TY - JOUR T1 - From Formation to Detection: Understanding Monoclonal Antibody Aggregation through Analytical Lenses A1 - Ajay Pakalapati A1 - Aluru Ranganadhareddy A1 - Narra Naga Pavan Kumar JF - Journal of Biochemical Technology JO - J Biochem Technol SN - 0974-2328 Y1 - 2024 VL - 15 IS - 2 DO - 10.51847/MgvdN50FBW SP - 27 EP - 32 N2 - 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. UR - https://jbiochemtech.com/article/from-formation-to-detection-understanding-monoclonal-antibody-aggregation-through-analytical-lenses-ufuiyb2ffss4yb5 ER -