Protein A affinity capture of IgG from CHO culture is an effective purification step with relatively high purity and yield. However, substantial amounts of host cell proteins still bind non-specifically to the resin and co-elute with the antibody. This presentation describes conditions designed to further reduce host cell proteins and streamline monoclonal antibody purification processes. Of the parameters tested, a secondary wash was found to reduce host cell proteins greater than 20% in the Protein A low pH eluate. A membrane filtration step was demonstrated to reduce host cell proteins by 10-fold. A Design of Experiments approach was used to screen a mixed mode resin as a 2nd chromatography step and optimal conditions were developed. As a result of decreased host cell proteins, a typical three-column purification process for monoclonal antibody products can now be reduced to a two-column process, thus significantly simplify manufacturing processes with potentially lower cost.

Improvement of monoclonal antibody purification platforms

245th National Meeting (2013)

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