Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development.
This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes.
This book is for industry professionals, including chemical engineers and pharmaceutical scientists.
Table of Contents
1. The Freeze-Drying of Pharmaceutical Products: Introduction and Basic Concepts
[Davide Fissore, Roberto Pisano, and Antonello Barresi]
2. Formulation Design and Optimization Using Molecular Dynamics
[Roberto Pisano and Andrea Arsiccio]
3. Established and Novel Excipients for Freeze-Drying of Proteins
[Ivonne Seifert and Wolfgang Friess]
4. Infrared Imaging and Multivariate Image Analysis (MIA): A New PAT for Freeze-Drying Monitoring and Control
[Domenico Colucci, José Manuel Prats-Montalbán, Alberto Ferrer, and Davide Fissore]
5. Through-Vial Impedance Spectroscopy (TVIS): A New Method for Determining the Ice Nucleation Temperature and the Solidification End Point
[Geoff Smith and Yowwares Jeeraruangrattana]
6. Innovations in Freeze-Drying Control and In-Line Optimization
[Antonello Barresi, Roberto Pisano, and Davide Fissore]
7. Use of a Micro Freeze-Dryer for Developing a Freeze-Drying Process
[Taylor N. Thompson and Davide Fissore]
8. Continuous Manufacturing in Lyophilization of Pharmaceuticals: Drawbacks of Batch Processing, Current Status, and Perspectives
[Roberto Pisano, Luigi C. Capozzi, and Jos A.W.M. Corver]
9. Use of CFD for the Design and Optimization of Freeze-Dryers
Davide Fissore is Professor of Chemical Engineering at Politecnico di Torino (Italy). His research activity is mainly focused on process modelling and optimisation, and on the design and validation of model-based tools for process monitoring and control. One of the topics of his research activity is the freeze-drying of pharmaceutical products and foodstuffs. He developed various devices to monitor and optimise in-line (using a control system) or offline (using the design space of the product) the freeze-drying process for a given product. He acted as a consultant of several pharmaceutical companies, focusing on process development and scale-up. Davide Fissore is author or co-author of 89 papers appeared in international peer reviewed journals, 15 book chapters and currently holds 9 patents, issued or pending.
Roberto Pisano is a Professor of Chemical Engineering at Politecnico di Torino (Italy), where he received his Ph.D. in 2009. Professor Pisano’s research focuses on the application of both computational and experimental methods to engineering chemical products and processes, with particular emphasis to pharmaceutical processing and formulation of both small molecules and biologics. He has been visitor researcher at Centre de Ressources Technologiques – Institut Technique Agro-Industriel (Strasbourg, France) in 2008, and at the Department of Chemical Engineering of Massachusetts Institute of Technology (Cambridge, USA) in 2016. He has worked with many pharmaceutical companies in research or consulting. He has published more than 75 papers, 7 book chapters, and currently has 4 patents issued or pending.
Antonello Barresi is currently full professor of Transport Phenomena at Politecnico di Torino, in charge of the course of Process Development and Design. Currently Italian national delegate in the Working Party on Drying of the European Federation of Chemical Engineers. His main research interests in drying include: drying and freeze drying of pharmaceuticals and enzymes, modelling and optimization of freeze-drying processes, control of industrial freeze-dryers. Most recent research is focused on process transfer, scale-up and cycle development, and new approaches for process development and quality control in freeze-drying of pharmaceutical and food products. Author of more than 250 papers (of which about 160 published on international journals or books) and more than 100 Conference presentations.