(151c) The Role of Process Modeling in Bioprocess Development and Technology Transfer

The successful development, scale-up, design, and optimization of integrated biochemical processes is a challenging task that requires collaboration of professionals from many disciplines. Process simulators and other computer aids can facilitate this task by introducing a common language of communication among the various teams involved in process development and product commercialization. They can facilitate answers to the following questions: What is the impact of product titer increase (through media change) on the capacity load of the downstream section, the overall throughput of a plant, and the total manufacturing cost? Can the cost of expensive chromatography steps be reduced through changes in preceding concentration steps? What is the impact of changes in scheduling and cycles times on the demand for resources (e.g., labor, utilities, raw materials, etc.) and the overall throughput of a plant? Our experience in addressing the above questions will be presented using an industrial example in which we evaluated alternative technologies for producing therapeutic monoclonal antibodies.