Continuous Pharmaceutical Processing And Process Analytical Technology
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Continuous Pharmaceutical Processing And Process Analytical Technology
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Author : Ajit S. Narang
language : en
Publisher: CRC Press
Release Date : 2023-03-01
Continuous Pharmaceutical Processing And Process Analytical Technology written by Ajit S. Narang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-01 with Medical categories.
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
Pharmaceutical Quality By Design
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Author : Walkiria S. Schlindwein
language : en
Publisher: John Wiley & Sons
Release Date : 2018-03-19
Pharmaceutical Quality By Design written by Walkiria S. Schlindwein 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 2018-03-19 with Science categories.
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Process Analytical Technology For The Food Industry
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Author : Colm P. O'Donnell
language : en
Publisher: Springer
Release Date : 2014-11-03
Process Analytical Technology For The Food Industry written by Colm P. O'Donnell and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-03 with Technology & Engineering categories.
The Process Analytical Technology (PAT) initiative aims to move from a paradigm of ‘testing quality in’ to ‘building quality in by design’. It can be defined as the optimal application of process analytical technologies, feedback process control strategies, information management tools, and/or product–process optimization strategies. Recently, there have been significant advances in process sensors and in model-based monitoring and control methodologies, leading to enormous opportunities for improved performance of food manufacturing processes and for the quality of food products with the adoption of PAT. Improvements in process efficiency, reduced product variability, enhanced traceability, process understanding, and decreased risk of contamination are some of the benefits arising from the introduction of a PAT strategy in the food industry. Process Analytical Technology for the Food Industry reviews established and emerging PAT tools with potential application within the food processing industry. The book will also serve as a reference for industry, researchers, educators, and students by providing a comprehensive insight into the objectives, challenges, and benefits of adopting a Process Analytical Technology strategy in the food industry.
Continuous Pharmaceutical Processing
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Author : Zoltan K Nagy
language : en
Publisher: Springer
Release Date : 2021-06-25
Continuous Pharmaceutical Processing written by Zoltan K Nagy and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-06-25 with Medical categories.
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.
Process Analytical Technology
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Author : Katherine A. Bakeev
language : en
Publisher: John Wiley & Sons
Release Date : 2008-04-15
Process Analytical Technology written by Katherine A. Bakeev 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 2008-04-15 with Science categories.
The use of real or near real time measurement of chemical production process parameters as the basis for achieving control or optimisation of a manufacturing process has wide application in the petrochemical, food and chemical industries. Process analytical chemistry (PAC), or process analytical technology (PAT) as it has recently been called, is now being deployed in the pharmaceutical industry, where it is seen as a technology that can help companies to improve their conformity with manufacturing compliance regulations. The objective of this book is to provide a starting point for implementing process analytical chemistry tools in process monitoring applications or as part of a total quality management system. Written from the perspective of the spectroscopist required to implant PAT tools in a process environment, attention is focussed on measurements that are made "in process" at-line or off-line, providing data on product during manufacture. With chapters covering the key spectroscopic tools, their applications in the pharmaceutical and chemical industries and basic chemometrics, the novice can quickly develop a sound understanding of the most practical technologies and applications. Implementation strategies are fully covered and address some of the critical issues that need to be tackled when setting up a PAT project – including choosing a project with a sound business justification in the first place.
Continuous Pharmaceutical Processing
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Author : Zoltan K Nagy
language : en
Publisher: Springer Nature
Release Date : 2020-06-10
Continuous Pharmaceutical Processing written by Zoltan K Nagy and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-10 with Medical categories.
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.
Continuous Manufacturing For The Modernization Of Pharmaceutical Production
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2019-04-05
Continuous Manufacturing For The Modernization Of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-05 with Medical categories.
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.
Continuous Manufacturing Of Pharmaceuticals
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Author : Peter Kleinebudde
language : en
Publisher: John Wiley & Sons
Release Date : 2024-10-28
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 2024-10-28 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.
Continuous Biomanufacturing
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2017-09-12
Continuous Biomanufacturing written by Ganapathy Subramanian 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 2017-09-12 with Science categories.
This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
Introduction To Quality By Design Qbd
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Author : N. K. Jain
language : en
Publisher: Springer Nature
Release Date : 2024-04-09
Introduction To Quality By Design Qbd written by N. K. Jain and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-09 with Science categories.
This book offers a comprehensive exploration of the Quality by Design (QbD) methodology, guiding readers from theory to practical application with accessible examples. It equips readers with both foundational and advanced knowledge, emphasizing the critical parameters necessary for designing pharmaceutical products that meet the highest quality standards. The book goes beyond theory to demonstrate how to effectively implement QbD principles in various aspects of pharmaceutical research and development, including analytical methods, formulation, and packaging processes. Through a step-by-step approach, it prepares researchers in pharmaceutical sciences, as well as professionals in the pharmaceutical and healthcare industries (including suppliers), to successfully integrate QbD into their work.