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" Biological drug products : "
edited by Wei Wang, Manmohan Singh.
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BL
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| Record Number
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746948
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b566899
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| Main Entry
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edited by Wei Wang, Manmohan Singh.
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| Title & Author
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Biological drug products : : development and strategies\ edited by Wei Wang, Manmohan Singh.
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| Publication Statement
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Hoboken, N.J. : Wiley, ©2014.
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| ISBN
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1118695038
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: 1118695089
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: 1118695224
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: 9781118695036
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: 9781118695081
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: 9781118695227
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| Contents
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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 [and others] --; 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 [and others] --; Multifunctional polymeric nano-systems for RNA interference therapy / Arun Iyer [and others] --; 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 [and others] --; Routes of delivery for biological drug products / Darrell J. Irvine, Xingfang Su, Brandon Kwong.
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| Subject
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Biological products.
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Biologicals.
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Drug development.
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| LC Classification
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QV241.E358 2014
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| Added Entry
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Manmohan Singh
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Wei Wang
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