Sartorius Stedim Biotech, a leading international partner to the biopharmaceutical industry, has signed a Memorandum of Understanding (MoU) with Sensible Biotechnologies to advance the industrialization and scale-up of Sensible's first-in-class cell-based platform for mRNA manufacturing. The collaboration aims to enable clinical-grade production of cell-based mRNA by 2026 and unlock the next generation of mRNA medicines.
Revolutionary Cell-Based mRNA Production Platform
Sensible Biotechnologies has developed what it describes as the first cell-based platform for the design, optimization, and manufacturing of highly functional, low-immunogenicity mRNA. This approach represents a departure from traditional mRNA manufacturing methods, promising to deliver mRNA with unprecedented purity and performance required for therapeutic applications.
"This partnership is a critical milestone in Sensible's journey to deliver first-in-class clinical-grade mRNA manufactured in living cells with unprecedented purity and performance, which is required for therapeutic applications of mRNA," said Miroslav Gašpárek, Sensible's CEO and co-founder.
Comprehensive Manufacturing Support and Global Expansion
As part of the agreement, Sartorius Stedim Biotech has already provided significant support through advanced equipment and consumables. The partnership will extend to process development, closed-system facility design, and technical support to rapidly establish Sensible's GMP-compliant mRNA production capabilities.
These activities will enable Sensible to expand production from its current base in Slovakia to the US, UK, and broader Europe. The collaboration reflects both companies' commitment to enabling scalable, high-quality mRNA manufacturing worldwide.
Industry Impact and Future Implications
Dr. René Fáber, CEO of Sartorius Stedim Biotech, emphasized the disruptive potential of the technology: "We are excited to support Sensible in scaling a disruptive, cell-based approach to mRNA production. We believe that Sensible's unique platform will deliver mRNA with the superior quality needed for emerging mRNA therapeutics, while also supporting a more resilient and flexible biomanufacturing ecosystem in Europe and globally."
Gašpárek highlighted Sartorius Stedim Biotech's established role in the biologics manufacturing sector: "Sartorius Stedim Biotech has played a vital role in enabling global biologics manufacturing - from vaccines to gene therapies - and we are honoured to work with them to build the industrial backbone to unlock the next generation of mRNA therapeutics."
Company Backgrounds and Investment
Sensible Biotechnologies, based in the US, UK, and Slovakia, has raised more than $13 million from leading investors including Onsight Ventures, founded by BioNTech and ARM co-founders Christoph Huber and Hermann Hauser. The company is positioning itself as a pioneer in cell-based design and manufacturing of mRNA therapeutics.
The MoU also outlines potential areas for deeper collaboration, indicating that this partnership may expand beyond the initial scope as both companies work to establish a new paradigm in mRNA manufacturing technology.
