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.

Just spreading the exciting news: Humberto Vega, one of the pharmaceutical industry's icon's in the cell and gene therapy space, recently released a book that describes a soup-to-nuts approach to commercialization of cell and gene therapies. It is rare to find any publications in this area that are this comprehensive and cover activities spanning from the early development phase all the way to commercialization. The book is written for a diverse audience that ranges from researchers, scientists and management to academic and research institutions--basically anyone involved in the support of the core technologies and supportive practices in this space. It is widely available for purchase on Amazon, Barnes and Noble, Routledge and many other sources. Congratulations to Humberto Vega and HAZEL ARANHA!

- Brian Kirk

The cell and gene therapies industry is growing rapidly. The "Handbook of Cell and Gene Therapy" is fresh off the presses and contains the latest details on the development, production, and delivery of life-saving cell and gene therapy materials. Co-editor Hazel Aranha, PhD, knows her stuff! Because I edit scientific bioprocessing papers from researchers and commercial production people, I need to stay on top of my knowledge base. This handbook will help me significantly. I am happy to own the book -- as of March 26, 2023 -- and have already started reading it.

- Marcie Brown