This book provides practical, comprehensive knowledge on how to use the advances in analytical measurements and basic and advanced control to improve batch profiles and endpoint consistency. The consequential integration of measurements, models, and controls into a digital twin with recently developed blocks to provide profiles and predict endpoints enables:

Developing dynamic models from trend charts that are used for experiment design, diagnosing the sources of limitations and inconsistences, and developing and testing solutions 500 times real time without interfering with existing plant operation.
Comprehensive views of basic process control with the possibilities of model predictive control to control and optimize batch profiles by non-intrusive development and confirmation.
The ability to determine how to maximize the performance of bioreactors, which are often the bottleneck and the key to product quality and consistency, without tests or trials in the actual plant.

The resulting improvements in batch cycle time and consistency can be designed, tested, quantified, and confirmed; and operators can be trained independently of actual plant operation. The benefit from the elimination of a bad batch―particularly for new biologics―is potentially worth ten or more million dollars.

About the Author

Gregory K. McMillan, CAP, has more than 50 years of experience in industrial process automation, with an emphasis on the synergy of dynamic modeling and process control. He retired as a Senior Fellow from Solutia and a senior principal software engineer from Emerson Process Systems and Solutions. He was also an adjunct professor in the Washington University Saint Louis Chemical Engineering department from 2001 to 2004. McMillan is the author of numerous ISA books and columns on process control, and he has been the monthly Control Talk columnist for Control magazine since 2002. He started and guided the ISA Standards and Practices committee on ISA-TR5.9-2023, PID Algorithms and Performance Technical Report, and he wrote "Annex A - Valve Response and Control Loop Performance, Sources, Consequences, Fixes, and Specifications" in ISA-TR75.25.02-2000 (R2023), Control Valve Response Measurement from Step Inputs. McMillan's achievements include the ISA Kermit Fischer Environmental Award for pH control in 1991, appointment to ISA Fellow in 1991, the Control magazine Engineer of the Year Award for the Process Industry in 1994, induction into the Control magazine Process Automation Hall of Fame in 2001, selection as one of InTech magazine's 50 Most Influential Innovators in 2003, the ISA Life Achievement Award in 2010, and the ISA Mentoring Excellence award in 2020. He has a BS in engineering physics from Kansas University and an MS in control theory from Missouri University of Science and Technology, both with emphasis on industrial processes.

Christopher Stuart is a senior software engineer for Emerson's Process Simulation Development group. He holds a bachelor of science degree in chemical engineering with a biochemical emphasis from Missouri University of Science and Technology. Stuart's research interests are in efficient algorithms for thermodynamic calculations and dynamic simulations.

Rehman Fazeem is an advanced chemical engineer at Honeywell's UOP, formally known as Universal Oil Products, in the UOP Process Technology (UPT) division. His areas of expertise are process design, simulation, equipment design, process control, automation, chemical reaction technology, and catalyst deactivation. Fazeem has more than 10 years of experience across process industries such as oil and gas, refining, petrochemicals, chemicals, paper and pulp, and pharmaceuticals. Before Honeywell, he worked at Emerson as lead project engineer in the Process Simulation group under the Process Systems and Solutions (PSS) division. He has a master of science degree in chemical engineering from Missouri University of Science and Technology.

Zachary Sample has more than seven years of experience delivering cross-industry simulation solutions in various roles ranging from technical implementation and engineering to project and sales management. In these roles, he has had a passion for helping process companies better leverage simulation to improve automation and operational performance. Sample has a bachelor of science degree in chemical engineering from Missouri University of Science and Technology and a master of science degree in chemical engineering from North Carolina State University.

Timothy Schieffer is a lead project engineer in Emerson's Process Systems and Solutions with more than 5 years of experience building first-principle dynamic simulations. He has helped implement the bioreactor model with the latest advances running at several hundred times real time in a digital twin. Schieffer has a bachelor of science degree in chemical engineering from Missouri University of Science and Technology.

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