Scalable mRNA Machine for Regulatory Approval of Variable Scale between 1000 Clinical Doses to 10 Million Manufacturing Scale Doses

The production of messenger ribonucleic acid (mRNA) and other biologics is performed primarily in batch mode. This results larger equipment, cleaning/sterilization volumes, dead times compared to any continuous approach. Consequently, throughput lower capital costs are relatively high. Switching thus reduces the footprint also lowers cost goods (COG). During process development, from provision clinical trial samples plant, different plant sizes usually required, operating at parameters. To speed up this step, it would be optimal if only one with same equipment piping could used for all sizes. In study, an efficient solution old challenge manufacturing demonstrated, namely qualification validation a setup doses about 1000 scale-up 10 million doses. Using current example Comirnaty BNT162b2 mRNA vaccine, cost-intensive vitro transcription was first optimized so that yield 12 g/L achieved, then successfully transferred segmented plug flow reactor subsequent purification using ultra- diafiltration, which enables recycling costly reactants. realize automated control as well real-time product release, use appropriate analytical technology essential. will efficiently capture slug no loss occurs contamination fill-up phase <1%. Further work focus on release testing during campaign under autonomous operational control. Such efforts enable direct industrialization collaboration industry partners, their regulatory affairs, quality assurance. A scale-operation directly supported managed by data-driven decisions.