{"product_id":"quality-by-design-for-biopharmaceuticals-principles-and-case-studies-hardback-9780470282335","title":"Quality by Design for Biopharmaceuticals; Principles and Case Studies (Hardback) 9780470282335","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eQuality by Design for Biopharmaceuticals\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003ePrinciples and Case Studies\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eAnurag S. Rathore (Edited by), AS Rathore (Author), Rohin Mhatre (Edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470282335, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 10 July 2009\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e328 pages\u003cbr\u003e24.1 x 16 x 1.9 cm, 0.585 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cb\u003eThe concepts, applications, and practical issues of Quality by Design\u003c\/b\u003e  \u003cp\u003eQuality 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eQuality by Design: Perspectives and Case Studies\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003eIn this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eThe understanding and development of the product's critical quality attributes (CQA)\u003c\/li\u003e \u003cli\u003eDevelopment of the design space for a manufacturing process\u003c\/li\u003e \u003cli\u003eHow to employ QbD to design a formulation process\u003c\/li\u003e \u003cli\u003eRaw material analysis and control strategy for QbD\u003c\/li\u003e \u003cli\u003eProcess Analytical Technology (PAT) and how it relates to QbD\u003c\/li\u003e \u003cli\u003eRelevant PAT tools and applications for the pharmaceutical industry\u003c\/li\u003e \u003cli\u003eThe uses of risk assessment and management in QbD\u003c\/li\u003e \u003cli\u003eFiling QbD information in regulatory documents\u003c\/li\u003e \u003cli\u003eThe application of multivariate data analysis (MVDA) to QbD\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eFilled with vivid case studies that illustrate QbD at work in companies today, \u003ci\u003eQuality by Design\u003c\/i\u003e is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eForeword xiii  \u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003ePreface to the Wiley Series on Biotechnology and Related Topics xvii\u003c\/p\u003e \u003cp\u003eContributors xix\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS 1\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eRohin Mhatre and Anurag S. Rathore\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 Critical Quality Attributes 2\u003c\/p\u003e \u003cp\u003e1.3 An Overview of Design Space 3\u003c\/p\u003e \u003cp\u003e1.4 Raw Materials and their Impact on QbD 4\u003c\/p\u003e \u003cp\u003e1.5 Process Analytical Technology 4\u003c\/p\u003e \u003cp\u003e1.6 The Utility of Design Space and QbD 5\u003c\/p\u003e \u003cp\u003e1.7 Conclusions 7\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN 9\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSteven Kozlowski and Patrick Swann\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 9\u003c\/p\u003e \u003cp\u003e2.2 Quality by Design 10\u003c\/p\u003e \u003cp\u003e2.3 Relevant Product Attributes 11\u003c\/p\u003e \u003cp\u003e2.4 Manufacturing Process 14\u003c\/p\u003e \u003cp\u003e2.5 Developing a Design Space 18\u003c\/p\u003e \u003cp\u003e2.6 Uncertainty and Complexity 22\u003c\/p\u003e \u003cp\u003e2.7 Future Horizons 23\u003c\/p\u003e \u003cp\u003e2.8 QbD Submission Thoughts 25\u003c\/p\u003e \u003cp\u003e2.9 Implementation Plans 26\u003c\/p\u003e \u003cp\u003e2.10 Summary 27\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris 31\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDavid L. Narum\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 31\u003c\/p\u003e \u003cp\u003e3.2 The Malaria Genome and Proteome 34\u003c\/p\u003e \u003cp\u003e3.3 Expression of Two Malaria Antigens in P. pastoris 