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.
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.
This is a reference handbook for young researchers exploring gene and cell therapy. Gene therapy could be defined as a set of strategies modifying gene expression or correcting mutant/defective genes...
This book reports the recent progress in gene and cell therapy through the liver and aims to facilitate a comprehensive understanding of the current aspects and future prospects from basic research...
Examples from various organs and diseases illustrate the potential benefit obtained when both therapeutic approaches are combined with delivery strategies. Representing the combined effort of several...
STEM CELL BIOLOGY AND GENE THERAPYEdited by Peter J. Quesenberry, Gary S. Stein, Bernard Forget, and Sherman WeissmanAdvances in molecular genetics and recombinant DNA technology have ushered in a...
This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies...
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