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

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Development of Biopharmaceutical Drug-Device Products

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 35))

Abstract

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.

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Acknowledgments

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

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Authors and Affiliations

  1. Regeneron Phamraceuticals Inc., Tarrytown, NY, USA

    Qingyan Hu, Bowen Jiang, Dingjiang (Dean) Liu, Xiaolin (Charlie) Tang, Thomas Daly & Mohammed Shameem

Authors
  1. Qingyan Hu
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  2. Bowen Jiang
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  3. Dingjiang (Dean) Liu
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  4. Xiaolin (Charlie) Tang
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  5. Thomas Daly
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  6. Mohammed Shameem
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Corresponding author

Correspondence to Dingjiang (Dean) Liu .

Editor information

Editors and Affiliations

  1. Formulation Development New Biological Entities, AbbVie (United States), North Chicago, IL, USA

    Feroz Jameel

  2. Drug Product Development (Retired), AbbVie (United States), North Chicago, IL, USA

    John W. Skoug

  3. Combination Product Development, AbbVie, Inc., North Chicago, IL, USA

    Robert R. Nesbitt

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Hu, Q., Jiang, B., Liu, D.(., Tang, X.(., Daly, T., Shameem, M. (2020). Chapter 14: Practical Considerations in High Concentration Formulation Development for Monoclonal Antibody Drug Products. In: Jameel, F., Skoug, J., Nesbitt, R. (eds) Development of Biopharmaceutical Drug-Device Products. AAPS Advances in the Pharmaceutical Sciences Series, vol 35. Springer, Cham. https://doi.org/10.1007/978-3-030-31415-6_14

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