IVT mRNA Encapsulation Efficiency Assessment Using Agilent Fragment Analyzer Systems

In vitro transcribed (IVT) mRNA has emerged as a groundbreaking biotherapeutic platform that offers innovative solutions for various medical applications. Given the complex and unique nature of IVT mRNA molecules, it is crucial to conduct thorough quality assessments at various stages of the development workflow to ensure the successful creation of IVT mRNA biotherapeutics. Several critical quality attributes (CQAs) have been identified to evaluate the effectiveness of DP formulations. One of the key CQAs, encapsulation efficiency, relies on accurate quantification of the IVT mRNA. Traditionally, fluorescence-based plate readers are used for this purpose to employ RNA quantitation assays such as RiboGreen. However, this application note introduces the Agilent Fragment Analyzer systems as an alternative method for assessing encapsulation efficiency.

The Agilent Fragment Analyzer systems utilize parallel capillary electrophoresis to separate samples by size, which provides the necessary resolution for analyzing integrity, purity, and sizing CQAs. Discover how the Fragment Analyzer significantly enhances the IVT mRNA CQA workflow.