Quality by design for biopharmaceuticals: principles and case studies
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Hoboken, NJ
Wiley
2009
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVI, 288 S. Ill., graph. Darst. |
| ISBN: | 9780470282335 |
Internformat
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Datensatz im Suchindex
| _version_ | 1804143700376289280 |
|---|---|
| adam_text | Titel: Quality by design for biopharmaceuticals
Autor: Rathore, Anurag S.
Jahr: 2009
CONTENTS
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
References 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 Thoughts 25
2.9 Implementation Plans 26
vjjj CONTENTS
2.10 Summary 27
Acknowledgments 27
References 27
3 MOLECULAR DESIGN OF RECOMBINANT MALARIA
VACCINES EXPRESSED BY Pichia pastoris 31
David L. Narum
3.1 Introduction 31
3.2 The Malaria Genome and Proteome 34
3.3 Expression of Two Malaria Antigens in P. pastoris 34
3.4 Summary 46
Acknowledgments 48
References 48
4 USING A RISK ASSESSMENT PROCESS TO DETERMINE
CRITICALITY OF PRODUCT QUALITY ATTRIBUTES 53
Mark A Schenerman, Milton J. Axley, Cynthia N. Oliver,
Kripa Ram, and Gail F. Wasserman
4.1 Introduction 53
4.2 Examples of Criticality Determination 60
4.3 Conclusion 81
Acknowledgments 82
References 82
5 CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE
FOR A MICROBIAL FERMENTATION STEP 85
Pirn van Hoek, Jean Harms, Xiangyang Wang,
and Anurag S. Rathore
5.1 Introduction 85
5.2 Approach Toward Process Characterization 87
5.3 Risk Analysis 88
5.4 Small-Scale Model Development and Qualification 89
5.5 Design of Experiment Studies 94
5.6 Worst Case Studies 96
5.7 Definition of Design Space 99
5.8 Definition of Validation Acceptance Limits 103
5.9 Regulatory Filing, Process Monitoring, and
Postapproval Changes 106
Acknowledgment 108
References 108
CONTENTS jx
6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL
FLOW FILTRATION OPERATIONS 111
Peter K. Wader and John Rozembersky
6.1 Introduction 111
6.2 Applications of TFF in Biotechnology 113
6.3 Tangential Flow Filtration Operating Principles 113
6.4 TFF Design Objectives 115
6.5 Membrane Selection 115
6.6 TFF Operating Parameter Design 118
6.7 TFF Diafiltration Operating Mode Design 122
6.8 Summary 125
References 125
7 APPLICATIONS OF DESIGN SPACE FOR
BIOPHARMACEUTICAL PURIFICATION PROCESSES 127
Douglas J. Cecchini
7.1 Introduction 127
7.2 Establishing Design Space for Purification Processes
during Process Development 128
7.3 Applications of Design Space 131
7.4 Cell Harvest and Product Capture Steps 131
7.5 Protein A Capture Column 136
7.6 Hydrophobic Interaction Chromatography 137
7.7 Anion Exchange Chromatography 138
7.8 Summary 141
Acknowledgments 141
References 141
8 VIRAL CLEARANCE: A STRATEGY FOR QUALITY
BY DESIGN AND THE DESIGN SPACE 143
Gail Sofer and Jeffrey Carter
8.1 Introduction 143
8.2 Current and Future Approaches to Virus Clearance
Characterization 143
8.3 Benefits of Applying Design Space Principles to
Virus Clearance 144
8.4 Technical Limitations Related to Adoption of QdB/Design
Space Concepts in Virus Clearance 145
x CONTENTS
8.5 Developing a Virus Clearance Design Space 148
8.6 Staying in the Design Space 156
8.7 Conclusion 157
Acknowledgments 15 7
References 158
9 APPLICATION OF QUALITY BY DESIGN AND RISK
ASSESSMENT PRINCIPLES FOR THE DEVELOPMENT
OF FORMULATION DESIGN SPACE 161
Kingman Ng and Natarajan Rajagopalan
9.1 Introduction 161
9.2 Quality by Design (QbD) Approach 162
9.3 Target Product Profile (TPP) 163
9.4 Molecular Degradation Characterization 164
9.5 Active Pharmaceutical Ingredient (API) Critical Properties 166
9.6 Preformulation Characterization 167
9.7 Initial Formulation Risk Assessments 168
9.8 Formulation Optimization and Design Space 169
9.9 Selection of Solution Formulation Composition 171
9.10 Summary 173
Acknowledgments 174
References 174
10 APPLICATION OF QbD PRINCIPLES TO BIOLOGICS
PRODUCT: FORMULATION AND PROCESS
DEVELOPMENT 175
Satish K. Singh, Carol F. Kirchhoff, and Amit Banerjee
10.1 Introduction: QbD in Biologies Product Development 175
10.2 Risk Assessment Process 177
10.3 Examples 178
10.4 Conclusions 191
References 191
11 QbD FOR RAW MATERIALS 193
Maureen Lanan
11.1 Introduction 193
11.2 Background 194
11.3 Current Practice for Raw Materials 195
11.4 QbD in Development 195
CONTENTS xi
11.5 QbD in manufacturing 196
11.6 QbD for organizations 197
11.7 Tests Available 197
11.8 Conclusions and Future Prospects 207
Acknowledgments 208
References 208
12 PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS
AND CHALLENGES 211
Michael Molony and Cenk Undey
12.1 Introduction 211
12.2 Cell Culture and Fermentation PAT Tools 214
12.3 Purification PAT Tools 223
12.4 Formulation PAT Tools 228
12.5 PAT Tools for Bioprocess Starting Materials, Defined Media,
and Complex Raw Materials 230
12.6 Chemometrics and Advanced Process Control Tools 232
12.7 The power of PLS and PCA 233
12.8 Relevant Time Column Integrity Monitoring
(Moments Analysis versus HETP) 240
12.9 Challenges for Implementation of PAT Tools 244
12.10 Future PAT Tools 247
Acknowledgments 248
References 249
13 EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN
AND PROCESS ANALYTICAL TECHNOLOGY 255
Duncan Low and Joseph Phillips
13.1 Introduction 255
13.2 Evolution of PAT and Quality by Design (QbD): Emerging
Guidelines and Standards 256
13.3 Process Analytical Technology (PAT) 261
13.4 Quality by Design 263
13.5 Implementing QbD and PAT 266
13.6 Conclusions 282
Acknowledgments 283
References 283
Index 287
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