Continuous Pharmaceutical Process Engineering and Economics
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Continuous Pharmaceutical Process Engineering and Economics
Wed, 03/02/2016 - 16:00 to 17:00
Location:
Speaker:
Dr. Dimitrios Gerogiorgis
Affiliation:
University of Edinburgh
Synopsis:
Continuous Pharmaceutical Manufacturing (CPM) emerges as a ground-breaking technology which can invigorate the global pharmaceutical industry by sustainably fostering its agility and the affordability of healthcare for large populations. Continuous production methods feature numerous significant technical advantages, which however need be ensured by robust, scaleable chemistry, systematic process design and efficient Process Analytical Technology (PAT) for control. Quality by Design (QbD) must be achieved by a relentless pursuit of efficiency in energy and solvent use, but above all the business case for a product must be strong enough to cover both synthesis and process R&D against competition. Advances in continuous organic synthesis routes have induced demonstrations of full (end-to-end) continuous pharmaceutical production and comparative economic analyses explicitly illustrate CPM advantages, thus attracting the strong and sustained interest of global pharmaceutical corporations and authoritative regulatory bodies. Remarkable corporate investments in production-scale CPM facilities illustrate the value and promise of this novel paradigm.
The foundation of every truly novel CPM process is the continuous synthesis chemistry, which has been demonstrated for numerous Active Pharmaceutical Ingredients (APIs), from common painkillers and blockbuster anti-cancer medications, to key therapeutic molecules against debilitating tropical diseases. Landmark experimental studies have also demonstrated viable end-to-end pilot-scale processes from raw feedstocks to final product formulations. Nevertheless, fully continuous separations must be fully elucidated and are critical toward maximising CPM potential at production scale. The importance of systematic process systems engineering methodologies is evident toward evaluating and demonstrating CPM benefits, both in primary/upstream as well as in secondary/downstream pharmaceutical processing.
This lecture will focus on our successful applications of process systems engineering methodologies (process synthesis, flowsheet modelling and simulation) toward evaluating the technical efficiency, environmental impact and economic viability of three novel continuous processes for manufacturing three APIs of critical importance (ibuprofen, artemisinin and diphenhydramine). Original final upstream separation and CPM economic evaluation results will be presented.
Biography:
Dr. Dimitrios Gerogiorgis is a lecturer (assistant professor) in Chemical Engineering at the Institute for Materials and Processes of the University of Edinburgh, focusing on process systems modeling, design and optimization. He holds a Diploma in Chemical Engineering with highest honors from the Aristotle University of Thessaloniki, Greece, an MSc in Electrical and Computer Engineering and a PhD in Chemical Engineering from Carnegie Mellon University, where he was advised by Prof. Erik Ydstie under Fulbright, Onassis and CMU fellowships. He also holds an Eberly Center Teaching Certificate and a Diploma in Translation (Institute of Linguists, UK). His research portfolio includes the model-based development of the Alcoa ARP carbothermic aluminium reactor and the NTUA vertical perlite expansion furnace, the optimization of investment planning for efficient polygeneration energy systems (CPSE, Imperial College London), the systematic methodology for interval arithmetic evaluation of candidate flowsheets, and the first comparative economic evaluation of batch vs. continuous pharmaceutical manufacturing strategies (Novartis-MIT Center for Continuous Manufacturing). His contributions have resulted in several externally funded projects (e.g. Combined CFD and Similarity Modeling of Carbothermic Reactors/Alcoa, Economic Optimization of Continuous Pharmaceutical Manufacturing/EPSRC-DTP). He is supervising 2 PhD students, 4 past postdoctoral researchers and 10 MSc/MEng projects, and published 30 peer-reviewed articles in journals and book series. He has been recognized with the Academy of Athens “L. Mousoulos” Research Excellence Prize (2015), the Best Oral Presentation Award of the 3rd CSIRO International CFD Conference (Melbourne, Australia), and with a Scottish Crucible membership (2015); he has delivered invited lectures at McGill University (Canada), Universitat Rovira i Virgili (Spain), NTUA (Greece), Strathclyde and Leeds (UK).
Selected Publications
1. H.G. Jolliffe, D.I. Gerogiorgis, Process modeling and simulation for the continuous pharmaceutical manufacturing of ibuprofen, Chem. Eng. Res. Des. 97: 175-191 (2015).
2. P.M. Angelopoulos, D.I. Gerogiorgis, I. Paspaliaris, Model-based sensitivity analysis and experimental investigation of perlite grain expansion in a vertical electrical furnace, Ind. Eng. Chem. Res. 52(50): 17953–17975 (2013).
3. S. Schaber, D.I. Gerogiorgis, P.I. Barton et al., Economic analysis of integrated continuous and batch pharmaceutical manufacturing: a case study, Ind. Eng. Chem. Res. 50(17): 10083–10092 (2011).
4. P. Liu, D.I. Gerogiorgis, E.N. Pistikopoulos, Modeling and optimization of polygeneration energy systems, Catal. Today 127(1-4): 347–359 (2007).
5. D.I. Gerogiorgis, B.E. Ydstie, Multiphysics CFD modeling for design and simulation of a multiphase chemical reactor, Chem. Eng. Res. Des. 83(A6): 603–610 (2005).