(585q) The Role of Simulation and Scheduling Tools in Bioprocess Development and Manufacturing

The successful scale up and commercialization of biopharmaceuticals is a challenging task that requires collaboration of professionals from many disciplines. Process simulators can facilitate this task by assisting scientists and engineers to answer the following and other related questions: What is the impact of product titer increase on the capacity load of the downstream section, the overall throughput of a plant, and the cost of goods? What changes are required in an existing multi-product facility to accommodate the process of a new product? What is the range of variability that a process can accommodate if it operates under a tight cycle time? What is the impact of single-use systems on the demand for utilities, the environment and the cost of goods? Our experience in addressing the above questions will be presented using industrial examples in which we evaluated alternative technologies for producing therapeutic monoclonal antibodies and vaccines. In bioprocessing, the balance of upstream and downstream capacity has become increasingly important. Upstream improvements have lead to high yield batches which may lead to bottlenecks in purification.