Quality by Design for Biopharmaceuticals (eBook, ePUB)

Principles and Case Studies
Redaktion: Rathore, Anurag S.; Mhatre, Rohin

• Format: ePub

Produktbeschreibung

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.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 312
• Erscheinungstermin: 20. September 2011
• Englisch
• ISBN-13: 9781118210918
• Artikelnr.: 37346169

Autorenporträt

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.

Inhaltsangabe

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 Concepts in Virus Clearance. 8.5 Developing a Virus Clearance Design
Space. 8.6 Staying in the Design Space. 8.7 Conclusion. Acknowledgments.
References. 9 APPLICATION OF QUALITY BY DESIGN AND RISK ASSESSMENT
PRINCIPLES FOR THE DEVELOPMENT OF FORMULATION DESIGN SPACE (Kingman Ng and
Natarajan Rajagopalan). 9.1 Introduction. 9.2 Quality by Design (QbD)
Approach. 9.3 Target Product Profile (TPP). 9.4 Molecular Degradation
Characterization. 9.5 Active Pharmaceutical Ingredient (API) Critical
Properties. 9.6 Preformulation Characterization. 9.7 Initial Formulation
Risk Assessments. 9.8 Formulation Optimization and Design Space. 9.9
Selection of Solution Formulation Composition. 9.10 Summary.
Acknowledgments. References. 10 APPLICATION OF QbD PRINCIPLES TO BIOLOGICS
PRODUCT: FORMULATION AND PROCESS DEVELOPMENT (Satish K. Singh, Carol F.
Kirchhoff, and Amit Banerjee). 10.1 Introduction: QbD in Biologics Product
Development. 10.2 Risk Assessment Process. 10.3 Examples. 10.4 Conclusions.
References. 11 QbD FOR RAW MATERIALS (Maureen Lanan). 11.1 Introduction.
11.2 Background. 11.3 Current Practice for Raw Materials. 11.4 QbD in
Development. 11.5 QbD in manufacturing. 11.6 QbD for organizations. 11.7
Tests Available. 11.8 Conclusions and Future Prospects. Acknowledgments.
References. 12 PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS AND CHALLENGES
(Michael Molony and Cenk Undey). 12.1 Introduction. 12.2 Cell Culture and
Fermentation PAT Tools. 12.3 Purification PAT Tools. 12.4 Formulation PAT
Tools. 12.5 PAT Tools for Bioprocess Starting Materials, Defined Media, and
Complex Raw Materials. 12.6 Chemometrics and Advanced Process Control
Tools. 12.7 The power of PLS and PCA. 12.8 ''Relevant Time'' Column
Integrity Monitoring (Moments Analysis versus HETP). 12.9 Challenges for
Implementation of PAT Tools. 12.10 Future PAT Tools. Acknowledgments.
References. 13 EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS
ANALYTICAL TECHNOLOGY (Duncan Low and Joseph Phillips). 13.1 Introduction.
13.2 Evolution of PAT and Quality by Design (QbD): Emerging Guidelines and
Standards. 13.3 Process Analytical Technology (PAT). 13.4 Quality by
Design. 13.5 Implementing QbD and PAT. 13.6 Conclusions. Acknowledgments.
References. Index.