{"product_id":"biological-drug-products-isbn-9781118148891","title":"Biological Drug Products","description":"\u003cp\u003e\u003cb\u003eTested and proven solutions to the challenges of biological drug product development\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBiological 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eBiological Drug Products\u003c\/i\u003e 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e\n\u003cb\u003ePart 1:\u003c\/b\u003e General Aspects\u003c\/li\u003e \u003cli\u003e\n\u003cb\u003ePart 2:\u003c\/b\u003e Proteins and Peptides\u003c\/li\u003e \u003cli\u003e\n\u003cb\u003ePart 3:\u003c\/b\u003e Vaccines\u003c\/li\u003e \u003cli\u003e\n\u003cb\u003ePart 4:\u003c\/b\u003e Novel Biologics\u003c\/li\u003e \u003cli\u003e\n\u003cb\u003ePart 5:\u003c\/b\u003e Product Administration\/Delivery\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eEach 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.\u003c\/p\u003e \u003cp\u003eBy incorporating lessons learned and future directions for research, \u003ci\u003eBiological Drug Products\u003c\/i\u003e enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.\u003c\/p\u003e  \u003cp\u003eDedication\u003c\/p\u003e \u003cp\u003ePreface\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart 1. General Aspects 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eChapter 1. An Overview of Discovery and Development Process For Biologics 3\u003cbr\u003e \u003ci\u003eHeather H. Shih, Paula Miller and Douglas C. Harnish\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 2. Nonclinical Safety Assessment of Biologics, Including Vaccines 31\u003cbr\u003e \u003ci\u003eLiangbiao George Hu, David W. Clarke\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 3 Clinical Assessment of Biologics Agents 57\u003cbr\u003e \u003ci\u003eLesley Ann Saketkoo, Shikha Mittoo and Luis R. Espinoza\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 4. Key Regulatory Guidelines for Development of Biologics In The U.S. And Europe 75\u003cbr\u003e \u003ci\u003eRichard Kingham, Gabriela Klasa and Krista Hessler Carver\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 5. Landscape and Consideration of Intellectual Property for Development Of Biosimilars 111\u003cbr\u003e \u003ci\u003eSrikumaran Melethil\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization 133\u003cbr\u003e \u003ci\u003eJames E. Akers and James P. Agalloco\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart 2. Proteins\/Peptides 163\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eChapter 7. Cell Cell Culture Processes in Monoclonal Antibody Production 165\u003cbr\u003e \u003ci\u003eFeng Li, Amy (Yijuan) Shen and Ashraf Amanullah\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 8. Protein\/Peptide Purification and Virus Reduction 203\u003cbr\u003e \u003ci\u003eBeckley K. Nfor, Esteban Freydell and Marcel Ottens\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 9. Chemical and Genetic Modification 233\u003cbr\u003e \u003ci\u003eM Farys, C Ginn, G Badescu, K Peciak, E Pawlisz, H Khalili and S Brocchini\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 10. Analytical Characterization of Proteins\/Peptides 285\u003cbr\u003e \u003ci\u003eYajun Jennifer Wang and Brian Hosken\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 11. Protein\/Peptide Formulation Development 323\u003cbr\u003e \u003ci\u003eSatoshi Ohtake and Wei Wang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 12. Regulatory Strategies and Lessons in the Development Of Biosimilars 367\u003cbr\u003e \u003ci\u003eUmang S. Shah\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart 3. Vaccines 409\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eChapter 13. Vaccine Development – History, Current Status and Future Trends 411\u003cbr\u003e \u003ci\u003eLeo Van Der Pol and Jean-Pierre Amorij\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 14. Role and Application of Adjuvants and Delivery Systems in Vaccines 437\u003cbr\u003e \u003ci\u003eRajesh K. Gupta\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations 469\u003cbr\u003e \u003ci\u003eMartinus A.H. Capelle, Emilie Poirier and Tudor Arvinte\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart 4. Novel Biologics 487\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eChapter 16. The State Of The Art and Future of Gene Medicines 489\u003cbr\u003e \u003ci\u003eFrank Jacobs, Stephanie C. Gordts and Bart De Geest\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 17. Nucleic Acid Vaccines 531\u003cbr\u003e \u003ci\u003eRachel Buglione-Corbett, John Suschak, Shixia Wang and Shan Lu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 18. Multifunctional Polymeric Nano-Systems for Rna Interference Therapy 569\u003cbr\u003e \u003ci\u003eArun Iyer, Shanthi Ganesh, Qiong L. Zhou and Mansoor Amiji\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 19. Advent and Maturation of Regenerative Medicine 601\u003cbr\u003e Abner M. Mhashilkar and Anthony Atala\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart 5. Product Administration\/Delivery 629\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eChapter 20. Conventional and Novel Container Closure\/Delivery Systems 631\u003cbr\u003e Joseph Wong and Mahesh V. Chaubal\u003c\/p\u003e \u003cp\u003eChapter 21. Controlled-Release Systems for Biologics 655\u003cbr\u003e \u003ci\u003eMayura Oak, Rhishikesh Mandke, Buddhadev Layek, Gitanjali Sharma and Jagdish Singh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 22. Routes of Delivery for Biological Drug Products 677\u003cbr\u003e \u003ci\u003eDarrell J. Irvine, Xingfang Su and Brandon Kwong\u003cbr\u003e \u003cbr\u003e \u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eINDEX 725\u003c\/b\u003e\u003c\/p\u003e  “Thus, it will be a valuable resource for both novice and expert alike.” (ChemMedChem, 1 October 2014)  \u003cp\u003e\u003cb\u003eWEI WANG, PhD,\u003c\/b\u003e 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eMANMOHAN SINGH, PhD,\u003c\/b\u003e 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.\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eTested and proven solutions to the challenges of biological drug product development\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBiological 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eBiological Drug Products\u003c\/i\u003e 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e\n\u003cb\u003ePart 1:\u003c\/b\u003e General Aspects\u003c\/li\u003e \u003cli\u003e\n\u003cb\u003ePart 2:\u003c\/b\u003e Proteins and Peptides\u003c\/li\u003e \u003cli\u003e\n\u003cb\u003ePart 3:\u003c\/b\u003e Vaccines\u003c\/li\u003e \u003cli\u003e\n\u003cb\u003ePart 4:\u003c\/b\u003e Novel Biologics\u003c\/li\u003e \u003cli\u003e\n\u003cb\u003ePart 5:\u003c\/b\u003e Product Administration\/Delivery\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eEach 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.\u003c\/p\u003e \u003cp\u003eBy incorporating lessons learned and future directions for research, \u003ci\u003eBiological Drug Products\u003c\/i\u003e enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988823523557,"sku":"NP9781118148891","price":200.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781118148891.jpg?v=1761781711","url":"https:\/\/k12savings.com\/es\/products\/biological-drug-products-isbn-9781118148891","provider":"K12savings","version":"1.0","type":"link"}