2nd Annual mRNA-Based Therapeutics Summit
Chromatographic tools in an mRNA process: from analytics to purification
Speaker: Tomas Kostelec, Product Manager, mRNA
Demand for mRNA as therapeutic modality has increased drastically owing to its successful use as vaccine during the Covid-19 pandemic. 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. Some of the technical challenges faced in large scale manufacturing can have an important impact on the economics of mRNA. Chromatographic solutions to support mRNA manufacturing are discussed here:
- Rapid, at-line HPLC assays for in-process monitoring of the IVT reaction can support optimisation of yields, and development of fed-batch IVT reactions, to lower reagent consumption
- Non polyadenylated RNA requires and alternative to affinity chromatography with CIM® Oligo dT18. Purification of non-polyadenylated RNA using different multimodal chromatographic solutions with different ligands is discussed in this talk.