| Manufacturing of Gene Therapeutics - Methods, Processing, Regulation and Validation |
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Edited by: Subramanian, G. © 2002
Springer - Verlag
Description: 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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Front Matter
Text
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Preface
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Table of Contents
Somatic Gene Therapy, Paradigm Shift or Pandora's Box
Gene Therapy for Cancer
Gene Self-Assembly (GENSA)
Gene Expression
Tumour Genotype and Response to Cytotoxic Gene Therapy
Protein Binding Matrices
Gene Transfer into Eukaryotic Cells
Plasmid DNA Manufacturing
Quality Assurance and Quality Control for Viral Therapeutics
Analytical Assays to Characterise Adenoviral Vectors and Their Applications
Validation of Gene Therapy Manufacturing Processes
Gene Delivery
Regulatory Issues in Gene Therapy
Regulatory Aspects in Gene Therapy
Regulatory Issues for Process Development and Manufacture of Plasmids under Contract
Risk Assessment in Gene Therapy
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Index
