Process for concentration of antibodies and therapeutic products thereof

A process for preparing highly concentrated monoclonal antibody in a pharmaceutical formulation comprising:

• a) concentrating a first purified antibody preparation by a first ultrafiltering to provide a second antibody preparation comprising the retentate of the first ultrafiltration in a first buffer, wherein the first purified antibody preparation has an antibody concentration of from about 0.1 to about 10 grams per liter, wherein the second antibody preparation has an antibody concentration of from about 10 to about 50 grams per liter, and 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 the retentate of the diafiltration, wherein the second buffer comprises excipients desired in the pharmaceutical formulation;
• c) concentrating the diafiltered intermediate antibody preparation generated in step b) by a second ultrafiltering to provide a third antibody preparation comprising the retentate of the second ultrafiltration, wherein the third antibody preparation is substantially free from aggregates and wherein the third antibody preparation has an antibody concentration of from about 150 to about 200 grams per liter;
• and
• d) formulating the third antibody preparation generated in step c) into the pharmaceutical formulation suitable for therapeutic administration;
• wherein the first ultrafiltering, second ultrafiltering, and the diafiltering are accomplished at 35° C. to about 50° C., and wherein the first and the second ultrafiltering are accomplished with an ultra-filter membrane having a nominal pore size of about 5 to about 50 kilo Daltons.