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Developments in Tissue Engineered and Regenerative Medicine Products

Book Description

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.

  • Addresses practical considerations for the field of tissue engineering and regenerative medicine from the perspective of the biotechnology industry
  • Written as a manual for tissue engineering and regenerative medicine product development applicable to the US and EU
  • Illustrates pathway integration of science and business required for successful product development

Table of Contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. List of figures, tables and boxes
  6. About the authors
  7. Woodhead Publishing Series in Biomaterials
  8. Preface
  9. Acknowledgements
  10. Chapter 1: Overview of tissue engineering/regenerative medicine
    1. 1.1 Introduction
    2. 1.2 Cells
    3. 1.3 Biomaterials
    4. 1.4 Therapeutic product delivery
  11. Chapter 2: Cells
    1. Abstract
    2. 2.1 Introduction
    3. 2.2 Mechanism of action of cell-based therapeutics
    4. 2.3 Other stem cell-based therapeutics currently under development
    5. 2.4 Development of genome modification technologies: gene-based cell therapies
    6. 2.5 Committed cell types: ideal candidates for TE/RM product development
    7. 2.6 Summary: key features favoring commercial development of cellular ABIs
  12. Chapter 3: Biomaterials for TE/RM products
    1. Abstract
    2. 3.1 Introduction
    3. 3.2 The ECM: comparator for biomaterials
    4. 3.3 Decell/recell: the ultimate biomaterial platform?
    5. 3.4 Selection of biomaterials for tissue engineering: illustrative example – kidney
    6. 3.5 Biomaterials candidates for renal tissue engineering
    7. 3.6 Selection of biomaterials for tubular organs: bladder, esophagus and small intestine
  13. Chapter 4: Neo-Bladder: a foundational technology platform for tubular organ regeneration
    1. Abstract
    2. 4.1 The need for urinary neo-organs
    3. 4.2 TE/RM methodologies for bladder replacement and augmentation
    4. 4.3 Demonstration of Neo-Bladder formation in large animals
    5. 4.4 Can neo-bladder constructs be made from cells sourced from diseased patients?
    6. 4.5 Neo-bladder replacement in human pediatric patients – first clinical trials of a neo-organ
    7. 4.6 Making the product: cell sourcing
    8. 4.7 Definition of the cell source used for seeding neo-bladders: adipose
    9. 4.8 Other approaches to tissue engineering neo-bladders
    10. 4.9 Key results from development of the Neo-Bladder: factors facilitating commercial viability of an organ regeneration platform
  14. Chapter 5: Neo-Urinary Conduit™
    1. Abstract
    2. 5.1 Introduction
    3. 5.2 Assembly of the NUC
    4. 5.3 Preclinical evaluation of the NUC
    5. 5.4 Assembly of an NUC cell/scaffold composite
    6. 5.5 GLP preclinical analysis of de novo NUC formation in a porcine cystectomy model
    7. 5.6 Alternate cell sourcing of SMC for seeding of the NUC
    8. 5.7 Clinical trials of the NUC
    9. 5.8 Regeneration of muco-cutaneous region at the skin/conduit junction
    10. 5.9 Speculations for the future
  15. Chapter 6: Tissue engineering of non-bladder tubular organs
    1. Abstract
    2. 6.1 Introduction
    3. 6.2 Vasculature
    4. 6.3 Lung
    5. 6.4 Gastrointestinal tract
    6. 6.5 Genito-urinary system
  16. Chapter 7: Tissue engineering of solid organs
    1. Abstract
    2. 7.1 Introduction
    3. 7.2 Kidney
    4. 7.3 Heart
    5. 7.4 Liver
    6. 7.5 Pancreas
    7. 7.6 Spleen
    8. 7.7 Central nervous system
    9. 7.8 Summary
  17. Chapter 8: Regulatory and quality control
    1. Abstract
    2. 8.1 Good manufacturing practice
    3. 8.2 Good tissue practices
    4. 8.3 GMP-compliant laboratories and manufacturing facilities
    5. 8.4 Standard operating procedures and batch records
    6. 8.5 Personnel training and documentation
    7. 8.6 Best practices and the need for harmonization
    8. 8.7 Investigational New Drug application
  18. Chapter 9: Pre-clinical and clinical evaluation of TE/RM products
    1. Abstract
    2. 9.1 Regulation of TE/RM products
    3. 9.2 Preclinical studies
    4. 9.3 Clinical protocol development
    5. 9.4 Clinical trial
    6. 9.5 Clinical trial site monitoring
    7. 9.6 Contract research organization
  19. Chapter 10: Manufacturing
    1. Abstract
    2. 10.1 Facility considerations
    3. 10.2 Clean rooms
    4. 10.3 Environmental monitoring
    5. 10.4 Process controls
    6. 10.5 Raw material qualification
    7. 10.6 Manufacturing process
  20. Chapter 11: Intellectual property
    1. Abstract
    2. 11.1 Definition of intellectual property
    3. 11.2 Landscape assessment
    4. 11.3 Operational documentation
    5. 11.4 Disclosure
    6. 11.5 Filing
    7. 11.6 Freedom to operate
    8. 11.7 Trade secrets
    9. 11.8 Trademarking
    10. 11.9 The Leahy–Smith America Invents Act
  21. Index