Chapter 16: Development of Robust Lyophilization Process for Therapeutic Proteins: A Case Study
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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.
KeywordsLyophilization Formulation Robustness Stability