Therapeutic Peptides and Proteins : Formulation, Processing, and Delivery Systems, Third Edition

Examining the fastest growing sector in the biopharmaceutical market, this book discusses the advancement of protein drug development using peptides and proteins as the basis for prophylactic agents such as newly developed vaccines. As in the first two editions, this book employs a simple and straightforward style to discuss protein formulation and delivery from the basic to the more complex factors affecting protein stability and delivery. This third edition includes new information on insulin analogs, monoclonals, microneedles, and U.S. FDA guidelines.

There are more than 500 biopharmaceuticals on the market, including more than 200 therapeutic proteins, making biologics the fastest growing sector in the biopharmaceutical market. These products include more than 40 monoclonal antibodies, for indications ranging from treatment or mitigation of various types of cancer to rheumatoid arthritis.

The clinical application of these therapeutic peptides and proteins is limited by several problems, such as lack of physical and chemical stability or the lack of desirable attributes for adequate absorption or distribution. Thus, as these therapeutic peptides and proteins are made available, it will be essential to formulate these drugs into safe, stable, and efficacious delivery systems. The pharmaceutical scientist involved in this effort needs to call upon the knowledge of several disciplines, such as pharmaceutics, medicinal chemistry, biochemistry, microbiology, and chemical engineering and needs to keep abreast with the latest research in the published literature.

provides a comprehensive overview of the field for scientists in industry and academia and for students, while also providing practical information on the challenges facing the formulation and delivery aspects of these unique macromolecules. In particular, the book:

• Explains how recombinant DNA techniques now allow us to produce therapeutic proteins in a commercially viable form
• Discusses the physical and chemical pathways of peptide and protein degradation
• Includes a detailed discussion of protein formulation and lyophilization
• Overviews the pharmacokinetic aspects of therapeutic peptides and proteins and discusses controlled delivery systems for parenteral administration, including microsphere formulations
• Discusses research progress on oral, transdermal, mucosal, and topical delivery systems discusses transdermal and topical delivery