演題概要

2P-17

PDF

オリゴヌクレオチド医薬品のバイオアナリシスの自動化および標準化を可能にする新たなキットベースのサンプル前処理ワークフロー

(¹日本ウォーターズ・ ²ウォーターズ)
^o押方基二¹・ 今奥麻実子¹・ Tanna, Nikunj²・ Trudeau, Mary²・ Lee, Margot²

Oligonucleotide Therapeutics (ONTs) are a key modality for drug development today given their powerful ability to address disease biology at the level of gene transcription and translation, and for their high target specificity and low toxicity. As the pipeline for ONTs continues to expand, so does the need for sensitive, accurate, and robust bioanalytical assays to support this drug development. LC-MS is a widely accepted technology for bioanalysis because of the performance of the technologies (i.e., sensitivity, selectivity, and linear dynamic range). However, the greatest source of variability for these assays arises from the sample preparation, and this is especially true for oligonucleotide. To this end, a simple, broadly applicable sample preparation workflow for ONTs that reduces the need for method development and brings greater consistency and reproducibility to LC-MS bioanalytical results is therefore highly desired. The OligoWorks™ SPE Microplate Kit (OligoWorks Kit) from Waters has been designed with this in mind. This work uses the OligoWorks Kit components and standard protocol automated on the Andrew+ Pipetting Robot to successfully extract a diverse range of ONTs from plasma and achieve accurate, robust, and reproducible bioanalytical performance, with little to no need for method development.