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:
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.
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Wiley Series in Biotechnology and bioengineering
Anurag S. Rathore, Series Editor
Quality by Design for Biopharmaceuticals
Principles and Case Studies
Anurag S. Rathore
Rohin MhatreAbout the Author:
Anurag S. Rathore received his PhD in chemical engineering from Yale University and is the Director of Process Development, Amgen Inc. His areas of interest include process development, scale-up, technology transfer, process validation, process analytical technology, and quality by design. He has authored more than 100 publications and presentations in these areas and serves on the editorial advisory boards for Biotechnology Progress, BioPharm International, Pharmaceutical Technology Europe, Journal of Biochemical and Biophysical Methods, and Separation and Purification Reviews.
Rohin Mhatre is a Senior Director in the BioProcess Development department at Biogen Idec, Cambridge, Massachusetts, and has been with the company since 1996. His group is responsible for development of analytical methods and product characterization to support the process and formulation development of early and late stage clinical programs. Mhatre is also leading the QbD initiative within Biogen Idec. He has authored several publications and been an invited speaker to numerous scientific meetings.
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Book Description John Wiley and Sons Ltd, United States, 2009. Hardback. Book Condition: New. 1. Auflage. Language: English . Brand New Book. This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD in biopharmaceutical manufacturing. A systematic approach leads the reader through a process, outlining the understanding of the critical quality attributes of the molecule, the development of the design space to meet the quality attributes, filing of the QbD information in regulatory documents, risk management, and the application of QbD. Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students. Bookseller Inventory # AAH9780470282335
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Book Description Wileyand#8211;Blackwell, 2009. HRD. Book Condition: New. New Book. Shipped from UK in 4 to 14 days. Established seller since 2000. Bookseller Inventory # FW-9780470282335