Fast In-Process Analytics to Enable Robust mRNA Manufacturing

Aleš Štrancar, Managing Director, Sartorius BIA Separations

Typical mRNA production process involves four key steps:
1) plasmid DNA (pDNA) expression in E.coli, linearization and pDNA purification, 2) in-vitro transcription (IVT) reaction, 3) mRNA purification and 4) mRNA encapsulation.

In the presentation given by Aleš Štrancar at the 2024 mRNA Technology Conference a chromatographic toolbox, optimised IVT synthesis and LNP quality, including instant in-process analytics, is presented.

This, by liquid chromatography, well controlled process reduces the overall number of purification steps, improves recoveries, results in extra low protein and dsRNA impurity levels and allows for more robust manufacturing.

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