New Approaches to HPLC Analysis of Antibody Aggregates and Fragments

Antibody therapeutics are enjoying high growth rates in the biopharmaceuticals market, major therapeutic areas being cancer and immune/inflammation-related disorders. The characterisation of monoclonal antibodies (mAbs) is a major challenge in process monitoring and quality control. The main product characteristics to be monitored are aggregate and fragment content, glycosylation pattern and charge variants. Fast size exclusion chromatography (SEC) and hydrophobic interaction chromatography (HIC) on nonporous stationary phases are new approaches for mAb aggregate analysis whereas reversed phase chromatography (RPC) is a suitable tool for fragmentation analysis.