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Springer Optimization and Its Applications 189
Antonios Fytopoulos
Rohit Ramachandran
Panos M. Pardalos Editors
Optimization of
Pharmaceutical
Processes
Springer Optimization and Its Applications
Volume 189
Series Editors
Panos M. Pardalos
My T. Thai
Honorary Editor
Ding-Zhu Du, University of Texas at Dallas
Advisory Editors
Roman V. Belavkin, Middlesex University
John R. Birge, University of Chicago
Sergiy Butenko, Texas A&M University
Vipin Kumar, University of Minnesota
Anna Nagurney, University of Massachusetts Amherst
Jun Pei, Hefei University of Technology
Oleg Prokopyev, University of Pittsburgh
Steffen Rebennack, Karlsruhe Institute of Technology
Mauricio Resende, Amazon
Tamás Ter laky, Lehigh University
Va n Vu , Yale University
Michael N. Vrahatis, University of Patras
Guoliang Xue, Arizona State University
Yinyu Ye, Stanford University
, University of Florida
, University of Florida
Aims and Scope
Optimization has continued to expand in all directions at an astonishing rate. New
algorithmic and theoretical techniques are continually developing and the diffusion
into other disciplines is proceeding at a rapid pace, with a spot light on machine
learning, artificial intelligence, and quantum computing. Our knowledge of all
aspects of the field has grown even more profound. At the same time, one of the
most striking trends in optimization is the constantly increasing emphasis on the
interdisciplinary nature of the field. Optimization has been a basic tool in areas
not limited to applied mathematics, engineering, medicine, economics, computer
science, operations research, and other sciences.
The series Springer Optimization and Its Applications (SOIA) aims to publish
state-of-the-art expository works (monographs, contributed volumes, textbooks,
handbooks) that focus on theory, methods, and applications of optimization. Topics
covered include, but are not limited to, nonlinear optimization, combinatorial optimization, continuous optimization, stochastic optimization, Bayesian optimization,
optimal control, discrete optimization, multi-objective optimization, and more. New
to the series portfolio include Works at the intersection of optimization and machine
learning, artificial intelligence, and quantum computing.
Volumes from this series are indexed by Web of Science, zbMATH, Mathematical
Reviews, and SCOPUS.
More information about this series at https://link.springer.com/bookseries/7393
Antonios Fytopoulos • Rohit Ramachandran
Panos M. Pardalos
Editors
Optimization of
Pharmaceutical Processes
Editors
https://t.me/medicina_free
Antonios Fytopoulos
Department of Chemical
Engineering, KU Leuven
Leuven, Belgium
School of Chemical Engineering
NTUA, Athens, Greece
Panos M. Pardalos
Department of Industrial and Systems
Engineering
University of Florida
Gainesville, FL, USA
Rohit Ramachandran
Department of Chemical and Biochemical
Engineering
Rutgers University
Piscataway, NJ, USA
ISSN 1931-6828 ISSN 1931-6836 (electronic)
Springer Optimization and Its Applications
ISBN 978-3-030-90923-9 ISBN 978-3-030-90924-6 (eBook)
https://doi.org/10.1007/978-3-030-90924-6
Mathematics Subject Classification: 49M99, 93A10
© The Editor(s) (if applicable)and The Author(s), under exclusive license to Springer Nature Switzerland
AG 2022
The useof general descriptive names, registerednames, trademarks, service marks, etc.in this publication
does not imply, even in the absence of a specific statement, that such names are exempt from the relevant
protective laws and regulations and therefore free for general use.
The publisher, the authors and the editors are safe to assume that the advice and information in this book
are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or
the editors give a warranty, expressed or implied, with respect to the material contained herein or for any
errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional
claims in published maps and institutional affiliations.
