Escherichia coli has been used for decades to produce recombinant proteins for basic research purposes and clinical indications. This bacterial production workhorse is rapid, versatile, economical, scalable and extremely well characterized. The genetics, physiology, molecular biology and biochemical analyses with this organism are straightforward and the regulatory hurdles are generally low. A survey of the published literature shows that numerous marketed protein drugs have been produced by from this bacterium including but not limited to human insulin, interferon-&alpha, interferon &beta-1b, interferon &gamma-1b, human growth hormone, bovine growth hormone, insulin growth factor-1 (IGF-1), keratinocyte growth factor, anti-VegF (Fab), human granulocyte colony stimulating factor (G-CSF) and interleukin-2.

Over the course of the last three decades here at Genentech, the Escherichia coli production platform has been used for a variety of research and development projects that includes growth factors, cytokines, ligands, antibody fragments and monovalent antibodies. An overview of the production technology and its current applications at Genentech will be described.