Pharmaceutical formulation of peptides and proteins has become an important part of modern drug development. Many new drugs are based on peptide or protein recombinant technology going hand in hand with more traditional pharmaceutical formulation. In order to develop products with optimal characters, it is important to give scientists interdisciplinary knowledge and a thorough understanding of the complex nature of pharmaceutical formulation of peptides and proteins.
This comprehensive volume brings the different aspects of peptide and protein formulation into focus, beginning with the fundamentals of the production of peptides and proteins, ranging from peptide synthesis and recombinant DNA technology to protein purification. It discusses the characterization and chemical stability of peptides and proteins, before moving on to formulation, detailing peptides and proteins in solution and as suspensions, as well as lyophilized peptide and protein products. There follows a case study on drug delivery systems for alternative routes of administration. Finally, regulatory aspects are discussed in terms of chemical and pharmaceutical documentation. Each chapter is written by experts in their respective areas.
Scientists in the industry and academia, and postgraduate students in pharmaceutical science will find this a valuable resource, which can be dipped in to as a reference, or studied as a whole.
Peptide Synthesis. Basics in Recombinant DNA Technology. Protein Purification. Peptide and Protein Characterization. Chemical Pathways of Peptide and Protein Degradation. Physical Stability of Proteins. Peptides and Proteins as Parenteral Suspensions: An Overview of Design, Development, and Manufacturing Considerations. Peptides and Proteins as Parenteral Solutions. Lyophilized Peptide and Protein Products. Roles of Protein Conformation and Glassy State in Storage Stability of Dried Protein Formulations. Peptide and Protein Drug Delivery Systems for Non-Parenteral Routes of Administration. Peptide and Protein Derivatives. Chemical and Pharmaceutical Documentation.