Plasmid Biopharmaceuticals
Basics, Applications, and Manufacturing
by Duarte Miguel F. Prazeres

Plasmid Biopharmaceuticals addresses the basics, applications, and manufacturing of plasmid biopharmaceuticals. The survey of the most relevant characteristics of plasmids provides the basics for designing plasmid products (applications) and processes (manufacturing).

Key features of the book are:

• consistency and clear line of direction
• an extensive use of cross-referencing between the individual chapters
• a rational integration of chapters
• appellative figures, tables and schemes
• an updated, but selected choice of references, with a focus on key papers

Contents

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 Recover
17. Final Purification
18. Process Synthesis

Part IV Concluding Remarks and Outlook

19. Concluding Remarks and Outlook

Index

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