2nd mRNA - Based Therapeutics Summit Europe

Connecting the mRNA production process with chromatography

Speaker: Tomas Kostelec, Product Manager mRNA

Abstract:
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. This presentation will discuss chromatographic solutions to support mRNA manufacturing:

• Using analytical HPLC solutions to improve IVT understanding, monitor production of mRNA, monitor purification unit operations, and develop new manufacturing strategies
• Purification of mRNA, including capture of non-polyadenylated mRNA with CIM® PrimaS multimodal chromatography. Exploring new multimodal ligands, solutions for dsRNA removal, and purification of self-amplified mRNA
• Implementation of high throughput screening devices such as 96-well plate for process optimisation and high throughput purification of mRNA

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