Suitability Testing For IVT mRNA Analysis Using Agilent Fragment Analyzer Systems

By Tim Butler, Sheng-Yuan Huang, Kyle Luttgeharm, Marko Marinkovich, and Whitney Pike, Agilent Technologies

Rigorous analytical procedures are essential for ensuring the quality of developing drugs and vaccines throughout the biopharmaceutical life cycle. Variations in factors like instrument settings, sample preparation, and method parameters can significantly affect analytical results. Evaluating these variables is crucial for validating and implementing analytical methods, helping to understand and minimize variability.

An automated capillary electrophoresis system, the Agilent Fragment Analyzer, was used in a suitability study to assess the size, concentration, and integrity of in vitro transcribed (IVT) mRNA. The study confirmed the system and method exhibit excellent precision and robustness for integrity analysis. Key findings also demonstrated strong linearity across a broad concentration range and validated the system's stability-indicating capability. This highlights the system's reliability and precision, confirming its suitability for IVT mRNA analysis in biopharmaceutical quality assessment.

Learn more about the study design and results by accessing the full application note.