Considerations in Manufacturing Process Development for Antibody-Based Therapeutics

  • Paula C. Miller
  • Peiling Xu


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.


Drug Substance Host Cell Protein Viral Contamination Cell Culture Process Downstream Purification 
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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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