Current Trends in Monoclonal Antibody Development and Manufacturing

Volume XI of the series Biotechnology: Pharmaceutical Aspects pp 295-308


Production of Monoclonal Antibodies in E. coli

  • Dorothea E. ReillyAffiliated withEarly Stage Cell Culture, Genentech, Inc.
  • , Daniel G. YansuraAffiliated withAntibody Engineering, Genentech, Inc.

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The number of monoclonal antibodies approved for use as therapeutic agents by regulatory agencies has increased in the past several years. Monoclonal antibodies are predicted to become an increasingly larger part of biopharmaceutical products, and perhaps dominate the market share by the end of the decade (Walsh 2006). Mammalian expression systems, such as Chinese Hamster Ovary cells (CHO), are currently the preferred system for producing full-length monoclonal antibodies. Fungal systems could become more of a contender for the production of antibodies if titers can be increased (Andersen and Reilly 2004). However, with fungal production systems, there may be concerns about potential non-native mammalian N-linked or O-linked glycosylation that could result in immunogenic responses in humans. Technology developed in recent years (Hamilton et al. 2003) could help to alleviate this concern.