The mRNA product can be purified by using affinity chromatography capturing the PolyA tail of the full-length mRNA molecules, and other chromatography and filtration techniques to reduce process related impurities.
The mRNA Therapeutics Boom
Plan for operation efficiency: Process liquids and buffers
Plasmid production is performed by microbial fermentation using a fermenter to produce large quantities of DNA plasmid template. The plasmid DNA is then purified and tested for purity, quality and identity.
Streamlining the Plasmid DNA Manufacturing
Learn More About Residual Host Cell DNA Quantitation
Supercoiled plasmid DNA is linearised by restriction enzymes before mRNA synthesis. In vitro transcription (IVT) creates mRNA from linearised DNA template in an enzymatic reaction
Watch the in vitro transcription and post transcriptional modifications animation
Quality control takes place across the workflow to ensure high quality production. The purified mRNA is characterized at the molecular level to verify sequence and identify modifications. The lipid nanoparticle (LNP) component of the mRNA vaccine or therapeutic is also characterized to verify lipid identity and composition and to profile any impurities
Analytical solutions for mRNA vaccines and therapeutics
Once the mRNA and excipients have been purified and analysed, they are ready for final formulation. The mRNA complex is processed into the finished vaccine or therapeutic, sterilized, and aseptically packaged in vials. The filled vials undergo final testing and are loaded into ultra-low.
Infographics from mRNA encapsulation to shipping