Biological Drug Products (eBook)

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.

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

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