The microbial ESETEC® expression and secretion system developed by WACKER is based on modified E. coli K12 strains and a set of proprietary plasmids. Similar to mammalian cells, the E. coli secretion strains can transfer proteins in their biologically active form across the outer cell membrane into the culture medium. ESETEC® is routinely used in biopharmaceutical manufacturing and has been scaled up to 4,500-liter fermentation batches. Secreted product titers can reach up to 14 g/l, depending on the protein of interest. More complex molecules such as single-domain antibodies and fragments have been successfully produced with yields of several grams per liter. In any case, ESETEC® allows recovery of the fully functional molecule from the culture broth, simplifies downstream purification and reduces manufacturing costs.
ESETEC® perfectly combines the benefits of secretion with the fast growth of microbial systems, enabling more cost- and time-efficient production of any non-glycosylated therapeutic protein. Based on cutting-edge process simulations, ESETEC® reduced the cost of goods by a factor of 3 compared to mammalian cells (assuming identical titers and process yields). The annual output of a dedicated 1,500-liter CHO facility was 30 kg compared to 111 kg using ESETEC® on the same scale. This recognizable advantage in productivity and costs is mainly driven by shorter fermentation times and no need for viral depletion steps.
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