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Informationen zum Autor 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. Klappentext 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. Zusammenfassung Provides an in-depth understanding of the underlying concepts of Quality by Design (QbD) and the practical aspects of the implementation of QbD in biopharmaceutical manufacturing. Inhaltsverzeichnis Foreword xiii Preface xv Preface to the Wiley Series on Biotechnology and Related Topics xvii Contributors xix 1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS 1 Rohin Mhatre and Anurag S. Rathore 1.1 Introduction 1 1.2 Critical Quality Attributes 2 1.3 An Overview of Design Space 3 1.4 Raw Materials and their Impact on QbD 4 1.5 Process Analytical Technology 4 1.6 The Utility of Design Space and QbD 5 1.7 Conclusions 7 2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN 9 Steven Kozlowski and Patrick Swann 2.1 Introduction 9 2.2 Quality by Design 10 2.3 Relevant Product Attributes 11 2.4 Manufacturing Process 14 2.5 Developing a Design Space 18 2.6 Uncertainty and Complexity 22 2.7 Future Horizons 23 2.8 QbD Submission T...
List of contents
Foreword.
Preface.
Preface to the Wiley Series on Biotechnology and Related Topics.
Contributors.
1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS (Rohin Mhatre and Anurag S. Rathore).
1.1 Introduction.
1.2 Critical Quality Attributes.
1.3 An Overview of Design Space.
1.4 Raw Materials and their Impact on QbD.
1.5 Process Analytical Technology.
1.6 The Utility of Design Space and QbD.
1.7 Conclusions.
References.
2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN (Steven Kozlowski and Patrick Swann).
2.1 Introduction.
2.2 Quality by Design.
2.3 Relevant Product Attributes.
2.4 Manufacturing Process.
2.5 Developing a Design Space.
2.6 Uncertainty and Complexity.
2.7 Future Horizons.
2.8 QbD Submission Thoughts.
2.9 Implementation Plans.
2.10 Summary.
Acknowledgments.
References.
3 MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris (David L. Narum).
3.1 Introduction.
3.2 The Malaria Genome and Proteome.
3.3 Expression of Two Malaria Antigens in P. pastoris.
3.4 Summary.
Acknowledgments.
References.
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).
4.1 Introduction.
4.2 Examples of Criticality Determination.
4.3 Conclusion.
Acknowledgments.
References.
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).
5.1 Introduction.
5.2 Approach Toward Process Characterization.
5.3 Risk Analysis.
5.4 Small-Scale Model Development and Qualification.
5.5 Design of Experiment Studies.
5.6 Worst Case Studies.
5.7 Definition of Design Space.
5.8 Definition of Validation Acceptance Limits.
5.9 Regulatory Filing, Process Monitoring, and Postapproval Changes.
Acknowledgment.
References.
6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS (Peter K. Watler and John Rozembersky).
6.1 Introduction.
6.2 Applications of TFF in Biotechnology.
6.3 Tangential Flow Filtration Operating Principles.
6.4 TFF Design Objectives.
6.5 Membrane Selection.
6.6 TFF Operating Parameter Design.
6.7 TFF Diafiltration Operating Mode Design.
6.8 Summary.
References.
7 APPLICATIONS OF DESIGN SPACE FOR BIOPHARMACEUTICAL PURIFICATION PROCESSES (Douglas J. Cecchini).
7.1 Introduction.
7.2 Establishing Design Space for Purification Processes during Process Development.
7.3 Applications of Design Space.
7.4 Cell Harvest and Product Capture Steps.
7.5 Protein A Capture Column.
7.6 Hydrophobic Interaction Chromatography.
7.7 Anion Exchange Chromatography.
7.8 Summary.
Acknowledgments.
References.
8 VIRAL CLEARANCE: A STRATEGY FOR QUALITY BY DESIGN AND THE DESIGN SPACE (Gail Sofer and Jeffrey Carter).
8.1 Introduction.
8.2 Current and Future Approaches to Virus Clearance Characterization.
8.3 Benefits of Applying Design Space Principles to Virus Clearance.
8.4 Technical Limitations Related to Adoption of QdB/Design Space Conc
