Analytical Characterization of Monoclonal Antibodies: Linking Structure to Function

  • Reed J. Harris
  • Edward T. Chin
  • Frank Macchi
  • Rodney G. Keck
  • Bao-Jen Shyong
  • Victor T. Ling
  • Armando J. Cordoba
  • Melinda Marian
  • Don Sinclair
  • John E. Battersby
  • Andy J. S. Jones
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XI)


The basic structural features of antibodies, including their primary structures (Edelman et al. 1969), were established well before the concept of therapeutic antibodies was conceived. These molecules are now known to bear multiple sources of microheterogenity that can have a dramatic effect on in vivo and in vitro properties. Rituximab (Rituxan®), Trastuzumab (Herceptin®) and omalizumab (Xolair®) are three examples of therapeutic IgG1/kappa subclass antibodies produced by Genentech, Inc.; these molecules are the main subject of this discussion on the impacts of common and unique antibody modifications on functional properties.


Cation Exchange Chromatography Critical Quality Attribute ADCC Activity Transfected Chinese Hamster Ovary Cell Core Fucose 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



Antibody-dependent cellular cytotoxicity


Succiminide at an aspartate residue


Complement-dependent cytotoxicity


Complementarity-determining regions


Chinese hamster ovary


Fragment antigen binding


Fragment crystallizable








Hydrophobic interaction chromatography


Ion exchange chromatography


Immunoglobulin gamma subclass 1




Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry




Variable region of the heavy chain


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Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  • Reed J. Harris
    • 1
  • Edward T. Chin
    • 2
  • Frank Macchi
    • 1
  • Rodney G. Keck
    • 1
  • Bao-Jen Shyong
    • 1
  • Victor T. Ling
    • 1
  • Armando J. Cordoba
    • 1
  • Melinda Marian
    • 3
  • Don Sinclair
    • 4
  • John E. Battersby
    • 1
  • Andy J. S. Jones
    • 2
  1. 1.Protein Analytical Chemistry Department, Genentech, Inc.South San FranciscoUSA
  2. 2.Analytical Chemistry, Genentech, Inc.South San FranciscoUSA
  3. 3.Clinical and Experimental Pharmacology, Genentech, Inc.South San FranciscoUSA
  4. 4.Clinical PK/PD, Genentech, Inc.South San FranciscoUSA

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