Abstract
Over the last decade or so, biopharmaceuticals have gained market share and become more complex in their composition. Therefore, new analytical workflows are needed to address these advances, and one of those workflows that has gained substantial traction over the last several years is the multi-attribute method (MAM). MAM was originally developed to be used throughout the product life cycle, from process development through quality control, and has become even more popular as quality by design (QbD) has become a more prevalent approach for biopharmaceutical development. MAM is designed to monitor critical quality attributes (CQAs) simultaneously and directly, such as sequence, post-translational modifications, and impurities, making it a more streamlined and productive workflow for biopharmaceutical analysis. In this column, we will discuss the role of liquid chromatography and mass spectrometry in MAM, as well as other new technologies and anticipated advances of MAM that are on the horizon.
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