LaScaRNA - Large Scale Production of mRNA for Therapeutic Applications
| Reference number | |
| Coordinator | Region Stockholm - Karolinska Centrum för Cellterapi |
| Funding from Vinnova | SEK 5 000 000 |
| Project duration | February 2022 - February 2026 |
| Status | Completed |
| Venture | Next-Generation Biologics 5 |
| Call | New and improved biological drugs in healthcare |
Important results from the project
The project´s goals were met by the establishment of SOPs for mRNA production and LNP-formulation and demonstration of scalable mRNA production. LaScaRNA also contributed to the establishment of a platform for production and analysis of mRNA–LNP, open to external users. Analytical capacity was established, GMP-compliant reagents were qualified, and experience at several scales was gained. The work led to increased competence, better processes and important knowledge for future development.
Expected long term effects
The project strengthens Sweden´s capacity in the area of mRNA-based drugs and vaccines. The network that has been built are strategically important for the area. The established platforms and technologies enable faster development of RNA-therapies. Together with the Vinnova project Nucleodry, the entire mRNA value chain is now covered and can contribute to future clinical studies. The project is also expected to contribute to an increased national preparedness for mRNA-based drug manufacturing.
Approach and implementation
The work went from small-scale tests to scale-up of reaction volumes. Reagents and process steps for mRNA and plasmid manufacturing were evaluated for stability and yield, which provided insight into critical parameters at increased scale. A platform has been established and is ready for further refinement. New preclinical vaccine candidates are being tested in vivo, demonstrating that the mRNA–LNP process is robust. Additional resources are required to fully establish GMP production.