Direct RNA sequencing - Accelerating GMP QC Testing of mRNA Therapeutics

The advent of mRNA in therapeutics has allowed more rapid engineering of targeted therapies, the safety and efficacy of which are dependent upon mRNA identity, integrity, and purity. The measurement of these mRNA critical quality attributes currently requires a panel of analytical methods, some of which require molecule-specific development. Lonza is collaborating with Oxford Nanopore Technologies to bring streamlined, multi-attribute methods into the cGMP environment. As platform methods that can measure multiple CQAs in a single assay with fast turn-around times and no upstream development, they will accelerate the optimization of mRNA manufacturing and the path to market of mRNA products.