The manufacture of one type of antibody-drug conjugates (ADCs) involves the conjugation of a maleimide containing linker-drug to a cysteine residue in the antibody framework. Maleimides react with high selectivity with cysteine residues but may also react with other amino acids in the antibody framework. This presentation will share results from studies of the conjugation kinetics for both the desired cysteine-linked product and product related variants. It was observed in some cases conditions that decreased the overall rate of conjugation also improved the selectivity for the desired cysteine-linked product relative to the off-target conjugation product variants. These conditions were further assessed in robustness studies to determine the impact to processing time, manufacturability and product quality.<br/><br/>The presentation will focus on how various conjugation process parameters may be used to improve process control and selectivity for the desired cysteine-linked conjugate.

Process control to minimize product related conjugation variants in the manufacture of ADCs

253rd National Meeting (2017)

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