How BioOrbit is Building a Pharmaceutical Factory in Space

By Owais AliReviewed by Lauren Hardaker

Introduction
The Biologics Delivery Problem
BioOrbit's Approach: Relocating Drug Manufacturing to Space
Commercial Implications for the Pharmaceutical Industry
Challenges Ahead
An Emerging Orbital Manufacturing Ecosystem
References and Further Reading

BioOrbit is developing a scalable in-orbit manufacturing platform to crystallize biologic drugs in microgravity, transforming hospital-based intravenous drug delivery systems into accessible, self-administered therapies.

Image credit: Shutterstock AI/Shutterstock.com

BioOrbit is a UK-based space-driven biotechnology startup addressing a critical challenge in pharmaceutical manufacturing: developing high-concentration, low-viscosity biologic formulations suitable for subcutaneous delivery. The company is focused on enabling the production of colloidal crystalline suspensions of monoclonal antibodies (mAbs) that maintain high concentration while reducing viscosity, a key barrier to subcutaneous administration.¹

The company’s approach is based on a well-documented principle that protein crystallization in microgravity yields, in many experimentally observed cases, larger, more uniform, and higher-purity crystals than those produced under terrestrial conditions. These improvements arise primarily from reduced buoyancy-driven convection and sedimentation, which allows diffusion-dominated mass transport during crystal growth. If implemented at a large scale, this technology could revolutionize cancer therapy by allowing patients to self-administer treatments via subcutaneous injection instead of relying on hospital-based intravenous infusions.^2,3

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The Biologics Delivery Problem

Biological therapeutics have become a cornerstone of modern medicine, enabling targeted intervention across a range of complex diseases. Monoclonal antibodies (mAbs) constitute a major class within this category, characterized by their ability to selectively bind disease-associated targets with high specificity. These large, structurally complex protein-based drugs are widely used to treat cancer and autoimmune disorders.

Traditionally, mAbs are administered intravenously in clinical settings, requiring repeated infusions over extended treatment cycles, which puts greater strain on healthcare resources, increases expenses, and causes inconvenience for patients. These treatments are commonly administered at approximately 3-week intervals and may continue for months or years, depending on the indication.¹

Subcutaneous delivery offers a more practical alternative by enabling self-administration and improving compliance. However, this transition is limited by small injection volumes, typically around 2 mL, and the high viscosity of concentrated mAb formulations, which restricts injectability and affects stability. Viscosity increases sharply at concentrations above ~100 mg/mL, complicating formulation development for therapeutic doses typically in the 150–200 mg range.¹

Protein crystallization offers a promising solution to these limitations. Crystalline suspensions have lower viscosity than concentrated solutions, allowing therapeutic doses to be delivered in small injection volumes, like insulin. For example, crystalline mAb suspensions have demonstrated dramatically lower viscosity compared to equivalent solution formulations at similar concentrations. However, producing mAb crystals with consistent size, uniformity, and purity remains challenging under terrestrial conditions, where environmental disturbances disrupt controlled crystal growth.¹

BioOrbit's Approach: Relocating Drug Manufacturing to Space

The Microgravity Advantage

BioOrbit plans to utilize the microgravity environment of space to enable controlled crystallization of protein therapeutics for improved drug formulation.

In this environment, microgravity suppresses terrestrial forces, providing a quiescent environment where mass transport is dominated by slow diffusion, enabling more uniform access of monomeric proteins to crystal surfaces. The absence of gravity-driven convection eliminates density-driven fluid motion, reducing impurity incorporation and enabling more stable crystal growth conditions. This limits impurity incorporation and promotes steady, ordered growth, resulting in crystals with greater size, uniformity, and purity, as well as improved structural and optical properties.^2,3

Experimental evidence from multiple spaceflight missions shows that crystals grown in microgravity often exhibit improved diffraction quality, reduced defect density, and enhanced morphological uniformity, although results remain protein-dependent. The suspension of proteins during crystallization further supports the formation of highly ordered lattice structures with fewer defects.²

These conditions also improve solubility, stability, and consistency, supporting more efficient drug delivery and enabling formulations suited for subcutaneous administration. Microgravity-grown crystals can also exhibit altered polymorphs and improved physicochemical properties compared to Earth-grown equivalents.¹

