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ABOUT THE 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.

TABLE OF CONTENTS

1. History of Gene Therapy Products

Bridget Heelan

2. Ethical Considerations on Cell and Gene Therapies

Hazel Aranha

3. Risk-based approach in the development of cell and gene therapy products

Bridget Heelan

4. Gene Therapy Products: Basics and manufacturing considerations

Humberto Vega

5. Cell therapy products: Basics and manufacturing considerations

Humberto Vega

6. Facility and Equipment Considerations

Humberto Vega

7. Analytical Methods for in-process testing and product reléase

Neil A. Haig

8. Validation, Verification and Qualification Considerations

Humberto Vega

9. Control of adventitious agent contamination during manufacture of cell and gene therapy products

Hazel Aranha

10. Training Approaches to Build Cell and Gene Therapy Workforce Capacity

Orin Chisholm

11. How to distribute Cell and Gene Therapies

Andrea Zobel

12. Regulatory Compliance and Approval

Siegfried Schmitt

13. (a) Regulatory Landscape in US, EU and Canada

Kirsten Messmer

1. (b) Regulatory Landscape in South America

Heloisa Mizrahy

1. (c) Regulatory Landscape in Australia and New Zealand

Orin Chisholm

13 (d1) Regulatory Landscape in Singapure

Stefanie Fasshauer

13 (d2) Regulatory Landscape in Malasya

Stefanie Fasshauer

13 (e) Regulatory Landscape in China

Kai Zhang

13 (f) Regulatory Landscape in Japan

Hazel Aranha

13 (g) Regulatory Landscape in India

Arun Bhatt

14. Lesson Learned - Success and Pitfalls (Cross functional Development & The Glycerba Path)

Kirsten Messmer

15. Going Forward - Existing and Evolving Technologies (CRISPR, mRNA, siRNA)

Hazel Aranha, Humberto Vega