Model Based Tools For Pharmaceutical Manufacturing Processes
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Model Based Tools For Pharmaceutical Manufacturing Processes
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Author : Krist V. Gernaey
language : en
Publisher: MDPI
Release Date : 2020-03-13
Model Based Tools For Pharmaceutical Manufacturing Processes written by Krist V. Gernaey and has been published by MDPI this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-13 with Technology & Engineering categories.
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.
Model Based Tools For Pharmaceutical Manufacturing Processes
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Author : Krist V. Gernaey
language : en
Publisher:
Release Date : 2020
Model Based Tools For Pharmaceutical Manufacturing Processes written by Krist V. Gernaey and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with Medicine (General) categories.
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.
Continuous Manufacturing Of Pharmaceuticals
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Author : Peter Kleinebudde
language : en
Publisher: John Wiley & Sons
Release Date : 2017-09-05
Continuous Manufacturing Of Pharmaceuticals written by Peter Kleinebudde and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-05 with Science categories.
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.
Process Systems Engineering For Pharmaceutical Manufacturing
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Author : Ravendra Singh
language : en
Publisher: Elsevier
Release Date : 2018-03-16
Process Systems Engineering For Pharmaceutical Manufacturing written by Ravendra Singh and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-16 with Technology & Engineering categories.
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
Predictive Modeling Of Pharmaceutical Unit Operations
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Author : Preetanshu Pandey
language : en
Publisher: Woodhead Publishing
Release Date : 2016-09-26
Predictive Modeling Of Pharmaceutical Unit Operations written by Preetanshu Pandey and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-26 with Medical categories.
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
Comprehensive Quality By Design For Pharmaceutical Product Development And Manufacture
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Author : Gintaras V. Reklaitis
language : en
Publisher: John Wiley & Sons
Release Date : 2017-08-30
Comprehensive Quality By Design For Pharmaceutical Product Development And Manufacture written by Gintaras V. Reklaitis and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-30 with Science categories.
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 scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.
Integrated Simulation And Optimization Of Continuous Pharmaceutical Manufacturing
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Author : Fani Boukouvala
language : en
Publisher:
Release Date : 2013
Integrated Simulation And Optimization Of Continuous Pharmaceutical Manufacturing written by Fani Boukouvala and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Drugs categories.
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.
Pharmaceutical Process Design And Management
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Author : Kate McCormick
language : en
Publisher: Routledge
Release Date : 2016-04-22
Pharmaceutical Process Design And Management written by Kate McCormick and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-22 with Business & Economics categories.
A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.
Pat Applied In Biopharmaceutical Process Development And Manufacturing
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Author : Cenk Undey
language : en
Publisher: CRC Press
Release Date : 2011-12-07
Pat Applied In Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-07 with Medical categories.
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
Bioprocess Systems Engineering Applications In Pharmaceutical Manufacturing
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Author :
language : en
Publisher:
Release Date : 2022-08-26
Bioprocess Systems Engineering Applications In Pharmaceutical Manufacturing written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-08-26 with Science categories.