RT Journal Article SR Electronic T1 The navigating and de-risking role of 89Zr-immuno-PET in the development of biopharmaceuticals JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP jnumed.119.239558 DO 10.2967/jnumed.119.239558 A1 Guus A.M.S. van Dongen A1 Wissam Beaino A1 Albert D. Windhorst A1 Gerben J.C. Zwezerijnen A1 Daniela E. Oprea-Lager A1 N. Harry Hendrikse A1 Cornelis C. Van Kuijk A1 Ronald Boellaard A1 Marc C. Huisman A1 Danielle J Vugts YR 2020 UL http://jnm.snmjournals.org/content/early/2020/12/04/jnumed.119.239558.abstract AB The identification of molecular drivers of disease and the compelling rise of biotherapeutics such as peptides, monoclonal antibodies, antibody fragments and non-traditional binding scaffolds, activatable antibodies, bispecific antibodies, immunocytokines, antibody drug conjugates, enzymes, polynucleotides, therapeutic cells as well as alternative drug carriers like nanoparticles have impacted clinical care but also came with challenges. Drug development is expensive, attrition rates are high, and efficacy rates are lower than desired. Nowadays almost all these drugs, that in general have a long residence time in the body, can be stably labeled with 89Zr for whole body-PET imaging and quantification. Although not restricted to monoclonal antibodies, this approach is called 89Zr-immuno-PET. This review summarizes at a high level the State of the Art of the technical aspects of 89Zr-immuno-PET, and illustrates why it has potential for steering the design, development and application of biological drugs. Appealing showcases are discussed to illustrate what can be learned with this emerging technology during preclinical and especially clinical studies about biological drug formats and disease targets. In addition, an overview of ongoing and completed clinical trials is provided. Although 89Zr-immuno-PET is a young tool in drug development, its application is rapidly expanding, with first clinical experiences giving insight why certain drug-target combinations might have better perspectives than others.