Building on Decades of Research

The concept of microgravity crystallization is not new. Early research during the Space Shuttle and Mir programs demonstrated that protein crystals grown in microgravity possess higher quality than those produced on Earth. The International Space Station has since become a platform for over 500 protein crystal growth experiments by drug companies, NASA, and academic institutions.⁵

Several studies have demonstrated the advantages of space-based crystallization for improving crystal properties such as uniformity, solubility, and injectability, as well as enabling higher-resolution structural analysis through improved X-ray diffraction data, as exemplified by MSD’s collaboration with the ISS National Laboratory to generate crystallized pembrolizumab.² 

Notably, space-based crystallization of pembrolizumab demonstrated improved particle homogeneity and reduced viscosity in crystalline suspensions compared to Earth-grown controls, supporting its potential for subcutaneous delivery.⁴

Despite these advances, translating microgravity crystallization into commercially scalable pharmaceutical production has remained challenging due to the lack of manufacturing infrastructure capable of producing pharmaceutical-grade crystals at scale.^3,6

From Research to Scalable Manufacturing Infrastructure

BioOrbit aims to bridge the gap between microgravity crystallization research and scalable pharmaceutical production by combining advances in launch and re-entry technologies with its proprietary crystallization platform.

The platform will enable automated, continuous protein crystallization at scales up to hundreds of kilograms, maintaining consistent crystal quality, uniformity, and reproducibility across production volumes required for industrial pharmaceutical manufacturing. This aligns with emerging in-space manufacturing approaches using automated, microfluidic, and lab-on-chip systems for controlled crystallization in orbit.^1,7,8

BioOrbit has already begun advancing its platform through early mission activities. In 2025, BioOrbit partnered with The Exploration Company (TEC) to launch its first experiment into space, testing the survivability of protein crystals under the harsh conditions of re-entry. The data from this mission is being used to refine a next-generation system for a 2026 launch, supporting the company’s long-term goal of developing a full-scale pharmaceutical factory in orbit within the next decade.^9,10

In addition, it has received support through a world-first regulatory framework established in March 2026 by the UK government and the Medicines and Healthcare products Regulatory Agency (MHRA) for the approval and safety testing of space-manufactured drugs. This framework includes regulatory sandboxes, case studies, and supply chain engagement to support the commercialization of in-orbit manufacturing.⁶

This milestone supports BioOrbit’s planned pre-clinical trials of microgravity-grown monoclonal antibodies and advances the integration of orbital manufacturing into mainstream pharmaceutical development.¹¹

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Commercial Implications for the Pharmaceutical Industry

The global monoclonal antibody market is a rapidly expanding segment of the biopharma industry, primarily driven by oncology therapies.

BioOrbit’s platform could produce high-quality monoclonal antibody crystals in microgravity, enabling improved formulations for subcutaneous delivery of cancer treatments and other biologics. By precisely controlling crystal size and uniformity, the technology facilitates self-administration, reducing dependence on hospital-based IV infusions and improving accessibility for patients in remote or immunocompromised settings.

For pharmaceutical companies, this approach can lower healthcare costs, enhance patient adherence, extend the commercial lifecycle of existing biologics, and support scalable production of premium-quality protein drugs with precision beyond terrestrial capabilities. Crystalline formulations may also enable longer circulation times and modified pharmacokinetics, potentially reducing dosing frequency.^1,3,7

Challenges Ahead

BioOrbit’s space-based pharmaceutical manufacturing faces intertwined challenges across technical, regulatory, and commercial domains.

The company must navigate a fragmented regulatory landscape, with the UK providing initial guidance but no established global framework, necessitating engagement with multiple agencies and development of novel validation and traceability protocols.

Simultaneously, pre-clinical and clinical studies are essential to demonstrate that microgravity-grown crystals consistently translate into therapeutic improvements. Additionally, experimental variability and the fact that not all proteins benefit equally from microgravity crystallization introduce scientific uncertainty. Logistical complexities, including launch schedules, cold-chain maintenance, and the safe return of crystalline material at commercial scale, must also be addressed.²

Furthermore, limited real-time observation of crystallization in orbit introduces uncertainty, as structural transformations may occur during growth or re-entry, requiring robust monitoring and process control strategies. Many experiments remain “black box” processes with limited in-situ observation, complicating the interpretation of results.⁴

An Emerging Orbital Manufacturing Ecosystem

BioOrbit’s platform addresses the growing demand for high-concentration subcutaneous biologics by leveraging the expanding in-space manufacturing infrastructure.

