Walking through the mRNA manufacturing process – and its many challenges

By Catherine Jomary

The groundwork of over three decades of mRNA research laid the foundations for the successful manufacture of the mRNA-based vaccines for SARS-CoV-2 – the first commercial realization of the technology. Going forward, mRNA technology will not only help the development of other vaccines for infectious diseases, but also address non-viral gene and cell therapy applications for diseases with unmet needs. The strong safety benefit of mRNA resides in the fact that it does not integrate into the human genome.

The process of producing mRNA from a DNA template is cell-free and scalable, but plasmid DNA (pDNA) manufacturing requires microbial fermentation. Even synthetic DNA synthesis requires pDNA as the starting material. The full manufacturing process from DNA template to mRNA encompasses three main stages.

Read the full article on The Medicine Maker website.