Quality by Design for Biopharmaceuticals

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.

The concepts, applications, and practical issues of Quality byDesignQuality 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) toQbDFilled with vivid case studies that illustrate QbD at work incompanies today, Quality by Design is a core reference forscientists in the biopharmaceutical industry, regulatory agenciesand students.

Preface.1. Quality by Design (QbD): An Overview of the Basic Concepts (Rohin Mhatre and Anurag S. Rathore).2. Considerations for Biotechnology Product Quality by Design (Steven Kozlowski and Patrick Swann).3. Molecular Design of Recombinant Malaria Vaccines Expressed (Pichia Pastoris).4. Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes (Mark A Schenerman, Milton J Axley, Cynthia N Oliver, Kripa Ram, and Gail F Wasserman).5. Case Study on Definition of Process Design Space for a Microbial Fermentation Step (Pim van Hoek, Jean Harms, Xiangyang Wang, and Anurag S. Rathore).6. Applications of Design Space for Biopharmaceutical Purification Processes (Douglas J. Cecchini).7. Viral Clearance: A Strategy for Quality by Design and the Design Space (Gail Sofer and Jeffrey Carter).8. Application of Quality by Design and Risk Assessment Principles for the Development of Formulation Design Space (Kingman Ng and Natarajan Rajagopalan).9. QbD for Raw Materials (Anurag S. Rathore).10. PAT Tools for Biologics: Considerations and Challenges (Michael Molony and Cenk Undey).11. Evolution and Integration of Quality by Design and Process Analytical Technology (Duncan Low and Joseph Phillips).