Introduction and background
Monoclonal antibodies (mABs) are immunoglobulin molecules that bind to the same epitope and have a variety of applications in medicine and healthcare. Although therapeutic mABs are extremely favourable due to their specificity, they are heterogenous due to their manufacturing process and hence provide a challenge for characterization. During expression, purification and storage, enzymatic and chemical modifications such as e.g. oxidation or glycosylation occur. Changes in these modifications can interfere with their safety and efficacy. In case these modifications are classified as critical quality attributes (CQAs), they are been mandated by the regulatory guidelines to be fully characterized. For their evaluation, stress studies can be applied.