Overcoming mRNA medicine supply hurdles: distributed, continuous and multi-product mRNA manufacturing in a box at high quality and low cost

There is a growing need for solutions to develop and manufacture high-quality, safe, and effective mRNA medicines in a disease-agnostic manner. Key barriers including scalability, high production costs, and limited access to GMP-compliant facilities lead to inequitable global access to mRNA medicines. To address these challenges, our team has been innovating and digitalizing mRNA medicines production processes, by: developing continuous flow IVT, continuous purification, and continuous LNP encapsulation processes; developing novel cost reduction strategies; developing advanced analytical methods; employing computational modeling to characterize a robust quality-by-design design space, guide process development, monitor the process (via soft sensors), and enable advanced automation (via digital twins). These innovations are being integrated into a GMP-compliant RNA-production platform process in a box: RNAbox™. This will provide rapid access to this transformative technology and enable the distributed, rapid production of high-quality, low-cost medicines to combat a wide range of diseases.