Space Drugs Are No Longer Science Fiction – They Are Science Fact

Varda Space Industries Briefing Note

 

Axendia was recently briefed by Delian Asparouhov, Co-Founder and President, Eric Lasker, Chief Revenue Officer, and Adrian Radocea, Chief Science Officer at Varda Space Industries. The company is designing and building infrastructure to make low Earth orbit accessible to the Biopharma industry, from in-orbit production equipment to reliable and economical reentry capsules. 

“What we are building is a microgravity-enabled life sciences company focused on the reformulation of small molecules in the near term, but in the long-term biologics,” declared Asparouhov.

Founded in 2020, the company has over 95 people primarily based in the Los Angeles area. The team is a mix of aerospace engineers with significant flight heritage, pharmaceutical scientists who have brought drugs to market, process engineers working on developing and building pharmaceutical processing equipment, and hypersonic analysts who understand the process of bringing those pharmaceutical products back to Earth.

According to Lasker, “Varda’s vision highlights opportunities for enhancing existing drugs and broadening patient accessibility. This customer-centric approach underscores Varda’s commitment to advancing pharmaceutical accessibility and patient-centered care.”

This is the first step in the commercial Biopharma space race!

Why Gravity Matters

Why go up to space for pharmaceutical processing? How does gravity affect various Biopharmaceutical manufacturing?

Image Source: Varda

“At the mesoscopic scale within chemical systems, the dynamics of movement transition away from the microscopic, single-molecular level dominated by Brownian motion,” commented Asparouhov. “Convective pressures become noticeable factors at this scale, influencing the behavior of particles and molecules.

However, in the microgravity environment of low Earth orbit, these convective pressures diminish entirely, leading to a predominant reliance on diffuse transport mechanisms for movement and interaction,” he added.

According to Radocea, “This shift is particularly consequential in pharmaceutical formulation. Microgravity environments have been shown to induce various changes, including shifts in particle size distribution and the emergence of new polymorphs and more structured crystalline therapeutics. These alterations can profoundly impact drug properties and performance, affecting factors such as particle size distribution, dissolution rates, stability, and bioavailability.”

The First Commercial Biopharma Manufacturing Spacecraft

In June 2023, Varda launched its first commercial biopharmaceutical manufacturing spacecraft. The mission launched the company’s manufacturing platform inside the W-1 capsule, which reached low Earth orbit on a Space-X Falcon 9 rocket. 

Image source: Varda

On Feb. 21, 2024, W-1, the world’s first fully autonomous, free-flying pharmaceutical microgravity manufacturing capsule landed in Utah.  This achievement represents the first step in the commercial Biopharma space race since the W-1 contained the first batch of Ritonavir, a small-molecule active pharmaceutical ingredient (API), commercially processed in space.

The recognition of the value of space-based research in pharmaceuticals is not new. This is evidenced by the involvement of top biopharmaceutical companies in experiments conducted aboard the International Space Station (ISS). Their efforts underscore the growing recognition of microgravity as a valuable tool for advancing drug development and innovation in the pharmaceutical industry. However, Varda offers a unique free-flying platform and reentry system, that is not constrained by human safety requirements and can develop bespoke launch and reentry cadence based on partner and program needs.  

The implications of microgravity-induced changes extend beyond mere scientific curiosity, as they offer potential avenues for innovation in drug development. By leveraging the unique environment of space, researchers can now access and explore new methods of drug administration and formulation to enhance therapeutic efficacy and patient outcomes. 

The effects of microgravity on pharmaceuticals have significant commercial implications. It has been shown that microgravity can cause everything from a shift in particle size distribution to new polymorphs and more structured crystals. And those can have a wide range of beneficial effects. It can enable new previously inaccessible patient-compliant routes of administration and enhance the bioavailability and efficacy of small molecule and biologic therapeutics. 

Microgravity also enables the generation of product and process IP for new chemical entities as well as the life cycle management of current marketed drugs. 

“Novel formulations and delivery methods developed in space may offer competitive advantages in terms of extended and enhanced patent protection, improved market positioning and product performance, and the potential for blockbuster drug status,” noted Lasker. 

Large Molecules Go To Space

Formulating highly concentrated monoclonal antibody drug products suitable for subcutaneous delivery on earth is very challenging. The pivotal issue is viscosity escalation as concentrations rise, a challenge that often leads to practical hurdles in dispensing and product stability issues due to sedimentation.

There has been a long-standing pursuit in the pharmaceutical industry to crystallize antibodies to counteract viscosity issues. However, there are challenges in scaling up such technologies despite promising small-scale results on Earth.

Radocea drew attention to research conducted by Merck which demonstrated significantly enhanced control over particle size distribution during crystallization in microgravity aboard the International Space Station (ISS).  “Under normal gravitational conditions, a wide range of particle sizes aggregate together; while under microgravity conditions, all particles exhibited uniformity in size. This breakthrough not only offers a solution to the viscosity challenge but also presents the possibility of formulating previously unattainable highly concentrated suspensions, such as pembrolizumab (Keytruda™), for clinical and commercial applications. Moreover, microgravity plays a transformative role as the key enabler in overcoming longstanding formulation obstacles,” he added.

“Varda is playing a pivotal role in translating promising research into tangible commercial solutions, providing a crucial off-ramp for studies previously confined to the realm of intriguing science due to the prohibitive costs and logistical challenges associated with space research on crewed spacecraft and orbital space stations,” said Lasker. “Varda is committed to integrating space-based innovations with industry needs, forging partnerships with Biopharma companies on Earth to accelerate pharmaceutical advancements and bridge the gap between space exploration and terrestrial applications,” he concluded.

The Future of Space Biopharma Manufacturing Looks Bright

Varda’s operational model is a departure from reliance on traditional space infrastructure.  The company plans to leverage the fully commercial infrastructure and SpaceX rockets for launches. This sidesteps the complexities associated with human-rated and/or NASA-run space stations. This strategic choice allows Varda to streamline its operations, enabling more frequent launches and reentries – potentially every 2 or 3 days – compared to the infrequent schedules associated with government-run space programs.

In addition, Varda’s manufacturing platform includes in-house developed drug crystallization equipment designed to withstand the rigors of microgravity environments.

This unique setup, coupled with Varda’s proprietary reentry pod, facilitates swift and efficient transportation of biopharmaceutical products, potentially reducing the timeline from experimental design to launch to reentry from years to mere months or weeks.

Image Source: Varda

Asparouhov paints a bright picture for Varda’s future: “I envision the possibility of revolutionizing pharmaceutical production through space-based batch manufacturing. I see the possibility of conducting monthly batch productions of pharmaceuticals in space, driven by promising results in both small molecule and biologics.”

This ambitious vision underscores Varda leadership’s commitment to pushing the boundaries of pharmaceutical innovation and meeting significant pharmaceutical demands by leveraging the unique capabilities offered by a microgravity environment.

In Brief

Off-world commercial Biopharmaceutical manufacturing crossed the line from science-fiction to science-fact.

Manufacturing Biopharmaceuticals in microgravity can offer significant scientific and commercial benefits. This approach could improve patient outcomes by enabling new routes of administration or enhancing drug efficacy while expanding the populations that can benefit from approved products.

The commercial Biopharma space race has begun, how will it impact your organization?

We will continue to provide updates on Varda as they become available.

To discuss how your organization could leverage manufacturing in microgravity,  Click on this link to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

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