Intact Mass Analysis–Based Multi-Attribute Methods (iMAMs) for Characterization of Biopharmaceuticals

Multi-attribute methods (MAMs) are becoming increasingly popular for their ability to analyze multiple critical quality attributes (CQA) in a single workflow. This capability becomes particularly attractive product class such as monoclonal antibodies, which large and complex, have many CQAs that need be monitored controlled during manufacturing so deliver consistent quality. In an earlier installment, we discussed the role of liquid chromatography mass spectrometry MAMs. this article, focus on intact analysis–based multi-attribute (iMAMs), suitable alternative can complement standard MAMs or used when there is rapid turnaround monitoring only limited number CQAs. Multiple case studies presented elucidate concept.