How Much Do You Know About mRNA Impurities?

mRNA impurities need to be removed to achieve high potency and safety throughout the production process. mRNA production begins with plasmid DNA, which then needs to be linearized. Following linearization, it goes through the in-vitro transcription reactor, and then it is buffered and loaded into affinity chromatography capture step followed by the chromatography polishing step. Finally, it undergoes ultrafiltration to result in the final product of mRNA. Many of these impurities can be linked to the in-vitro transcription (IVT) reactor step.

The unreacted reagents in the IVT step may include nucleotides, enzymes, or plasmid DNA, which are impurities. Impurities can also be byproducts, such as dsRNA (double stranded RNA), short mRNA, and mRNA aggregates. Additionally, impurities may come from the source of the reagents; host cell DNA and RNA are examples of these impurities.

Impurities may be process-related or product-related in mRNA production. Process-related impurities are related to the manufacturing process, which can include the previously mentioned host cell DNA. Product-related impurities can include the mRNA aggregates or molecular variants of the desired product.

Purilogics develops various membranes for mRNA purification; we have OdT membranes for mRNA capture-step. Our Hydrophobic Interaction Chromatography (HIC) membranes can be used in the polishing step of mRNA purification.

If interested, please contact us at bd@purilogics.com or +1(864) 455-1457.