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Optimisation of a Quality Control Method for Identity, Purity and Quantity for Oligonucleotide Therapeutics

Thomas Franz, Steven A. Watt, Rita Beel, Lejon Martens

Full-length messenger ribonucleic acid (mRNA) based vaccines came into fame in the aftermath of the 2019 coronavirus outbreak, which has rapidly developed into a global pandemic. The two mRNA vaccines developed by Moderna and BioNTech/ Pfizer were the first mRNA therapeutics to be granted an Emergency Use Authorization by the EMA and US-FDA and proved to be safe and efficacious treatments against COVID infection. In this application note, A&M STABTEST wants to present an LC MS-based platform method for the determination of the identity, purity and quantity of oligonucleotides and which parameters are worth investigating to optimise the method in terms of chromatographic resolution of impurities.