mRNA-based therapeutics and vaccines are considered major advances in the fight against infectious diseases, cancer, and genetic disorders. However, the rapid development and growing importance of these drugs place high demands on production and quality assurance. Traditional manufacturing processes are complex, time-consuming, and require numerous manual steps, which limits scalability and accessibility.
To address these challenges, the RNAuto project developed a modular production facility that enables the automated and fully digitally controlled manufacture of mRNA therapeutics. Quality control is performed continuously throughout the process, thereby largely eliminating interruptions and manual intermediate steps. The system also includes digital twins that virtually map all components and capture production data in real time. This allows manufacturing and quality parameters to be transparently documented and used to optimize future production cycles.
Particular emphasis was placed on encapsulating the sensitive mRNA in protective lipid nanoparticles, which are formulated, stabilized, and filtered using a continuous, automated process. This enables the safe and efficient delivery of the active ingredients and can be flexibly adapted to various bioprocesses and product variants.
With the successful completion of the project, a technology platform is now available that opens up new opportunities, particularly for developers and manufacturers of gene and cell therapies as well as vaccines. Regulatory requirements such as Good Manufacturing Practice (GMP) were taken into account during the development phase to ensure high standards of safety and quality.
Fraunhofer Institute for Experimental Software Engineering IESE