Biological drug products development and strategies

Biological drug products development and strategies

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Bibliographic Details
Other Authors: Wang, Wei 1957 March 10-, Manmohan Singh 1964 November 8-
Format: Book
Published: Hoboken, NJ Wiley c2014
Subjects:
Biological Agents > therapeutic use
Drug Delivery Systems > pharmacology
Drug Discovery
Biological Agents > pharmacology
Online Access:Click Here to View Status and Holdings.
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Table of Contents:
  • 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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