Anurag S. Rathore | Authors

Charge detection mass spectrometry (CDMS) is a useful tool to characterize larger, more complex biopharmaceuticals like bispecific antibodies and ADCs.

We review different approaches and coupling strategies for analyzing monoclonal antibody aggregates with 2D-LC.

Intact mass analysis is becoming increasingly useful for characterizing biologics. We describe the current application of intact mass analysis, including quantitation, sequencing, and structural characterization.

We present the main analytical techniques for performing functional characterization of biotherapeutic products. Such assessments are particularly critical for biosimilars, where analytical testing must ensure functional comparability with the innovator product.

New analytical workflows are needed to address the advances in biopharmaceutical product composition. A description of the multi-attribute method (MAM) is given, which has been developed to monitor critical quality attributes (CQAs) simultaneously and directly.

Multidimensional separations, in which two or more separation methods are coupled, are a valuable analytical tool for higher peak capacity and improved selectivity for the analysis of complex samples like biotherapeutics.