared
to those manufactured on Earth.”
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 cuttingedge 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-focussed approach to
regulating spaceflight activities, which
can accommodate the licensing of novel
activities such as operating in-space
manufacturing platforms.
For example, see recent demonstration
missions such as 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. Additionally, 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
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