Monitoring modifications in biopharmaceuticals: Toolbox for a generic and robust high-throughput quantification method.

Monoclonal antibodies (mAbs) constitute one of the most important and fastest growing sector within the pharmaceutical industry. The variety of different formats and the large molecule sizes of the mAbs result in an inherent complexity. In addition, the posttranslational modifications (PTMs) that can occur during production, formulation and storage pose a major analytical challenge for their characterization.