Plasmid Biopharmaceuticals: Basics, Applications, and Manufacturing

Acknowledgment.

Abbreviations.

Part I Basics.

1 Historical Perspective.

2 Gene Transfer with Plasmid Biopharmaceuticals.

3 Product and Process Development.

4 Structure.

5 Analytical Characterization.

6 Delivery.

Part II Applications.

7 Ethical and Safety Issues.

8 Human and Veterinary Markets.

9 Human Case Studies: Pandemic Infl uenza and Critical Limb Ischemia.

10 Veterinary Case Studies: West Nile, Infectious Hematopoietic Necrosis, and Melanoma.

Part III Manufacturing.

11 Good Manufacturing Practice and Validation.

12 Product Specifi cations and Quality Control.

13 Cell Culture.

14 An Overview of Downstream Processing.

15 Primary Isolation.

16 Intermediate Recovery.

17 Final Purifi cation.

18 Process Synthesis.

Part IV Concluding Remarks and Outlook.

19 Concluding Remarks and Outlook.

Index.