Process development for effective mRNA vaccine synthesis and purification

Offentlig prosjektsammendrag

The world has recently gone through a serious pandemic, where mRNA vaccines became the successful weapon to fight the disease. The use of mRNA as a therapeutic is expanding to different disease areas like oncology, rare diseases, replacement therapies in addition to infectious diseases. These areas have very different needs when it comes to volume, dose, purity etc. To bring mRNA therapeutics to the next level, there are several challenges that need to be solved. Target screening needs to be simplified, target sequences need to be optimized to increase stability and expression level in vivo and thereby reduce the dose needed. This requires automated high throughput solutions and new analytical methods. Scale up of the manufacturing process must be flexible and cost needs to come down. The Dynabeads(TM) magnetic bead technology for mRNA synthesis and purification has the potential to meet all these needs. By immobilizing the template to beads we increase the purity already from the start and in several steps of the process. The technology is designed for automation and thereby simplifying target screening. Reduction of cost is achieved by reusability of the template in several in vitro transcription reactions, thereby reducing template production and antibiotics use, in addition to enabling production of increased amounts of RNA in a limited space. The technology is flexible, scalable and GMP-compliant. The process is however not completely optimized and there is room for improvement in every step. This is what we will address in the current project application.