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Considerations in Manufacturing Process Development for Antibody-Based Therapeutics

  • Paula C. Miller
  • Peiling Xu
Chapter

Abstract

Antibody-based therapeutics are a rapidly growing sector of new pharmaceutical drug candidates. As the therapeutic utility of monoclonal antibodies continues to grow, development of robust manufacturing processes has been a significant focus within the pharmaceutical industry. This chapter describes the work-processes, challenges, and opportunities for platform production of antibodies with a focus on production for use in human clinical trials and marketing applications.

Keywords

Drug Substance Host Cell Protein Viral Contamination Cell Culture Process Downstream Purification 
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 Science+Business Media New York 2012

Authors and Affiliations

  1. 1.Pfizer PharmaceuticalsBiotherapeutics Pharmaceutical SciencesSt. LouisUSA

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