December 8, 2021 – MSDG Meeting

Abstract:  Development of biopharmaceuticals requires a thorough understanding of product quality attributes (PQAs) and impurities to ensure that the product meets desired safety and efficacy profiles. Multi-attribute method (MAM), based on LC-MS peptide mapping technology, enables direct site-specific monitoring of challenging PQAs and allows enhanced product and process understanding. In this presentation, we will demonstrate how we utilize a BioAccord MAM workflow to increase our product knowledge through both PQA monitoring and new peak detection.

Abstract:  The 5’ cap of mRNA is vital to characterize in vaccine development. Ion-pairing reversed phase liquid-chromatography mass spectrometry (LC-MS) can be used to analyze pre-defined 5’ fragments of synthetic mRNA. However, accurate quantitation can be difficult to achieve due to non-specific binding with the system. Moreover, the choice of ion-pairing system can heavily influence the quality and sensitivity of the mass spectra. We developed a rapid and sensitive LC-MS method applicable to synthetic mRNA capping using MaxPeak™ Premier Columns in combination with the compliance-ready BioAccord LC-MS system. Analysis of 5’ capping of IVT mRNA preparations could be achieved in less than 5-minutes. Linearity was demonstrated to detecting product-related impurities down to less than 0.1% of the target 5’ capped fragment.