title: Analytical methods for physicochemical characterization of antibody drug conjugates.
abstract: Antibody-drug conjugates (ADCs), formed through the chemical linkage of a potent small molecule cytotoxin (drug) to a monoclonal antibody, have more complex and heterogeneous structures than the corresponding antibodies. This review describes the analytical methods that have been used in their physicochemical characterization. The selection of the most appropriate methods for a specific ADC is heavily dependent on the properties of the linker, the drug, and the choice of attachment sites (lysines, inter-chain cysteines, Fc glycans). Improvements in analytical techniques such as protein mass spectrometry and capillary electrophoresis have significantly increased the quality of information that can be obtained for use in product and process characterization, and for routine lot release and stability testing.
authors: Late Stage Pharmaceutical and Processing Development, Genentech, Inc., South San Francisco, CA, USA. awakanka@gene.com
authors: Aditya
authors: A
authors: Wakankar
authors: Yan
authors: Y
authors: Chen
authors: Yatin
authors: Y
authors: Gokarn
authors: Fredric S
authors: FS
authors: Jacobson
mesh_terms: D000911:Antibodies, Monoclonal / Q000737:chemistry*; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D002845:Chromatography / Q000379:methods; D019075:Electrophoresis, Capillary; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D018796:Immunoconjugates / Q000737:chemistry* / Q000276:immunology; D013058:Mass Spectrometry; D004364:Pharmaceutical Preparations / Q000737:chemistry
chemical_list: D000911:Antibodies, Monoclonal; D018796:Immunoconjugates; D004364:Pharmaceutical Preparations