Chapter 10: Analytical Methods for Antibody Drug Conjugate Characterization
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Antibody-drug conjugates (ADCs) are advance biologic molecules in which chemical drugs are bound to an antibody targeting a specific antigen on the surface of cells. ADCs are a new kind of therapeutic agents in the treatment of various cancers. As they are the combination of an antibody and a small molecule drug, they present unique challenges for analytical characterization. Attributes from both the small and large molecule components should be considered as quality attributes. This chapter will present the current approaches in analytical methodologies used for ADC characterization.
KeywordsAntibody-drug conjugate (ADC) Drug Linker Drug-linker Drug-to-antibody ratio (DAR) Higher-order structure (HOS) Targeted delivery Purity Potency Impurities
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