A purification strategy for the production of clinical grade monoclonal antibodies.

A strategy for the purification of murine IgG monoclonal antibodies (MAbs) is described. It consists of a combination of protein A affinity chromatography and ion exchange chromatography. The method was used for the purification of two MAbs, WT31 and MN12. After in vitro cultivation in the presence of foetal bovine serum, the medium components were efficiently removed from the MAbs, yielding clinical grade products. Automated purification under aseptic conditions was effectuated by employing a computer-controlled four-column system.