Process Systems Engineering For Pharmaceutical Manufacturing

Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing

Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing industry. It covers elements of the design, installation, validation, and usage of critical processes associated with sterile product manufacture. From water systems to clean-in-place systems, to sterile powder handling and robotic applications in sterile production environments, this book addresses the issues of system implementation, integration, and operations. Written by recognized experts and peer reviewed for accuracy, all chapters include references to supplemental resources and numerous illustrations.

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

14th International Symposium on Process Systems Engineering, Volume 49 brings together the international community of researchers and engineers interested in computing-based methods in process engineering. The conference highlights the contributions of the PSE community towards the sustainability of modern society and is based on the 2021 event held in Tokyo, Japan, July 1-23, 2021. It contains contributions from academia and industry, establishing the core products of PSE, defining the new and changing scope of our results, and covering future challenges. Plenary and keynote lectures discuss real-world challenges (globalization, energy, environment and health) and contribute to discussions on the widening scope of PSE versus the consolidation of the core topics of PSE. Highlights how the Process Systems Engineering community contributes to the sustainability of modern society Establishes the core products of Process Systems Engineering Defines the future challenges of Process Systems Engineering

Biopharmaceutical and pharmaceutical manufacturing are strongly influenced by the process analytical technology initiative (PAT) and quality by design (QbD) methodologies, which are designed to enhance the understanding of more integrated processes. The major aim of this effort can be summarized as developing a mechanistic understanding of a wide range of process steps, including the development of technologies to perform online measurements and real-time control and optimization. Furthermore, minimization of the number of empirical experiments and the model-assisted exploration of the process design space are targeted. Even if tremendous progress has been achieved so far, there is still work to be carried out in order to realize the full potential of the process systems engineering toolbox. Within this reprint, an overview of cutting-edge developments of process systems engineering for biopharmaceutical and pharmaceutical manufacturing processes is given, including model-based process design, Digital Twins, computer-aided process understanding, process development and optimization, and monitoring and control of bioprocesses. The biopharmaceutical processes addressed focus on the manufacturing of biopharmaceuticals, mainly by Chinese hamster ovary (CHO) cells, as well as adeno-associated virus production and generation of cell spheroids for cell therapies.

Process Systems Engineering brings together the international community of researchers and engineers interested in computing-based methods in process engineering. This conference highlights the contributions of the PSE community towards the sustainability of modern society and is based on the 13th International Symposium on Process Systems Engineering PSE 2018 event held San Diego, CA, July 1-5 2018. The book contains contributions from academia and industry, establishing the core products of PSE, defining the new and changing scope of our results, and future challenges. Plenary and keynote lectures discuss real-world challenges (globalization, energy, environment and health) and contribute to discussions on the widening scope of PSE versus the consolidation of the core topics of PSE. Highlights how the Process Systems Engineering community contributes to the sustainability of modern society Establishes the core products of Process Systems Engineering Defines the future challenges of Process Systems Engineering

25th European Symposium on Computer-Aided Process Engineering contains the papers presented at the 12th Process Systems Engineering (PSE) and 25th European Society of Computer Aided Process Engineering (ESCAPE) Joint Event held in Copenhagen, Denmark, 31 May - 4 June 2015. The purpose of these series is to bring together the international community of researchers and engineers who are interested in computing-based methods in process engineering. This conference highlights the contributions of the PSE/CAPE community towards the sustainability of modern society. Contributors from academia and industry establish the core products of PSE/CAPE, define the new and changing scope of our results, and future challenges. Plenary and keynote lectures discuss real-world challenges (globalization, energy, environment, and health) and contribute to discussions on the widening scope of PSE/CAPE versus the consolidation of the core topics of PSE/CAPE. Highlights how the Process Systems Engineering/Computer-Aided Process Engineering community contributes to the sustainability of modern society Presents findings and discussions from both the 12th Process Systems Engineering (PSE) and 25th European Society of Computer-Aided Process Engineering (ESCAPE) Events Establishes the core products of Process Systems Engineering/Computer Aided Process Engineering Defines the future challenges of the Process Systems Engineering/Computer Aided Process Engineering community

While the PSE community continues its focus on understanding, synthesizing, modeling, designing, simulating, analyzing, diagnosing, operating, controlling, managing, and optimizing a host of chemical and related industries using the systems approach, the boundaries of PSE research have expanded considerably over the years. While early PSE research was largely concerned with individual units and plants, the current research spans wide ranges of scales in size (molecules to processing units to plants to global multinational enterprises to global supply chain networks; biological cells to ecological webs) and time (instantaneous molecular interactions to months of plant operation to years of strategic planning). The changes and challenges brought about by increasing globalization and the the common global issues of energy, sustainability, and environment provide the motivation for the theme of PSE2012: Process Systems Engineering and Decision Support for the Flat World. Each theme includes an invited chapter based on the plenary presentation by an eminent academic or industrial researcher Reports on the state-of-the-art advances in the various fields of process systems engineering Addresses common global problems and the research being done to solve them