Finance

Why drug development is heading off track

The much-anticipated SpaceX mega-IPO is part of a space frenzy that extends beyond satellite connectivity, vehicle launches, and aerospace defense to the medical field. A growing number of companies are aiming to lower Earth orbit to make medicine in zero gravity.

The range of business opportunities is growing as the basic aerospace industries put in place the necessary infrastructure. Morgan Stanley predicts that the aerospace economy could exceed $1 trillion by 2040, and while industries from semiconductors to fiber-optic cables will benefit, medicine could see immediate disruption.

Last year, a local technology and defense company RedwHe founded a dedicated subsidiary, SpaceMD, to commercialize pharmaceutical products made in space. It has spent years developing orbital bioprinting but sees its biggest commercial opportunity in creating ways to deliver drugs to patients.

The most successful technology is the PIL-BOX, a new drug-making technology, SpaceMD CEO John Vellinger told CNBC.

SpaceMD has already flown 54 PIL-BOX units — special, automated laboratories designed to crystallize proteins in orbit — and tested 37 drug compounds, he said.

“We have worked with him Eli Lilly, Bristol Myers Squibbother pharmaceutical companies, and we showed them these new crystal forms, and they want to continue to bring us new people who need drugs,” Vellinger said.

Why are drugs made in space?

On Earth, chemical composition is constantly disturbed by gravity using methods such as sedimentation, where heavy particles sink to the bottom of a test tube, and convection, where hot liquids rise and cold liquids sink.

In space, the absence of gravity means scientists can grow the same crystals at higher temperatures, says Phil Williams, professor of biophysics at the University of Nottingham. Crystals planted in low Earth orbit are therefore more visible and free from defects.

Glycine crystals grown with Redwire’s PIL-BOX on the ISS. Glycine is an amino acid that works in many areas of the human body as a neurotransmitter, collagen building block, and the structure of other important molecules in the body. The crystals returned to Earth in April 2024. Photo: Redwire

Redwire

Once the molecules are more similar, it’s often easier to administer to patients, Williams said. When the crystals are a mixture of different sizes, the smaller crystals hide in the spaces of the larger ones, making the liquid thicker.

This is important because the viscosity – the thickness of the medicine – determines how well patients absorb the medicine. Thicker biologics and drugs often require larger needles and longer hospitalizations. By reducing the viscosity, complex treatments can be converted into small, painless injections. Heavy, unstable liquids can also be stored without significant financial and environmental costs, for example, frozen air transport.

Merck’s proof of concept

Space pharma was started by Merckknown as MSD outside the US In 2014, it conducted crystal growth experiments on the International Space Station to better understand how the lack of gravity affects drugs, including its best-selling cancer drug Keytruda.

IN SPACE – FEBRUARY 18: In this photo provided by the European Space Agency (ESA) and NASA, the International Space Station is seen from Atlantis as the orbiter recedes February 18, 2008 in space. Atlantis launched the long-awaited addition to the Columbus science lab built by ESA on the space station. (Photo by ESA/NASA via Getty Images)

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Keytruda is a lab-made antibody that helps the body fight disease. First delivered to patients in hospitals using injections that took hours, the experiment helped inform the type of injection patients could use at home.

UV imaging of spaceflight samples revealed that growing antibodies in space produces a homogeneous, stable mixture that dissolves easily.

Merck found a way to replicate those conditions on Earth. This delivery route takes minutes to administer and secures FDA approval in 2025.

Marketing strategies in space

The medical industry alone spends hundreds of billions a year on research and development and working with contract research organizations (CROs) to conduct clinical trials.

“We only need a thimble full of these crystals … we’ve shown that you can replicate that crystal for five different generations,” SpaceMD’s Vellinger said. “We have drug candidates, we have spaceflight-proven hardware… and we have royalty agreements in place.”

Varda is betting on continuous orbital production and has developed independent production satellites of 300 kilograms equipped with special reinsertion pods. It recently completed its sixth capsule, launched on SpaceX’s Transporter-16.

“We strongly believe that local industrialization is what will do it [human expansion] it’s happening, and the first industrial use case is in aerospace,” said Delian Asparouhov, president and founder of Varda Space Industries, told CNBC.

The active ingredients (API) in the drugs are so concentrated that Varda can produce a significant amount from small loads.

The amount of crystalline API needed to dose 450 million patients per Pfizer The Covid-19 vaccine will fill just two jugs of milk, said Asparouhov.

Companies like United Therapeuticswhich recently announced a collaboration with Varda to test the use of microgravity to improve the treatment of lung diseases, do not buy spacecraft from Varda, Asparouhov said. “They just send us medicine and we send them back a better medicine.”

Overcoming obstacles

The aerospace industry created a strong chain to go into space, but a thin, expensive chain to bring it back. Existing spacecraft designed for human reentry, such as SpaceX’s Dragon, are sophisticated, expensive vehicles designed for safety.

They are not economically viable for high-quality, low-cost manufacturing, according to Asparouhov.

Varda and SpaceMD agree that reliance on the International Space Station, which will end in a few years, is unsustainable for long-term commercial production.

“When you’re working in a government-run research lab … there’s just no clear way to do business,” Asparouhov said. “You know the whims of geopolitics… a channel owned partly by the United States, partly by the Russians.”

Control is another obstacle. Across the Atlantic, the UK earlier this year agreed that patients can benefit from high-quality medicines and set up a route to bring drugs produced in space to market. The UK Space Agency is also investing in projects such as a feasibility study by Britain’s BioOrbit.

BioOrbit is testing a high-risk system to refine and manufacture complex biologic drugs in space to enable cancer treatment at home. It recently poached two of Redwire’s top executives: Molly Mulligan as president and Ken Savin as chief scientific officer.

Given the financial and environmental costs of orbital-scale production, Williams, a professor of biophysics, expects the future lies in making small batches of research in space and replicating that on Earth.

Whether that can be done is a “deadly question,” he said, adding: “This is really exciting science and technology… I don’t see a future like this in it. [BioOrbit and other space drug manufacturers] do.”

What’s next for space pharmacy?

As the ISS nears retirement, companies are already moving away from government-run research labs. SpaceMD is establishing partnerships with commercial low earth orbit space providers such as Vast and StarLab.

SpaceMD’s Vellinger said he wants to eventually use space to develop promising drug compounds that are hampered by crystallization defects or instability.

Varda plans to nearly double its fleet to seven next year, and eventually roll out a vehicle that is nearly 10 times larger and fully reusable, switching to a fixed infrastructure in orbit where small spacecraft carry ingredients up and down.

Although the initial operation is automated to keep costs down, Asparouhov added: “If we can economically justify a person in the environment doing that kind of productive work, we will probably be able to justify 10, 100, 1,000, and at some point basically build the first industrial city in low Earth orbit.”

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