DNA Pharmaceuticals collates literature about DNA drug formulation keenly desired by biotechnologists, molecular biologists and pharmacists.

Features:

• Focus on a completely novel class of pharmaceuticals
• Presents a wide range of gene delivery systems needed for different therapeutic applications
• Fills the gap between research and clinical trials and describes pharmaceutical fundamentals for the development of efficient DNA pharmaceuticals

Contents

DNA Vaccines – An Overview

• Rational for DNA Vaccines.
• Preclinical Proof of Concept.
• Clinical trials.
• Second-Generation Vaccines

DNA as a Pharmaceutical – Regulatory Aspects

• Quality Requirements for DNA used as a Gene Therapy Product
• Safety Studies for Clinical Trials
• Special Issues
• Biosafety Issues and Environmental Risk Assessment

From Bulk to Delivery: Plasmid Manufacturing and Storage

• Manufacturing of Plasmid DNA
• Quality Control of Plasmid DNA Vectors
• Plasmid Topology (Structural Homogeneity)
• Future Developments

Minimized, CpG-Depleted, and Methylated DNA Vectors: Toward Perfection in Nonviral Gene Therapy

• The Mammalian Immune System as a Barrier to Nonviral Gene Delivery
• Strategies of Minimize DNA Vectors
• Depletion of CpG Dinucleotides on the Bacterial Vector Backbone
• Methylation of CpG Dinucleotides in Plasmid DNA
• Towards an Ideal Nonviral Vector

Localized Nucleic Acid Delivery: A Discussion of Selected Methods

• Nucleic Acid Delivery – What For
• Nucleic Acid Delivery – How
• Why Is Localization of Drug and Nucleic Acid Delivery Important
• Hierarchies of Localization (Targeting)

DNA Needle Injection

• From Mouse to Human
• Intramuscular Injection
• Intradermal Injection

Needleless Jet Injection of Naked DNA for Nonviral in vivo Gene transfer

• In vivo Application of Jet Injection

Plasmid Inhalation: Delivery to the Airways

• Delivery Methods
• Future Directions

Hydrodynamic Gene Delivery

• Definition
• Initial Discovery of the Technique
• The Systemic Hydrodynamic Approach
• The Regional Hydrodynamic Approach to the Liver
• Gene Delivery to the Liver in Large Animals
• Hydrodynamic Gene Delivery to Tissues Other Than Liver
• Mechanisms of Gene Delivery
• Safety and Clinical Applicability

DNA Pharmaceuticals for Skin Diseases

• Recombinant DNA-Based Skin Gene Therapy
• DNA Vaccines
• Physical Methods of DNA Delivery

Electrotransfection - An Overview

• Theory and Mechanisms
• In vivo DNA Elctrotransfer in Practice
• Targeted Tissues
• Therapeutic Applications

Electrogenetransfer in Chemical Applications

• Summary of the Basis of Electrogenetherapy
• The Road to Clinical Electrogenetherapy

Cancer Inhibition in Mice After Systemic Application of Plasmid-Driven Expression of Small Interfering RNAs

• Plasmid-Expressed siRNA

Index

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