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Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scie...
Since process models are nowadays ubiquitous in many applications, the challenges and alternatives related to their development, validation, and efficient use have become more apparent. In addition, the massive amounts of both offline and online data available today open the door for new applications and solutions. However, transforming data into useful models and information in the context of the process industry or of bio-systems requires specific approaches and considerations such as new modelling methodologies incorporating the complex, stochastic, hybrid and distributed nature of many processes in particular. The same can be said about the tools and software environments used to describ...
Updated third edition of the authoritative textbook on business models and trends in the tech sectors of the healthcare industry.
Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability. Features: Discusses scientific solutions and process analytical technolog...
The Special Issue on “Model-Based Tools for Pharmaceutical Manufacturing Processes” will curate novel advances in the development and application of model-based tools to address ever-present challenges of the traditional pharmaceutical manufacturing practice as well as new trends. This book provides a collection of nine papers on original advances in the model-based process unit, system-level, quality-by-design under uncertainty, and decision-making applications of pharmaceutical manufacturing processes.
This book is a printed edition of the Special Issue "Feature Papers for Celebrating the Fifth Anniversary of the Founding of Processes" that was published in Processes
Computer-aided process engineering (CAPE) plays a key design and operations role in the process industries, from the molecular scale through managing complex manufacturing sites. The research interests cover a wide range of interdisciplinary problems related to the current needs of society and industry. ESCAPE 23 brings together researchers and practitioners of computer-aided process engineering interested in modeling, simulation and optimization, synthesis and design, automation and control, and education. The proceedings present and evaluate emerging as well as established research methods and concepts, as well as industrial case studies. - Contributions from the international community using computer-based methods in process engineering - Reviews the latest developments in process systems engineering - Emphasis on industrial and societal challenges
The European Symposium on Computer Aided Process Engineering (ESCAPE) series presents the latest innovations and achievements of leading professionals from the industrial and academic communities. The ESCAPE series serves as a forum for engineers, scientists, researchers, managers and students to present and discuss progress being made in the area of computer aided process engineering (CAPE). European industries large and small are bringing innovations into our lives, whether in the form of new technologies to address environmental problems, new products to make our homes more comfortable and energy efficient or new therapies to improve the health and well being of European citizens. Moreover, the European Industry needs to undertake research and technological initiatives in response to humanity's "Grand Challenges," described in the declaration of Lund, namely, Global Warming, Tightening Supplies of Energy, Water and Food, Ageing Societies, Public Health, Pandemics and Security. Thus, the Technical Theme of ESCAPE 21 will be "Process Systems Approaches for Addressing Grand Challenges in Energy, Environment, Health, Bioprocessing & Nanotechnologies."
Over the last two decades, Digital Twins (DTs) have become the intelligent representation of future development in industrial production and daily life. Consisting of over 50 chapters by more than 100 contributors, this comprehensive handbook explains the concept, architecture, design specification and application scenarios of DTs. As a virtual model of a process, product or service to pair the virtual and physical worlds, DTs allow data analysis and system monitoring by using simulations. The fast-growing technology has been widely studied and developed in recent years. Featured with centralization, integrity and dynamics, it is cost-effective to drive innovation and performance. Many field...
How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning a...