By Akash Sriram and Mariam Sunny
Sept 17 (Reuters) - As the International Space Station nears the end of its operational life, drugmakers are laying the groundwork for commercial pharmaceutical research and manufacturing in low Earth orbit, while working with regulators to establish rules for producing medicines in space.
Pharmaceutical, biotechnology and space company executives told Reuters they are working to demonstrate that such manufacturing outside the bounds of Earth can be done reliably and inexpensively.
Researchers have long studied how microgravity allows for appropriate distribution of cells and particles in biological materials that is difficult to reproduce on Earth.
LambdaVision, for example, is using microgravity to design an artificial retinal implant in which proteins and polymers must be layered carefully onto a scaffold. It has completed nine ISS missions since 2018 and hopes to begin clinical trials in 2028.
Auxilium Biotechnologies has successfully used its 3D bioprinter aboard the ISS to manufacture structures containing human liver, kidney and cartilage cells. Auxilium's vice president of engineering, Isac Lazarovits, said the company sees this as a step toward production of transplantable tissues in orbit.
Merck collaborated on ISS research that informed the development of a subcutaneous formulation of its top-selling cancer immunotherapy Keytruda, providing a faster, more convenient alternative to intravenous infusion.
COMMERCIAL INFRASTRUCTURE GROWTH
Such work has largely depended on the ISS, where laboratory space, astronaut time and return flights are scarce, creating bottlenecks. Experiments can take months or years to repeat, slowing refinement of manufacturing techniques.
The ISS operates more as a "test kitchen," ISS National Lab Chief Scientist Michael Roberts said. "It's not an environment that was built for the ability to scale these experiments."
That is changing as NASA prepares to retire the ISS by the end of the decade.
Next-generation commercial stations are being designed with scalability in mind, enabling companies to increase production volumes over time and potentially do so at significantly lower cost than on the ISS, he said.
Ariel Ekblaw, CEO of Aurelia Institute, a space architecture research institute, agreed that growth of commercial orbital infrastructure could make routine pharmaceutical research and manufacturing more economically viable.
Auxilium has signed agreements with companies developing orbital platforms expected to operate after the ISS retires.
Starlab, Vast and Axiom Space are developing privately operated stations, while Varda Space Industries is building autonomous capsules designed to process materials in orbit and return them to Earth.
Companies say the new platforms could provide more frequent access, dedicated manufacturing equipment and greater commercial flexibility.
Orbital laboratories tailored to the industry's needs could incorporate more automation, dedicated manufacturing areas, specialized crew training and more predictable launch and return schedules, a spokesperson for Bristol Myers Squibb told Reuters.
REGULATORY HURDLES
Regulators have yet to establish a dedicated pathway to ensure products manufactured in orbit meet the same standards as those produced on land.
Max Haot, CEO of commercial space station developer Vast, said the lack of a defined regulatory process could be a more persistent obstacle than transportation.
The FDA and NASA signed a memorandum of understanding in 2018 covering biomedical research and product development during space missions but have not created a framework for regulating and approving the fruits of such work.
Britain's Medicines and Healthcare products Regulatory Agency said in March it would work with the UK Space Agency to develop guidance for medicines manufactured in space. It expects to publish its roadmap later this year, potentially making it the first major regulator to outline a formal approval pathway.
The FDA did not respond to requests for comment.
A LONG RUNWAY
Launching payloads has become easier as the commercial rocket industry has expanded, but returning them on predictable schedules remains a challenge.
Executives say return capacity is a larger bottleneck than launch availability because companies often cannot design the next experiment without results of the previous one.
Commercial stations could allow developers to run several experiments across different platforms rather than waiting months between individual missions, industry executives said.
Starlab's chief scientist, Luis Zea, said it plans to allow companies to rent laboratory capacity and use shared equipment rather than build their own orbital infrastructure.
The ISS laid the groundwork for a future low Earth orbit economy by giving scientists continuous access to a microgravity laboratory and the ability to gather data over long periods, ISS' Roberts said.
"We're looking forward to seeing at least an order of magnitude leap in those capabilities as we move to the commercial platforms."
(Reporting by Akash Sriram and Mariam E Sunny in Bengaluru; Editing by Nancy Lapid and Bill Berkrot)
