Process for concentration of antibodies and therapeutic products thereof

A process for preparing a concentrated anti-IgE rhuMAb E25 antibody composition, comprising:

• a) concentrating a first purified antibody preparation by a first ultrafiltering to provide a second antibody preparation comprising a retentate of the first ultrafiltering in a first buffer, wherein the first purified antibody preparation has been purified with ion-exchange chromatography prior to step a);
• b) exchanging the first buffer of the second antibody preparation generated in step a) into a second buffer by a diafiltering to provide a diafiltered intermediate antibody preparation comprising a retentate of the diafiltering;
• and
• c) concentrating the diafiltered intermediate antibody preparation generated in step b) by a second ultrafiltering to provide a third antibody preparation comprising a retentate of the second ultrafiltering, wherein the third antibody preparation has an antibody concentration from greater than 150 grams per liter to 250 grams per liter;
• wherein one or more of the first ultrafiltering, the second ultrafiltering, and the diafiltering are carried out at a temperature of 35° C. to 50° C.,
• wherein the first ultrafiltering and the second ultrafiltering are accomplished with an ultra-filter membrane having a nominal pore size of about 5 to about 50 kilo Daltons, and
• wherein the anti-IgE rhuMAb E25 antibody is as described in U.S. Pat. No. 6,172,213.