Chapter 16: Development of Robust Lyophilization Process for Therapeutic Proteins: A Case Study

  • Ehab M. Moussa
  • Tong Zhu
  • Feroz JameelEmail author
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)


Biotherapeutics is a general term that describes several different therapeutic modalities that are produced by biological means. Such modalities include proteins, peptides, RNA, gene therapy, cell therapy, vaccines, etc. Among these modalities, therapeutic proteins constitute the largest class of approved products as well as new biological entities (NBEs) in development. Therapeutic proteins encompass a large number of different modalities including monoclonal antibodies, antibody-based molecules, protein conjugates, fusion proteins and enzymes.


Lyophilization Formulation Robustness Stability 


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Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  1. 1.Formulation Development, New Biological Entities, AbbVie (United States)North ChicagoUSA

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