(189m) Filtration Process Modeling and Scale-up for Robust Drug Substance Manufacturing

During drug substance manufacturing, the products and intermediates are normally isolated from crystallization, filtration and drying processes. Filtration is a typical liquid-solid separation process that sometimes has operational challenges which may reduce process efficiency and/or impact product quality. In this presentation, a filtration process modeling and scale-up approach will be discussed. A lab scale column setup was used to characterize the slurry and wet cake. The obtained parameters such as specific cake resistance and compressibility index are then used to develop a model to predict the filtration performance for larger scale filtration equipment. The model was validated with the pilot scale operational data. The simulation results with typical filtration equipment, such as pressure filter pots and centrifuges, can be used to guide selection of the appropriate filtration equipment. For selected filtration equipment, the model can be utilized to explore the operational design space and identify the optimum operation conditions for minimum cycle time.