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Integrated Simulation And Optimization Of Continuous Pharmaceutical Manufacturing
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Book Synopsis Integrated Simulation and Optimization of Continuous Pharmaceutical Manufacturing by : Fani Boukouvala
Download or read book Integrated Simulation and Optimization of Continuous Pharmaceutical Manufacturing written by Fani Boukouvala and published by . This book was released on 2013 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of this work focuses mainly in the development of reduced-order modeling tools for the design and optimization of manufacturing of pharmaceutical oral solid dosage form products. This work- as part of a collective effort of the Engineering Research Center for Structured Organic Particulate Systems (ERC-SOPS)- aims to combine all the research findings of the Center in terms of material properties and process understanding in order to design efficient continuous integrated manufacturing processes. Different surrogate-based methodologies are assessed for reduced-order model building based on either experimental data or computer simulation data. In addition, the effects of uncertainty of the available data, material properties and model parameters on model performance are addressed systematically. Finally, unit operation models are combined into a flowsheet simulation model which can be used for process design through the development of a simulation-based optimization strategy for noisy expensive flowsheets with complex constraints.
Book Synopsis Continuous Manufacturing of Pharmaceuticals by : Peter Kleinebudde
Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-09-05 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Continuous Manufacturing of Pharmaceuticals by : Peter Kleinebudde
Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-07-14 with total page 695 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Process Systems Engineering for Pharmaceutical Manufacturing by : Ravendra Singh
Download or read book Process Systems Engineering for Pharmaceutical Manufacturing written by Ravendra Singh and published by Elsevier. This book was released on 2018-03-16 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems by : Fernando Muzzio
Download or read book How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems written by Fernando Muzzio and published by Elsevier. This book was released on 2022-04 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 about, continuous processing in pharmaceutical manufacturing. Discusses the development of strategy blueprints in the design of continuous processes Shows how to create process flowsheet models from individual unit operation models Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases Covers the evolving regulatory expectations for continuous manufacturing Provides readers with ways to more effectively navigate these expectations
Book Synopsis 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering by :
Download or read book 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering written by and published by Elsevier. This book was released on 2015-07-14 with total page 2667 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Optimization of Pharmaceutical Processes by : Antonios Fytopoulos
Download or read book Optimization of Pharmaceutical Processes written by Antonios Fytopoulos and published by Springer Nature. This book was released on 2022-04-06 with total page 437 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Continuous Pharmaceutical Processing and Process Analytical Technology by : Ajit S. Narang
Download or read book Continuous Pharmaceutical Processing and Process Analytical Technology written by Ajit S. Narang and published by CRC Press. This book was released on 2023-03-01 with total page 723 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 technology to enable continuous manufacturing in the development of new drugs Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized Addresses economic and practical considerations, unlike many other technical books Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309487811 Total Pages :69 pages Book Rating :4.3/5 (94 download)
Book Synopsis Continuous Manufacturing for the Modernization of Pharmaceutical Production by : National Academies of Sciences, Engineering, and Medicine
Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Continuous Pharmaceutical Processing by : Zoltan K Nagy
Download or read book Continuous Pharmaceutical Processing written by Zoltan K Nagy and published by Springer Nature. This book was released on 2020-06-10 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.
Book Synopsis Predictive Modeling of Pharmaceutical Unit Operations by : Preetanshu Pandey
Download or read book Predictive Modeling of Pharmaceutical Unit Operations written by Preetanshu Pandey and published by Woodhead Publishing. This book was released on 2016-09-26 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points
Book Synopsis 21st European Symposium on Computer Aided Process Engineering by : E. N. Pistikopoulos
Download or read book 21st European Symposium on Computer Aided Process Engineering written by E. N. Pistikopoulos and published by Elsevier. This book was released on 2011-07-21 with total page 2087 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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."
Book Synopsis Continuous Pharmaceutical Processing and Process Analytical Technology by : Ajit S. Narang
Download or read book Continuous Pharmaceutical Processing and Process Analytical Technology written by Ajit S. Narang and published by CRC Press. This book was released on 2023-03-01 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 technology to enable continuous manufacturing in the development of new drugs Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized Addresses economic and practical considerations, unlike many other technical books Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies
Book Synopsis Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture by : Marianthi G. Ierapetritou
Download or read book Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture written by Marianthi G. Ierapetritou and published by Humana. This book was released on 2015-10-02 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This thorough volume aims to provide pharmaceutical engineers with an introduction to the current state of the art in modeling and simulation of pharmaceutical processes and to summarize a number of practical applications of relevant methodologies in drug product development. Chapters include explorations of simulation and modeling methodologies, data collection and analysis, development of novel sensing techniques, development and integration of individual unit models, optimization approaches for data-based models, design space evaluation techniques, informatics-based methodologies, and emerging topics in pharmaceutical process development. As a part of the Methods in Pharmacology and Toxicology series, the chapters contain the kind of detail and implementation advice that will make the transition into the laboratory as smooth as possible. Authoritative and cutting edge, Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture seeks to promote research into process systems methodologies and their application in pharmaceutical product and process development, which will undoubtedly become an increasingly important area in the future.
Book Synopsis Process Systems Engineering Methods for the Development of Continuous Pharmaceutical Manufacturing Processes by : Amanda Rogers
Download or read book Process Systems Engineering Methods for the Development of Continuous Pharmaceutical Manufacturing Processes written by Amanda Rogers and published by . This book was released on 2015 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of this dissertation is to develop mathematical methods to assist in the development of continuous processes for the manufacture of pharmaceutical drug products. Specifically, modeling, analysis and optimization techniques will be developed in order to apply concepts from the field of process systems engineering to pharmaceutical development. These concepts, including sensitivity analysis, feasibility and flexibility analysis and optimal design under uncertainty, can contribute to the development of robust and well-understood manufacturing processes. This is consistent with the aim Quality-by-Design in the pharmaceutical process development. Throughout this dissertation, case studies related to continuous solids-based manufacturing will be used to demonstrate the role that process systems engineering can play in process development. The mathematical methods introduced in this dissertation will emphasize the use of reduced-order and surrogate models to address the unique challenges associated with modeling, analysis and optimization of solids-based processes.
Book Synopsis Continuous Processing in Pharmaceutical Manufacturing by : Ganapathy Subramanian
Download or read book Continuous Processing in Pharmaceutical Manufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2015-02-09 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.
Book Synopsis Proceedings of the 8th International Conference on Foundations of Computer-Aided Process Design by :
Download or read book Proceedings of the 8th International Conference on Foundations of Computer-Aided Process Design written by and published by Elsevier. This book was released on 2014-07-14 with total page 835 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume collects together the presentations at the Eighth International Conference on Foundations of Computer-Aided Process Design, FOCAPD-2014, an event that brings together researchers, educators, and practitioners to identify new challenges and opportunities for process and product design. The chemical industry is currently entering a new phase of rapid evolution. The availability of low-cost feedstocks from natural gas is causing renewed investment in basic chemicals in the OECD, while societal pressures for sustainability and energy security continue to be key drivers in technology development and product selection. This dynamic environment creates opportunities to launch new products and processes and to demonstrate new methodologies for innovation, synthesis and design. FOCAPD-2014 fosters constructive interaction among thought leaders from academia, industry, and government and provides a showcase for the latest research in product and process design. Focuses exclusively on the fundamentals and applications of computer-aided design for the process industries. Provides a fully archival and indexed record of the FOCAPD14 conference Aligns the FOCAPD series with the ESCAPE and PSE series
