About the Book:

Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market.

            Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided i nto five parts, the book examines:

Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery

            Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field.

            By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.

Contents:

Part 1. General Aspects

1. An Overview of Discovery and Development Process For Biologics

2. Nonclinical Safety Assessment of Biologics, Including Vaccines

3. Clinical Assessment of Biologics Agents

4. Key Regulatory Guidelines for Development of Biologics In The U.S. And Europe

5. Landscape and Consideration of Intellectual Property for Development Of Biosimilars

6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization

Part 2. Proteins/Peptides

7. Cell Cell Culture Processes in Monoclonal Antibody Production

8. Protein/Peptide Purification and Virus Reduction

9. Chemical and Genetic Modification

10. Analytical Characterization of Proteins/Peptides

11. Protein/Peptide Formulation Development

12. Regulatory Strategies and Lessons in the Development Of Biosimilars

Part 3. Vaccines

13. Vaccine Development – History, Current Status and Future Trends

14. Role and Application of Adjuvants and Delivery Systems in Vaccines

15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations

Part 4. Novel Biologics

16. The State Of The Art and Future of Gene Medicines

17. Nucleic Acid Vaccines           

18. Multifunctional Polymeric Nano-Systems for Rna Interference Therapy

19. Advent and Maturation of Regenerative Medicine

Part 5. Product Administration/Delivery

20. Conventional and Novel Container Closure/Delivery Systems

21. Controlled-Release Systems for Biologics

About the Editors:

Wei Wang, PhD, is a Research Fellow for Pfizer BioTherapeutics Pharmaceutical Sciences. In addition, Dr. Wang is Adjunct Professor in the School of Pharmacy and Health Sciences at the University of the Pacific.