Developments in Tissue Engineered and Regenerative Medicine Products: A Practical Approach

by Joydeep Basu, John W Ludlow

Overview

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

Product Details

ISBN-13:	9781908818119
Publisher:	Woodhead Publishing, Limited
Publication date:	04/19/2012
Series:	Woodhead Publishing Series in Biomaterials
Sold by:	Barnes & Noble
Format:	eBook
Pages:	226
File size:	3 MB

About the Author

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.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.

Table of Contents

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