The unparalleled versatility of monoclonal antibodies as therapeutics has inspired sci‑ entists for decades. As early as the 1980s, antibody engineers aimed to create novel ver‑ sions of antibodies that would be more potent and engage alternate biological pathways compared to antibodies that are naturally produced in humans. Now, some 40 years later, this aim has been achieved, and the creation of antibody therapeutics is currently industrialized into a global enterprise. The commercial clinical pipeline has grown from a few dozen in the 1980s to over 1300 by 2023, driven by technological advances, global distribution of relevant knowledge, substantial nancial investments, and, criti‑ cally, the successful approval and marketing of these biotherapeutic macromolecules. Current protein engineering methods now allow the creation of molecules with a wide range of shapes and sizes. Antibody therapeutics may be monospecic or they may engage two or more different antigens or different epitopes on the same antigens. They may be conjugated to a variety of other biologically active components, such as small molecule cytotoxic agents or steroids, interleukins, or non‑antibody protein‑binding domains. These therapeutics may be composed of only an antibody fragment that has been stabilized through protein engineering (e.g., single‑chain variable fragments) or they may be small antibody domains derived from non‑human species (e.g., VHH). Importantly, over 200 antibody therapeutics have been granted marketing approvals or are the subject of marketing applications undergoing review in at least one country (https://www.antibodysociety.org/antibody‑therapeutics‑product‑data/).

Dr. Andrew E. Nixon is currently the Senior Vice President & Global Head, Biotherapeutics Discovery at Boehringer Ingelheim Pharmaceuticals, Inc., Ridgeeld, CT, USA. He earned his Ph.D. in Physical Biochemistry from the University of London for studies completed at the MRC’s National Institute for Medical Research. He has over 20 years of experience in biologic drug discovery and has contributed to over 100 anti‑ body discovery programs resulting in numerous clinical candidates and approved bio‑ logics, including TAKHZYRO, a fully human antibody inhibitor of plasma kallikrein.