Protein drugs -- Development and production

Author: (USA) S.L. Nai
Publisher:
Publish Date: 2006-05-01
Features: This book primarily describes the industrialization process of peptide and protein drug formulations. Each chapter's topic is carefully selected based on the importance of peptides and protein active ingredients in the successful development of commercial drug formulations. It covers: the properties and stability of protein drugs, a review of quality assurance and quality control issues in the production process of protein drugs from bulk raw materials to finished products, the crucial processing steps in peptide and protein drug production—sterile processing, heat sterilization, membrane filtration, and freeze-drying, as well as the evolution and current status of U.S. biologic drug regulations. This book elaborates on the commercialization process of converting peptides and proteins from active compounds (drugs) into final formulations (medicines), with all discussed topics being critical for the successful development of protein and peptide formulations. The book consists of 8 chapters. Chapter 1 systematically introduces pre-formulation research, the foundation of formulation development, with a focus on the properties and stability of protein drugs. Chapter 2 is an overview chapter that comprehensively discusses the development of protein drug formulations. Chapters 3 to 6 elaborate on the crucial processing steps in peptide and protein drug production—sterile processing, heat sterilization, membrane filtration, and freeze-drying, including successful application examples. Chapter 7 reviews the quality assurance and quality control issues in the production process of protein drugs from bulk raw materials to finished products, emphasizing the most common considerations and practical methods. Chapter 8 provides a very complete and detailed introduction to the evolution and current status of U.S. biologic drug regulations. This book elaborates on the commercialization process of converting peptides and proteins from active compounds (drugs) into final formulations (medicines), with all discussed topics being critical for the successful development of protein and peptide formulations.