Best Practices For Analysis Of IVT mRNA Using The Agilent Fragment Analyzer Systems

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 characteristics, method parameters, individual users, and laboratories 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 (CE) 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 system, method, and intermediate precision 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 robustness and precision, confirming its suitability for IVT mRNA analysis in biopharmaceutical quality assessment.

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