Plasmid biopharmaceuticals : basics, applications, and manufacturing /
Duarte Miguel F. Prazeres.
- Hoboken, N.J. : John Wiley, c2011.
- xix, 590 p. : ill. ; 25 cm.
Includes bibliographical references and index.
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.