Procedure to produce recombinant proteins with low levels of DHNA (1,4-dihydroxy-2-naphthoate)

摘要

A method for producing a recombinant protein, which includes peptides, polypeptides and antibodies, comprising (a) fermenting an E. coli cell and wherein said E. coli cell has been transformed with a nucleic acid encoding said recombinant protein , and (b) collecting said recombinant protein under conditions in which dissolved oxygen (dO2) is maintained at levels greater than 0% continuously during the collection operations of step (b), in which the operations of collection comprises a homogenization stage, and in which said dO2 is maintained 1) before homogenization at levels greater than 75%; and / or 2) after homogenization at approximately 50% or at levels above 50%; and (c) purifying said recombinant protein to obtain a filtrate for storage (FBS), wherein said filtrate does not contain detectable amounts of 1,4-dihydroxy-2-naphthoate (DHNA) adduct and recombinant protein, measured by an ion exchange chromatography (IEC) test at 310 nm.