Quality by Design for Biopharmaceuticals
Principles and Case Studies
Herausgegeben von Rathore, Anurag S.; Mhatre, Rohin
Quality by Design for Biopharmaceuticals
Principles and Case Studies
Herausgegeben von Rathore, Anurag S.; Mhatre, Rohin
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- 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. - Outlines the critical quality attributes for the molecule, 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 for routine manufacturing - Case studies are provided e to further enhance the understanding of QbD and provide the reader with "real-world" examples of its various aspects
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- Outlines the critical quality attributes for the molecule, 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 for routine manufacturing
- Case studies are provided e to further enhance the understanding of QbD and provide the reader with "real-world" examples of its various aspects
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.
- Produktdetails
- Wiley Series in Biotechnology and Bioengineering
- Verlag: Wiley & Sons
- 1. Auflage
- Seitenzahl: 312
- Erscheinungstermin: 1. Juni 2009
- Englisch
- Abmessung: 240mm x 161mm x 22mm
- Gewicht: 576g
- ISBN-13: 9780470282335
- ISBN-10: 0470282339
- Artikelnr.: 26177725
- Wiley Series in Biotechnology and Bioengineering
- Verlag: Wiley & Sons
- 1. Auflage
- Seitenzahl: 312
- Erscheinungstermin: 1. Juni 2009
- Englisch
- Abmessung: 240mm x 161mm x 22mm
- Gewicht: 576g
- ISBN-13: 9780470282335
- ISBN-10: 0470282339
- Artikelnr.: 26177725
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.
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.