Journal
MABS
Volume 3, Issue 2, Pages 161-172Publisher
LANDES BIOSCIENCE
DOI: 10.4161/mabs.3.2.14960
Keywords
antibody drug conjugates; physicochemical characterization; analytical methods; auristatins; maytansines; biophysical characterization; drug distribution; drug loading; drug to antibody ratio
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Antibody-drug conjugates (ADCs) produced 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 (lysinces, inter chain cysteines, Fc glycans). Improvements in analytical technique 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.
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