W Wang
John Wiley & Sons
e druk, 2013
9781118148891
Biological Drug Products – Development and Strategies
Development and Strategies
Specificaties
Gebonden, 744 blz.
|
Engels
John Wiley & Sons |
e druk, 2013
ISBN13: 9781118148891
Rubricering
Verwachte levertijd ongeveer 9 werkdagen
Samenvatting
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.
Specificaties
Inhoudsopgave
<p>Dedication</p>
<p>Preface</p>
<p>Part 1. General Aspects 1</p>
<p>Chapter 1. An Overview of Discovery and Development Process For Biologics 3<br /> Heather H. Shih, Paula Miller and Douglas C. Harnish</p>
<p>Chapter 2. Nonclinical Safety Assessment of Biologics, Including Vaccines 31<br /> Liangbiao George Hu, David W. Clarke</p>
<p>Chapter 3 Clinical Assessment of Biologics Agents 57<br /> Lesley Ann Saketkoo, Shikha Mittoo and Luis R. Espinoza</p>
<p>Chapter 4. Key Regulatory Guidelines for Development of Biologics In The U.S. And Europe 75<br /> Richard Kingham, Gabriela Klasa and Krista Hessler Carver</p>
<p>Chapter 5. Landscape and Consideration of Intellectual Property for Development Of Biosimilars 111<br /> Srikumaran Melethil</p>
<p>Chapter 6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization 133<br /> James E. Akers and James P. Agalloco</p>
<p>Part 2. Proteins/Peptides 163</p>
<p>Chapter 7. Cell Cell Culture Processes in Monoclonal Antibody Production 165<br /> Feng Li, Amy (Yijuan) Shen and Ashraf Amanullah</p>
<p>Chapter 8. Protein/Peptide Purification and Virus Reduction 203<br /> Beckley K. Nfor, Esteban Freydell and Marcel Ottens</p>
<p>Chapter 9. Chemical and Genetic Modification 233<br /> M Farys, C Ginn, G Badescu, K Peciak, E Pawlisz, H Khalili and S Brocchini</p>
<p>Chapter 10. Analytical Characterization of Proteins/Peptides 285<br /> Yajun Jennifer Wang and Brian Hosken</p>
<p>Chapter 11. Protein/Peptide Formulation Development 323<br /> Satoshi Ohtake and Wei Wang</p>
<p>Chapter 12. Regulatory Strategies and Lessons in the Development Of Biosimilars 367<br /> Umang S. Shah</p>
<p>Part 3. Vaccines 409</p>
<p>Chapter 13. Vaccine Development History, Current Status and Future Trends 411<br /> Leo Van Der Pol and Jean–Pierre Amorij</p>
<p>Chapter 14. Role and Application of Adjuvants and Delivery Systems in Vaccines 437<br /> Rajesh K. Gupta</p>
<p>Chapter 15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations 469<br /> Martinus A.H. Capelle, Emilie Poirier and Tudor Arvinte</p>
<p>Part 4. Novel Biologics 487</p>
<p>Chapter 16. The State Of The Art and Future of Gene Medicines 489<br /> Frank Jacobs, Stephanie C. Gordts and Bart De Geest</p>
<p>Chapter 17. Nucleic Acid Vaccines 531<br /> Rachel Buglione–Corbett, John Suschak, Shixia Wang and Shan Lu</p>
<p>Chapter 18. Multifunctional Polymeric Nano–Systems for Rna Interference Therapy 569<br /> Arun Iyer, Shanthi Ganesh, Qiong L. Zhou and Mansoor Amiji</p>
<p>Chapter 19. Advent and Maturation of Regenerative Medicine 601<br /> Abner M. Mhashilkar and Anthony Atala</p>
<p>Part 5. Product Administration/Delivery 629</p>
<p>Chapter 20. Conventional and Novel Container Closure/Delivery Systems 631<br /> Joseph Wong and Mahesh V. Chaubal</p>
<p>Chapter 21. Controlled–Release Systems for Biologics 655<br /> Mayura Oak, Rhishikesh Mandke, Buddhadev Layek, Gitanjali Sharma and Jagdish Singh</p>
