Why drug development is heading to orbit

The highly anticipated SpaceX mega-IPO is part of a space frenzy that is moving beyond satellite connectivity, launch vehicles and aerospace defense to pharmaceuticals. A growing number of companies are pushing into Earth orbit to make medicines in microgravity.

The range of commercial opportunities is expanding as core aerospace industries establish the necessary infrastructure. Morgan Stanley predicts space economy could surpass $1 trillion by 2040While industries from semiconductors to fiber optic cables will benefit, medicine may see the most sudden disruption.

Last year, the space and defense technologies company RedwIre founded a private subsidiary called SpaceMD. Commercializing pharmaceutical products developed in space. He has spent years developing orbital bioprinting, but sees his most commercial opportunity in creating ways to deliver drugs to patients.

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

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

“We worked together Eli Lilly, Bristol Myers Squibb“To other pharmaceutical companies, we’ve shown them these new crystal forms, and they want to continue to bring us new drug candidates,” Vellinger said.

On Earth, pharmaceutical formulation is constantly disrupted by gravity through mechanisms such as sedimentation, in which heavy particles sink to the bottom of the test tube, and convection, in which hot liquids rise and cold liquids sink.

Phil Williams, professor of biophysics at the University of Nottingham, said the absence of gravity in space meant scientists could produce more uniform and better quality crystals. Therefore, crystals grown in low Earth orbit are more predictable and precise.

When molecules are more uniform, they often become easier to administer to patients, Williams said. When 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 viscosity (the thickness of the medication) determines how patients absorb the medication. Intensive biologics and medications often require large needles and long hospital infusions. By lowering the viscosity, complex treatments can be transformed into thin, painless injections. Heavy, unstable liquids, such as deep freezers, can also be stored without the large financial and environmental costs associated with air transportation.

Origin of space pharmacy MerckKnown as MSD outside the US in 2014 crystal growth experiments He will travel to the International Space Station to better understand how the lack of gravity affects drugs, including the best-selling cancer drug Keytruda.

Keytruda is a laboratory-made antibody that helps the body fight disease. Initially administered via hour-long intravenous infusions to patients in hospitals, experiments have helped create an injectable version that patients could potentially administer at home.

UV imaging of spaceflight samples revealed that growing the antibodies in space produced a fairly uniform, stable mixture that dissolved easily.

Merck found a way to replicate these conditions on Earth. This delivery route takes only a few minutes to implement and receive FDA approval in 2025.

Varda focuses on sustained orbital production and has developed 300-kilogram autonomous production satellites equipped with special re-entry capsules. completed recently sixth capsule flightIt was launched with SpaceX’s Transporter-16.

“Fundamentally, we believe in what the industrialization of space will bring us to [human expansion] “This happened, and its first industrial use was in space manufacturing,” Delian Asparouhov, president and co-founder of Varda Space Industries, told CNBC.

The active ingredients (APIs) in drugs are in such high concentration that Varda is able to generate significant value from relatively small payloads.

Volume of crystalline API required to dose 450 million patients Pfizer Asparouhov said the Covid-19 vaccine can only fill a two-gallon milk bottle.

like companies Combined TherapeuticsAsparouhov, who recently announced that he is collaborating with Varda to research the use of microgravity to improve treatments for lung diseases, said that he did not purchase the spacecraft from Varda. “They just send us a drug, and we give them back a better drug.”

Regulation is another hurdle. On the other side of the Atlantic, the UK acknowledged earlier this year that patients could benefit from better quality medicines and The way to bring drugs produced in space to market. The UK Space Agency is also investing in projects such as the feasibility study of British startup BioOrbit.

BioOrbit is investigating a scalable system to crystallize and produce complex biological drugs in space to enable at-home cancer treatments. He recently poached two top executives from Redwire: Molly Mulligan as president and Ken Savin as chief scientific officer.

Williams, the biophysics professor, thinks the future is to do small research batches in space and replicate it on Earth, given the financial and environmental costs of large-scale production in orbit.

Whether it can be done is “the killer question,” he said, adding: “This is really exciting science and technology… I don’t see the same future as them. [BioOrbit and other space drug manufacturers] To do.”

As the ISS approaches retirement, companies are already moving away from state-run research laboratories. SpaceMD is building relationships with commercial low earth orbit destination providers such as Vast and StarLab.

SpaceMD’s Vellinger said he ultimately wants to use space to develop promising drug compounds that are derailed by crystallization errors or instability.

Varda plans to nearly double the flight pace to seven next year and eventually launch a vehicle that’s about 10 times larger and fully reusable, shifting toward fixed infrastructure in orbit where mini spaceplanes carry supplies up and down.

Although initial operations will be automated to keep costs low, Asparouhov added: “Once we can economically justify having someone in orbit doing that kind of productive activity, we’ll probably be able to justify 10, 100, 1,000 people, and at some point we can build the first industrial city in low Earth orbit.”