Process Monitoring And Quality By Design For Biotechnology Products

Download Process Monitoring And Quality By Design For Biotechnology Products full books in PDF, epub, and Kindle. Read online Process Monitoring And Quality By Design For Biotechnology Products ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!

Process Monitoring and Quality by Design for Biotechnology Products

Author : Neslihan Delacruz
Publisher : Morgan & Claypool Publishers
ISBN 13 : 1615041141
Total Pages : 39 pages
Book Rating : 4.6/5 (15 download)

DOWNLOAD NOW!

Book Synopsis Process Monitoring and Quality by Design for Biotechnology Products by : Neslihan Delacruz

Download or read book Process Monitoring and Quality by Design for Biotechnology Products written by Neslihan Delacruz and published by Morgan & Claypool Publishers. This book was released on 2010-12-31 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use.

Quality by Design for Biopharmaceutical Drug Product Development

Author : Feroz Jameel
Publisher : Springer
ISBN 13 : 1493923161
Total Pages : 710 pages
Book Rating : 4.4/5 (939 download)

DOWNLOAD NOW!

Book Synopsis Quality by Design for Biopharmaceutical Drug Product Development by : Feroz Jameel

Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel and published by Springer. This book was released on 2015-04-01 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Process Monitoring and Quality by Design for Biotechnology Products

Author : Neslihan Delacruz
Publisher : Biota Publishing
ISBN 13 : 161504115X
Total Pages : 38 pages
Book Rating : 4.6/5 (15 download)

DOWNLOAD NOW!

Book Synopsis Process Monitoring and Quality by Design for Biotechnology Products by : Neslihan Delacruz

Download or read book Process Monitoring and Quality by Design for Biotechnology Products written by Neslihan Delacruz and published by Biota Publishing. This book was released on 2010-09-01 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use. Table of Contents: Abbreviations / Introduction / From the Traditional Development Path to Quality by Design / Continuous Process Verification and Process Monitoring / Process Monitoring and Statistical Control Limits / Multivariate Analysis: A Mature State of Statistical Process Monitoring / Conclusion / Bibliography

Quality by Design for Biopharmaceuticals

Author : Anurag S. Rathore
Publisher : John Wiley & Sons
ISBN 13 : 1118210913
Total Pages : 279 pages
Book Rating : 4.1/5 (182 download)

DOWNLOAD NOW!

Book Synopsis Quality by Design for Biopharmaceuticals by : Anurag S. Rathore

Download or read book Quality by Design for Biopharmaceuticals written by Anurag S. Rathore and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

PAT Applied in Biopharmaceutical Process Development And Manufacturing

Author : Cenk Undey
Publisher : CRC Press
ISBN 13 : 1439829454
Total Pages : 330 pages
Book Rating : 4.4/5 (398 download)

DOWNLOAD NOW!

Book Synopsis PAT Applied in Biopharmaceutical Process Development And Manufacturing by : Cenk Undey

Download or read book PAT Applied in Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and published by CRC Press. This book was released on 2011-12-07 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Author : Gintaras V. Reklaitis
Publisher : John Wiley & Sons
ISBN 13 : 0470942371
Total Pages : 418 pages
Book Rating : 4.4/5 (79 download)

DOWNLOAD NOW!

Book Synopsis Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by : Gintaras V. Reklaitis

Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Introduction to Quality by Design (QbD)

Author : N. K. Jain
Publisher : Springer Nature
ISBN 13 : 9819980348
Total Pages : 505 pages
Book Rating : 4.8/5 (199 download)

DOWNLOAD NOW!

Book Synopsis Introduction to Quality by Design (QbD) by : N. K. Jain

Download or read book Introduction to Quality by Design (QbD) written by N. K. Jain and published by Springer Nature. This book was released on with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
ISBN 13 : 1118895215
Total Pages : 368 pages
Book Rating : 4.1/5 (188 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Quality by Design

Author : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128163720
Total Pages : 448 pages
Book Rating : 4.1/5 (281 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Quality by Design by : Sarwar Beg

Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Biopharmaceutical Processing

Author : Gunter Jagschies
Publisher : Elsevier
ISBN 13 : 0128125527
Total Pages : 1308 pages
Book Rating : 4.1/5 (281 download)

DOWNLOAD NOW!

Book Synopsis Biopharmaceutical Processing by : Gunter Jagschies

Download or read book Biopharmaceutical Processing written by Gunter Jagschies and published by Elsevier. This book was released on 2018-01-18 with total page 1308 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Cell Culture Engineering

Author : Gyun Min Lee
Publisher : John Wiley & Sons
ISBN 13 : 3527343342
Total Pages : 436 pages
Book Rating : 4.5/5 (273 download)

DOWNLOAD NOW!

