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Biological Drug Products
Development and Strategies
Wei Wang (Edited by), W Wang (Author), Manmohan Singh (Edited by)
9781118148891, Wiley
Hardback, published 29 November 2013
744 pages
23.9 x 15.5 x 4.3 cm, 1.157 kg
“Thus, it will be a valuable resource for both novice and expert alike.” (ChemMedChem, 1 October 2014)
Tested and proven solutions to the challenges of biological drug product development 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 into five parts, the book examines: 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.
Dedication Preface Part 1. General Aspects 1 Chapter 1. An Overview of Discovery and Development Process For Biologics 3 Chapter 2. Nonclinical Safety Assessment of Biologics, Including Vaccines 31 Chapter 3 Clinical Assessment of Biologics Agents 57 Chapter 4. Key Regulatory Guidelines for Development of Biologics In The U.S. And Europe 75 Chapter 5. Landscape and Consideration of Intellectual Property for Development Of Biosimilars 111 Chapter 6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization 133 Part 2. Proteins/Peptides 163 Chapter 7. Cell Cell Culture Processes in Monoclonal Antibody Production 165 Chapter 8. Protein/Peptide Purification and Virus Reduction 203 Chapter 9. Chemical and Genetic Modification 233 Chapter 10. Analytical Characterization of Proteins/Peptides 285 Chapter 11. Protein/Peptide Formulation Development 323 Chapter 12. Regulatory Strategies and Lessons in the Development Of Biosimilars 367 Part 3. Vaccines 409 Chapter 13. Vaccine Development – History, Current Status and Future Trends 411 Chapter 14. Role and Application of Adjuvants and Delivery Systems in Vaccines 437 Chapter 15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations 469 Part 4. Novel Biologics 487 Chapter 16. The State Of The Art and Future of Gene Medicines 489 Chapter 17. Nucleic Acid Vaccines 531 Chapter 18. Multifunctional Polymeric Nano-Systems for Rna Interference Therapy 569 Chapter 19. Advent and Maturation of Regenerative Medicine 601 Part 5. Product Administration/Delivery 629 Chapter 20. Conventional and Novel Container Closure/Delivery Systems 631 Chapter 21. Controlled-Release Systems for Biologics 655 Chapter 22. Routes of Delivery for Biological Drug Products 677 INDEX 725
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Subject Areas: Chemistry [PN]
