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Poster Presentations
Day 1, June 10（Mon.） Room P1 (Multipurpose Hall)・Room P2 (Conference Room 101+102)
- 1P-46
Rapid Profiling of Impurities in Synthetic Oligonucleotides Using a Semi-Automated Data Analysis Workflow with TOF-MS
(1Nihon Waters, 2Waters)
oEtsuko Yada1, Maki Terasaki1, Kellen Delaney2, Jo-Anne Riley2, Jonathan Fox2, Heidi Gastall2, Laetitia Denbigh2, Ying Qing Yu2, Nick Pittman2, Scott Berger2, Kenji Hirose1
Nucleic acid therapeutics have gained substantial interest in recent years. Synthetic oligonucleotides are a class of nucleic acid therapeutics that are attractive for their ability to selectively target specific genes. While oligonucleotides are synthesized, they can introduce impurities that may affect their safety and efficacy. As the length and complexity of the synthetic oligonucleotide increases, the complexity of the impurity profile also increases.
We developed impurity workflow using ion pair reversed chromatography mode Ultra-performance chromatography-time of flight mass spectrometer (UPLC-TOF MS) and an integrated informatics platform was developed to streamline oligonucleotide analysis. The workflow automated several data review steps to expedite data analysis, such as system suitability checks, injection repeatability evaluation, calibration curve generation, and soft-vs-harsh ionization comparison. To detect and quantify impurities in Nusinersin, a component list containing the full-length product (FLP) and 16 impurities was imported into the analysis method. Report templates were created to distill the large volume of information into a simplified document that summarizes the key information from each analysis. The complete workflow reduced data analysis time from hours to minutes and is readily amended for different synthetic oligonucleotides and impurity lists without LC-MS expertise.