Abstract

Table of contents

Poster Presentations

Day 3, June 24（Fri.）　　Room P (501, 502 and 503)

3P-12　　PDF

CONFIRM Sequence: A New Software Tool for Sequence Confirmation and Impurity Analysis of Synthetic Oligonucleotides

(¹Nihon Waters, ²Waters)
^oMaki Terasaki¹, Etsuko Yada¹, Ryotaro Hirabayashi¹, Catalin Doneanu², Matthew Gorton², Chris Knowles², Ian Morns², Chris Preston², Ian Reah², Mike Broughton², Simon Jones², Jonathan Rewcastle², Rory Mullins², Karmonas Edvinas², Paul Henesey², Townsley David², Dave Jackson², Pete Reay², Gavin Hope², Emma Harry², Jonathan Fox², Jo-Anne Riley², Henry Shion², Joe Fredette², Ying Qing Yu², Kenji Hirose¹

Synthetic oligonucleotides have emerged in recent years as a powerful alternative to small molecule and protein therapeutics. Manufacturing and quality control of oligonucleotide therapeutics requires highly selective and sensitive LC-MS methods for impurity sequencing and quantification. The most often used mass spectrometry-based method for oligonucleotide analysis has been reversed-phase chromatography employing a variety of ion-pairing reagents and modifiers in negative ESI-MS mode (IP-RP LC-MS). One critical step for identification of oligonucleotide impurities is mass spectrometry based sequencing and data interpretation. Here we introduce a novel software suite – CONFIRM Sequence, developed for fast processing of both MS/MS and MS^E (no specific precursor selection) mass spectra recorded by IP-RP LC-MS for a chemically modified oligonucleotides and a variety of impurities.