(12c) Facilitating Process Development and Technology Transfer with Computer Aids

The successful scale up and commercialization of pharmaceutical APIs and products is a challenging task that requires collaboration of professionals from many disciplines. Process simulators and other computer aids 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 equipment on the demand for utilities and the cost of goods? Our experience in addressing the above and other related questions will be presented using industrial examples spanning production of APIs and pharmaceutical products.