This Springer imprint is published by the registered company Springer Nature Switzerland AG
The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Preface
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Although manufacturing industries have made huge achievements in many sectors,
in the pharmaceutical sector the need of a more structured approach and better
control and optimization of pharmaceutical processes is still the main goal of
industry and academia. The demand for better quality, higher yield, more efficientoptimized and green pharmaceutical processes indicates that optimal conditions for
production should be applied. Optimization and control methods are very powerful
tools and can pave the way towards this direction. However, the application of such
methods is not trivial in the pharmaceutical industry, as in a process, many unwanted
phenomena can take place compromising total control. Thus, experimental values
given in real time and modelling provide the required framework for better understanding and control of the processes. In this volume, world leading researchers
summarize a number of practical applications and methodologies that can help
pharmaceutical and chemical engineers apply modelling, optimization and control
methodologies in several aspects of pharmaceutical manufacturing.
The book starts with chapter “Process Control and Intensification of Solution
Crystallization” that summarizes the design and optimization of solution crystalliza-
tion process. In this chapter, topics such as the application of intensification methods
and optimization of seeding are discussed among others. In chapter “Method of
Characteristics for the Efficient Simulation of Population Balance Models”,the
method of characteristics (MOCH) is presented as a methodology able to reduce
the computational cost of Population Balance Models. Numerical examples that
demonstrate the accuracy and efficiency of this method are mentioned.
Chapter “Linearized Parameter Estimation Methods for Modeled Crystallization
Phenomena Using In-Line Measurements and Their Application to Optimization
of Partially Seeded Crystallization in Pharmaceutical Processes” focusses on the
linearized parameter estimation methods coupled with in-line measurements using
Process Analytical Technologies. Optimal operating conditions are applied to the
case study of partially seeded crystallization of L-arginine. Chapter “Mathematical
Modeling of Different Breakage PBE Kernels Using Monte Carlo Simulation
Results” covers the modelling of breakage processes. The authors discuss the
development of different breakage kernels that can be used in PBMs and their
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ability to describe different breakage types, such as linear–nonlinear breakage and
sonofragmentation.
The book continues with chapter “Optimization of Tablet Coating”, where
the significance of coating is discussed and different optimization techniques
are presented. Chapter “Continuous Twin-Screw Granulation Processing” places
the focus on continuous twin screw granulation processing. In this chapter, the
advantages of TSG are mentioned and examples of granule optimization achieved
by the implementation of QbD approach and PAT monitoring are included.
Chapter “Continuous Powder Feeding: Equipment Design and Material Consid-
erations” covers the continuous feeding of raw materials and highlights its effect
on the designing of robust and efficient manufacturing of solid dosage forms, while
chapter “Ultrasound for Improved Encapsulation and Crystallization with Focus on
Pharmaceutical Applications” gives an overview of the application of ultrasounds
as a tool for improved encapsulation and crystallization.
In chapter “Nonsmooth Modeling for Simulation and Optimization of Continu-
ous Pharmaceutical Manufacturing Processes”, non-smooth formulation approach
is demonstrated for dynamic simulation and optimization of continuous pharmaceutical manufacturing. This powerful method optimizes the overall campaign
performance in terms of productivity and yield. Chapter “Integrated Synthesis,
Crystallization, Filtration, and Drying of Active Pharmaceutical Ingredients: A
Model-Based Digital Design Framework for Process Optimization and Control ” is
on integrated synthesis, crystallization, filtration and drying of APIs. In this chapter,
the authors demonstrate a structured approach for process analysis and optimization
of the aforementioned processes based on mathematical models.
Chapter “Fast Model Predictive Control of Modular Systems for Continuous
Manufacturing of Pharmaceuticals” introduces methodologies that can be used
for the plant-wide optimization and control of nonlinear modular systems. In this
chapter, dynamic optimization is used as a tool to determine optimal trajectories for
quadratic dynamic matrix control in order to control the plant. In chapter “Dynamic
Modeling and Control of a Continuous Biopharmaceutical Manufacturing Plant” , a
dynamic modelling is used for a continuous biopharmaceutical manufacturing plant.
Effectiveness and control are achieved and the method is applied to the case study
of lovastatin.
Chapter “Overview of Scheduling Methods for Pharmaceutical Production”
reviews the most important scheduling methods for pharmaceutical production.
