New Dynabeads(TM) platform for mRNA vaccine GMP production manufacturing

Offentlig prosjektsammendrag

The ongoing COVID-19 pandemic has shown the world the urgent need for a simple, flexible and highly scalable production of mRNA for the development of vaccines against SARS-CoV-2. Development time is reduced due to the worldwide urgency of availability and the scaling up from research to industrialized volumes must be as simple and standardized as possible. The success of the mRNA vaccines, has proven the potential of the mRNA technology to also expand to other infectious diseases, cancer therapeutics and replacement therapy. Our magnetic bead technology, including solid-phase in vitro transcription and generic capture purification on carboxylic acid activated beads is a simple, scalable and flexible way to produce and purify mRNA. For use in clinical applications, there are high regulatory demands for documentation on both safety and performance. We are therefor developing a new Dynabeads magnetic bead platform, and two new Dynabeads products, a streptavidin conjugated bead for solid-phase in vitro transcription and a carboxylic acid activated bead for generic capture purification of mRNA. The beads are designed to be suitable as raw materials/ancillary materials for use in GMP manufacturing of mRNA vaccines. They will be in compliance with ISO13485 and ISO20399, and delivered with regulatory support documentation. Manuals for a complete workflow with performance data and analytical data on mRNA yield, integrity and purity from different bioprocessing alternatives, will be developed.