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Day 1, June 10(Mon.) Room P1 (Multipurpose Hall)・Room P2 (Conference Room 101+102)
- 1P-16
mRNA Critical Quality Attribute Analysis Using a UPLC-TOF MS System and Customized Software
(1Nihon Waters, 2Waters)
oMaki Terasaki1, Etsuko Yada1, Kenji Hirose1, Rebecca D'Esposito2, Catalin Doneanu2, Ying Qing Yu2
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.