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. The PATfix® mRNA Platform paired with CIMac PrimaS® columns, was crucial for at-line analytics, enabling precise tracking of mRNA production and nucleotide consumption. This combination ensured accurate monitoring and control, guiding feed timing and reaction end-points while maintaining the integrity and quality of the mRNA produced.
In combination, the Biostat RM, the PATfix® mRNA Platform, and the CIMac PrimaS® chromatographic column provide a robust, scalable, GMP-ready solution that increases yields and offers clear process insight.
