Antibody drug conjugates: Development, characterization, and regulatory considerations

Previously, cancer chemotherapy was often accompanied by severe side effects. Antibody drug conjugates (ADCs) were introduced to address this treatment complication. ADCs are a potent category of bioconjugates and immunoconjugates designed as targeted therapy for the treatment of cancer. ADCs are complex molecules composed of an antibody linked via linker chemistry to a cytotoxic payload or drug. Therefore, biologic properties of the cell-surface target antigen are important in designing an effective ADC as an anticancer agent. ADCs have the ability to discriminate between the healthy and diseased tissue, so that healthy cells are less effected and get maximum therapeutic benefit. This review describes the development, characterization, and regulatory consideration of ADCs, and it summarizes the approved products in the market and in clinical trials.