Handbook of cell and gene therapy : from proof-of-concept through manufacturing to commercialization / edited by Hazel Aranha, Humberto Vega-Mercado. -- Boca Raton : CRC Press, 2023. – (63.499073/H236)

Contents

Keywords
Preface
Author Biography
Contributors
Abbreviations
Chapter 1  History of Gene Therapy Products
Chapter 2  Gene Editing in Humans: How Bioethics Discussions Can Guide Responsible Research and Product Development
Chapter 3  Applying a Risk-Based Approach in the Development and Manufacture of Advanced Therapy Medicinal Products
Chapter 4  Gene Therapy Products: Basics and Manufacturing Considerations
Chapter 5  Cell Therapy Products: Basics and Manufacturing Considerations
Chapter 6  Facility and Equipment Considerations
Chapter 7  Analytical Methods for In-Process Testing and Product Release
Chapter 8  Validation, Verification and Qualification Considerations..
Chapter 9  Adventitious Agent Contamination Considerations during the Manufacture of Cell and Gene Therapy Products
Chapter 10  Training Approaches to Build Cell and Gene Therapy Workforce Capacity
Chapter 11  How to Distribute Cell and Gene Therapies
Chapter 12  Regulatory Compliance and Approval
Chapter 13a  Regulatory Landscape in US, EU and Canada
Chapter 13b  Regulatory Landscape in South America
Chapter 13c  Regulatory Landscape in Australia and New Zealand
Chapter 13dl  Regulatory Landscape in Singapore
Chapter 13d2  Regulatory Landscape in Malaysia
Chapter 13e  Regulatory Landscape in China
Chapter 13f  Regulatory Landscape in Japan
Chapter 13g  Regulatory Landscape in India
Chapter 14  Avoiding Pitfalls during Advanced Therapy Development
Chapter 15  Going Forward - Existing and Evolving Technologies (CRISPR, mRNA, siRNA)
Glossary
Index