Drugmakers Chart Path for Space Pharma as ISS Retirement Looms

As the International Space Station (ISS) approaches the end of its operational life, pharmaceutical and biotechnology companies are laying the groundwork for commercial research and manufacturing in low Earth orbit. Executives say the focus now is on proving that such production can be done reliably and at reasonable cost, while regulators work to establish rules for medicines made in space.

Microgravity has long intrigued researchers because it allows cells and particles in biological materials to distribute in ways difficult to replicate on Earth. LambdaVision is exploiting this to build an artificial retinal implant that requires proteins and polymers to be layered precisely onto a scaffold. The company has completed nine ISS missions since 2018 and aims to begin clinical trials in 2028.

Auxilium Biotechnologies has used its 3D bioprinter aboard the ISS to create structures containing human liver, kidney and cartilage cells. Isac Lazarovits, the company's vice president of engineering, described the work as a step toward producing transplantable tissues in orbit.

Merck's ISS research contributed to the development of a subcutaneous formulation of its cancer immunotherapy Keytruda, offering a faster and more convenient alternative to intravenous infusion.

Commercial infrastructure growth

Until now, such work has relied heavily on the ISS, where lab space, astronaut time and return flights are limited. Experiments can take months or years to repeat, slowing the refinement of manufacturing techniques. Michael Roberts, chief scientist at the ISS National Lab, likened the station to a "test kitchen" not built for scaling experiments.

That is set to change as NASA prepares to retire the ISS by the end of the decade. Next-generation commercial stations are being designed with scalability in mind, which could allow companies to increase production volumes and potentially cut costs significantly compared with the ISS, Roberts said.

Ariel Ekblaw, CEO of the Aurelia Institute, a space architecture research group, agreed that growing 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 offer more frequent access, dedicated manufacturing equipment and greater commercial flexibility. A Bristol Myers Squibb spokesperson said orbital laboratories tailored to industry needs could incorporate more automation, dedicated manufacturing areas, specialized crew training and more predictable launch and return schedules.

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 prove 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 results of such work. The FDA did not respond to requests for comment.

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.

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 from 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 the company plans to let companies rent laboratory capacity and use shared equipment rather than build their own orbital infrastructure.

Roberts said 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. "We're looking forward to seeing at least an order of magnitude leap in those capabilities as we move to the commercial platforms," he said.