Biological drug products: development and strategies edited by Wei Wang, Manmohan Singh
Material type: TextPublication details: Hoboken, N.J. : Wiley, c2014.Description: xv, 728 p. : ill. ; 25 cmISBN:- 9781118148891 (cloth)
- 615.19 22
- RM301.25 .B57 2014
- QV 241
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
---|---|---|---|---|---|---|
Books | Tan Tao University General Stacks | Non-fiction | 615.19 (Browse shelf(Opens below)) | Not For Loan | A-2018-0263 | |
Books | Tan Tao University General Stacks | Non-fiction | 615.19 (Browse shelf(Opens below)) | Not For Loan | A-2018-0264 |
Includes bibliographical references and index.
An overview of discovery and development process for biologics / Heather H. Shih, Paula Miller, Douglas C. Harnish -- Nonclinical safety assessment of biologics, including vaccines / Liangbiao George Hu, David W. Clarke -- Clinical assessment of biologics agents / Lesley Ann Saketkoo, Shikha Mittoo, Luis R. Espinoza -- Key regulatory guidelines for development of biologics in the U.S. and Europe / Richard Kingham, Gabriela Klasa, Krista Hessler Carver -- Landscape and consideration of intellectual property for development of biosimilars / Srikumaran Melethil -- Scientific aspects of sterility assurance, sterility, asepsis, and sterilization / James E. Akers and James P. Agalloco -- Cell cell culture processes in monoclonal antibody production / Feng Li, Amy (Yijuan) Shen, Ashraf Amanullah -- Protein/peptide purification and virus reduction / Beckley K. Nfor, Esteban Freydell, and Marcel Ottens -- Chemical and genetic modification / M Farys ... [et al.] -- Analytical characterization of proteins/peptides / Yajun Jennifer Wang and Brian Hosken -- Protein/peptide formulation development / Satoshi Ohtake and Wei Wang -- Regulatory strategies and lessons in the development of biosimilars / Umang S. Shah -- Vaccine development : history, current status, and future trends / Leo Van Der Pol, Jean-Pierre Amorij -- Role and application of adjuvants and delivery systems in vaccines / Rajesh K. Gupta -- Methods for characterizing proteins in aluminum adjuvant formulations / Martinus A.H. Capelle, Emilie Poirier, Tudor Arvinte -- The state of the art and future of gene medicines / Frank Jacobs, Stephanie C. Gordts, Bart De Geest -- Nucleic acid vaccines / Rachel Buglione-Corbett ... [et al.] -- Multifunctional polymeric nano-systems for RNA interference therapy / Arun Iyer ... [et al.] -- Advent and maturation of regenerative medicine / Abner M. Mhashilkar, Anthony Atala -- Conventional and novel container closure/delivery systems / Joseph Wong, Mahesh V. Chaubal -- Controlled-release systems for biologics / Mayura Oak ... [et al.] -- Routes of delivery for biological drug products / Darrell J. Irvine, Xingfang Su, Brandon Kwong.
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