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Quality by Design for Biopharmaceuticals: Principles and Case Studies [Hardback]

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Edited by (Biogen Idec, USA), Edited by (Indian Institute of Technology, India)
  • Formāts: Hardback, 312 pages, height x width x depth: 241x160x19 mm, weight: 585 g
  • Sērija : Wiley Series in Biotechnology and Bioengineering
  • Izdošanas datums: 10-Jul-2009
  • Izdevniecība: Wiley-Interscience
  • ISBN-10: 0470282339
  • ISBN-13: 9780470282335
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Quality by Design for Biopharmaceuticals: Principles and Case StudiesPalielināt
  • Formāts: Hardback, 312 pages, height x width x depth: 241x160x19 mm, weight: 585 g
  • Sērija : Wiley Series in Biotechnology and Bioengineering
  • Izdošanas datums: 10-Jul-2009
  • Izdevniecība: Wiley-Interscience
  • ISBN-10: 0470282339
  • ISBN-13: 9780470282335
Citas grāmatas par šo tēmu:
Permanent link: https://www.kriso.lv/db/9780470282335.html
Keywords:

Wiley Series in Biotechnology and bioengineering

Anurag S. Rathore, Series Editor

Quality by Design for Biopharmaceuticals

Principles and Case Studies

Edited by

Anurag S. Rathore

Rohin Mhatre

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.

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
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
Pim 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
6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS 111
Peter K. Watler 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
8.5 Developing a Virus Clearance Design Space
148
8.6 Staying in the Design Space
156
8.7 Conclusion
157
Acknowledgments
157
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 Biologics 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
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
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.