Development of a Multi-Product SE-UHPLC Method for the Determination of Size- Variants in Bispecific Antibody Formats.

The article focuses on the monitoring of product related impurities using size exclusion-high performance liquid chromatography (SE-HPLC) method. Topics discussed include characterization of bispecific monoclonal antibody formats for process optimization, stability testing, and release analytics, critical quality attributes (CQA) by the International Conference on Harmonization (ICH) and the U.S. Food and Drug Administration (FDA), and chromatograms on various tests.