Quantitative Assessment of mRNA Drug Biological Activity by Cell-Based Assays

Biological activity of mRNA drugs, historically assessed via animal study, is critical to drug development, mechanistic evaluation of drug candidates, and as a manufacturing critical quality attribute (CQA). However, animal testing is costly, time-consuming and presents a significant environmental impact highlighted by the recent passing of Bill S.5002 - FDA Modernization Act 2.0 which aims to mediate the ecological impact of drug discovery and development by reducing animal use. The aim of this study is to develop quantitative assessment of mRNA drug biological activity by cell-based Assays.

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