There is currently significant demand for the development of new and improved analytical methods for the characterization of mRNA therapeutics. We have developed an automated, high-throughput workflow for the rapid characterization and direct sequence mapping of large RNA and mRNA molecules. Multiple innovations were developed to overcome challenges in digestion, oligonucleotide separation and identification. Comprehensive sequence coverage for a range of large RNAs and mRNAs is routinely obtained in a single analysis. The ability to rapidly identify, characterize and sequence map large mRNA therapeutics with high sequence coverage provides important information for identity testing, sequence validation and impurity analysis.
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