Analytical Characterization of Monoclonal Antibodies: Linking Structure to Function

Abstract

The basic structural features of antibodies, including their primary structures (Edelman et al. 1969), were established well before the concept of therapeutic antibodies was conceived. These molecules are now known to bear multiple sources of microheterogenity that can have a dramatic effect on in vivo and in vitro properties. Rituximab (Rituxan®), Trastuzumab (Herceptin®) and omalizumab (Xolair®) are three examples of therapeutic IgG1/kappa subclass antibodies produced by Genentech, Inc.; these molecules are the main subject of this discussion on the impacts of common and unique antibody modifications on functional properties.