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Drug Companies Explore Making Some of Their Most Lucrative Drugs in Space

Experiments in orbit have shown the advantages of crystallizing valuable protein-based medicines in microgravity, possibly yielding new patents.

Bloomberg Businessweek

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Startup  LambdaVision Inc. has big plans to develop the world’s first protein-based artificial retina for patients with retinitis pigmentosa, a genetic cause of blindness. Manufacturing the retina involves depositing 200 paper-thin layers of a light-sensitive protein in a polymer mesh. The protein layers must be perfectly even for the retina to work properly, a process that’s hard to get right on Earth.

So starting in late 2018, the company turned to the International Space Station in the hopes that the microgravity there could help. In the eight experiments it has sent to the Space Station so far, it’s improved the production quality dramatically. In space, “you get nice even layers” of the protein with less wasted material, says Nicole Wagner, LambdaVision’s chief executive officer. “The goal is to be one of the first products manufactured in space that would be used here on Earth.”

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Wagner. Photographer: Nathan Oldham/UConn Photo

There aren’t yet any marketed drugs that have been invented in space—let alone ones that are produced there. But that day is inching closer as experiments show the advantages of crystallizing valuable protein-based drugs in microgravity. That’s raising interest among some of the world’s largest drug companies.

Proteins are complicated, finicky molecules that are notoriously difficult to produce in their crystal form. But without gravity, fluid convection lessens, the molecules move more slowly and temperature can be more precisely controlled. That yields fewer crystal defects, enhanced crystal size and uniformity, according to an Eli Lilly & Co. spokesperson. A study published in 2022 by researchers from Butler University in Indianapolis found that 90% of various types of crystals produced in space had one or more improved properties, including many desirable to drugmakers.

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Retina implants under development at LambdaVision. Photographer: Peter Morenus/UConn Photo

Drug companies have been sending protein crystallization experiments into space for decades. Many focused on producing crystal forms of disease-promoting proteins, which could be used to help develop drugs that bind exactly onto the crystals’ unique shape. One such experiment from the early days of the space station provided clues that helped researchers design a potential muscular dystrophy drug now in final-stage trials at Taiho Pharmaceutical, a unit of Japan’s Otsuka Holdings Co. Another experiment from Lilly underway on the ISS is examining crystal growth of marketed and experimental drugs for diabetes, pain and cardiovascular disease, in conjunction with Lilly’s partner  Redwire Corp., which makes the high-tech gear housing the experiment.

Interest in devising drugs in space has really taken off since  Merck & Co. showed in a 2019 study that it could use microgravity to devise an  improved formulation of its popular cancer drug Keytruda, which boasts sales of more than $20 billion annually. That suggested that space-based drug formulation work could lead to lucrative versions of existing blockbusters.

Like many hot-selling cancer medicines, Keytruda is a monoclonal antibody that must be slowly infused into patients at a medical office. A higher-concentration version that could be given at home in a simple injection could make administration easier—and might win the company lucrative new patents.

If you tried to do this with the existing formulation, the concentrations needed would make it so viscous “it would be like pushing out molasses,” says Merck protein chemist Paul Reichert. But on a Space Station experiment that went up in 2017, Merck identified an unexpected way to pack more Keytruda antibody crystals into a fast-flowing suspension. The pharma giant has since figured out how to duplicate that process on Earth. The space-derived formulation is a candidate to go into human trials soon, says Reichert.

Merck rival Bristol Myers Squibb Co. is also doing space-based protein drug formulation work, including an experiment at the ISS in March. In space, you can get crystals that are better quality and more uniform, says Robert Garmise, director of formulations development. While the company won’t reveal which drugs it’s working on in space, one of its biggest sellers is the cancer drug Opdivo, an $8.2 billion-a-year competitor to Merck’s Keytruda.

For now, both Merck and Bristol Myers are using the space experiments to come up with ideas for better formulations that would be produced terrestrially. But one possibility in the future is a hybrid scenario where favorable conditions in space are used to produce small quantities of a “seed” protein that would then be brought to Earth to grow much larger quantities, says Michael Roberts, chief scientific officer for the International Space Station National Lab. Think sourdough starter for drug manufacturing.

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The International Space Station. Source: NASA

The timing of such an advance remains unclear. The International Space Station could be decommissioned after 2030, and private companies are already working on alternatives that could provide dedicated facilities in space for drug formulation work. Varda Space Industries, an El Segundo, California, startup with more than $50 million in venture funding, has designed a satellite that’s essentially an automated drug production biolab. Its first mission was launched in June; it aims to show it could make a crystalline form of the HIV drug ritonavir. Illustrating the potential pitfalls of space-based production, the return flight has been delayed multiple times as Varda awaits permissions from the Federal Aviation Administration and the US Department of Defense to land the drug-containing reentry vehicle onto US soil. For its next launch in 2024, Varda plans to land the payload at a range in Australia set up for private space missions, says co-founder Delian Asparouhov.

Still, manufacturing finished drug ingredients in space may be impractical for high-volume products even if there are technical advantages. Merck makes Keytruda by the ton on Earth; each of its space station experiments has produced only enough for one dose, says Reichert.

But some potential drugs require much smaller quantities of the finished product. LambdaVision’s artificial retina, for instance, is lightweight and the size of a paper hole punch. The company, a University of Connecticut spinout in Farmington, says its artificial retina could be ready for human testing in three to four years if the space-based production stays on track. Says LambdaVision’s Wagner: “If we continue to see the success we are seeing in microgravity, there would be nothing to make me think we couldn’t do this in space.”

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This post originally appeared on Bloomberg Businessweek and was published December 5, 2023. This article is republished here with permission.

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