Biological Drug Products: Development and Strategies

Wei Wang, Manmohan Singh

ISBN: 9788126577606




This book overviews the fundamental aspects, challenges, and development strategies for biological drug entities. It is divided into 5 parts, covering general aspects in the development of biologics (Part 1) and challenges and strategies in the development of specific types of biologics (Parts 2-5). In the overview section, contributing authors discuss the development process, safety and clinical assessments, manufacturing, and regulatory and intellectual property issues. Following this opening, the major classes of biologics are discussed: proteins and peptides, vaccines, oligonucleotides, and gene and regenerative medicines.




Part 1. General Aspects

Chapter 1. An Overview of Discovery and Development Process for Biologics
Chapter 2. Nonclinical Safety Assessment of Biologics, Including Vaccines
Chapter 3 Clinical Assessment of Biologics Agents
Chapter 4. Key Regulatory Guidelines for Development of Biologics in The U.S. And Europe
Chapter 5. Landscape and Consideration of Intellectual Property for Development of Biosimilars
Chapter 6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis and Sterilization

Part 2. Proteins / Peptides 

Chapter 7. Cell Culture Processes in Monoclonal Antibody Production
Chapter 8. Protein/Peptide Purification and Virus Reduction
Chapter 9. Chemical and Genetic Modification
Chapter 10. Analytical Characterization of Proteins / Peptides
Chapter 11. Protein/Peptide Formulation Development
Chapter 12. Regulatory Strategies and Lessons in the Development of Biosimilars


Part 3. Vaccines

Chapter 13. Vaccine Development -- History, Current Status and Future Trends
Chapter 14. Role and Application of Adjuvants and Delivery Systems in Vaccines
Chapter 15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations

Part 4. Novel Biologics

Chapter 16. The State of The Art and Future of Gene Medicines
Chapter 17. Nucleic Acid Vaccines
Chapter 18. Multifunctional Polymeric Nano-Systems for RNA Interference Therapy
Chapter 19. Advent and Maturation of Regenerative Medicine

Part 5. Product Administration / Delivery

Chapter 20. Conventional and Novel Container Closure / Delivery Systems
Chapter 21. Controlled-Release Systems for Biologics
Chapter 22. Routes of Delivery for Biological Drug Products