METHODS OF PURIFYING RANIBIZUMAB OR A RANIBIZUMAB VARIANT

摘要

Provided herein are processes for manufacturing recombinant ranibizumab or a ranibizumab variant that include providing a liquid comprising recombinant ranibizumab or a ranibizumab variant that is substantially free of cells; capturing the recombinant ranibizumab or the ranibizumab variant in the liquid using an affinity chromatography column, wherein the eluate of the affinity chromatography column comprises the recombinant ranibizumab or the ranibizumab variant; purifying the recombinant ranibizumab or the ranibizumab variant in the eluate of step (b) using a first cation exchange chromatography column and buffers that have a pH of about pH 5.5 to about 7.5, wherein the eluate from the first cation exchange chromatography column comprises the recombinant ranibizumab or the ranibizumab variant; and purifying the recombinant ranibizumab or the ranibizumab variant in the eluate from the first cation exchange chromatography column using a second cation chromatography column and buffers that have a pH of about pH 4.0 to about pH 5.4, wherein the eluate from the second cation chromatography column comprises the recombinant ranibizumab or the ranibizumab variant.