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.

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

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 AspectsPart 2: Proteins and PeptidesPart 3: VaccinesPart 4: Novel BiologicsPart 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.