Charge variant and aggregation analysis of innovator and biosimilars of rituximab

Monoclonal antibodies are an important class of biomolecules used for the treatment of various diseases. Biosimilars, the copy versions of an innovator molecule, need to be characterized in detail for their critical quality attributes such as aggregates and charge variants. This application note compares two rituximab biosimilars from different manufacturers to the innovator for their aggregation and charge variant profiles by following two analytical workflows using Agilent 1260 Infinity II Bio-Inert LC and Agilent AdvancedBio columns.