SINGLE UNIT CHROMATOGRAPHY ANTIBODY PURIFICATION

摘要

The present invention relates to a method for the purification of antibodies from a protein mixture produced in a bioreactor, at least comprising the steps of intermediate purification and polishing, wherein the intermediate and polishing step comprises in-line anion exchange chromatography (AEX) treatment and mixed mode chromatography (MiMo) treatment in flow through mode. The present invention further relates to a single operational unit comprising both an anion exchange chromatography part and a mixed mode chromatography part, which are serially connected, wherein the unit comprises an inlet at the upstream end of the anion exchange chromatography part and an outlet at the downstream end of the mixed mode chromatography part and wherein the unit also comprises an inlet between the anion exchange chromatography part and the mixed mode chromatography part.

主权项

1. Method for the purification of antibodies from a protein mixture produced in a bioreactor, at least comprising the steps of intermediate purification and polishing, wherein the intermediate purification and polishing steps comprise serial in-line anion exchange chromatography (AEX) and mixed-mode chromatography (MiMo) both in flow-through mode, wherein the AEX step yields as a flow-through fraction a separation mixture containing antibodies, wherein the separation mixture is subjected to a step without intermediate storage, yielding as a flow through fraction a purified antibody preparation, and wherein the purified antibody preparation is subjected to at least one further purification step, wherein the separation mixture prior to the MiMo step is supplemented with an adequate amount of a suitable adjusting solution in order to adjust the pH and/or conductivity and/or concentration or type of specific ionic components for removal of impurities from the antibodies in the step.