Up in space: How microgravity could transform pharma manufacturing

The California-based start-up claims that, by removing gravity, they are able to make medicines that are not viable on earth.

“Processing in a microgravity environment dramatically alters buoyancy, natural convection, sedimentation, phase separation and drives significant differences in transport-driven phenomena,” the company’s website reads.

Essentially, Varda argues that drug formulations, both small molecules and biologics, behave differently when put through their microgravity platform.

These effects are ‘locked’ into the material, typically through material crystallization, before being brought back to earth.

“Microgravity offers the ability to eliminate factors such as natural convection and sedimentation, processing in a microgravity environment provides a path to formulating small molecules and biologics that traditional manufacturing processes cannot address,” the company said.

“The resulting tunable particle size distributions, more ordered crystals and novel forms can lead to improved bioavailability, extended shelf-life, novel intellectual property and innovative routes of administration.”

“Gravity is kind of like a parameter,” Will Bruey, CEO of Varda, told Marketplace.

“If you put a temperature knob on an oven, you create a whole world of new recipes and new food you can create. Similarly, if you can change gravity, you can also change the chemical process for drug formulations.”

The company’s first space manufacturing mission, a miniature lab in orbit which grew crystals of the HIV drug ritonavir, was hailed a success.  

The aircraft launched back in June this year and the drug manufacturing lasted 27 hours.
The experiment’s 27-hour run was completed on June 30, and data downlinked from the spacecraft showed everything went well.

“For the first time ever, orbital drug processing happened outside of a government-run space station,” Varda tweeted.

“This is our first step in commercializing microgravity and building an industrial park in LEO (Low Earth Orbit).”

At the time, Varda co-founder Delian Asparouhov told Ars Technica he was thrilled with how the mission had gone.

“One of the critical parts of pharmaceutical processing is being able to maintain appropriate temperature ranges for extended periods of time. It was exactly per our expectations, which is really great to see,” he said.

However, due to regulatory processes that must completed for the spacecraft to land, it will continue to orbit until further notice.

In response to regulatory challenges, Varda recently announced an agreement with Australian company Southern Launch to coordinate future projects at its Koonibba test range.

As a result, the company will have more freedom as they will not be required to liaise with US agencies.

According to Asparouhov, Varda always had its sights set on multiple landing sites, but this became a priority after the company did not secure US government approval for the landing of its ritonavir project.

“It’s always been in the plan, but we definitely accelerated this," he told Arcs Technica.

Moving forward, the company is planning its second mission – with launch scheduled in mid-2024. Varda is planning to work with its new Australian partner to take-off and land at its Koonibba Test Range.

“We plan, with the Koonibba Test Range, to conduct a reentry operation as soon as our second orbital mission, which the launch and reentry would be in mid-2024. To be clear, this isn’t to say that we won’t be reentering in the United States on some regular basis as well,” Asparouhov told Ars.

Lloyd Damp, CEO of Southern Launch, commented: “In-space manufacturing is the next evolution of humanity’s industrial capacity, and elements produced in orbit have the potential to change the course of history. We are excited to be partnering with Varda Space Industries to bring this emerging industry to Australia through the Koonibba Test Range.”