Show notes
A year ago, Mark Herbert, VP of Biopharma Business Development at Varda Space Industries, joined me on one of the most popular episodes of this podcast. Today, he’s back with some exciting updates on Varda's latest mission, which involved launching a satellite and conducting pioneering drug manufacturing experiments in space. From overcoming regulatory hurdles to making groundbreaking discoveries, Varda’s journey is a glimpse into the future of pharmaceuticals—and it’s happening above our heads.Launching and Landing: The Mission to SpaceMark began by describing Varda’s June 2023 launch, where they became the first company to send a satellite with re-entry capabilities on a SpaceX Falcon 9 rocket. Varda was one of 35 satellites on the launch, but the only one designed to return to Earth. After orbiting for eight months, the spacecraft re-entered the atmosphere and landed at the Utah Testing and Training Range. The mission took longer than expected due to the complexities of obtaining a re-entry license from the FAA—a groundbreaking process as they were the first to go through it.While in orbit, they reproduced terrestrial experiments using their custom-designed hardware. One of the key achievements was rediscovering a new form of ritonavir, a widely studied HIV drug, which had experienced stability issues in the past. This discovery and the successful replication of these results in orbit demonstrated Varda’s ability to conduct controlled pharmaceutical manufacturing in space—a major leap forward in drug development.Navigating Challenges: The Complexities of Space Re-EntryThe mission wasn’t just about science—it was also a complex regulatory and logistical feat. One doesn’t just bring a satellite back whenever and wherever you like.There is a lot of planning required for the re-entry, from coordinating with the FAA to clearing commercial airspace over the Western United States during their 35-minute descent. The spacecraft re-entered the atmosphere at Mach 25, a speed that necessitated strict safety protocols to avoid any conflicts with other air traffic.Varda’s spacecraft had to endure extreme temperatures during re-entry, reaching three times the surface temperature of the sun. The team licensed the protective shield licensed from NASA, allowing them to maintain a stable internal temperature throughout the process. This ensured that the drug samples remained intact and unchanged during their return to Earth—a critical validation for future missions.Small Capsule, Big Impact: The Benefits of Space ManufacturingThe whole purpose of manufacturing in space is to solve formulation challenges. In microgravity, Varda was able to manipulate ritonavir’s crystal forms in ways that are impossible on Earth. Beyond the chemistry, the technical and logistical challenges of this mission, honestly, blow my mind. The spacecraft’s small size belies the complexity: inside, the “huggable” capsule maintains the temperature within a one-degree range, even while moving from sunlight to shadow multiple times every day in orbit.To ensure they could isolate the effects of microgravity, the team included controls—different forms of ritonavir that were stable on Earth. This careful experimental design allowed Varda to confirm that the re-entry process did not alter the drug samples, proving that drugs manufactured in space could be brought back without compromising their integrity.Are you subscribed yet? If not, let’s fix that.Looking Forward: Expanding Horizons in Space-Based Drug ManufacturingVarda’s success presents new possibilities in space-based manufacturing. Currently, their focus is on small molecule crystallization. By 2025, Varda plans to expand into solvent-based applications, allowing them to test a broader range of small molecules. By 2026, the company hopes to launch biologics—complex molecules used in cutting-edge therapeutics that often face formulation challenges on Earth.Mark spoke about how Varda’s work could eventually transform biologics manufacturing. For instance, many biologics are currently restricted to intravenous administration because of stability issues tied to Earth’s gravity. Microgravity could help overcome these limitations, enabling new formulations that are more convenient and accessible to patients.Hypergravity: A New Tool for Drug DevelopmentHow does one determine that gravity influences the crytallization of any particular molecule? Draw the curve for the effect of increased gravity and extrapolate backward. Varda has developed a hypergravity platform at their El Segundo facility, which allows them to study the effects of increased gravity on pharmaceutical processes. By simulating up to 5G conditions, Varda is able to screen molecules and processes terrestrially, providing valuable data before investing in the high costs of spaceflight. This approach not only maximizes the chances of success in orbit but also adds a new dimension—literally—to pharmaceutical research.Hypergravity serves as a negative dataset, helping researchers anticipate how microgravity might alter their processes. By tweaking the “gravity knob,” Varda can better design experiments that leverage the unique conditions of space to create novel drug formulations.Future Vision: Monthly Missions and New FrontiersVarda’s ultimate goal is to conduct space missions on a regular cadence, with plans to have quarterly launches through 2026 and the potential for monthly missions if the demand arises. Their focus remains on pharmaceuticals, particularly small molecule crystallization and biologics. Varda’s platform is designed to make space accessible for drug development, offering new tools to researchers looking to solve problems that Earth’s 1G environment cannot.Beyond the immediate applications, Varda’s work represents a paradigm shift in how we think about drug development. As Mark pointed out, this technology could enable the creation of entirely new therapeutics that would be impossible under Earth’s gravity. It’s a thrilling prospect—one that could redefine the future of medicine and bring treatments manufactured in orbit into everyday healthcare.Final ThoughtsVarda’s journey is not just about the technology—it’s about opening up new possibilities for researchers and patients alike. As someone who grew up during the space age, I never imagined that some day, we could be receiving treatments that were made in space. This is just the beginning, and Varda is leading the way into a new era of drug manufacturing.Your deepest insights are your best branding. I’d love to help you share them. Chat with me about custom content for your life science brand. Or visit my website.If you appreciate this content, you likely know someone else who will appreciate it too. Please share it with them. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit cclifescience.substack.com