Process for concentration of antibodies and therapeutic products thereof

A process for preparing highly concentrated 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;
• 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
• 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.