This book overviews the fundamental aspects, challenges, and strategies for developing a variety of biological drugs –– a large and growing segment of the pharmaceutical industry. Contributing authors discuss the development process, safety and clinical assessments, manufacturing, 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. A concluding section details administration and delivery routes and systems. The book incorporates both lessons learned and future directions to make for a valuable resource and reference for pharmaceutical scientists involved in the dynamic field of biologics. INDICE: Dedication Preface Part 1. General Aspects 1 Chapter 1. An Overview of Discovery and Development Process For Biologics 3 Heather H. Shih, Paula Miller and Douglas C. Harnish Chapter 2. Nonclinical Safety Assessment of Biologics, Including Vaccines 31 Liangbiao George Hu, David W. Clarke Chapter 3 Clinical Assessment of Biologics Agents 57 Lesley Ann Saketkoo, Shikha Mittoo and Luis R. Espinoza Chapter 4. Key Regulatory Guidelines for Development of Biologics In The U.S. And Europe 75 Richard Kingham, Gabriela Klasa and Krista Hessler Carver Chapter 5. Landscape and Consideration of Intellectual Property for Development Of Biosimilars 111 Srikumaran Melethil Chapter 6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization 133 James E. Akers and James P. Agalloco Part 2. Proteins/Peptides 163 Chapter 7. Cell Cell Culture Processes in Monoclonal Antibody Production 165 Feng Li, Amy (Yijuan) Shen and Ashraf Amanullah Chapter 8. Protein/Peptide Purification and Virus Reduction 203 Beckley K. Nfor, Esteban Freydell and Marcel Ottens Chapter 9. Chemical and Genetic Modification 233 M Farys, C Ginn, G Badescu, K Peciak, E Pawlisz, H Khalili and S Brocchini Chapter 10. Analytical Characterization of Proteins/Peptides 285 Yajun Jennifer Wang and Brian Hosken Chapter 11. Protein/Peptide Formulation Development 323 Satoshi Ohtake and Wei Wang Chapter 12. Regulatory Strategies and Lessons in the Development Of Biosimilars 367 Umang S. Shah Part 3. Vaccines 409 Chapter 13. Vaccine Development – History, Current Status and Future Trends 411 Leo Van Der Pol and Jean–Pierre Amorij Chapter 14. Role and Application of Adjuvants and Delivery Systems in Vaccines 437 Rajesh K. Gupta Chapter 15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations 469 Martinus A.H. Capelle, Emilie Poirier and Tudor Arvinte Part 4. Novel Biologics 487 Chapter 16. The State Of The Art and Future of Gene Medicines 489 Frank Jacobs, Stephanie C. Gordts and Bart De Geest Chapter 17. Nucleic Acid Vaccines 531 Rachel Buglione–Corbett, John Suschak, Shixia Wang and Shan Lu Chapter 18. Multifunctional Polymeric Nano–Systems for Rna Interference Therapy 569 Arun Iyer, Shanthi Ganesh, Qiong L. Zhou and Mansoor Amiji Chapter 19. Advent and Maturation of Regenerative Medicine 601 Abner M. Mhashilkar and Anthony Atala Part 5. Product Administration/Delivery 629 Chapter 20. Conventional and Novel Container Closure/Delivery Systems 631 Joseph Wong and Mahesh V. Chaubal Chapter 21. Controlled–Release Systems for Biologics 655 Mayura Oak, Rhishikesh Mandke, Buddhadev Layek, Gitanjali Sharma and Jagdish Singh Chapter 22. Routes of Delivery for Biological Drug Products 677 Darrell J. Irvine, Xingfang Su and Brandon Kwong INDEX 725
- ISBN: 978-1-118-14889-1
- Editorial: Wiley–Blackwell
- Encuadernacion: Cartoné
- Páginas: 744
- Fecha Publicación: 29/11/2013
- Nº Volúmenes: 1
- Idioma: Inglés