Bioprocess Design, Computer-Aided

Abstract

Design and evaluation of integrated biochemical processes is carried out at various levels of detail, depending on the stage of product and process development. Back-of-the envelope and preliminary evaluations are performed at the early stages of development; detailed design and evaluation are performed prior to the construction of a new facility. Both the preliminary and detailed design of integrated bioprocesses can be greatly facilitated by the use of appropriate computer aids, such as process simulators, discrete-event simulators, finite capacity scheduling tools, and so on. The benefits of computer-aided bioprocess design are illustrated using a typical monoclonal antibody production process. The process is described in detail, including thorough material balances. The batch execution of the process is visualized through Gantt charts and the concepts of cycle time analysis and reduction are presented. A methodology for sizing purified water supply systems and other utilities of batch manufacturing plants is described. Estimates of the capital and operating cost of such processes are provided with detailed breakdowns for the cost of materials and consumables are presented. The impact of multiple bioreactor trains, bioreactor scale, and product titer on the manufacturing cost is evaluated through sensitivity analysis. An introduction to Monte Carlo simulation is provided as a means for quantifying the impact of uncertainty and variability in process and market parameters. Finally, an introduction is provided to the design and operational challenges associated with multiproduct facilities.