Purified antibody composition
AssigneeAbbVie Inc.
InventorsMin M. Wan, George Avgerinos, Gregory Zarbis-Papastoitsis
Life of this patent
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Abstract
The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.
Claims23
A method of treating a disorder in which TNFα activity is detrimental in a subject, the method comprising administering a composition comprising an isolated human anti-TNFα antibody to the subject, such that the disorder is treated, wherein the composition has a cathepsin L activity of less than 1.84 RFU/s/mg antibody, and wherein the human anti-TNFα antibody comprises a light chain variable region comprising a light chain CDR3 domain comprising the amino acid sequence of SEQ ID NO:
- 3;
- a light chain CDR2 domain comprising the amino acid sequence of SEQ ID NO:
- 5;
- and a light chain CDR1 domain comprising the amino acid sequence of SEQ ID NO:
- 7;
- and comprises a heavy chain variable reason comprising a heavy chain CDR3 domain comprising the amino acid sequence of SEQ ID NO:
- 4;
- a heavy chain CDR2 domain comprising the amino acid sequence of SEQ ID NO:
- 6;
- and a heavy chain CDR1 domain comprising the amino acid sequence of SEQ ID NO:
- 8.
A method of treating a disorder in which TNFα activity is detrimental in a subject, the method comprising administering a composition comprising an isolated human anti-TNFα antibody to the subject, such that the disorder is treated, wherein the composition has a cathepsin L activity of less than 1.84 RFU/s/mg antibody, and wherein the human anti-TNFα antibody comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:
- 1, and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:
- 2.
A method of treating a disorder in which TNFα activity is detrimental in a subject, the method comprising administering a composition comprising an isolated human anti-TNFα antibody to the subject, such that the disorder is treated, wherein the composition has a cathepsin L activity of less than 1.84 RFU/s/mg antibody, and wherein the antibody is adalimumab.
A method of treating a disorder in which TNFα activity is detrimental in a subject, the method comprising administering a composition comprising an isolated human anti-TNFα antibody to the subject, such that the disorder is treated, wherein the composition has a cathepsin L activity of 0.6 to less than 1.84 RFU/s/mg antibody, and wherein the human anti-TNFα antibody comprises a light chain variable region comprising a light chain CDR3 domain comprising the amino acid sequence of SEQ ID NO:
- 3;
- a light chain CDR2 domain comprising the amino acid sequence of SEQ ID NO:
- 5;
- and a light chain CDR1 domain comprising the amino acid sequence of SEQ ID NO:
- 7;
- and comprises a heavy chain variable reason comprising a heavy chain CDR3 domain comprising the amino acid sequence of SEQ ID NO:
- 4;
- a heavy chain CDR2 domain comprising the amino acid sequence of SEQ ID NO:
- 6;
- and a heavy chain CDR1 domain comprising the amino acid sequence of SEQ ID NO:
- 8.
A method of treating a disorder in which TNFα activity is detrimental in a subject, the method comprising administering a composition comprising an isolated human anti-TNFα antibody to the subject, such that the disorder is treated, wherein the composition has a cathepsin L activity of 0.6 to less than 1.84 RFU/s/mg antibody, and wherein the human anti-TNFα antibody comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:
- 1, and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:
- 2.
A method of treating a disorder in which TNFα activity is detrimental in a subject, the method comprising administering a composition comprising an isolated human anti-TNFα antibody to the subject, such that the disorder is treated, wherein the composition has a cathepsin L activity of 0.6 to less than 1.84 RFU/s/mg antibody, and wherein the human anti-TNFα antibody is adalimumab.
A method of treating a disorder in which TNFα activity is detrimental in a subject, the method comprising subcutaneously administering a composition comprising an isolated human anti-TNFα antibody to the subject, such that the disorder is treated,
- wherein the composition has a cathepsin L activity of less than 1.84 RFU/s/mg antibody;
- wherein the human anti-TNFα antibody comprises a light chain variable region comprising a light chain CDR3 domain comprising the amino acid sequence of SEQ ID NO:
- 3;
- a light chain CDR2 domain comprising the amino acid sequence of SEQ ID NO:
- 5;
- and a light chain CDR1 domain comprising the amino acid sequence of SEQ ID NO:
- 7;
- and comprises a heavy chain variable reason comprising a heavy chain CDR3 domain comprising the amino acid sequence of SEQ ID NO:
- 4;
- a heavy chain CDR2 domain comprising the amino acid sequence of SEQ ID NO:
- 6;
- and a heavy chain CDR1 domain comprising the amino acid sequence of SEQ ID NO:
- 8;
- and
- wherein the disorder is selected from the group consisting of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis, and juvenile rheumatoid arthritis.
A method of treating a disorder in which TNFα activity is detrimental in a subject, the method comprising subcutaneously administering a composition comprising an isolated human anti-TNFα antibody to the subject, such that the disorder is treated,
- wherein the composition has a cathepsin L activity of 0.6 to less than 1.84 RFU/s/mg antibody;
- wherein the human anti-TNFα antibody comprises a light chain variable region comprising a light chain CDR3 domain comprising the amino acid sequence of SEQ ID NO:
- 3;
- a light chain CDR2 domain comprising the amino acid sequence of SEQ ID NO:
- 5;
- and a light chain CDR1 domain comprising the amino acid sequence of SEQ ID NO:
- 7;
- and comprises a heavy chain variable reason comprising a heavy chain CDR3 domain comprising the amino acid sequence of SEQ ID NO:
- 4;
- a heavy chain CDR2 domain comprising the amino acid sequence of SEQ ID NO:
- 6;
- and a heavy chain CDR1 domain comprising the amino acid sequence of SEQ ID NO:
- 8;
- and
- wherein the disorder is selected from the group consisting of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis, and juvenile rheumatoid arthritis
Dependencies are inferred from the claim text.