General concepts and challenges are discussed and mathematical programming
models are applied to several case studies. Chapter “Model-Based Risk Assess-
ment of mAb Developability” discusses the model-based risk assessment of mAb
developability. Optimality in terms of time needed for manufacturing is presented.
Chapter “Design Framework and Tools for Solid Drug Product Manufactur-
ing Processes” describes a design framework for solid drug product production.
Simulation-oriented analysis is conducted leading to a more efficient and rational
process design. Finally, in chapter “Challenges and Solutions in Drug Product
Process Development from a Material Science Perspective” the impact of material
Preface vii
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attributes on drug production is discussed. Optimal product quality and robustness
is proved to be correlated with material science.
We wish to thank all invited contributors and their groups who made this work
possible. The editors want also to express their gratitude to the editors of Springer
for their guidance and support through the entire project.
Leuven, Belgium Antonios Fytopoulos
Piscataway, NJ, USA Rohit Ramachandran
Gainesville, FL, USA Panos M. Pardalos
Contents
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Process Control and Intensification of Solution Crystallization ............ 1
Junbo Gong and Zhenguo Gao
Method of Characteristics for the Efficient Simulation
of Population Balance Models .................................................. 33
Xiaoxiang Zhu, Lifang Zhou, and Richard D. Braatz
Linearized Parameter Estimation Methods for Modeled
Crystallization Phenomena Using In-Line Measurements
and Their Application to Optimization of Partially Seeded
Crystallization in Pharmaceutical Processes .................................. 53
Izumi Hirasawa, Joi Unno, and Ikuma Masaki
Mathematical Modeling of Different Breakage PBE Kernels
Using Monte Carlo Simulation Results ........................................ 79
Ashok Das and Jitendra Kumar
Optimization of Tablet Coating ................................................. 103
Preksha Vinchhi and Mayur M. Patel
Continuous Twin-Screw Granulation Processing ............................ 135
Uttom Nandi, Tumpa Dey, and Dennis Douroumis
Continuous Powder Feeding: Equipment Design and Material
Considerations.................................................................... 171
Brian M. Kerins and Abina M. Crean
Ultrasound for Improved Encapsulation and Crystallization
with Focus on Pharmaceutical Applications .................................. 193
Chinmayee Sarode, Yashraj Jagtap, and Parag Gogate
Nonsmooth Modeling for Simulation and Optimization of
Continuous Pharmaceutical Manufacturing Processes ...................... 231
Michael Patrascu and Paul I. Barton
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Integrated Synthesis, Crystallization, Filtration, and Drying
of Active Pharmaceutical Ingredients: A Model-Based Digital
Design Framework for Process Optimization and Control .................. 253
Daniel J. Laky, Daniel Casas-Orozco, Francesco Destro,
Massimiliano Barolo, Gintaras V. Reklaitis, and Zoltan K. Nagy
Fast Model Predictive Control of Modular Systems for
Continuous Manufacturing of Pharmaceuticals .............................. 289
Anastasia Nikolakopoulou, Matthias von Andrian, and Richard D. Braatz
Dynamic Modeling and Control of a Continuous
Biopharmaceutical Manufacturing Plant ..................................... 323
Mohammad Amin Boojari, Simone Perra, Giorgio Colombo,
Matteo Grossi, Mark Nicholas Jones, Isuru Udugama,
Morteza Nikkhah Nasab, Mohammad Fakroleslam, Ali M. Sahlodin,
Seyed Abbas Shojaosadati, Krist V. Gernaey, and Seyed Soheil Mansouri
Overview of Scheduling Methods for Pharmaceutical Production ......... 355
Shamik Misra and Christos T. Maravelias
Model-Based Risk Assessment of mAb Developability ...................... 373
M. Karlberg, A. Kizhedath, and J. Glassey
Design Framework and Tools for Solid Drug Product
Manufacturing Processes........................................................ 393
Kensaku Matsunami, Sara Badr, and Hirokazu Sugiyama
Challenges and Solutions in Drug Product Process Development
from a Material Science Perspective ........................................... 413
Fanny Stauffer, Pierre-François Chavez, Julie Fahier, Corentin Larcy,
Mehrdad Pasha, and Gabrielle Pilcer
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