A (RP)UHPLC/UV analytical method to quantify dsRNA during the mRNA vaccine manufacturing process.
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ABSTRACT:
SUBMITTER: Rosa SS
PROVIDER: S-EPMC11293613 | biostudies-literature | 2024 Aug
REPOSITORIES: biostudies-literature
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A (RP)UHPLC/UV analytical method to quantify dsRNA during the mRNA vaccine manufacturing process.
Rosa Sara Sousa SS Zhang Shuran S Sari Yustika Y Marques Marco P C MPC
Analytical methods : advancing methods and applications 20240801 30
dsRNA is a product related impurity produced during the mRNA manufacturing process. The established immuno-based detection methods lack the flexibility and speed required to be applied throughout the manufacturing process. The RP-HPLC method developed outperforms these in terms of precision, broader detection range, LOD and LOQ, as well as in output variance. Using this method, dsRNA can be quantified in under 30 min for a single sample. ...[more]
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