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Production of Monoclonal Antibodies in E. coli

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Current Trends in Monoclonal Antibody Development and Manufacturing

Part of the book series: Biotechnology: Pharmaceutical Aspects ((PHARMASP,volume XI))

Abstract

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.

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Abbreviations

ADCC:

Antibody dependent cellular cytotoxicity

bp:

Base pairs

C1q:

Subcomponent of C1, a complement activator

CDC:

Complement dependent cytotoxicity

CHO:

Chinese hamster ovary

E. coli :

Escherichia coli

ELISA:

Enzyme-linked immunosorbent assay

FcRn:

Neonatal Fc receptor

IPTG:

Isopropyl β-D-thiogalactopyranoside

IV:

Intravenous

kDa:

Kilodaltons

PBS:

Phosphate buffered saline

SEC:

Size-exclusion chromatography

TIR:

Translation initiation region

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Acknowledgments:

The authors would like to thank Lisa A. Damico, Sean Kelley, and David Xie for the use of unpublished data on the pharmacokinetic analyses of the antibodies, Ralph Schwall for efficacy studies, Gloria Meng and An Song for binding studies, Amy Lim for SEC data, and Michael W. Laird for help with the manuscript preparation.

Author information

Authors and Affiliations

  1. Early Stage Cell Culture, Genentech, Inc., South San Francisco, CA, USA

    Dorothea E. Reilly

  2. Antibody Engineering, Genentech, Inc., South San Francisco, CA, USA

    Daniel G. Yansura

Authors
  1. Dorothea E. Reilly
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  2. Daniel G. Yansura
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Editor information

Editors and Affiliations

  1. Genentech Inc., DNA Way 1, San Francisco, 94080, U.S.A.

    Steven J. Shire

  2. Omeros Corporation, Fifth Ave Ste 2600 1420, Seattle, 98101, U.S.A.

    Wayne Gombotz

  3. Boehringer Ingelheim Pharma KG, Birkendorfer Str. 65, Biberach, 88397, Germany

    Karoline Bechtold-Peters

  4. Genentech, Inc., DNA Way 1, South San Francisco, 94080, U.S.A.

    James Andya

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© 2010 American Association of Pharmaceutical Scientists

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Reilly, D.E., Yansura, D.G. (2010). Production of Monoclonal Antibodies in E. coli . In: Shire, S., Gombotz, W., Bechtold-Peters, K., Andya, J. (eds) Current Trends in Monoclonal Antibody Development and Manufacturing. Biotechnology: Pharmaceutical Aspects, vol XI. Springer, New York, NY. https://doi.org/10.1007/978-0-387-76643-0_17

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