Patent ID: 9708399
Date: 2017-07-18
CPC Classifications: C07K

Claim:
1. A method for producing a low acidic species human anti-TNFα antibody composition comprising a human anti-TNFα antibody, or antigen-binding portion thereof, wherein the human anti-TNFα antibody, or antigen-binding portion thereof, comprises a light chain variable region (LCVR) having a CDR1 domain, a CDR2 domain, and a CDR3 domain of adalimumab; and a heavy chain variable region (HCVR) having a CDR1 domain, a CDR2 domain, and a CDR3 domain of adalimumab, the method comprising: (a) contacting a first composition comprising the human anti-TNFα antibody, or antigen-binding portion thereof, with a chromatography media, wherein the first composition comprises more than 10% total acidic species of the human anti-TNFα antibody, or antigen-binding portion thereof; wherein the acidic species of the human anti-TNFα antibody, or antigen-binding portion thereof, comprise species selected from the group consisting of charge variants, structure variants, fragmentation variants, and any combinations thereof, wherein the acidic species of the human anti-TNFα antibody, or antigen-binding portion thereof, do not include process-related impurities selected from the group consisting of host cell proteins, host cell DNA, and media components, and wherein the human anti-TNFα antibody, or antigen-binding portion thereof, binds to the chromatography media; (b) displacing the human anti-TNFα antibody, or antigen-binding portion thereof, bound to the chromatography media with a displacing buffer; and (c) collecting a second composition comprising the displaced human anti-TNFα antibody, or antigen-binding portion thereof, wherein the second composition comprises less than 10% total acidic species of human anti-TNFα antibody, or antigen-binding portion thereof, thereby producing a low acidic species human anti-TNFα antibody composition.