34\u003c\/p\u003e \u003cp\u003e3.4 Summary 46\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES 53\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMark A Schenerman, Milton J. Axley, Cynthia N. Oliver, Kripa Ram, and Gail F. Wasserman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 53\u003c\/p\u003e \u003cp\u003e4.2 Examples of Criticality Determination 60\u003c\/p\u003e \u003cp\u003e4.3 Conclusion 81\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP 85\u003cbr\u003e \u003c\/b\u003e\u003ci\u003ePim van Hoek, Jean Harms, Xiangyang Wang, and Anurag S. Rathore\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 85\u003c\/p\u003e \u003cp\u003e5.2 Approach Toward Process Characterization 87\u003c\/p\u003e \u003cp\u003e5.3 Risk Analysis 88\u003c\/p\u003e \u003cp\u003e5.4 Small-Scale Model Development and Qualification 89\u003c\/p\u003e \u003cp\u003e5.5 Design of Experiment Studies 94\u003c\/p\u003e \u003cp\u003e5.6 Worst Case Studies 96\u003c\/p\u003e \u003cp\u003e5.7 Definition of Design Space 99\u003c\/p\u003e \u003cp\u003e5.8 Definition of Validation Acceptance Limits 103\u003c\/p\u003e \u003cp\u003e5.9 Regulatory Filing, Process Monitoring, and Postapproval Changes 106\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS 111\u003cbr\u003e \u003c\/b\u003e\u003ci\u003ePeter K. Watler and John Rozembersky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 111\u003c\/p\u003e \u003cp\u003e6.2 Applications of TFF in Biotechnology 113\u003c\/p\u003e \u003cp\u003e6.3 Tangential Flow Filtration Operating Principles 113\u003c\/p\u003e \u003cp\u003e6.4 TFF Design Objectives 115\u003c\/p\u003e \u003cp\u003e6.5 Membrane Selection 115\u003c\/p\u003e \u003cp\u003e6.6 TFF Operating Parameter Design 118\u003c\/p\u003e \u003cp\u003e6.7 TFF Diafiltration Operating Mode Design 122\u003c\/p\u003e \u003cp\u003e6.8 Summary 125\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 APPLICATIONS OF DESIGN SPACE FOR BIOPHARMACEUTICAL PURIFICATION PROCESSES 127\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDouglas J. Cecchini\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 127\u003c\/p\u003e \u003cp\u003e7.2 Establishing Design Space for Purification Processes during Process Development 128\u003c\/p\u003e \u003cp\u003e7.3 Applications of Design Space 131\u003c\/p\u003e \u003cp\u003e7.4 Cell Harvest and Product Capture Steps 131\u003c\/p\u003e \u003cp\u003e7.5 Protein A Capture Column 136\u003c\/p\u003e \u003cp\u003e7.6 Hydrophobic Interaction Chromatography 137\u003c\/p\u003e \u003cp\u003e7.7 Anion Exchange Chromatography 138\u003c\/p\u003e \u003cp\u003e7.8 Summary 141\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 VIRAL CLEARANCE: A STRATEGY FOR QUALITY BY DESIGN AND THE DESIGN SPACE 143\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eGail Sofer and Jeffrey Carter\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 143\u003c\/p\u003e \u003cp\u003e8.2 Current and Future Approaches to Virus Clearance Characterization 143\u003c\/p\u003e \u003cp\u003e8.3 Benefits of Applying Design Space Principles to Virus Clearance 144\u003c\/p\u003e \u003cp\u003e8.4 Technical Limitations Related to Adoption of QdB\/Design Space Concepts in Virus Clearance 145\u003c\/p\u003e \u003cp\u003e8.5 Developing a Virus Clearance Design Space 148\u003c\/p\u003e \u003cp\u003e8.6 Staying in the Design Space 156\u003c\/p\u003e \u003cp\u003e8.7 Conclusion 157\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 APPLICATION OF QUALITY BY DESIGN AND RISK ASSESSMENT PRINCIPLES FOR THE DEVELOPMENT OF FORMULATION DESIGN SPACE 161\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eKingman Ng and Natarajan Rajagopalan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 161\u003c\/p\u003e \u003cp\u003e9.2 Quality by Design (QbD) Approach 162\u003c\/p\u003e \u003cp\u003e9.3 Target Product Profile (TPP) 163\u003c\/p\u003e \u003cp\u003e9.4 Molecular Degradation