Antibody-drug conjugates (ADCs) are an emerging class of biopharmaceutical combining the specific targeting nature of monoclonal antibodies (mAbs) with highly cytotoxic payloads. Currently eleven ADCs have been approved for use and there are many more in clinical trials. ADCs present unique analytical challenges due to the inherent heterogeneity of the mAb scaffolds combined with varying numbers of conjugated drug. Drug-antibody-ratio (DAR)for ADCs is a critical quality attribute (CQA) affecting the efficacy and safety of the final product. Conjugation of the toxic drug to the antibody can be done through various kinds of chemical linker reacting to different amino acids.
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