Asia BioPharma Industry Innovation Summit 2021

Manufacturing of clinical grade mRNA

Speaker: Ales Strancar, Managing Director

Key points:

The recently demonstrated efficacy of mRNA-based Covid-19 vaccines has shown promise of this therapeutic format, but also highlighted the need for higher efficiency of mRNA production to meet enormous needs for global vaccine supply.

Typical mRNA production process involves three key steps: 1) plasmid DNA (pDNA) production in supercoiled (sc) isoform, linearization and purification, 2) in-vitro transcription (IVT) reaction and 3) mRNA purification.

Here we present a chromatographic toolbox and mRNA IVT synthesis for integrated mRNA production from pDNA to mRNA purification, including in-process analytics.

This high yield process reduces the overall number of purification steps required, improves recoveries, results in extra low protein impurity and allows for very efficient dsRNA removal.

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