演題概要

1P-16

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UPLC-TOF MSシステムとカスタマイズされたソフトウェアを用いたmRNAの重要品質特性解析

(¹日本ウォーターズ・ ²ウォーターズ)
^o寺崎真樹¹・ 矢田絵都子¹・ 廣瀬賢治¹・ D'Esposito, Rebecca²・ Doneanu, Catalin²・ Yu, Ying Qing²

There has been a surge in the development of RNA based therapeutics and vaccines in the last decade. The recent development and approval of the two COVID mRNA-based vaccines has brought RNA-based therapeutics to the forefront of the biopharma industry. As such, development of analytical methods for monitoring the CQAs of RNA-based therapeutics has become a high priority for ensuring proper control of manufacturing processes. CQAs for nucleic acid therapeutics can include sequence confirmation, 5’ capping efficiency (mRNA) and structure, 3’ poly(A) tail heterogeneity (mRNA) analysis, localization of post transcriptional modifications (PTMs), and purity assessment of the active RNA product. This study presents UPLC-MS system and customized software to facilitate the CQA characterization of RNA molecules.