Could this be the moment that drug manufacturing takes off in orbit?

NASA has enabled scientists to study the impact of microgravity on drug development for decades, beginning with the Space Shuttle. This work accelerated in the 2010s, with the completion of the International Space Station and full-time crew members devoted to scientific research.

There have been some notable successes during this timeframe, such as the ability to grow a more uniform crystalline form of the cancer drug Keytruda in 2019. This opened up the possibility of administering the drug via injection rather than requiring a patient to spend hours in a clinic setting to receive the drug intravenously.

NASA subsidized much of this work, typically paying the considerable costs to transport research to the ISS and for astronaut time to conduct research there. There were, however, trade-offs, such as long lead times to get research into space. Nevertheless, it has become clear that there could be some commercial applications for making drugs in space.

Varda starts cooking

A private space company, Varda Space Industries, has begun flying small, uncrewed capsules equipped with autonomous bioreactors that spend a few weeks to months in microgravity that can process pharmaceuticals in the absence of gravity. The company launched the first of these vehicles, W-1, in mid-2023. Five other vehicles have launched since then.

The pharmaceutical industry appears to be starting to notice. On Wednesday morning, Varda announced a significant new collaboration with United Therapeutics Corporation to explore the use of microgravity to develop improved treatments for rare lung disease. As part of the agreement, Varda and United Therapeutics will use microgravity’s influence on the structure and crystallization properties of therapeutic compounds in order to improve their stability and delivery.

In an interview, the president and co-founder of Varda, Delian Asparouhov, said this was an important moment for the orbital economy.

“This is the first time that a large, publicly traded company is using capital from their own balance sheet, not just from NASA, to build and produce a product in microgravity,” Asparouhov said. “This is the first, and we expect there to be many more. I do think it’s a really good historical moment for the space industry.”

More frequent access

Asparouhov said that several trend lines have converged, enabling Varda and United Therapeutics to collaborate. There is the bedrock of research done on board the ISS, increased capital for space startups like Varda, and the rise of reusable rockets that has brought down the cost of access to space and increased the cadence. Varda’s spacecraft, with a mass of a few hundred kilograms, typically fly on SpaceX’s periodic Transporter missions that launch dozens of space missions at a time.

Although he declined to discuss the explicit financial details of this agreement, Asparouhov said it will allow his company and United Therapeutics to do a large number of screening tests on the ground, principally in Varda’s new 10,000 square-foot pharmaceutical lab in El Segundo, California, and then to take these most promising applications to space.

Over time, scientists have come to understand that when molecules assemble in microgravity—that is, in Earth orbit—they do so more slowly and consistently. The crystalline structure of molecules is more uniform, rather than a broad variation.

This turns out to be quite useful in some pharmaceutical applications, including allowing drugs to dissolve more consistently, retain a longer shelf life or reduce cold storage requirements, and reducing side effects. Essentially, yanking gravity away is another tool, just like temperature or pressure, that drug manufacturers can apply to improve their products.

I’m not just the president, I’m also a client

Varda’s W-6 spacecraft is presently in orbit, and Asparouhov said three more vehicles are being prepped to launch this year. The plan is to increase that cadence to seven launches next year. The company presently has about 200 employees and has raised $330 million to date.

Long term, Varda’s goal is not to be a space company, but rather a pharmaceutical company that operates in space and brings valuable materials back to Earth.

“We’re not just building the reentry systems,” Asparouhov said. “We’re also building the largest customer for those reentry systems, which is our whole internal pharmaceutical business. Because at the end of the day, what are you reentering? If you’re bringing things back from space it’s either humans, in which case there’s plenty of sort of human-rated things; and then if you’re not bringing back humans, it’s got to be a pretty darn valuable product.”