Characterization 164\u003c\/p\u003e \u003cp\u003e9.5 Active Pharmaceutical Ingredient (API) Critical Properties 166\u003c\/p\u003e \u003cp\u003e9.6 Preformulation Characterization 167\u003c\/p\u003e \u003cp\u003e9.7 Initial Formulation Risk Assessments 168\u003c\/p\u003e \u003cp\u003e9.8 Formulation Optimization and Design Space 169\u003c\/p\u003e \u003cp\u003e9.9 Selection of Solution Formulation Composition 171\u003c\/p\u003e \u003cp\u003e9.10 Summary 173\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 APPLICATION OF QbD PRINCIPLES TO BIOLOGICS PRODUCT: FORMULATION AND PROCESS DEVELOPMENT 175\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSatish K. Singh, Carol F. Kirchhoff, and Amit Banerjee\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction: QbD in Biologics Product Development 175\u003c\/p\u003e \u003cp\u003e10.2 Risk Assessment Process 177\u003c\/p\u003e \u003cp\u003e10.3 Examples 178\u003c\/p\u003e \u003cp\u003e10.4 Conclusions 191\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 QbD FOR RAW MATERIALS 193\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMaureen Lanan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 193\u003c\/p\u003e \u003cp\u003e11.2 Background 194\u003c\/p\u003e \u003cp\u003e11.3 Current Practice for Raw Materials 195\u003c\/p\u003e \u003cp\u003e11.4 QbD in Development 195\u003c\/p\u003e \u003cp\u003e11.5 QbD in manufacturing 196\u003c\/p\u003e \u003cp\u003e11.6 QbD for organizations 197\u003c\/p\u003e \u003cp\u003e11.7 Tests Available 197\u003c\/p\u003e \u003cp\u003e11.8 Conclusions and Future Prospects 207\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS AND CHALLENGES 211\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMichael Molony and Cenk Undey\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 211\u003c\/p\u003e \u003cp\u003e12.2 Cell Culture and Fermentation PAT Tools 214\u003c\/p\u003e \u003cp\u003e12.3 Purification PAT Tools 223\u003c\/p\u003e \u003cp\u003e12.4 Formulation PAT Tools 228\u003c\/p\u003e \u003cp\u003e12.5 PAT Tools for Bioprocess Starting Materials, Defined Media, and Complex Raw Materials 230\u003c\/p\u003e \u003cp\u003e12.6 Chemometrics and Advanced Process Control Tools 232\u003c\/p\u003e \u003cp\u003e12.7 The power of PLS and PCA 233\u003c\/p\u003e \u003cp\u003e12.8 \"Relevant Time\"Column Integrity Monitoring (Moments Analysis versus HETP) 240\u003c\/p\u003e \u003cp\u003e12.9 Challenges for Implementation of PAT Tools 244\u003c\/p\u003e \u003cp\u003e12.10 Future PAT Tools 247\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY 255\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eDuncan Low and Joseph Phillips\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 255\u003c\/p\u003e \u003cp\u003e13.2 Evolution of PAT and Quality by Design (QbD): Emerging Guidelines and Standards 256\u003c\/p\u003e \u003cp\u003e13.3 Process Analytical Technology (PAT) 261\u003c\/p\u003e \u003cp\u003e13.4 Quality by Design 263\u003c\/p\u003e \u003cp\u003e13.5 Implementing QbD and PAT 266\u003c\/p\u003e \u003cp\u003e13.6 Conclusions 282\u003c\/p\u003e \u003cp\u003eAcknowledgments 283\u003c\/p\u003e \u003cp\u003eReferences 283\u003c\/p\u003e \u003cp\u003eIndex 287\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Biology, life sciences [\u003ca title=\"See our other books on Biology, life sciences\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Biology,%20life%20sciences%20%5BPS%5D%22\"\u003ePS\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley-Interscience","offers":[{"title":"Brand New","offer_id":52276160037144,"sku":"9780470282335","price":104.99,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780470282335.jpg?v=1781364627","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/quality-by-design-for-biopharmaceuticals-principles-and-case-studies-hardback-9780470282335","provider":"Freshly Printed Books","version":"1.0","type":"link"}