Plasmid Biopharmaceuticals

Duarte Miguel F. Prazeres, PhD, DSc, is Associate Professor at the Instituto Superior Técnico (IST) and Senior Researcher at the Instituto de Biotecnologia e Bioengenharia, both within the Universidade Técnica de Lisboa. Dr. Prazeres has published 140 peer-reviewed articles and fifteen book chapters on such topics as biocatalysis, downstream processing, and nanobiotechnology.

Preface. 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.