Guides you through every step of development and manufacturing
Plasmid–based gene transfer techniques have the potential to provide society with a broad new range of therapeutic and prophylactic medicinal agents. Addressing the challenges faced by today′s scientists and engineers, this book presents both the fundamentals as well as the latest emerging research in order to explain the characteristics of plasmid DNA and support the development and manufacture of new plasmid biopharmaceuticals.
Plasmid Biopharmaceuticals is logically organized into three major sections: Basics, Applications, and Manufacturing. Readers will find detailed discussions and reviews of all the key scientific, engineering, and technological breakthroughs and challenges. Moreover, the author delves into key issues in regulation, ethics, markets, and innovation. The final chapter examines how plasmid biopharmaceutical research has evolved and is expected to evolve in the future.
Several features help readers fully grasp new concepts and put them into practice:
Case studies guide readers through the development of approved products as well as examine products that are still in development stages
Extensive cross–referencing among the chapters helps create a complete picture of the development and manufacturing process
Figures and diagrams enable readers to better visualize key concepts and procedures
Tables offer at–a–glance summaries of important information
References guide readers to landmark papers published in the field
Plasmid Biopharmaceuticals is written for all researchers involved in the development and manufacture of plasmid biopharmaceuticals. Its extensive coverage of fundamentals makes it ideal for novices, whereas its coverage of the latest breakthroughs and challenges makes it equally appropriate for experienced researchers.
Part I Basics.
1 Historical Perspective.
2 Gene Transfer with Plasmid Biopharmaceuticals.
3 Product and Process Development.
5 Analytical Characterization.
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.