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 : 66. 21 MB
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The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in assuming that drug quality cannot betested into products; rather, it must be built into every step ofthe product creation process. Quality by Design: Perspectives and Case Studies presentsthe first systematic approach to QbD in the biotech industry. Acomprehensive resource, it combines an in-depth explanation ofbasic concepts with real-life case studies that illustrate thepractical aspects of QbD implementation. In this single source, leading authorities from thebiotechnology industry and the FDA discuss such topics as: The understanding and development of the product's criticalquality attributes (CQA) Development of the design space for a manufacturingprocess 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 toQbD Relevant PAT tools and applications for the pharmaceuticalindustry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) toQbD Filled with vivid case studies that illustrate QbD at work incompanies today, Quality by Design is a core reference forscientists in the biopharmaceutical industry, regulatory agencies,and students.

Biopharmaceutical Processing

Author : Gunter Jagschies
ISBN : 9780128125526
Genre : Technology & Engineering
File Size : 36. 94 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

Risk Management Applications In Pharmaceutical And Biopharmaceutical Manufacturing

Author : Hamid Mollah
ISBN : 9780470552346
Genre : Science
File Size : 53. 66 MB
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This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM for biological and pharmaceutical product manufacture. The book also includes useful references and a bibliography for the reader who wishes to gain additional knowledge in the subject. It aids in assisting both industry and regulatory agencies to implement compliant and effective risk management approaches, and includes case studies to help with understanding.

Vaccine Development And Manufacturing

Author : Emily P. Wen
ISBN : 9780470261941
Genre : Technology & Engineering
File Size : 46. 38 MB
Format : PDF
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Preparative Chromatography For Separation Of Proteins

Author : Arne Staby
ISBN : 9781119031109
Genre : Science
File Size : 72. 70 MB
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"Preparative Chromatography for Separation of Proteins addresses a wide range of the most current modeling techniques, strategies, and case studies of industrial separation of proteins and peptides to aid in the efficiency and efficacy of this broadly-used technique in the purification of biopharmaceuticals"--

The British National Bibliography

Author : Arthur James Wells
ISBN : STANFORD:36105211722686
Genre : English literature
File Size : 22. 71 MB
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