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 ischemia -- Veterinary case studies : West Nile, infectious hematopoietic necrosis, and melanoma -- Good manufacturing practice 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