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Handbook of Cell and Gene Therapy
From Proof-of-Concept through Manufacturing to Commercialization
Hazel Aranha, Humberto Vega-Mercado, Hazel Aranha, Humberto Vega-Mercado
- 328 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
Handbook of Cell and Gene Therapy
From Proof-of-Concept through Manufacturing to Commercialization
Hazel Aranha, Humberto Vega-Mercado, Hazel Aranha, Humberto Vega-Mercado
About This Book
This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish, as well as delivery options. Planning steps for compliance with current good manufacturing practice (cGMP) to readiness for chemistry, manufacturing and controls (CMC) are also discussed. This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor.
Features
- Provides the most up-to-date information on the development of gene therapy, from the technology involved to gene correction and genome editing
- Discusses siRNA, mRNA, and plasmid manufacturing
- Describes the importance of supplier-sponsor synergies on the path to commercialization
- Written for a diverse audience with a large number of individuals in the core technologies and supportive practices
It is intended as a one-stop resource for the availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions.
Frequently asked questions
Information
Table of contents
- Cover Page
- Half Title page
- Title Page
- Copyright Page
- Dedication
- Contents
- Keywords
- Preface
- Author Biography
- Contributors
- Abbreviations
- 1 History of Gene Therapy Products
- 2 Gene Editing in Humans: How Bioethics Discussions Can Guide Responsible Research and Product Development
- 3 Applying a Risk-Based Approach in the Development and Manufacture of Advanced Therapy Medicinal Products
- 4 Gene Therapy Products: Basics and Manufacturing Considerations
- 5 Cell Therapy Products: Basics and Manufacturing Considerations
- 6 Facility and Equipment Considerations
- 7 Analytical Methods for In-Process Testing and Product Release
- 8 Validation, Verification and Qualification Considerations
- 9 Adventitious Agent Contamination Considerations during the Manufacture of Cell and Gene Therapy Products
- 10 Training Approaches to Build Cell and Gene Therapy Workforce Capacity
- 11 How to Distribute Cell and Gene Therapies
- 12 Regulatory Compliance and Approval
- 13a Regulatory Landscape in US, EU and Canada
- 13b Regulatory Landscape in South America
- 13c Regulatory Landscape in Australia and New Zealand
- 13d1 Regulatory Landscape in Singapore
- 13d2 Regulatory Landscape in Malaysia
- 13e Regulatory Landscape in China
- 13f Regulatory Landscape in Japan
- 13g Regulatory Landscape in India
- 14 Avoiding Pitfalls during Advanced Therapy Development
- 15 Going Forward â Existing and Evolving Technologies (CRISPR, mRNA, siRNA)
- Glossary
- Index