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

Abstract

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