The increased use of biodegradable synthetic or natural scaffolds combined with cells and/or biological molecules, in order to create functional replacement tissue in a damaged tissue site, has led to the need for the development of ‘best practice’ methods in the area of tissue engineering to help ensure the creation of safe, high quality products. Standardisation in cell and tissue engineering introduces concepts and current practice in the field of cell and tissue engineering to a wide audience and aims to provide awareness of the importance of standardisation in this area while suggesting directions for further investigation. Part one provides an overview of methods for cell and tissue engineering and includes chapters on the fundamentals of cell and matrix biology for tissue engineering, 3D collagen biomatrix development, and control and vascularisation of tissue-engineered constructs. Part two begins with a chapter exploring the methods and protocols of standardisation in cell and tissue engineering before moving on to highlight issues of quality control in cell and tissue engineering, standardised chemical analysis and testing of biomaterials and principles of good laboratory practice (GLP) for in vitro cell culture applications. Standardisation in cell and tissue engineering is a standard reference for leading research groups, government agencies, regulatory bodies, and researchers and technicians at all levels across the whole range of disciplines using cell culture within the pharmaceutical, biotechnology and biomedical industries.

Table of Contents:
Contributor contact details Woodhead Publishing Series in Biomaterials Foreword Introduction Part I: Methods for cell and tissue engineering Chapter 1: Fundamentals of cell and matrix biology for tissue engineering Abstract: 1.1 Introduction 1.2 Extracellular matrices (ECMs) 1.3 ECM and cell interaction 1.4 ECM and mechanical signalling 1.5 Future trends 1.6 Conclusion Chapter 2: Three-dimensional collagen biomatrix development and control Abstract: 2.1 Engineering cell-rich and matrix-rich tissues using collagen scaffolds 2.2 Controlling the mechanical properties of collagen 2.3 Architectural features: introducing elements of tissue complexity 2.4 Future trends Chapter 3: Two- and three-dimensional tissue culture bioprocessing methods for soft tissue engineering Abstract: 3.1 Introduction 3.2 Bioreactor configurations 3.3 Selecting scaffold materials and architectures for your bioreactor 3.4 Mass transfer in tissue engineering bioreactors 3.5 Important parameters and taking measurements of bioreactor cultures 3.6 Tissue engineering process design 3.7 Future trends 3.8 Conclusion 3.9 Sources of further information and advice Chapter 4: Two- and three-dimensional tissue culture methods for hard tissue engineering Abstract: 4.1 Introduction 4.2 Culture of bone and cartilage cells 4.3 Cell culture parameters: bone tissue culture 4.4 Cell culture parameters: cartilage tissue culture 4.5 Two-dimensional tissue culture methods for hard tissues 4.6 Two-and-a-half- and three-dimensional tissue culture methods for hard tissues 4.7 Conclusion Chapter 5: Vascularisation of tissue-engineered constructs Abstract: 5.1 Introduction 5.2 Growth of healthy vessels ‒ embryonic vasculogenesis 5.3 Angiogenic diseases 5.4 Angiogenesis and bone formation 5.5 Cell sources for vascular tissue engineering 5.6 Co-culture of cells: the interactions between angiogenesis and osteogenesis 5.7 Strategies to induce in vitro prevascularisation 5.8 Tubular formation 5.9 Conclusion Part II: Standards and protocols in cell and tissue engineering Chapter 6: Standards in cell and tissue engineering Abstract: 6.1 Introduction 6.2 How and by whom are standards produced? 6.3 The importance of an agreed lexicon 6.4 Drivers for standardization 6.5 How will standards help me? 6.6 What standards currently exist in tissue engineering? 6.7 Characterization of biomaterials and biomolecules 6.8 Characterization of tissue scaffolds 6.9 Characterization of cell-seeded scaffolds 6.10 Manufacture, processing and storage 6.11 Characterization of cells and cell-surface interactions 6.12 Conclusion Chapter 7: Principles of good laboratory practice (GLP) for in vitro cell culture applications Abstract: 7.1 Introduction 7.2 GLP governing bodies 7.3 Resources required for GLP compliance 7.4 Characterisation 7.5 Standards and regulations 7.6 Documentation of results 7.7 Independent monitoring of research processes and quality assurance (QA) personnel 7.8 Application of GLP to human cell culture systems 7.9 Conclusion 7.10 Acknowledgements Chapter 8: Quality control in cell and tissue engineering Abstract: 8.1 Introduction 8.2 Quality control to ensure a well-defined cell therapy product 8.3 Commercial quality control/quality assurance in large-scale manufacture 8.4 Conclusion Chapter 9: Standardised chemical analysis and testing of biomaterials Abstract: 9.1 Introduction: why we need standard methods for testing biomaterials 9.2 Standardised chemical analysis: when and why we assess chemistries 9.3 Chemical properties 9.4 Imaging methods for measuring porosity 9.5 Physical characterisation – permeability 9.6 Surface properties 9.7 Degradation and stability in physiological fluids 9.8 Implant–tissue interface tests 9.9 Limitations of current standardised testing methods Chapter 10: Sterilisation procedures for tissue allografts Abstract: 10.1 Introduction 10.2 Interaction of ionising radiation with matter 10.3 Sources of ionising radiation 10.4 Validation and international standards of sterilisation by ionising radiation 10.5 Conclusions and future trends 10.6 Sources of further information and advice Chapter 11: Commercial manufacture of cell therapies Abstract: 11.1 Introduction: cells as therapies 11.2 The transition from laboratory to commercial- scale manufacture of cell therapies 11.3 Key regulatory requirements for commercial manufacture of cell therapies 11.4 Cell-based therapy versus monoclonal antibody therapies: lessons from existing biopharmaceutical manufacture 11.5 Conclusion Index