Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated successful commercialization are emphasized and roadblocks to successful product development are also highlighted. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented. This book represents a complete 'how-to' manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing.
1. Cover image - p. Cover 2. Title page - p. Cover 3. Table of Contents - p. Cover 4. Copyright - p. Cover 5. List of figures, tables and boxes - p. Cover 6. About the authors - p. Cover 7. Woodhead Publishing Series in Biomaterials - p. Cover 8. Preface - p. Cover 9. Acknowledgements - p. Cover 10. Chapter 1: Overview of tissue engineering/regenerative medicine - p. Cover 11. Chapter 2: Cells - p. 6 12. Chapter 3: Biomaterials for TE/RM products - p. 20 13. Chapter 4: Neo-Bladder: a foundational technology platform for tubular organ regeneration - p. 44 14. Chapter 5: Neo-Urinary Conduit™ - p. 64 15. Chapter 6: Tissue engineering of non-bladder tubular organs - p. 86 16. Chapter 7: Summary of key features of a commercially viable solid organ regeneration platform - p. 99 17. Chapter 8: Regulatory and quality control - p. 122 18. Chapter 9: Pre-clinical clinical evaluation of TE/RM products - p. 148 19. Chapter 10: Manufacturing - p. 166 20. Chapter 11: Intellectual property - p. 182 21. Index - p. 202
Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated successful commercialization are emphasized and roadblocks to successful product development are also highlighted. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented. This book represents a complete 'how-to' manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing.
1. Cover image - p. Cover 2. Title page - p. Cover 3. Table of Contents - p. Cover 4. Copyright - p. Cover 5. List of figures, tables and boxes - p. Cover 6. About the authors - p. Cover 7. Woodhead Publishing Series in Biomaterials - p. Cover 8. Preface - p. Cover 9. Acknowledgements - p. Cover 10. Chapter 1: Overview of tissue engineering/regenerative medicine - p. Cover 11. Chapter 2: Cells - p. 6 12. Chapter 3: Biomaterials for TE/RM products - p. 20 13. Chapter 4: Neo-Bladder: a foundational technology platform for tubular organ regeneration - p. 44 14. Chapter 5: Neo-Urinary Conduit™ - p. 64 15. Chapter 6: Tissue engineering of non-bladder tubular organs - p. 86 16. Chapter 7: Summary of key features of a commercially viable solid organ regeneration platform - p. 99 17. Chapter 8: Regulatory and quality control - p. 122 18. Chapter 9: Pre-clinical clinical evaluation of TE/RM products - p. 148 19. Chapter 10: Manufacturing - p. 166 20. Chapter 11: Intellectual property - p. 182 21. Index - p. 202
