quality by design for biopharmaceuticals principles and case studies wiley series in biotechnology and bioengineering

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Quality By Design For Biopharmaceuticals

Author : Anurag S. Rathore
ISBN : 9781118210918
Genre : Science
File Size : 54. 4 MB
Format : PDF
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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.

Biopharmaceutical Processing

Author : Gunter Jagschies
ISBN : 9780128125526
Genre : Technology & Engineering
File Size : 90. 54 MB
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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

Biophysical Characterization Of Proteins In Developing Biopharmaceuticals

Author : Damian J. Houde
ISBN : 9780444595904
Genre : Science
File Size : 33. 77 MB
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Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure this book takes the reader on a journey on how to best achieve this goal using the key relevant and practical methods commonly employed in the biopharmaceutical industry today as well as up and coming promising methods that are now gaining increasing attention. As a general resource guide this book has been written with the intent to help today’s industrial scientists working in the biopharmaceutical industry or the scientists of tomorrow who are planning a career in this industry on how to successfully implement these biophysical methodologies. In so doing a keen focus is placed on understanding the capability of these methodologies in terms of what information they can deliver. Aspects of how to best acquire this biophysical information on these very complex drug molecules, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development are key points that are also covered. Presents the reader with a clear understanding of the real world issues and challenges in using these methods. Highlights the capabilities and limitations of each method. Discusses how to best analyze the data generated from these methods. Points out what one needs to look for to avoid making faulty conclusions and mistakes. In total it provides a check list or road map that empowers the industrial scientists as to what they need to be concerned with in order to effectively do their part in successfully developing these new drugs in an efficient and cost effective manner.

Vaccine Development And Manufacturing

Author : Emily P. Wen
ISBN : 9780470261941
Genre : Technology & Engineering
File Size : 80. 45 MB
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Preparative Chromatography For Separation Of Proteins

Author : Arne Staby
ISBN : 9781119031178
Genre : Technology & Engineering
File Size : 67. 97 MB
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Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides. • Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives • Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling • Features a variety of chromatographic case studies not readily accessible to the general public • Represents an essential reference resource for academic, industrial, and pharmaceutical researchers

Risk Management Applications In Pharmaceutical And Biopharmaceutical Manufacturing

Author : Hamid Mollah
ISBN : 9781118514344
Genre : Science
File Size : 80. 67 MB
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Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

The British National Bibliography

Author : Arthur James Wells
ISBN : STANFORD:36105211722686
Genre : English literature
File Size : 82. 18 MB
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3d And 4d Printing In Biomedical Applications

Author : Mohammed Maniruzzaman
ISBN : 9783527344437
Genre : Science
File Size : 85. 5 MB
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Tierische Zellkulturen

Author : R. Ian Freshney
ISBN : 9783110889024
Genre : Science
File Size : 71. 95 MB
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Die Biotechnologie Industrie

Author : Julia Schüler
ISBN : 9783662471609
Genre : Science
File Size : 43. 77 MB
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Dieses Kompendium zur Biotechnologie-Industrie bietet eine fundierte Einführung und Übersicht zu einer Zukunfts- und Schlüsselbranche. Es informiert über die dahinter stehende Biotechnologie, beleuchtet Entstehung und Rahmenbedingungen der Industrie und stellt umfangreiches sowie aktuelles Zahlenmaterial zum Nachschlagen bereit. Neben der Analyse der US-Biotech-Industrie liegt ein besonderer Fokus auf der Situation in Deutschland. Das Buch ist als Einführungs-, Übersichts- und Nachschlagewerk für alle zu empfehlen, die einen fundierten Einblick in die Biotechnologie-Industrie erhalten möchten, wie z.B. Investoren, branchenfremde Unternehmer, Journalisten, Politiker und andere Interessierte. Für Branchenkenner bietet es eine Zusammenstellung aktueller Trends und Daten.

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