Control of Conformational Integrity and Aggregation Stability of Monoclonal Antibodies and Their Conjugates by Nanodifferential Scanning Fluorimetry

Therapeutic agents based on monoclonal antibodies (mAbs) are successfully used in the diagnostics and treatment of a wide range of infectious and autoimmune diseases, as well as in the combating malignancies. Due to their high specificity, mAbs are used to target signalling or acting agents to a cell of interest in vivo. Thus, radioactively labelled antibodies are among important tools in nuclear medicine. Stringent control of the conformational integrity and aggregation stability of the mAb preparation is critical for successful biotherapeutic development. In this study, we describe the application of nanodifferential scanning fluorimetry (nanoDSF) to obtain a radioactively labelled monoclonal antibody (161Tb-DOTA-mAb). Using this method, we optimized the procedure of DOTA-mAb conjugate preparation and determined the storage conditions suitable for subsequent rapid radionuclide labelling of the conjugate.