Identifying Oligonucleotide Impurities and Metabolites With High-Resolution Mass Spectrometry

With the rapid increase in the development of oligonucleotide therapeutics and gene therapies, workflows for the identification, characterization and quantification of full-length products, their impurities and metabolites, are critical. High-resolution time-of-flight mass spectrometry (TOF-MS) can be used for this analysis offering several advantages over ligand-binding assays or fluorescence-based liquid chromatography. Notably, TOF-MS can provide simultaneous identification and sequence confirmation for drug substances as well as impurities/metabolites.

In this webinar, a novel LC-MS/MS Q-TOF instrument (ZenoTOF 7600 system, SCIEX) equipped with a patented ion trap will be applied to the acquisition of highly modified oligonucleotides. Furthermore, the advanced data processing capabilities of a novel software application (Molecule Profiler software, SCIEX) will be demonstrated for their ability to enable identification and relative quantification of synthetic impurities as well as metabolites of oligonucleotide therapeutics.