Chapter 14: Practical Considerations in High Concentration Formulation Development for Monoclonal Antibody Drug Products

  • Qingyan Hu
  • Bowen Jiang
  • Dingjiang (Dean) LiuEmail author
  • Xiaolin (Charlie) Tang
  • Thomas Daly
  • Mohammed Shameem
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)


This book chapter covers practical consideration and strategies in developing high concentration formulations and drug products for commercial use. The discussions presented in this chapter are based on authors’ hands-on experience supplemented with literature findings, and focus on formulation and analytical aspects, as well as primary container considerations unique for high concentration formulation development.


Monoclonal antibody High concentration formulation Drug product development Solubility Aggregation Primary container selection Frozen storage stability Subcutaneous formulation Viscosity reduction High protein concentration 



The authors would like to thank Dr. Suhaas Aluri and Dr. David Hauss for reviewing the manuscript.


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Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  • Qingyan Hu
    • 1
  • Bowen Jiang
    • 1
  • Dingjiang (Dean) Liu
    • 1
    Email author
  • Xiaolin (Charlie) Tang
    • 1
  • Thomas Daly
    • 1
  • Mohammed Shameem
    • 1
  1. 1.Regeneron Phamraceuticals Inc.TarrytownUSA

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