TIDES Expert Opinion Webinar Series

Chromatography in mRNA Production: From Analytics to Purification

Speaker: Rok Sekirnik, Head of Process Development, mRNA/pDNA 

Abstract:

The recently demonstrated efficacy of mRNA-based Covid-19 vaccines has shown the promise of this therapeutic format, but also highlighted the need for higher efficiency of mRNA production to meet enormous needs for global vaccine supply. The production process typically involves 10-15 steps including plasmid production, plasmid linearization, an in vitro transcription (IVT) reaction, mRNA purification, and lipid nanoparticle (LNP) production. This webinar will discuss the versatility of chromatography as applied to mRNA production, starting with the purification of the key raw material (plasmid DNA) to final polishing of mRNA drug substance. Utilizing multiple attributes of mRNA (charge, hydrophobicity, size, polyadenylation) and suitable design of chromatographic supports, chromatography can be applied to increase yield and purity at preparative scale for selective mRNA capture (by affinity or charge) and removal of key contaminants (e.g. dsRNA). Compared to traditional analytical approaches, chromatography  can also be used to  increase the throughput and information output of analytical testing by simultaneously determining mRNA, NTP, capping reagent content throughout the process (including during IVT) and monitoring of critical quality attributes (e.g. capping efficiency, dsRNA). 

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