PROCESS FOR ISOLATION AND STABILISATION OF KEY INTERMEDIATES FOR HIGH EFFICIENCY REFOLDING OF RECOMBINANT PROTEINS

摘要

A process for obtaining a refolded recombinant protein from an unfolded recombinant protein present in inclusion bodies isolated from wet cells harvested from a cell culture is provided. The process includes a) reducing the inclusion bodies by treating the inclusion bodies with a reducing buffer, to obtain reduced inclusion bodies; b) obtaining stable first intermediate state l1 of the unfolded recombinant protein present in the reduced inclusion bodies; and c) refolding the stable first intermediate state h of the unfolded recombinant protein, present in the reduced inclusion bodies, in refolding buffer to obtain a second intermediate state l2 that folds to produce the refolded recombinant protein.