Optimization of Pharmaceutical Processes

Optimization of Pharmaceutical Processes presents contributions from leading authorities in the fields of optimization and pharmaceutical manufacturing. Formulated within structured frameworks, practical examples and applications are given as guidance to apply optimization techniques to most aspects of pharmaceutical processes from design, to lab and pilot scale, and finally to manufacturing. The increasing demand for better quality, higher yield, more efficient-optimized and green pharmaceutical processes, indicates that optimal conditions for production must be applied to achieve simplicity, lower costs and superior yield. The application of such methods in the pharmaceutical industry is not trivial. Quality of the final product is of major importance to human health and the need for deep knowledge of the process parameters and the optimization of the processes are imperative. 

The volume, which includes new methods as well as review contributions will benefit a wide readership including engineers in pharmaceuticals, chemical, biological, to name just a few.

Table of contents

Front Matter
Pages i-xiv
​​​​​​​Process Control and Intensification of Solution Crystallization
Junbo Gong, Zhenguo Gao
Pages 1-31
Method of Characteristics for the Efficient Simulation of Population Balance Models
Xiaoxiang Zhu, Lifang Zhou, Richard D. Braatz
Pages 33-51
Linearized Parameter Estimation Methods for Modeled Crystallization Phenomena Using In-Line Measurements and Their Application to Optimization of Partially Seeded Crystallization in Pharmaceutical Processes
Izumi Hirasawa, Joi Unno, Ikuma Masaki
Pages 53-77
Mathematical Modeling of Different Breakage PBE Kernels Using Monte Carlo Simulation Results
Ashok Das, Jitendra Kumar
Pages 79-101
Optimization of Tablet Coating
Preksha Vinchhi, Mayur M. Patel
Pages 103-133
Continuous Twin-Screw Granulation Processing
Uttom Nandi, Tumpa Dey, Dennis Douroumis
Pages 135-169
Continuous Powder Feeding: Equipment Design and Material Considerations
Brian M. Kerins, Abina M. Crean
Pages 171-191
Ultrasound for Improved Encapsulation and Crystallization with Focus on Pharmaceutical Applications
Chinmayee Sarode, Yashraj Jagtap, Parag Gogate
Pages 193-229
Nonsmooth Modeling for Simulation and Optimization of Continuous Pharmaceutical Manufacturing Processes
Michael Patrascu, Paul I. Barton
Pages 231-252
Integrated Synthesis, Crystallization, Filtration, and Drying of Active Pharmaceutical Ingredients: A Model-Based Digital Design Framework for Process Optimization and Control
Daniel J. Laky, Daniel Casas-Orozco, Francesco Destro, Massimiliano Barolo, Gintaras V. Reklaitis, Zoltan K. Nagy
Pages 253-287
Fast Model Predictive Control of Modular Systems for Continuous Manufacturing of Pharmaceuticals
Anastasia Nikolakopoulou, Matthias von Andrian, Richard D. Braatz
Pages 289-322
Dynamic Modeling and Control of a Continuous Biopharmaceutical Manufacturing Plant
Mohammad Amin Boojari, Simone Perra, Giorgio Colombo, Matteo Grossi, Mark Nicholas Jones, Isuru Udugama et al.
Pages 323-353
Overview of Scheduling Methods for Pharmaceutical Production
Shamik Misra, Christos T. Maravelias
Pages 355-371
Model-Based Risk Assessment of mAb Developability
M. Karlberg, A. Kizhedath, J. Glassey
Pages 373-391
Design Framework and Tools for Solid Drug Product Manufacturing Processes
Kensaku Matsunami, Sara Badr, Hirokazu Sugiyama
Pages 393-412
Challenges and Solutions in Drug Product Process Development from a Material Science Perspective
Fanny Stauffer, Pierre-François Chavez, Julie Fahier, Corentin Larcy, Mehrdad Pasha, Gabrielle Pilcer
Pages 413-435