Wei Wang & Manmohan Singh 
Biological Drug Products 
Development and Strategies

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:

* 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.

Table of Content

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

About the author

WEI WANG, Ph D, is a Research Fellow for Pfizer
Bio Therapeutics 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, Ph D, 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.