عنوان

Biological drug products :

1118695038

1118695089

1118695224

9781118695036

9781118695081

9781118695227

b566899

Biological drug products :

[Book]

development and strategies

edited by Wei Wang, Manmohan Singh.

Hoboken, N.J.

Wiley

©2014.

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.

Biological products.

Biologicals.

Drug development.

edited by Wei Wang, Manmohan Singh.

Manmohan Singh

Wei Wang

[Book]

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