Intact mass analysis of a therapeutic lysine linked antibody drug conjugate

Biologics represent a growing class of pharmaceuticals being developed to target a variety of disease and illness vectors. Antibody Drug Conjugates (ADCs) combine a monoclonal antibody (mAb) with a cytotoxic drug via a linker. This allows the mAb to target a specific cell type or antigen and deliver a potent molecule without affecting surrounding cells. There are currently twelve approved ADCs with a variety of linkage chemistries of varying specificities. Lysine conjugations are non-specifically conjugated meaning that a heterogenous distribution of payload molecules are present on the final ADC. Measurement of DAR during manufacture is important to ensure correct dosing to the patient.

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