A monoclonal antibody (mAb) is a highly specific antibody produced from a single B cell clone, designed to bind with high affinity and selectivity to a defined target antigen. Monoclonal antibodies are among the most successful biopharmaceutical therapeutics, with applications in oncology, autoimmune diseases, infectious diseases, and rare disorders. They are produced using mammalian cell culture — predominantly CHO cell lines — and require extensive downstream purification, analytical characterization, and quality control to meet regulatory specifications set by agencies such as the European Medicines Agency (EMA) and Food and Drug Administration (FDA).
