Guidelines on the nonclinical and clinical evaluation of monoclonal antibodies and related products intended for the prevention or treatment of infectious diseases

Overview

Monoclonal antibodies (mAbs) represent the largest class of therapeutic proteins in clinical use. However, the majority of currently marketed mAbs are used for the treatment of noncommunicable diseases such as cancer or autoimmune disorders. Although only a small number of mAbs have to date been licensed to treat or prevent infectious diseases, the number of such products in development is growing (1–4).