Biological drug products
Subtitle: development and strategies
By: edited by Wei Wang, Manmohan Singh
Contributors: Manmohan Singh, 1964 November 8-
Publisher: Wiley
Published: 2014
Place of publication: Hoboken, N.J
Language: eng
Number of pages: 728
ISBN-13: 9781118148891
Subjects: Biological Agents; Pharmacology; Therapeutic use; Drug Delivery Systems; Drug Discovery
Notes: Includes bibliographical references and index.
Table of contents: title: An overview of discovery and development process for biologics / Heather H. Shih, Paula Miller, Douglas C. Harnish; title: Nonclinical safety assessment of biologics, including vaccines / Liangbiao George Hu, David W. Clarke; title: Clinical assessment of biologics agents / Lesley Ann Saketkoo, Shikha Mittoo, Luis R. Espinoza; title: Key regulatory guidelines for development of biologics in the U.S. and Europe / Richard Kingham, Gabriela Klasa, Krista Hessler Carver; title: Landscape and consideration of intellectual property for development of biosimilars / Srikumaran Melethil; title: Scientific aspects of sterility assurance, sterility, asepsis, and sterilization / James E. Akers and James P. Agalloco; title: Cell cell culture processes in monoclonal antibody production / Feng Li, Amy (Yijuan) Shen, Ashraf Amanullah; title: Protein/peptide purification and virus reduction / Beckley K. Nfor, Esteban Freydell, and Marcel Ottens; title: Chemical and genetic modification / M Farys ... [et al.]; title: Analytical characterization of proteins/peptides / Yajun Jennifer Wang and Brian Hosken; title: Protein/peptide formulation development / Satoshi Ohtake and Wei Wang; title: Regulatory strategies and lessons in the development of biosimilars / Umang S. Shah; title: Vaccine development : history, current status, and future trends / Leo Van Der Pol, Jean-Pierre Amorij; title: Role and application of adjuvants and delivery systems in vaccines / Rajesh K. Gupta; title: Methods for characterizing proteins in aluminum adjuvant formulations / Martinus A.H. Capelle, Emilie Poirier, Tudor Arvinte; title: The state of the art and future of gene medicines / Frank Jacobs, Stephanie C. Gordts, Bart De Geest; title: Nucleic acid vaccines / Rachel Buglione-Corbett ... [et al.]; title: Multifunctional polymeric nano-systems for RNA interference therapy / Arun Iyer ... [et al.]; title: Advent and maturation of regenerative medicine / Abner M. Mhashilkar, Anthony Atala; title: Conventional and novel container closure/delivery systems / Joseph Wong, Mahesh V. Chaubal; title: Controlled-release systems for biologics / Mayura Oak ... [et al.]; title: Routes of delivery for biological drug products / Darrell J. Irvine, Xingfang Su, Brandon Kwong.