mRNA Purification: Technology Aspects and Impurities TFF, Chromatography, UF/DF (Resins, Magnetic Beads, Monoliths)

Abstract

m RNA VACCINE production like other biopharmaceutical need various purification stages in the manifacturing process. In this process are used techniques like: (TFF) tangential flow filtration followed by different chromatographic procedure (affinity and ion exchange separation) with various kinds of resin and then UF/DF technique (Ultrafiltration-diafiltration). So it is of interest to verify that the materials used for this kind of procedure is solid phases or for the membrane and if released impurity in the final product. For Silica-based Reversed-Phase packing’s, a carbon load percentage indicates the amount of functional bonded phase attached to the Silica-base material. Aim of this work is to investigate the role played by these characteristics in the separation process of mRNA. Because this parameter influence the retention time it is interesting to evaluate the use in separation technique of biopharmaceuticals and this also is for the carbon coated silica columns. Silica gel for chromatography can be produced by systemic process but also form Rice treated at high temperature. What kind of effect can be played using an high level of carbon coated silica material on the final purified product? The graphitic particle can be found as impurity during the manufacturing process of these resins? And what is the role played by carbon (graphene-quantum dots) membrane as reported in various research application?