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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
Intended as a one-stop resource for availability of
state-of-the-art information related to cell and gene therapy
products for researchers, scientists, management and other academic
and research institutions. 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. Diverse audience with a
large number of individuals in the core technologies and supportive
practices.
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