mRNA Production in GMP-Compliant Biostat® RM Systems

The application note outlines a GMP-compliant in vitro transcription workflow for mRNA on the single-use Biostat RM with Flexsafe RM bags, demonstrating a smooth transfer from a thermal shaker. Scale-up from 100 µL to 100 mL achieved comparable final mRNA concentrations while maintaining control via defined rocking and pump settings. Switching to a fed-batch IVT strategy markedly increased productivity, reaching about 2 g final yield—more than double the batch process at similar scale. At-line process analytics with the PATfix® biochromatography system paired with an analytical column CIMac PrimaS® enabled tracking of mRNA formation and nucleotide consumption to guide feed timing and reaction end-points. In combination, the Biostat RM, the PATfix® analytical system, and the CIMac PrimaS® chromatographic column provide a robust, scalable, GMP-ready solution that increases yields and offers clear process insight.