Quality By Design For Biopharmaceuticals

Author: Anurag S. Rathore
Editor: John Wiley & Sons
ISBN: 1118210913
Size: 15,91 MB
Format: PDF, Mobi
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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
Editor: Elsevier
ISBN: 0128125527
Size: 20,42 MB
Format: PDF, ePub, Mobi
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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
Editor: Newnes
ISBN: 0444595902
Size: 10,89 MB
Format: PDF, Kindle
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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
Editor: John Wiley & Sons
ISBN: 0470261943
Size: 12,99 MB
Format: PDF, Kindle
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Preparative Chromatography For Separation Of Proteins

Author: Arne Staby
Editor: John Wiley & Sons
ISBN: 1119031176
Size: 16,59 MB
Format: PDF, ePub, Mobi
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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
Editor: John Wiley & Sons
ISBN: 1118514343
Size: 17,32 MB
Format: PDF, Docs
Read: 273
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Sets forth tested and proven risk management practices indrug manufacturing Risk management is essential for safe and efficientpharmaceutical and biopharmaceutical manufacturing, control, anddistribution. With this book as their guide, readers involved inall facets of drug manufacturing have a single, expertly written,and organized resource to guide them through all facets of riskmanagement and analysis. It sets forth a solid foundation in riskmanagement concepts and then explains how these concepts areapplied to drug manufacturing. Risk Management Applications in Pharmaceutical andBiopharmaceutical Manufacturing features contributions fromleading international experts in risk management and drugmanufacturing. These contributions reflect the latest research,practices, and industry standards as well as the authors' firsthandexperience. Readers can turn to the book for: Basic foundation of risk management principles, practices, andapplications Tested and proven tools and methods for managing risk inpharmaceutical and biopharmaceutical product manufacturingprocesses Recent FDA guidelines, EU regulations, and internationalstandards governing the application of risk management to drugmanufacturing Case studies and detailed examples demonstrating the use andresults of applying risk management principles to drug productmanufacturing Bibliography and extensive references leading to the literatureand helpful resources in the field With its unique focus on the application of risk management tobiopharmaceutical and pharmaceutical manufacturing, this book is anessential resource for pharmaceutical and process engineers as wellas safety and compliance professionals involved in drugmanufacturing.

The British National Bibliography

Author: Arthur James Wells
Editor:
ISBN:
Size: 16,63 MB
Format: PDF, ePub
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3d And 4d Printing In Biomedical Applications

Author: Mohammed Maniruzzaman
Editor: Wiley-VCH
ISBN: 3527344438
Size: 13,45 MB
Format: PDF, Kindle
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Ein professioneller Leitfaden zu 3D- und 4D-Drucktechniken in der Biomedizin und Pharmazie. 3D and 4D Printing in Biomedical Applications führt fundiert in 3D- und 4D-Drucktechniken in der Biomedizin und Pharmazie ein. Dieses Fachbuch enthält Beiträge von internationalen Wissenschaftlern und Industrieexperten und bietet einen Überblick über das Thema, aktuelle Forschungsergebnisse und Innovationen zu Anwendungen in der Pharmazie und Biomedizin. Untersucht werden Prozessoptimierung, Innovationsprozesse, Engineering- und Plattformtechnologien. Darüber hinaus informiert das Werk über Entwicklungen in der Biomedizin, u. a. über Formgedächtnispolymere, Biofabrikation in 4D und Knochen aus dem Drucker. Eine Fülle von Themen werden behandelt und näher beleuchtet: Potenzial des 3D-Drucks für die Wirkstoffverabreichung, neue Fertigungsprozess, Bio-Scaffolding, neueste Trends und Herausforderungen für 3D- und 4D-Bioprinting in der Biofabrikation. Dieses wertvolle Referenzwerk - ist ein umfassender Leitfaden zu 3D- und 4D-Drucktechniken in der Biomedizin und Pharmazie. - informiert u. a. über die erste 3D-Druckplattform mit FDA-Zulassung für ein pharmazeutisches Erzeugnis. - enthält Reviews der derzeit verfügbaren pharmazeutischen Erzeugnisse, die per 3D-Druck hergestellt wurden. - präsentiert die jüngsten Fortschritte bei neuartigen Materialien für den 3D- und 4D-Druck und biomedizinische Anwendungen.

Zukunftsbranche Biotechnologie

Author: Cynthia Robbins-Roth
Editor: Springer-Verlag
ISBN: 3322823512
Size: 12,90 MB
Format: PDF
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Die Autorin zeigt, welche gigantischen Profitpotenziale biotechnologischer Fortschritt auf allen Stufen von Geschäft und Investment generiert. Sie gewährt Einblick in Forschung sowie Produkt-Entwicklung in neuen Geschäfts- und Finanzierungsmodellen. Hinweise zu profitabler Anlagestrategie runden das Buch ab.

Biotechnology

Author: Wulf Crueger
Editor:
ISBN: 9780878931354
Size: 15,13 MB
Format: PDF, ePub
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