Antibody Drug Conjugate (ADC) Separation Using A Mixed Mode Cation Exchange Chromatography Step In A Monoclonal Antibody (mAb) Process

This application note provides a description of the steps followed and considerations taken during the development of antibody drug conjugate separation using a mixed mode cation exchange chromatography step.

Antibody drug conjugates (ADC) is a new class of high potency drugs dedicated to cancer treatment. Whereby the antibody molecule is dedicated for the specific recognition of cancer cells, the toxic payload carried by the antibody molecule destroys them (Adcetris®, Kadcyla®). These new drugs are manufactured by conjugating a toxic molecule (payload) on the monoclonal antibody (mAb) molecule and is achieved through controlled chemical conjugation with specific amino acid residues exposed on the surface of the mAb (for example: Lysine or Cysteine after cysteine bond reduction) that results into a heterogeneous mixture of ADC species with variable drug to antibody ratio (DAR).