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Books > Professional & Technical > Biochemical engineering > Biotechnology
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Manufacturing of Gene Therapeutics - Methods, Processing, Regulation, and Validation (Paperback, Softcover reprint of the original 1st ed. 2002)
Loot Price: R5,163
Discovery Miles 51 630
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Manufacturing of Gene Therapeutics - Methods, Processing, Regulation, and Validation (Paperback, Softcover reprint of the original 1st ed. 2002)
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Advances in molecular biology and recombinant DNA technology have
accelerated progress in many fields of life science research,
including gene therapy. A large number of genetic engineering
approaches and methods are readily available for gene cloning and
therapeutic vector construction. Significant progress is being made
in genomic, DNA sequencing, gene expression, gene delivery and
cloning. Thus gene therapy has already shown that it holds great
promise for the treatment of many diseases and disorders. In
general it involves the delivery of recombinant genes or transgenes
into somatic cells to replace proteins with a genetic defect or to
transfer with the pathological process of an illness. The viral and
non-viral delivery systems may hold the potential for future
non-invasive, cost-effective oral therapy of genetically-based
disorders. Recent years have seen considerable progress in the
discovery and early clinical development of a variety of gene
therapeutic products. The availability, validation, and
implementation of gene therapeutic products has also enabled
success in testing and evaluation. New challenges will need to be
overcome to ensure that products will also be successful in later
clinical development and ultimately for marketing authorisation.
These new challenges will include improvements in delivery systems,
better control of in-vivo targeting, increased level transduction
and duration of expression of the gene, and manufacturing process
efficiencies that enable reduction in production costs. Perhaps
profound understanding of regulated gene design may result in
innovative bioproducts exhibiting safety and efficacy profiles that
are significantly superior to those achieved by the use of
naturally occurring genes. This procedure may contribute
considerably to fulfilling standards set by regulatory authorities.
This book provides an overview of the current advances in the field
of gene therapy and the methods that are being successfully applied
in the manufacture of gene therapeutic products, and hopefully will
stimulate further progress and advancement in this field to meet
the ever-increasing demands.
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