Developments in Tissue Engineered and Regenerative Medicine Products

Developments in Tissue Engineered and Regenerative Medicine Products

A Practical Approach

1st Edition - April 19, 2012

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  • Authors: Joydeep Basu, John Ludlow
  • Hardcover ISBN: 9781907568763
  • eBook ISBN: 9781908818119

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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.

Key Features

  • 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

Table of Contents

  • List of figures, tables and boxes

    About the authors

    Woodhead Publishing Series in Biomaterials



    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


    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


    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


    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„¢


    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


    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


    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


    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


    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


    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


    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


Product details

  • No. of pages: 226
  • Language: English
  • Copyright: © Woodhead Publishing 2012
  • Published: April 19, 2012
  • Imprint: Woodhead Publishing
  • Hardcover ISBN: 9781907568763
  • eBook ISBN: 9781908818119

About the Authors

Joydeep Basu

Dr Joydeep Basu is Senior Scientist, Bioprocess R&D, Tengion Inc., in Winston-Salem, North Carolina, USA. He has over 10 years' experience in the creation, research and development of cell therapy, gene therapy, regenerative medicine and tissue engineered products within entrepreneurial biotechnology companies including Athersys Inc (Cleveland, USA) and Tengion Inc (North Carolina, USA). Dr. Basu is a recognized global authority on the development of non-integrative gene therapy products and has published and presented broadly within the field of regenerative medicine/tissue engineering. He is currently focused on driving development of Tengion's tubular organ regeneration platform technology for applications beyond regeneration of bladder.

John Ludlow

Dr John W. Ludlow is Senior Director, Process Research and Assay Development, Tengion Inc., in Winston-Salem, North Carolina, USA. With experiences as Director of the Cell Therapy Program at Incara Pharmaceuticals, and Senior Director of the Cell Therapy Program at Vesta Therapeutics (North Carolina, USA), he has achieved demonstrable successes in managing and directing therapeutic area-specific research and regenerative medicine and tissue engineering product development. Responsibilities have included bringing new products into bioprocessing research and development, taking new products to demonstration in animal models, GLP and non-GLP production, and initiation of human clinical trial sites. Dr. Ludlow has previous held faculty memberships at the Rochester Institute of Technology and the University of Rochester Cancer Center, with authorship on over 80 scientific publications.

Affiliations and Expertise

Tengion Inc, USA

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