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Preparation of Clinical Trial Supplies of Biopharmaceuticals

  • A. S. Lubiniecki
  • J. C. Erickson
  • C. L. Nolan
  • R. G. Scott
  • P. J. Shadle
  • T. M. Smith
  • D. W. Zabriskie
Part of the Handbook of Experimental Pharmacology book series (HEP, volume 137)

Abstract

For most monoclonal antibodies (MAbs), preparation of research supplies is relatively straightforward. Cell culture is done by brute force, since little time is available to optimize product gene expression or cell growth. Systems that are often employed include: 1) suspension culture in spinner vessels, roller bottles or other containers, 2) ascites production in mice, and 3) hollow-fiber bioreactors.

Keywords

Suspension Culture Load Ratio Hydrophobic Interaction Chromatography Purification Cost Clinical Supply 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer-Verlag Berlin Heidelberg 1999

Authors and Affiliations

  • A. S. Lubiniecki
  • J. C. Erickson
  • C. L. Nolan
  • R. G. Scott
  • P. J. Shadle
  • T. M. Smith
  • D. W. Zabriskie

There are no affiliations available

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