SpaceX’s highly anticipated mega-IPO is part of a space frenzy that is expanding beyond satellite connectivity, launch vehicles and aerospace defense to include pharmaceuticals. More and more companies are moving below Earth orbit to manufacture medicines in microgravity.
As the basic aerospace industry develops the necessary infrastructure, the scope of commercial opportunities is expanding. Morgan Stanley predicts the space economy could exceed $1 trillion by 2040, and while industries from semiconductors to fiber optic cables will benefit, health care may suffer the most immediate disruption.
Last year, space and defense technology companies red wire We have established SpaceMD, a specialized subsidiary to commercialize medicines developed in space. The company has spent years developing orbital bioprinting, but believes the most commercial opportunity lies in developing a way to deliver drugs to patients.
SpaceMD CEO John Bellinger told CNBC that the most successful technology is PIL-BOX, a new drug formulation technology.
SpaceMD has already flown 54 PIL-BOX units, a specialized automated microlaboratory designed to crystallize proteins in orbit, and tested 37 drug compounds, he said.
“We have been working together Eli Lilly, bristol myers squibother drug companies, and we have shown them these new crystal forms, and they want to continue to bring us new drug candidates,” Bellinger said.
Why are drugs being made in space?
On Earth, pharmaceutical formulations are constantly destroyed by gravity through mechanisms such as sedimentation, where heavy particles settle to the bottom of test tubes, and convection, where hot liquids rise and cold liquids sink.
Phil Williams, professor of biophysics at the University of Nottingham, said the absence of gravity in space allows scientists to grow more uniform, high-quality crystals. Therefore, crystals grown in low Earth orbit are more predictable and free of defects.
Glycine crystals grown using Redwire’s PIL-BOX on the ISS. Glycine is an amino acid that functions in many areas of the human body, including as a neurotransmitter, a component of collagen, and a building block of other important molecules in the body. The crystal returned to Earth in April 2024. Image: Redwire
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When a molecule is more homogeneous, it is usually easier to administer to patients, Williams said. If crystals of different sizes are mixed, the small crystals will hide in the spaces between the large crystals, making the liquid thicker.
This is important because the viscosity, or thickness of the drug, determines how the patient absorbs the drug. Bulky biologics and medications typically require large needles and lengthy hospital infusions. By reducing viscosity, complex treatments can be reconstituted into thin, painless injections. Heavy and unstable liquids can also be stored without incurring significant economic and environmental costs such as refrigerated air transport.
Merck proof of concept
The origin of space medicine MerckIn 2014, the company, known as MSD outside the United States, conducted crystal growth experiments on the International Space Station to better understand how the lack of gravity affects medicines such as the best-selling cancer drug Keytruda.
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 undocks in space on February 18, 2008. Atlantis has delivered the long-awaited ESA-built $2 billion Columbus Science Institute addition to the space station. (Photo courtesy of ESA/NASA via Getty Images)
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Keytruda is a lab-made antibody that helps the body fight disease. Initially administered to patients in the hospital via an intravenous infusion over several hours, this experiment helped provide an injectable version that patients could potentially administer at home.
UV imaging of spaceflight samples revealed that growing antibodies in space produces a highly homogeneous and stable mixture that dissolves easily.
Merck has found a way to recreate those conditions on Earth. This delivery route takes only minutes to administer and will secure FDA approval in 2025.
The path to space commercialization
The pharmaceutical industry alone spends hundreds of billions of dollars annually in collaboration with contract research organizations (CROs) to conduct research and development and clinical trials.
“All you need is a thimble filled with these crystals…We actually showed that you can replicate those crystals over five different generations,” SpaceMD’s Bellinger said. “We have drug candidates, we have spaceflight-proven hardware, and we have royalty agreements in place.”
Varda is betting on continued in-orbit production and has developed a 300-kilogram autonomously manufactured satellite with a specialized re-entry pod. It recently completed its sixth capsule flight, launched on SpaceX’s Transporter 16.
“We fundamentally believe that the industrialization of space is an enabler, and the first industrial use case is space manufacturing,” Derian Asparoukhov, president and co-founder of Varda Space Industries, told CNBC.
Active pharmaceutical ingredients (APIs) are highly concentrated, allowing Varda to generate significant value from relatively small loads.
Amount of crystalline API needed to administer drug to 450 million patients pfizer According to Asparoukhov, the coronavirus vaccine only fills two milk gallon jugs.
companies like united therapeuticsrecently announced a partnership with Varda to explore the use of microgravity to improve treatments for lung diseases, but don’t buy a spacecraft from Varda, Asparoukhov said. “They just send us medicine and we send back better medicine.”
Overcoming bottlenecks
The aerospace industry has established a robust supply chain for going to space, but the chain for returning is narrow and expensive. Existing spacecraft built for human reentry, like SpaceX’s Dragon, are high-end, expensive vehicles designed with safety in mind.
According to Asparoukhov, these are not economically viable for high-pace, low-cost commercial manufacturing logistics.
Varda and Space MD agree that relying on the International Space Station, which will be decommissioned within a few years, will not be possible to sustain long-term commercial production.
“When you’re running a government-run research institute, there’s no clear path to commercialization at all,” Asparoukhov said. “You are well aware of the vagaries of geopolitics…This station is run half by the United States and half by Russia.”
Regulation is also a hurdle. Across the Atlantic, Britain earlier this year recognized that patients could benefit from high-quality medicines and set out a route to bring medicines made in space to market. The UK Space Agency is also investing in projects such as a feasibility study by British startup BioOrbit.
BioOrbit is exploring scalable systems to crystallize and manufacture complex biologics in space to enable at-home cancer treatments. The company recently poached two senior executives from Redwire. Molly Mulligan as president and Ken Sabin as chief scientific officer.
Given the economic and environmental costs of manufacturing at scale in orbit, Williams, the biophysics professor, predicts the future lies in creating small research batches in space and replicating them on Earth.
The “killer question” is whether that’s possible, he said, adding: “This is really exciting science and technology…I don’t see the same future as them (Bio-Orbit and other space drug makers).”
What’s next for space pharmaceuticals?
As the ISS nears retirement, companies are already starting to move away from government-run laboratories. SpaceMD has established relationships with commercial low-Earth orbit destination providers such as Vast and StarLab.
SpaceMD’s Bellinger said he hopes to use space to ultimately develop promising drug compounds whose plans can be derailed by crystallization errors or instability.
Next year, Varda plans to nearly double its flight cadence to seven, eventually debuting a fully reusable vehicle that’s about 10 times larger and moving toward fixed infrastructure in orbit, where small spaceplanes carry food up and down.
Initial operations will be automated to keep costs low, but Asparoukhov added, “Once it becomes economically justifiable for someone to do that kind of production activity in orbit, you could probably justify 10, 100, 1,000 people and at some point be able to basically build the first industrial city in low Earth orbit.”
