Method for reducing heterogeneity of antibodies and a process of producing the antibodies thereof

摘要

The present disclosure relates to a method of reducing heterogeneity in antibodies during culturing, wherein the heterogeneity is due to proportion of charge variant of the antibody. The disclosure also comprises a process of growing cells in a cell culture system that results in antibodies with the reduced heterogeneity. In one embodiment antibody heterogeneity is reduced by the addition of divalent transitional metal ions such as zinc (Zn2+) to the cell culture medium. In another embodiment antibody heterogeneity is reduced by decreasing the osmolality of the cell culture medium.

主权项

1. A method of reducing heterogeneity in antibodies obtained by cell culturing by reducing the proportion of lysine residue on C-terminal of the antibodies, said method comprises adding a divalent transitional metal ion at a concentration ranging from 0.05 mM to 5 mM to the antibody producing culture medium or altering osmolality of the culture medium or a combination thereof to obtain said antibodies with reduced heterogeneity wherein the osmolality of the culture medium is reduced to provide osmolality ranging from 240 mOsm/Kg to 260 mOsm/Kg, wherein the cells are Chinese Hamster Ovary (CHO) cells.