Richard Braatz, Ph.D.
This presentation describes opportunity, needs, and challenges in control systems technologies for integrated continuous bioprocessing. The use of mathematical modeling and simulation techniques in the design, control, and optimization of biomanufacturing operations is discussed. An opportunity is the use of a “virtual” plant for the dynamic operations of the entire end-to-end continuous biomanufacturing process, including all of its unit operations, e.g., perfusion bioreactors, chromatography columns, and buffer mixing units. The virtual plant can guide the selection of a control strategy for each critical quality attribute (CQA), design of startup and shutdown operations, and design of control systems that ensure that the product CQAs are insensitive to model uncertainties and disturbances.