Bioprocessing of inclusion bodies from E. coli. to produce bioactive recombinant proteins

Recombinant protein production has revolutionized healthcare with biopharmaceutical products, dominating the pharmaceutical pipelines today. E. coli remains one of the most used bacterial hosts for this purpose. Recom-binant proteins in E. coli can be either expressed as a soluble or insoluble fraction, depending on the expression strategy. The insoluble fraction of expressed protein is aggregated as inclusion bodies (IBs) in the cytoplasm. Retrieving active, correctly folded protein from the IBs becomes a major challenge for the manufacturer, with considerable efforts spent on optimization of various upstream and downstream approaches. In this review, major advances and challenges associated with the upstream and downstream processing of recombinant protein production in the form of inclusion bodies in the E. coli host system have been summarized.