<p>Chapter 22. Routes of Delivery for Biological Drug Products 677<br /> Darrell J. Irvine, Xingfang Su and Brandon Kwong<br /> <br /> </p>
<p>INDEX 725</p>
<p>Preface</p>
<p>Part 1. General Aspects 1</p>
<p>Chapter 1. An Overview of Discovery and Development Process For Biologics 3<br /> Heather H. Shih, Paula Miller and Douglas C. Harnish</p>
<p>Chapter 2. Nonclinical Safety Assessment of Biologics, Including Vaccines 31<br /> Liangbiao George Hu, David W. Clarke</p>
<p>Chapter 3 Clinical Assessment of Biologics Agents 57<br /> Lesley Ann Saketkoo, Shikha Mittoo and Luis R. Espinoza</p>
<p>Chapter 4. Key Regulatory Guidelines for Development of Biologics In The U.S. And Europe 75<br /> Richard Kingham, Gabriela Klasa and Krista Hessler Carver</p>
<p>Chapter 5. Landscape and Consideration of Intellectual Property for Development Of Biosimilars 111<br /> Srikumaran Melethil</p>
<p>Chapter 6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization 133<br /> James E. Akers and James P. Agalloco</p>
<p>Part 2. Proteins/Peptides 163</p>
<p>Chapter 7. Cell Cell Culture Processes in Monoclonal Antibody Production 165<br /> Feng Li, Amy (Yijuan) Shen and Ashraf Amanullah</p>
<p>Chapter 8. Protein/Peptide Purification and Virus Reduction 203<br /> Beckley K. Nfor, Esteban Freydell and Marcel Ottens</p>
<p>Chapter 9. Chemical and Genetic Modification 233<br /> M Farys, C Ginn, G Badescu, K Peciak, E Pawlisz, H Khalili and S Brocchini</p>
<p>Chapter 10. Analytical Characterization of Proteins/Peptides 285<br /> Yajun Jennifer Wang and Brian Hosken</p>
<p>Chapter 11. Protein/Peptide Formulation Development 323<br /> Satoshi Ohtake and Wei Wang</p>
<p>Chapter 12. Regulatory Strategies and Lessons in the Development Of Biosimilars 367<br /> Umang S. Shah</p>
<p>Part 3. Vaccines 409</p>
<p>Chapter 13. Vaccine Development History, Current Status and Future Trends 411<br /> Leo Van Der Pol and Jean–Pierre Amorij</p>
<p>Chapter 14. Role and Application of Adjuvants and Delivery Systems in Vaccines 437<br /> Rajesh K. Gupta</p>
<p>Chapter 15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations 469<br /> Martinus A.H. Capelle, Emilie Poirier and Tudor Arvinte</p>
<p>Part 4. Novel Biologics 487</p>
<p>Chapter 16. The State Of The Art and Future of Gene Medicines 489<br /> Frank Jacobs, Stephanie C. Gordts and Bart De Geest</p>
<p>Chapter 17. Nucleic Acid Vaccines 531<br /> Rachel Buglione–Corbett, John Suschak, Shixia Wang and Shan Lu</p>
<p>Chapter 18. Multifunctional Polymeric Nano–Systems for Rna Interference Therapy 569<br /> Arun Iyer, Shanthi Ganesh, Qiong L. Zhou and Mansoor Amiji</p>
<p>Chapter 19. Advent and Maturation of Regenerative Medicine 601<br /> Abner M. Mhashilkar and Anthony Atala</p>
<p>Part 5. Product Administration/Delivery 629</p>
<p>Chapter 20. Conventional and Novel Container Closure/Delivery Systems 631<br /> Joseph Wong and Mahesh V. Chaubal</p>
<p>Chapter 21. Controlled–Release Systems for Biologics 655<br /> Mayura Oak, Rhishikesh Mandke, Buddhadev Layek, Gitanjali Sharma and Jagdish Singh</p>
<p>Chapter 22. Routes of Delivery for Biological Drug Products 677<br /> Darrell J. Irvine, Xingfang Su and Brandon Kwong<br /> <br /> </p>
<p>INDEX 725</p>