Anti-TNF antibody formulations
DCFirst Claim
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1. An aqueous pharmaceutical formulation consisting essentially of:
- (a) an anti-tumor necrosis factor alpha antibody comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO;
3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO;
5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO;
7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO;
4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO;
6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO;
8, wherein the concentration of the antibody is 50 to 200 mg/ml; and
(b) water.
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Abstract
The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.
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Citations
30 Claims
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1. An aqueous pharmaceutical formulation consisting essentially of:
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(a) an anti-tumor necrosis factor alpha antibody comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO;
3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO;
5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO;
7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO;
4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO;
6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO;
8, wherein the concentration of the antibody is 50 to 200 mg/ml; and(b) water. - View Dependent Claims (2, 3, 4, 5)
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6. An aqueous pharmaceutical formulation comprising:
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(a) an anti-tumor necrosis factor alpha antibody comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO;
3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO;
5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO;
7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO;
4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO;
6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO;
8, wherein the concentration of the antibody is 50 to 200 mg/ml; and(b) water; wherein the formulation does not comprise a tonicity modifier. - View Dependent Claims (7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. An aqueous pharmaceutical formulation comprising:
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(a) an anti-tumor necrosis factor alpha antibody comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO;
3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO;
5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO;
7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO;
4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO;
6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO;
8, wherein the concentration of the antibody is 50 to 200 mg/ml; and(b) water; wherein the formulation does not comprise a buffering system. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification