Modeling and Optimization of Antibody-drug Conjugate Production Using Process Intensified Solid-phase Method

Conventional solution-phase method currently employed for the production of Antibody-drug Conjugates (ADC) has certain drawbacks, which makes production inefficient and cost extensive process. In this study, we developed a rigorous cost model for an intensified solid-phase production method utilizing a packed bed resin column to carry out all the steps involved in the production of ADC, at an industrial scale. The aim of this study was to find a suitable operating region (column length and feed velocity) to minimize the cost of ADC production. Simulation results showed that productivity was maximum when the process was operated at a linear velocity ranging between 120-140 cm/hr and unit cost of ADC production was minimum when column length was 60 cm and operated at 100 cm/hr. We found that production cost is highly dependent on monoclonal antibody (mAb) cost, followed by cytotoxic drug as being the second-highest contributor to the overall production cost.