Monoclonal antibodies represent the rapidly expanding class of biotherapeutics having applications in the treatment of cancer, autoimmune disorders, metabolic disorders, and infectious diseases. One of the major challenges in mAb-based therapeutics development lies in the significant issue of aggregation which in turn has an impact on the quality, safety, and efficacy of the antibody drug. The presence of aggregates in the drug substance or final drug product potentially affects its biological activity thereby making it a critical quality attribute to be assessed. State-of-the-art analytical techniques are required for quality control and detailed characterization. This review provides insight into monoclonal antibody aggregation and the analytical techniques used to detect and quantify these aggregates.
