Charge variant and aggregation analysis of innovator and biosimilars of rituximab

27 Jun 2021

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.

Agilent 1260 Infinity II Bio-Inert LC System

Agilent Technologies

The 1260 Infinity II Bio-Inert LC is a dedicated solution for analysis of large biomolecules in biological samples, including monoclonal antibody (mAb) and protein analysis. Metal-free components in the sample flow path and the absence of iron and steel in solvent delivery lines ensure the integrity of your biomolecules, minimize unwanted surface interactions, and increase column lifetime.

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AdvanceBio HIC

Agilent Technologies

Agilent AdvanceBio HIC columns deliver robust and reproducible high-resolution separations of native proteins at the intact level. 

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Charge variant and aggregation analysis of innovator and biosimilars of rituximab