Protein drugs - Development and Production

Author: Na Yi
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 proteins as 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 process of transforming bulk raw materials into finished drug products for protein drugs, and the crucial processing steps in peptide and protein drug production—sterile processing, thermal sterilization, membrane filtration, and freeze-drying. Additionally, it provides an introduction to the evolution and current status of biologic drug regulation in the United States. This book elaborates on the commercialization process of transforming peptides and proteins from active compounds (drugs) into final formulations (medicines), with all discussed topics being critical to 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 a comprehensive chapter that outlines the development of protein drug formulations. Chapters 3 to 6 elaborate on the crucial processing steps in peptide and protein drug production—sterile processing, thermal sterilization, membrane filtration, and freeze-drying, including examples of successful applications. Chapter 7 reviews the quality assurance and quality control issues in the process of transforming bulk raw materials into finished drug products for protein drugs, emphasizing the most common considerations and practices. Chapter 8 provides a very complete and detailed introduction to the evolution and current status of biologic drug regulation in the United States. This book is suitable for technical personnel in the research, development, production, quality control, and management departments of biopharmaceutical companies.