ポスター：核酸医薬品のハイスループット同一性試験を可能にする全自動サンプル別データワークフロー

CASSS-MS 2023, Chicago, IL, USA
September 5, 2023

核酸医薬品には、高度な解析・特性解析・定量化手法による、厳格な品質管理と不純物同定が求められます。本ポスターでは、質量分析による核酸医薬品のハイスループット同一性試験を可能にした、データ処理・解析・レポーティングまでの全自動ワークフローを紹介しています。

Nucleic acid-based biotherapeutics and vaccines comprise diverse modalities such as mRNA, siRNA, antisense oligos (ASOs), and CRISPR/Cas, and offer many outstanding therapeutic characteristics (high specificity, functional diversity, easy adjustment). Although oligonucleotides are comparable to small-molecule pharmaceuticals, their complex structures and multistep synthesis processes often lead to the generation of impurities and degradation products. Consequently, oligonucleotide drugs require stringent quality control and impurity identification, with advanced methods for analysis, characterization, and quantitation. We present a fully automated data processing, analysis, and reporting workflow enabling high-throughput identity testing of oligonucleotide therapeutics.

We present a fully automated data processing workflow capable of processing MS data from any instrument that enables sample-specific identity confirmation of thousands of oligonucleotide therapeutics per day.