Biological Drug Products

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.MANMOHAN SINGH, PhD, is Head of Technical Development at Novartis Vaccines and Diagnostics. Dr. Singh has authored over 120 peer-reviewed manuscripts, reviews, and book chapters in the area of vaccine formulations and adjuvant research. He is also an Adjunct Professor at the Eshelman School of Pharmacy at University of North Carolina, Chapel Hill.

• DedicationPrefacePart 1. General Aspects 1Chapter 1. An Overview of Discovery and Development Process For Biologics 3Heather H. Shih, Paula Miller and Douglas C. HarnishChapter 2. Nonclinical Safety Assessment of Biologics, Including Vaccines 31Liangbiao George Hu, David W. ClarkeChapter 3 Clinical Assessment of Biologics Agents 57Lesley Ann Saketkoo, Shikha Mittoo and Luis R. EspinozaChapter 4. Key Regulatory Guidelines for Development of Biologics In The U.S. And Europe 75Richard Kingham, Gabriela Klasa and Krista Hessler CarverChapter 5. Landscape and Consideration of Intellectual Property for Development Of Biosimilars 111Srikumaran MelethilChapter 6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization 133James E. Akers and James P. AgallocoPart 2. Proteins/Peptides 163Chapter 7. Cell Cell Culture Processes in Monoclonal Antibody Production 165Feng Li, Amy (Yijuan) Shen and Ashraf AmanullahChapter 8. Protein/Peptide Purification and Virus Reduction 203Beckley K. Nfor, Esteban Freydell and Marcel OttensChapter 9. Chemical and Genetic Modification 233M Farys, C Ginn, G Badescu, K Peciak, E Pawlisz, H Khalili and S BrocchiniChapter 10. Analytical Characterization of Proteins/Peptides 285Yajun Jennifer Wang and Brian HoskenChapter 11. Protein/Peptide Formulation Development 323Satoshi Ohtake and Wei WangChapter 12. Regulatory Strategies and Lessons in the Development Of Biosimilars 367Umang S. ShahPart 3. Vaccines 409Chapter 13. Vaccine Development – History, Current Status and Future Trends 411Leo Van Der Pol and Jean-Pierre AmorijChapter 14. Role and Application of Adjuvants and Delivery Systems in Vaccines 437Rajesh K. GuptaChapter 15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations 469Martinus A.H. Capelle, Emilie Poirier and Tudor ArvintePart 4. Novel Biologics 487Chapter 16. The State Of The Art and Future of Gene Medicines 489Frank Jacobs, Stephanie C. Gordts and Bart De GeestChapter 17. Nucleic Acid Vaccines 531Rachel Buglione-Corbett, John Suschak, Shixia Wang and Shan LuChapter 18. Multifunctional Polymeric Nano-Systems for Rna Interference Therapy 569Arun Iyer, Shanthi Ganesh, Qiong L. Zhou and Mansoor AmijiChapter 19. Advent and Maturation of Regenerative Medicine 601Abner M. Mhashilkar and Anthony AtalaPart 5. Product Administration/Delivery 629Chapter 20. Conventional and Novel Container Closure/Delivery Systems 631Joseph Wong and Mahesh V. ChaubalChapter 21. Controlled-Release Systems for Biologics 655Mayura Oak, Rhishikesh Mandke, Buddhadev Layek, Gitanjali Sharma and Jagdish SinghChapter 22. Routes of Delivery for Biological Drug Products 677Darrell J. Irvine, Xingfang Su and Brandon Kwong INDEX 725

“Thus, it will be a valuable resource for both novice and expert alike.” (ChemMedChem, 1 October 2014)