ENGLISH

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Book information

Year
2009
ISBN
9780470282335, 9780470466315
DOI
10.1002/9780470466315
Language
english
Format
PDF
Filesize
26 MB (26762426 bytes)
Pages
315\315
Orientation
yes
Scanned
yes
Time added
2013-08-01 04:00:00

Description

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.Content: Chapter 1 Quality by Design: An Overview of the Basic Concepts (pages 1–8): Rohin Mhatre and Anurag S. RathoreChapter 2 Considerations for Biotechnology Product Quality by Design (pages 9–30): Steven Kozlowski and Patrick SwannChapter 3 Molecular Design of Recombinant Malaria Vaccines Expressed by Pichia pastoris (pages 31–52): David L. NarumChapter 4 Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes (pages 53–84): Mark A. Schenerman, Milton J. Axley, Cynthia N. Oliver, Kripa Ram and Gail F. WassermanChapter 5 Case Study on Definition of Process Design Space for a Microbial Fermentation Step (pages 85–109): Pim van Hoek, Jean Harms, Xiangyang Wang and Anurag S. RathoreChapter 6 Application of QbD Principles to Tangential Flow Filtration Operations (pages 111–126): Peter K. Watler and John RozemberskyChapter 7 Applications of Design Space for Biopharmaceutical Purification Processes (pages 127–142): Douglas J. CecchiniChapter 8 Viral Clearance: A Strategy for Quality by Design and the Design Space (pages 143–159): Gail Sofer and Jeffrey CarterChapter 9 Application of Quality by Design and Risk Assessment Principles for the Development of Formulation Design Space (pages 161–174): Kingman Ng and Natarajan RajagopalanChapter 10 Application of QbD Principles to Biologics Product: Formulation and Process Development (pages 175–192): Satish K. Singh, Carol F. Kirchhoff and Amit BanerjeeChapter 11 QbD for Raw Materials (pages 193–209): Maureen LananChapter 12 Pat Tools for Biologics: Considerations and Challenges (pages 211–253): Michael Molony and Cenk UndeyChapter 13 Evolution and Integration of Quality by Design and Process Analytical Technology (pages 255–286): Duncan Low and Joseph Phillips

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