Gene Therapy Technologies, Applications and Regulations: From Laboratory to Clinic / Edition 1

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Overview

The development of gene-based technologies has been rapid over the past decade and has consequently resulted in a surge of interest in human gene therapy, the deliberate transfer of genes to somatic cells to cure or alleviate disease symptoms.
Hundreds of clinical protocols involving variously designed vectors for efficient gene transfer have been developed. However, the use of such complex 'gene medicines' containing potentially heritable genes has raised numerous concerns regarding quality, efficacy and safety.
Encompassing recent developments in the field and addressing current concerns this book:
surveys many of the current technologies for preparing vectors for use in gene therapy protocols
reviews the application of gene-mediated therapies to a range of medical conditions
considers the regulatory aspects of gene therapy including product quality and safety requirements
appraises the transfer of technologies from laboratory to clinic with regard to the attendant requirements and facilities for:
good laboratory practice (GLP) conditions in the R&D laboratory
large-scale production methods and good manufacturing practice (GMP)
current in-process and final product testing Written by international experts knowledgeable about many aspects of human somatic gene therapy, this book will be an essential guide for those embarking on gene therapy technologies relevant to specifications of production and testing of products (and procedures) required to meet existing regulations, including quality, efficacy and safety considerations.

Disc. cationic liposomes; DNA condensation; viral vectors; gene transfer advances; GLP; clinical applications.

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Product Details

  • ISBN-13: 9780471967095
  • Publisher: Wiley
  • Publication date: 11/30/1999
  • Edition number: 1
  • Pages: 440
  • Product dimensions: 6.26 (w) x 9.27 (h) x 1.15 (d)

Table of Contents

List of contributors
Preface
1 Cationic Liposomes for Gene Therapy Applications 1
2 DNA Condensation and Receptor-mediated Gene Transfer 13
3 Retroviral Vectors 35
4 Lentiviral Vectors 61
5 Adenoviral Vectors 87
6 Adeno-associated Viral Vectors 109
7 Advances in Engineering HSV Vectors for Gene Transfer to the Nervous System 127
8 Mammalian Artificial Chromosomes: Prospects for Gene Therapy 165
9 Gene Therapy for Severe Combined Immunodeficiency 179
10 Gene Therapy for Haemophilia 195
11 Cystic Fibrosis: Gene Therapy Approaches 207
12 Therapeutic Approaches to Haemoglobinopathies 227
13 Gene Therapy Approaches to Duchenne Muscular Dystrophy 243
14 Lysosomal Storage Diseases 267
15 Prospects for Gene Therapy of HIV Infections and AIDS 291
16 The Development of the Regulatory Process in Europe for Biological Medicines: how it Affects Gene Therapy Products 319
17 Development and Regulation of Gene Therapy Drugs in Germany 347
18 The Transfer of Technology from the Laboratory to the Clinic: In process Controls and Final Product Testing 359
19 Good Laboratory Practice in the Research and Development Laboratory 375
20 Facilities for Large-scale Production of Vectors Under GMP Conditions 383
Addendum 401
Index 403
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