Book Synopsis Cell Culture Engineering by : Gyun Min Lee

Download or read book Cell Culture Engineering written by Gyun Min Lee and published by John Wiley & Sons. This book was released on 2020-01-13 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offers a comprehensive overview of cell culture engineering, providing insight into cell engineering, systems biology approaches and processing technology In Cell Culture Engineering: Recombinant Protein Production, editors Gyun Min Lee and Helene Faustrup Kildegaard assemble top class authors to present expert coverage of topics such as: cell line development for therapeutic protein production; development of a transient gene expression upstream platform; and CHO synthetic biology. They provide readers with everything they need to know about enhancing product and bioprocess attributes using genome-scale models of CHO metabolism; omics data and mammalian systems biotechnology; perfusion culture; and much more. This all-new, up-to-date reference covers all of the important aspects of cell culture engineering, including cell engineering, system biology approaches, and processing technology. It describes the challenges in cell line development and cell engineering, e.g. via gene editing tools like CRISPR/Cas9 and with the aim to engineer glycosylation patterns. Furthermore, it gives an overview about synthetic biology approaches applied to cell culture engineering and elaborates the use of CHO cells as common cell line for protein production. In addition, the book discusses the most important aspects of production processes, including cell culture media, batch, fed-batch, and perfusion processes as well as process analytical technology, quality by design, and scale down models. -Covers key elements of cell culture engineering applied to the production of recombinant proteins for therapeutic use -Focuses on mammalian and animal cells to help highlight synthetic and systems biology approaches to cell culture engineering, exemplified by the widely used CHO cell line -Part of the renowned "Advanced Biotechnology" book series Cell Culture Engineering: Recombinant Protein Production will appeal to biotechnologists, bioengineers, life scientists, chemical engineers, and PhD students in the life sciences.

Comprehensive Biotechnology

Author :
Publisher : Newnes
ISBN 13 : 0080885047
Total Pages : 5304 pages
Book Rating : 4.0/5 (88 download)

DOWNLOAD NOW!

Book Synopsis Comprehensive Biotechnology by :

Download or read book Comprehensive Biotechnology written by and published by Newnes. This book was released on 2011-08-26 with total page 5304 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of Comprehensive Biotechnology, Six Volume Set continues the tradition of the first inclusive work on this dynamic field with up-to-date and essential entries on the principles and practice of biotechnology. The integration of the latest relevant science and industry practice with fundamental biotechnology concepts is presented with entries from internationally recognized world leaders in their given fields. With two volumes covering basic fundamentals, and four volumes of applications, from environmental biotechnology and safety to medical biotechnology and healthcare, this work serves the needs of newcomers as well as established experts combining the latest relevant science and industry practice in a manageable format. It is a multi-authored work, written by experts and vetted by a prestigious advisory board and group of volume editors who are biotechnology innovators and educators with international influence. All six volumes are published at the same time, not as a series; this is not a conventional encyclopedia but a symbiotic integration of brief articles on established topics and longer chapters on new emerging areas. Hyperlinks provide sources of extensive additional related information; material authored and edited by world-renown experts in all aspects of the broad multidisciplinary field of biotechnology Scope and nature of the work are vetted by a prestigious International Advisory Board including three Nobel laureates Each article carries a glossary and a professional summary of the authors indicating their appropriate credentials An extensive index for the entire publication gives a complete list of the many topics treated in the increasingly expanding field

Process Understanding

Author : Ian Houson
Publisher : John Wiley & Sons
ISBN 13 : 352763715X
Total Pages : 346 pages
Book Rating : 4.5/5 (276 download)

DOWNLOAD NOW!

Book Synopsis Process Understanding by : Ian Houson

Download or read book Process Understanding written by Ian Houson and published by John Wiley & Sons. This book was released on 2011-04-08 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Understanding is the underpinning knowledge that allows the manufacture of chemical entities to be carried out routinely, robustly and to the required standard of quality. This area has gained in importance over the last few years, particularly due to the recent impetus from the USA`s Food and Drug Administration. This book covers the multidisciplinary aspects required for successful process design, safety, modeling, scale-up, PAT, pilot plant implementation, plant design as well the rapidly expanding area of outsourcing. In discussing what process understanding means to different disciplines and sectors throughout a product`s life cycle, this handbook and ready reference reveals the factors important to the development and manufacture of chemicals. The book focuses on the fundamental scientific understanding necessary. for a smoother technical transfer between the disciplines, leading to more effective and effi cient process development and manufacturing. A range of case studies are used to exemplify and illustrate the main issues raised. As a result, readers will appreciate that process understanding can deliver a real competitive advantage within the pharmaceuticals and fine chemicals industry. This book serves as an aid to meeting the stringent regulations required by the relevant authorities through demonstrable understanding of the underlying science.

