Unlike traditional monoclonal antibodies, ADCs combine an antibody backbone with linker chemistry and a cytotoxic payload. This multi-component architecture introduces overlapping layers of heterogeneity, including drug-to-antibody ratio (DAR) distributions, charge variants, post-translational modifications, and structural changes at both the intact and subunit levels. Across ADC development, these characteristics are considered critical quality attributes that must be characterized, understood, and monitored.
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Managing ADC characterization: The challenge of turning complexity into confidence
Unlike traditional monoclonal antibodies, ADCs combine an antibody backbone with linker chemistry and a cytotoxic payload. This multi-component architecture introduces overlapping layers of heterogeneity, including drug-to-antibody ratio (DAR) distributions, charge variants, post-translational modifications, and structural changes at both the intact and subunit levels. Across ADC development, these characteristics are considered critical quality attributes that must be characterized, understood, and monitored.
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