Periodic Reporting for period 1 - SPACTORY (SPACTORY, revolutionising pharmaceutical development and manufacturing through microgravity)
Periodo di rendicontazione: 2024-08-01 al 2025-03-31
Pharmaceutical research and development face critical challenges in bringing innovative, effective therapies to market. Traditional drug development methods are often constrained by the limitations of Earth’s gravity, affecting the purity, stability, and overall efficacy of complex biological products such as monoclonal antibodies (mAbs). These constraints result in high costs, long development timelines, and frequent clinical trial failures. In this context, microgravity offers a transformative environment that can revolutionise how we design, test, and manufacture pharmaceuticals.
The SPACTORY project introduces a pioneering solution: the first fully automated, miniaturised drug manufacturing facility designed for operation in space. Leveraging microgravity and advanced lab-on-a-chip technologies, SPACTORY enables the production of high-value biological compounds with superior quality and performance. The facility, weighing only 24 kg and meeting ESA safety standards, is remotely operable and highly modular, making it suitable for current and future space missions, including those on the International Space Station (ISS).
SPACTORY’s overall objective is to validate and demonstrate space-based drug manufacturing with a focus on a target mAb molecule. The project’s pathway to impact includes adapting and qualifying the SPACTORY unit for spaceflight, executing a commercial demonstration mission, and engaging with pharmaceutical stakeholders to establish partnerships for market deployment. The ultimate goal is to open an entirely new frontier in pharmaceutical production, where space is not just a research domain but a platform for scalable, industrial-grade biomanufacturing.
This approach directly supports the European Union’s strategic ambitions in health innovation, technological sovereignty, and space commercialisation. By enabling the production of purer, more stable, and potentially more effective therapeutics, SPACTORY can improve treatment outcomes, reduce healthcare costs, and increase the resilience of medical supply chains. Additionally, the project contributes to the EU’s broader goals in sustainability and competitiveness by laying the foundation for a new industry at the intersection of space and life sciences.
The SPACTORY project introduces a pioneering solution: the first fully automated, miniaturised drug manufacturing facility designed for operation in space. Leveraging microgravity and advanced lab-on-a-chip technologies, SPACTORY enables the production of high-value biological compounds with superior quality and performance. The facility, weighing only 24 kg and meeting ESA safety standards, is remotely operable and highly modular, making it suitable for current and future space missions, including those on the International Space Station (ISS).
SPACTORY’s overall objective is to validate and demonstrate space-based drug manufacturing with a focus on a target mAb molecule. The project’s pathway to impact includes adapting and qualifying the SPACTORY unit for spaceflight, executing a commercial demonstration mission, and engaging with pharmaceutical stakeholders to establish partnerships for market deployment. The ultimate goal is to open an entirely new frontier in pharmaceutical production, where space is not just a research domain but a platform for scalable, industrial-grade biomanufacturing.
This approach directly supports the European Union’s strategic ambitions in health innovation, technological sovereignty, and space commercialisation. By enabling the production of purer, more stable, and potentially more effective therapeutics, SPACTORY can improve treatment outcomes, reduce healthcare costs, and increase the resilience of medical supply chains. Additionally, the project contributes to the EU’s broader goals in sustainability and competitiveness by laying the foundation for a new industry at the intersection of space and life sciences.
The SPACTORY project has advanced the development of the first in-space, modular pharmaceutical manufacturing facility through a combination of technical design, prototyping, and early-stage experimentation. The initial phase of the project focused on designing a flexible, modular production platform capable of supporting multiple drug manufacturing methodologies. This phase included the successful construction of a prototype of the core production chip—where the drug synthesis and crystallisation processes take place—marking a key technical milestone.
A critical part of the project's scientific work involved preparing and executing a space-based crystallisation experiment. This experiment, launched on 26 March 2025, was designed to test extreme crystallisation conditions in microgravity, specifically targeting the optimisation of a monoclonal antibody (mAb) formulation. While data from this mission is currently under analysis, it is expected to provide crucial insights into process refinement for future in-space production.
In parallel, the team has conducted a series of terrestrial experiments to develop and validate a robust crystallisation process for mAbs. One significant achievement is the successful crystallisation on Earth of a monoclonal antibody that had previously failed to crystallise using conventional techniques. This scientific breakthrough was enabled by the unique formulation and fluidics expertise developed as part of the SPACTORY initiative.
The current phase of the project focuses on further refining these processes based on the results of both ground and space-based trials. While integration of electronic, thermal, and fluidic subsystems is still in the design and feasibility stage, these foundational efforts lay the groundwork for upcoming
A critical part of the project's scientific work involved preparing and executing a space-based crystallisation experiment. This experiment, launched on 26 March 2025, was designed to test extreme crystallisation conditions in microgravity, specifically targeting the optimisation of a monoclonal antibody (mAb) formulation. While data from this mission is currently under analysis, it is expected to provide crucial insights into process refinement for future in-space production.
In parallel, the team has conducted a series of terrestrial experiments to develop and validate a robust crystallisation process for mAbs. One significant achievement is the successful crystallisation on Earth of a monoclonal antibody that had previously failed to crystallise using conventional techniques. This scientific breakthrough was enabled by the unique formulation and fluidics expertise developed as part of the SPACTORY initiative.
The current phase of the project focuses on further refining these processes based on the results of both ground and space-based trials. While integration of electronic, thermal, and fluidic subsystems is still in the design and feasibility stage, these foundational efforts lay the groundwork for upcoming
SPACTORY is the first fully autonomous, scalable drug manufacturing facility designed for operation in microgravity, without any human intervention. It goes far beyond existing solutions by combining advanced microfluidics, lab-on-a-chip integration, remote control, modularity, and compliance with NASA/ESA space safety standards.
The system enables high-precision crystallisation of monoclonal antibodies (mAbs), which has already led to a breakthrough: successful crystallisation on Earth of a mAb previously considered non-crystallisable. This sets the stage for improved drug purity, stability, and shelf life.
One of SPACTORY’s most impactful innovations is its potential to shift drug delivery from intravenous to subcutaneous injection. This would improve patient comfort, reduce hospitalisation costs, simplify cold-chain logistics, and lower overall healthcare system expenses.
The project is currently collaborating with a major pharmaceutical company to test SPACTORY on existing drugs, aiming to validate real-world applications.
To ensure broader uptake and success, key next steps include:
Further research on the quality and bioactivity of space-grown crystals
Additional in-orbit demonstration missions
Regulatory alignment with EMA/FDA standards
Commercialisation support and funding
Engagement with standardisation and certification bodies
These efforts will help position SPACTORY as a disruptive enabler of next-generation space-enabled biomanufacturing.
The system enables high-precision crystallisation of monoclonal antibodies (mAbs), which has already led to a breakthrough: successful crystallisation on Earth of a mAb previously considered non-crystallisable. This sets the stage for improved drug purity, stability, and shelf life.
One of SPACTORY’s most impactful innovations is its potential to shift drug delivery from intravenous to subcutaneous injection. This would improve patient comfort, reduce hospitalisation costs, simplify cold-chain logistics, and lower overall healthcare system expenses.
The project is currently collaborating with a major pharmaceutical company to test SPACTORY on existing drugs, aiming to validate real-world applications.
To ensure broader uptake and success, key next steps include:
Further research on the quality and bioactivity of space-grown crystals
Additional in-orbit demonstration missions
Regulatory alignment with EMA/FDA standards
Commercialisation support and funding
Engagement with standardisation and certification bodies
These efforts will help position SPACTORY as a disruptive enabler of next-generation space-enabled biomanufacturing.