Monoclonal antibodies (mAbs) have proved to be one of the most successful classes of biotherapeutics. The FDA has approved an increasing number of mAbs for clinical
uses against cancer, autoimmune disorder, Crohn’s disease and rheumatoid arthritis among other diseases. Recombinant mAbs are subject to a variety of biochemical
modifications during processing, delivery and storage (Figure 1). Due to the potential impact of these modifications on mAb safety
and efficacy, thorough characterization of mAb products has become increasingly
important
United States