However, the company is not operating in isolation, as the broader in-space manufacturing sector has gained significant momentum. For example, Varda Space Industries successfully produced an HIV therapy, ritonavir, in microgravity and returned it to Earth, demonstrating the technical and logistical feasibility of orbital pharmaceutical manufacturing.¹²

This progress reflects a maturing orbital manufacturing ecosystem, where declining launch costs, enhanced re-entry capabilities, and an increasing mission cadence are making space-based drug production increasingly practical and commercially viable. Industry estimates suggest that microgravity-grown crystals have a high probability of improved structural quality compared to Earth-grown equivalents, though outcomes remain system-specific.⁵

While the scientific foundation is established and the commercial rationale compelling, the scalability, regulatory compliance, and integration of orbital manufacturing into pharmaceutical supply chains remain crucial to realizing routine space-based biologics production.

References and Further Reading

1. Amselem, S., Kogan, D., Loboda, O., Levy, A., Feuchtwanger, Y., & Bavli, D. (2024). Monoclonal Antibodies from Space: Improved Crystallization Under Microgravity During Manufacturing in Orbit. Journal of Exploratory Research in Pharmacology, 9(2), 96–105. DOI:10.14218/jerp.2023.00020, https://www.xiahepublishing.com/2472-0712/JERP-2023-00020
2. Yu, Y., Li, K., Lin, H., & Li, J. C. (2018). The Study of the Mechanism of Protein Crystallization in Space by Using Microchannel to Simulate Microgravity Environment. Crystals, 8(11). DOI:10.3390/cryst8110400, https://www.mdpi.com/2073-4352/8/11/400
3. Mulligan, M. K., Tuma, S., Mullins, S., Savin, K. A., & Wilson, A. (2025). Protein Crystallization in Microgravity: Commercialization and the Next Chapter. Current Stem Cell Reports, 11(1). DOI:10.1007/s40778-025-00248-z, https://link.springer.com/article/10.1007/s40778-025-00248-z
4. McPherson, A., & DeLucas, L. J. (2015). Microgravity protein crystallization. NPJ microgravity, 1, 15010. DOI:10.1038/npjmgrav.2015.10, https://www.nature.com/articles/npjmgrav201510
5. Ana Guzman. (2023). Crystallizing Proteins in Space Helping to Identify Potential Treatments for Diseases. https://www.nasa.gov/missions/station/iss-research/crystallizing-proteins-in-space-helping-to-identify-potential-treatments-for-diseases/
6. Space Insider. (2025). Charting the Space Biotech Landscape: A Look at the Industry’s Key Players and Emerging Trends. https://spaceinsider.tech/2024/06/17/charting-the-space-biotech-landscape-a-look-at-the-industrys-key-players-and-emerging-trends/
7. BioOrbit. (2026). BioOrbit: The Hospital to home via space. https://www.bioorbit.space/
8. UKSpace. (2026). BioOrbit. https://www.ukspace.org/sme-member/bioorbit/
9. Space Biotech Hub. (2026). BioOrbit. https://spacebiohub.com/companies/bioorbit
10. UK Parliament. (2024). Life Sciences: Stevenage - Hansard - UK Parliament. Parliament.uk. https://hansard.parliament.uk/Commons/2024-10-16/debates/4FC63FCA-177E-47B7-B6D4-E84A29F64E0C/LifeSciencesStevenage#contribution-8CCB51F9-AB6E-4E77-9C03-49E0F4C3E48F
11. Saša Janković. (2026). Regulators set out support for in-orbit pharmaceutical manufacturing. https://pharmaceutical-journal.com/article/news/regulators-set-out-support-for-in-orbit-pharmaceutical-manufacturing
12. Giles Sparrow. (2024). The next generation of drugs could be made in space. Here’s why. https://www.sciencefocus.com/space/space-labs-drugs

Last Updated: Apr 16, 2026