PAT Applied in Biopharmaceutical Process Development And Manufacturing Book

PAT Applied in Biopharmaceutical Process Development And Manufacturing


  • Author : Cenk Undey
  • Publisher : CRC Press
  • Release Date : 2011-12-07
  • Genre: Medical
  • Pages : 327
  • ISBN 10 : 9781439829455

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PAT Applied in Biopharmaceutical Process Development And Manufacturing 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.

PAT Applied in Biopharmaceutical Process Development And Manufacturing Book

PAT Applied in Biopharmaceutical Process Development And Manufacturing


  • Author : Cenk Undey
  • Publisher : CRC Press
  • Release Date : 2011-12-07
  • Genre: Medical
  • Pages : 327
  • ISBN 10 : 9781439829462

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PAT Applied in Biopharmaceutical Process Development And Manufacturing 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 comp

Biopharmaceutical Processing Book
Score: 5
From 1 Ratings

Biopharmaceutical Processing


  • Author : Gunter Jagschies
  • Publisher : Elsevier
  • Release Date : 2018-01-18
  • Genre: Technology & Engineering
  • Pages : 1308
  • ISBN 10 : 9780128125526

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Biopharmaceutical Processing 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

Pharmaceutical Quality by Design Book

Pharmaceutical Quality by Design


  • Author : Sarwar Beg
  • Publisher : Academic Press
  • Release Date : 2019-03-27
  • Genre: Business & Economics
  • Pages : 448
  • ISBN 10 : 9780128163726

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Pharmaceutical Quality by Design 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

Process Analytical Technology Book

Process Analytical Technology


  • Author : Katherine A. Bakeev
  • Publisher : John Wiley & Sons
  • Release Date : 2008-04-15
  • Genre: Science
  • Pages : 472
  • ISBN 10 : 9781405173193

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Process Analytical Technology Excerpt :

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.

New Bioprocessing Strategies  Development and Manufacturing of Recombinant Antibodies and Proteins Book

New Bioprocessing Strategies Development and Manufacturing of Recombinant Antibodies and Proteins


  • Author : Bob Kiss
  • Publisher : Springer
  • Release Date : 2018-12-06
  • Genre: Science
  • Pages : 469
  • ISBN 10 : 9783319971100

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New Bioprocessing Strategies Development and Manufacturing of Recombinant Antibodies and Proteins Excerpt :

This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

Chemical Engineering in the Pharmaceutical Industry Book

Chemical Engineering in the Pharmaceutical Industry


  • Author : Mary T. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-08
  • Genre: Technology & Engineering
  • Pages : 688
  • ISBN 10 : 9781119285502

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Chemical Engineering in the Pharmaceutical Industry Excerpt :

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sc

Advances and Challenges in Pharmaceutical Technology Book

Advances and Challenges in Pharmaceutical Technology


  • Author : Amit Kumar Nayak
  • Publisher : Academic Press
  • Release Date : 2021-02-09
  • Genre: Business & Economics
  • Pages : 568
  • ISBN 10 : 9780128203002

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Advances and Challenges in Pharmaceutical Technology Excerpt :

Advances and Challenges in Pharmaceutical Technology: Materials, Process Development and Drug Delivery Strategies examines recent advancements in pharmaceutical technology. The book discusses common formulation strategies, including the use of tools for statistical formulation optimization, Quality by design (QbD), process analytical technology, and the uses of various pharmaceutical biomaterials, including natural polymers, synthetic polymers, modified natural polymers, bioceramics, and other bioinorganics. In addition, the book covers rapid advancements in the field by providing a thorough understanding of pharmaceutical processes, formulation developments, explorations, and exploitation of various pharmaceutical biomaterials to formulate pharmaceutical dosage forms. Provides extensive information and analysis on recent advancements in the field of pharmaceutical technology Includes contributions from global leaders and experts in academia, industry and regulatory agencies Uses high quality illustrations, flow charts and tables to explain concepts and text to readers, along with practical examples and research case studies

Chemical Engineering in the Pharmaceutical Industry Book

Chemical Engineering in the Pharmaceutical Industry


  • Author : Mary T. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-01
  • Genre: Technology & Engineering
  • Pages : 688
  • ISBN 10 : 9781119285519

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Chemical Engineering in the Pharmaceutical Industry Excerpt :

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sc

Computer Aided Applications in Pharmaceutical Technology Book

Computer Aided Applications in Pharmaceutical Technology


  • Author : Jelena Djuris
  • Publisher : Elsevier
  • Release Date : 2013-04-10
  • Genre: Medical
  • Pages : 300
  • ISBN 10 : 9781908818324

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Computer Aided Applications in Pharmaceutical Technology Excerpt :

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications

Computer aided applications in pharmaceutical technology Book

Computer aided applications in pharmaceutical technology


  • Author : Jelena Djuris
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-04-10
  • Genre: Technology & Engineering
  • Pages : 300
  • ISBN 10 : 9780128091876

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Computer aided applications in pharmaceutical technology Excerpt :

This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept is presented from both regulatory and manufacturers’ points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and ease of its application.

Emerging Non Clinical Biostatistics in Biopharmaceutical Development and Manufacturing Book

Emerging Non Clinical Biostatistics in Biopharmaceutical Development and Manufacturing


  • Author : Harry Yang
  • Publisher : CRC Press
  • Release Date : 2016-11-30
  • Genre: Mathematics
  • Pages : 386
  • ISBN 10 : 9781315354453

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Emerging Non Clinical Biostatistics in Biopharmaceutical Development and Manufacturing Excerpt :

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.

Quality by Design for Biopharmaceutical Drug Product Development Book

Quality by Design for Biopharmaceutical Drug Product Development


  • Author : Feroz Jameel
  • Publisher : Springer
  • Release Date : 2015-04-01
  • Genre: Medical
  • Pages : 710
  • ISBN 10 : 9781493923168

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Quality by Design for Biopharmaceutical Drug Product Development 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.

Chemical Engineering in the Pharmaceutical Industry  Active Pharmaceutical Ingredients Book

Chemical Engineering in the Pharmaceutical Industry Active Pharmaceutical Ingredients


  • Author : David J. am Ende
  • Publisher : Wiley
  • Release Date : 2019-04-23
  • Genre: Technology & Engineering
  • Pages : 1168
  • ISBN 10 : 9781119285861

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Chemical Engineering in the Pharmaceutical Industry Active Pharmaceutical Ingredients Excerpt :

A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: • Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety • Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying • Presents updated and expanded example calculations • Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical

Drying Technologies for Biotechnology and Pharmaceutical Applications Book

Drying Technologies for Biotechnology and Pharmaceutical Applications


  • Author : Satoshi Ohtake
  • Publisher : John Wiley & Sons
  • Release Date : 2020-02-03
  • Genre: Medical
  • Pages : 400
  • ISBN 10 : 9783527802098

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Drying Technologies for Biotechnology and Pharmaceutical Applications Excerpt :

A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, proce