Pharmaceutical Biotechnology

Author : Adalberto Pessoa
Publisher : CRC Press
ISBN 13 : 1000399842
Total Pages : 400 pages
Book Rating : 4.0/5 (3 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Biotechnology by : Adalberto Pessoa

Download or read book Pharmaceutical Biotechnology written by Adalberto Pessoa and published by CRC Press. This book was released on 2021-07-16 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Biotechnology: A Focus on Industrial Application covers the development of new biopharmaceuticals as well as the improvement of those being produced. The main purpose is to provide background and concepts related to pharmaceutical biotechnology, together with an industrial perspective. This is a comprehensive text for undergraduates, graduates and academics in biochemistry, pharmacology and biopharmaceutics, as well as professionals working on the interdisciplinary field of pharmaceutical biotechnology. Written with educators in mind, this book provides teachers with background material to enhance their classes and offers students and other readers an easy-to-read text that examines the step-by-step stages of the development of new biopharmaceuticals. Features: Discusses specific points of great current relevance in relation to new processes as well as traditional processes Addresses the main unitary operations used in the biopharmaceutical industry such as upstream and downstream Includes chapters that allow a broad evaluation of the production process Dr. Adalberto Pessoa Jr. is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo and Visiting Senior Professor at King’s College London. He has experience in enzyme and fermentation technology and in the purification processes of biotechnological products such as liquid–liquid extraction, cross-flow filtration and chromatography of interest to the pharmaceutical and food industries. Dr. Michele Vitolo is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo. He has experience in enzyme technology, in immobilization techniques (aiming the reuse of the biocatalyst) and in the operation of membrane reactors for obtaining biotechnological products of interest to the pharmaceutical, chemical and food industries. Dr. Paul F. Long is Professor of Biotechnology at King's College London and Visiting International Research Professor at the University of São Paulo. He is a microbiologist by training and his research uses a combination of bioinformatics, laboratory and field studies to discover new medicines from nature, particularly from the marine environment.

Measurement, Monitoring, Modelling and Control of Bioprocesses

Author : Carl-Fredrik Mandenius
Publisher : Springer
ISBN 13 : 3642368387
Total Pages : 288 pages
Book Rating : 4.6/5 (423 download)

DOWNLOAD NOW!

Book Synopsis Measurement, Monitoring, Modelling and Control of Bioprocesses by : Carl-Fredrik Mandenius

Download or read book Measurement, Monitoring, Modelling and Control of Bioprocesses written by Carl-Fredrik Mandenius and published by Springer. This book was released on 2014-07-08 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Automated Measurement and Monitoring of Bioprocesses: Key Elements of the M3C Strategy, by Bernhard Sonnleitner Automatic Control of Bioprocesses, by Marc Stanke, Bernd Hitzmann An Advanced Monitoring Platform for Rational Design of Recombinant Processes, by G. Striedner, K. Bayer Modelling Approaches for Bio-Manufacturing Operations, by Sunil Chhatre Extreme Scale-Down Approaches for Rapid Chromatography Column Design and Scale-Up During Bioprocess Development, by Sunil Chhatre Applying Mechanistic Models in Bioprocess Development, by Rita Lencastre Fernandes, Vijaya Krishna Bodla, Magnus Carlquist, Anna-Lena Heins, Anna Eliasson Lantz, Gürkan Sin and Krist V. Gernaey Multivariate Data Analysis for Advancing the Interpretation of Bioprocess Measurement and Monitoring Data, by Jarka Glassey Design of Pathway-Level Bioprocess Monitoring and Control Strategies Supported by Metabolic Networks, by Inês A. Isidro, Ana R. Ferreira, João J. Clemente, António E. Cunha, João M. L. Dias, Rui Oliveira Knowledge Management and Process Monitoring of Pharmaceutical Processes in the Quality by Design Paradigm, by Anurag S Rathore, Anshuman Bansal, Jaspinder Hans The Choice of Suitable Online Analytical Techniques and Data Processing for Monitoring of Bioprocesses, by Ian Marison, Siobhán Hennessy, Róisín Foley, Moira Schuler, Senthilkumar Sivaprakasam, Brian Freeland

Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development

Author : Márcia Cristina Breitkreitz
Publisher : Springer Nature
ISBN 13 : 3031315057
Total Pages : 268 pages
Book Rating : 4.0/5 (313 download)

DOWNLOAD NOW!

Book Synopsis Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development by : Márcia Cristina Breitkreitz

Download or read book Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development written by Márcia Cristina Breitkreitz and published by Springer Nature. This book was released on 2023-07-13 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

Author : Anurag S. Rathore
Publisher : CRC Press
ISBN 13 : 1439850933
Total Pages : 535 pages
Book Rating : 4.4/5 (398 download)

DOWNLOAD NOW!

Book Synopsis Process Validation in Manufacturing of Biopharmaceuticals, Third Edition by : Anurag S. Rathore

Download or read book Process Validation in Manufacturing of Biopharmaceuticals, Third Edition written by Anurag S. Rathore and published by CRC Press. This book was released on 2012-05-09 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.