(Lecture, September 20) Notice of academic presentation by Professor Zoltan Nagy, Purdue University
Title：Quality Control (QbC) and digital design methods for integrated pharmaceutical systems
Time: Friday, September 20, 2024 15:00-16:30 PM
Venue: Conference room 214, Building 16
[Biography]
Dr. Zoltan Nagy is a professor at Purdue University's School of Chemical Engineering. He received his bachelor's, Master's and doctorate degrees in 1994, 1995 and 2001 respectively from "Babesz-Boyayi" University in Cluj, Romania, and previously held positions at Loughborough University in the United Kingdom, where he was Professor of Process Systems Engineering and co-founder of the Interdisciplinary Loughborough Control Centre. Professor Nagy joined Purdue University in 2012 and is a principal member or co-founding member of several interdisciplinary programs and research centers at Purdue, and is one of the world's foremost experts in the fields of crystallization, particle technology and process control. He has more than 20 years of dedicated research in the areas of advanced process control, process analysis techniques, crystallization modeling and control methods, and advanced control of particle systems, with a focus on the application of system methods and tools to the design and robust control of batch and continuous crystallization systems, process analysis techniques, and integrated advanced pharmaceutical manufacturing processes. Professor Nagy chairs the IEEE Process Control Technical Committee, is an associate editor in chief of several international journals, a member of the Steering Committee of the American Association for Crystallization Technology, and a member of the European Federation of Chemical Engineering's Crystallization Working Group. He has published more than 200 high-level journal papers and more than 250 conference papers, and has won awards from IEEE, IFAC, European Federation of Chemical Engineering, Society of Chemical Engineering, Chemical Research Council, Royal Academy of Engineering, European Research Council, PSE and AIChE for his outstanding work in the field of crystallization and control. These include the 2018 AIChE Research Award for Excellence in Process Development and the 2019 AIChE Outstanding Contribution Award for his leading contributions in the field of crystallization systems and process strengthening of pharmaceutical products.
[Abstract]
Process analysis technology (PAT) has been widely used in advanced control of pharmaceutical processes for more than 20 years, and the role of advanced feedback control concepts and digital design techniques in improving batch process performance, developing end-to-end optimal systems, and as a driving force in the paradigm shift from batch to continuous manufacturing has been fully validated. The report will include examples of how advanced control and digital design methods can be used to achieve process enhancement and improve the production of drug pellets, including a comprehensive digital design and comparative analysis of the end-to-end optimal batch, mixing and continuous manufacturing systems for a cancer drug. The optimization and advanced control technology for the continuous integrated modular crystallization, filtration, washing and drying process, as well as the integrated crystallization and wet grinding system, continuous oscillating flow crystallization platform, spherical crystallization process strengthening method are discussed in depth. These platforms, combined with advanced digital design and control-centric quality frameworks, effectively integrate drug substance processing and product manufacturing, achieving the ideal balance between manufacturability and bioavailability through spatial distribution control strategies. The presentation will demonstrate the development of an Industry 4.0 and Control-centric Quality (QbC) framework and its successful application at the Purdue pilot Plant. Finally, we will introduce an innovative on-demand additive manufacturing system that seamlessly integrates into API manufacturing to enable an end-to-end integrated pharmaceutical micro-factory (MiniPharm).
Announced by School of Chemistry and Chemical Engineering
