Method of reducing aggregation in the virus-inactivated preparation of anti-cd40 antibodies

A method of minimizing formation of high molecular weight aggregates in an antibody preparation comprising an anti-CD40 antibody, or antigen-binding portion thereof, during a viral inactivation step, the method comprising incubating a sample comprising the anti-CD40 antibody, or antigen-binding portion thereof, at a pH of about 3.6-3.9 during the viral inactivation step, thereby minimizing formation of high molecular weight aggregates in the virus-inactivated antibody preparation.

A method of reducing formation of high molecular weight aggregates in a antibody preparation comprising an anti-CD40 antibody, or antigen-binding portion thereof, during a viral inactivation step, the method comprising incubating a sample comprising the anti-CD40 antibody, or antigen-binding portion thereof, at a pH of about 3.6-3.9 during the viral inactivation step, thereby reducing the formation of high molecular weight aggregates in the virus-inactivated antibody preparation.

A method of maximizing the level of antibody monomers in a virus-inactivated antibody preparation comprising an anti-CD40 antibody, or antigen-binding portion thereof, the method comprising incubating a sample comprising the anti-CD40 antibody, or antigen-binding portion thereof, at a pH of about 3.6-3.9 during a viral inactivation step, thereby maximizing antibody monomers in the virus-inactivated antibody preparation.

A method of stabilizing a virus-inactivated antibody preparation comprising an anti-CD40 antibody, or antigen-binding portion thereof, the method comprising incubating a sample comprising the anti-CD40 antibody, or antigen-binding portion thereof, at a pH of about 3.6-3.9 during a viral inactivation step, thereby stabilizing the virus-inactivated antibody preparation.

A method of reducing the number and/or activity of viral particles in an antibody preparation comprising an anti-CD40 antibody, or antigen-binding portion thereof, the method comprising incubating a sample comprising the anti-CD40 antibody, or antigen-binding portion thereof, at a pH of about 3.6-3.9 during a viral inactivation step, thereby reducing the level the number and/or activity of viral particles in the antibody preparation.

A composition comprising an anti-CD40 antibody, or antigen-binding portion thereof, wherein the composition comprises a virus-inactivated eluate collected from an affinity chromatography column, wherein the eluate comprises less than about 10%, about 9%, about 8%, about 7%, about 6%, about 5%, about 4%, about 3%, about 2%, about 1%, about 0.9%, about 0.8%, about 0.7%, about 0.6%, about 0.5%, about 0.4%, about 0.3%, about 0.2%, or about 0.1% high molecular weight aggregates.

A method of producing a pharmaceutical composition comprising an anti-CD40 antibody and a pharmaceutically acceptable carrier, the method comprising incubating a sample comprising the anti-CD40 antibody, or antigen-binding portion thereof, at a pH of about 3.6-3.9 during a viral inactivation step, thereby producing the pharmaceutical composition comprising the anti-CD40 antibody and the pharmaceutically acceptable carrier.