From Formation to Detection: Understanding Monoclonal Antibody Aggregation through Analytical Lenses
Ajay Pakalapati, Aluru Ranganadhareddy, Narra Naga Pavan Kumar
Abstract
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 a
Topics & Concepts
Monoclonal antibodyChemistryAntibodyMedicineImmunologyProtein purification and stabilityMonoclonal and Polyclonal Antibodies ResearchBiosimilars and Bioanalytical Methods