mRNA Process Development & Manufacturing Europe

Development of In-Process Analytics to Enable Robust mRNA Manufacturing

Speaker: Ales Strancar, Managing Director of Sartorius BIA Separations 

Abstarct:
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 this paper a chromatographic toolbox and optimised IVT synthesis, including instant in-process analytics, will be presented.
This well controlled and high IVT yield process reduces the overall number of purification steps, improves recoveries, results in extra low protein and dsRNA impurity levels and allows for rapid scale-up and straightforward tech transfer to different manufacturing sites.

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