Developments in Tissue Engineered and Regenerative Medicine Products

List of figures, tables and boxes

About the authors

Woodhead Publishing Series in Biomaterials

Preface

Acknowledgements

Chapter 1: Overview of tissue engineering/regenerative medicine

1.1 Introduction

1.2 Cells

1.3 Biomaterials

1.4 Therapeutic product delivery

Chapter 2: Cells

Abstract

2.1 Introduction

2.2 Mechanism of action of cell-based therapeutics

2.3 Other stem cell-based therapeutics currently under development

2.4 Development of genome modification technologies: gene-based cell therapies

2.5 Committed cell types: ideal candidates for TE/RM product development

2.6 Summary: key features favoring commercial development of cellular ABIs

Chapter 3: Biomaterials for TE/RM products

Abstract

3.1 Introduction

3.2 The ECM: comparator for biomaterials

3.3 Decell/recell: the ultimate biomaterial platform?

3.4 Selection of biomaterials for tissue engineering: illustrative example – kidney

3.5 Biomaterials candidates for renal tissue engineering

3.6 Selection of biomaterials for tubular organs: bladder, esophagus and small intestine

Chapter 4: Neo-Bladder: a foundational technology platform for tubular organ regeneration

Abstract

4.1 The need for urinary neo-organs

4.2 TE/RM methodologies for bladder replacement and augmentation

4.3 Demonstration of Neo-Bladder formation in large animals

4.4 Can neo-bladder constructs be made from cells sourced from diseased patients?

4.5 Neo-bladder replacement in human pediatric patients – first clinical trials of a neo-organ

4.6 Making the product: cell sourcing

4.7 Definition of the cell source used for seeding neo-bladders: adipose

4.8 Other approaches to tissue engineering neo-bladders

4.9 Key results from development of the Neo-Bladder: factors facilitating commercial viability of an organ regeneration platform

Chapter 5: Neo-Urinary Conduitâ„¢

Abstract

5.1 Introduction

5.2 Assembly of the NUC

5.3 Preclinical evaluation of the NUC

5.4 Assembly of an NUC cell/scaffold composite

5.5 GLP preclinical analysis of de novo NUC formation in a porcine cystectomy model

5.6 Alternate cell sourcing of SMC for seeding of the NUC

5.7 Clinical trials of the NUC

5.8 Regeneration of muco-cutaneous region at the skin/conduit junction

5.9 Speculations for the future

Chapter 6: Tissue engineering of non-bladder tubular organs

Abstract

6.1 Introduction

6.2 Vasculature

6.3 Lung

6.4 Gastrointestinal tract

6.5 Genito-urinary system

Chapter 7: Tissue engineering of solid organs

Abstract

7.1 Introduction

7.2 Kidney

7.3 Heart

7.4 Liver

7.5 Pancreas

7.6 Spleen

7.7 Central nervous system

7.8 Summary

Chapter 8: Regulatory and quality control

Abstract

8.1 Good manufacturing practice

8.2 Good tissue practices

8.3 GMP-compliant laboratories and manufacturing facilities

8.4 Standard operating procedures and batch records

8.5 Personnel training and documentation

8.6 Best practices and the need for harmonization

8.7 Investigational New Drug application

Chapter 9: Pre-clinical and clinical evaluation of TE/RM products

Abstract

9.1 Regulation of TE/RM products

9.2 Preclinical studies

9.3 Clinical protocol development

9.4 Clinical trial

9.5 Clinical trial site monitoring

9.6 Contract research organization

Chapter 10: Manufacturing

Abstract

10.1 Facility considerations

10.2 Clean rooms

10.3 Environmental monitoring

10.4 Process controls

10.5 Raw material qualification

10.6 Manufacturing process

Chapter 11: Intellectual property

Abstract

11.1 Definition of intellectual property

11.2 Landscape assessment

11.3 Operational documentation

11.4 Disclosure

11.5 Filing

11.6 Freedom to operate

11.7 Trade secrets

11.8 Trademarking

11.9 The Leahy–Smith America Invents Act

Index

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

Industry professionals and entrepreneurial academics contemplating new start-ups focused on tissue engineering and regenerative medicine; Entrepreneurially minded students interested in biotechnology