Table of Contents

Historical perspective.
Gene transfer with plasmid biopharmaceuticals.
Product and process development.
Structure.
Analytical characterization.
Delivery.
Ethical and safety issues.
Human and veterinary markets.
Human case studies : pandemic influenza and critical limb ischaemia.
Veterinary case studies : West Nile, infectious hematopoietic necrosis, and melanoma.
GMPS and validation.
Product specifications and quality control.
Cell culture.
An overview of downstream processing.
Primary isolation.
Intermediate recovery.
Final purification.
Process synthesis.
Concluding remarks and outlook. The book 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 that the authors include in the book are: i) consistency and clear line of direction, ii) an extensive use of cross-referencing between the individual chapters, iii) a rational integration of chapters, iv) appellative figures, tables and schemes, and v) an updated, but selected choice of references, with a focus on key papers.