Multiple E. coli cultivations, producing recombinant proteins, lead to the formation of inclusion bodies (IBs). IBs historically were considered as nondesired by-products, due to their time- and cost-intensive purification. Nowadays, many obstacles in IB processing can be overcome. As a consequence, several industrial processes with E. coli favor IB formation over soluble production options due to the high space time yields obtained. Within this chapter, we discuss the state-of-the art biopharmaceutical IB process, review its challenges, highlight the recent developments and perspectives, and also propose alternative solutions, compared to the state-of-the art processing.
Keywords: E. coli; IB-based products; Inclusion bodies; Inclusion body processing; Recombinant protein production, inclusion body refolding, inclusion body challenges, inclusion body quality.
© 2023. The Author(s), under exclusive license to Springer Science+Business Media, LLC, part of Springer Nature.