Development and production of commercial therapeutic monoclonal antibodies in Mammalian cell expression systems: an overview of the current upstream technologies.
This article provides an overview of the upstream technologies used in the industrial production of therapeutic monoclonal antibodies (mAbs) based on the cultivation of mammalian cells. More specifically, in a first section, after a short discussion of relevant biochemical characteristics of antibodies, we review the cell lines currently employed in commercial production and the methods of constructing and isolating production clones. This is followed with a review of the most current methods of commercial scale production and their associated technologies. Selected references and short discussions pertaining to emerging and relevant technologies have been embedded throughout the text in order to give a sense of the overall direction the field is taking.
Chartrain
Michel
M
Department of Bioprocess R&D, Merck Research Laboratories, P.O. Box 2000, Rahway, NJ 07065, USA. michel_chartrain@merck.com
Chu
Lily
L
D000818:Animals; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002478:Cells, Cultured / Q000276:immunology*; D015195:Drug Design; D004345:Drug Industry / Q000639:trends*; D005544:Forecasting; D006801:Humans; D007167:Immunotherapy / Q000379:methods / Q000639:trends; D008322:Mammals; D015202:Protein Engineering / Q000639:trends*; D013678:Technology, Pharmaceutical / Q000639:trends*
D000911:Antibodies, Monoclonal