Systematic LC/MS/MS Investigations for the IND-Enabling Extended Characterization of Antibody–Drug Conjugate Modifications
Summary: ADCs are an important class of biologic drugs that are well-represented in clinical trials for oncology and other indications. These medicines harbor both chemical and post-translational modifications (PTMs) that require characterization and provide strong challenges for platform analytical methods that were built to address more traditional, less-complicated molecular formats, such as monoclonal antibodies. This article published in the Journal Antibodies outlines a method for investigational new drug (IND)-enabling extended characterization for ADCs.