Manufacturing of Gene Therapeutics

Methods, Processing, Regulation, and Validation

Nonfiction, Science & Nature, Science, Chemistry, Clinical, Health & Well Being, Medical, Specialties, Pharmacy
Cover of the book Manufacturing of Gene Therapeutics by , Springer US
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: ISBN: 9781461513537
Publisher: Springer US Publication: December 6, 2012
Imprint: Springer Language: English
Author:
ISBN: 9781461513537
Publisher: Springer US
Publication: December 6, 2012
Imprint: Springer
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Springer US

Cover of the book Values, Achievement, and Justice by
Cover of the book Photostasis and Related Phenomena by
Cover of the book Successful Aging by
Cover of the book Sapphire by
Cover of the book Special Education Law by
Cover of the book UML-B Specification for Proven Embedded Systems Design by
Cover of the book Biomedical Institutions, Biomedical Funding, and Public Policy by
Cover of the book Perception, Consciousness, Memory by
Cover of the book New Challenges in Communication with Cancer Patients by
Cover of the book Neurobiology of Amino Acids, Peptides and Trophic Factors by
Cover of the book Cardiac Dysfunction in Chronic Uremia by
Cover of the book Air-Sea Interaction by
Cover of the book Rehabilitation by
Cover of the book Isoquinolines And Beta-Carbolines As Neurotoxins And Neuroprotectants by
Cover of the book Hurricanes and Climate Change by
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy