Pharmaceutical composition comprising anti-human TSLP receptor antibody
Provided is a stable pharmaceutical composition comprising an anti-human TSLP receptor antibody, capable of inhibiting the generation of chemically modified substances, such as deamidated forms and oxidized forms, or degradants, or multimers. The pharmaceutical composition comprises an anti-human TSLP receptor antibody, a pharmaceutically acceptable buffer, arginine or a pharmaceutically acceptable salt thereof, and a surfactant.
1. A stable pharmaceutical composition comprising an anti-human TSLP receptor antibody, a pharmaceutically acceptable buffer, arginine or a pharmaceutically acceptable salt thereof, and a surfactant, wherein the following (1) and/or (2) is contained as the anti-human TSLP receptor antibody:
(1) an anti-human TSLP receptor antibody comprising a heavy chain consisting of the amino acid sequence of SEQ ID NO: 1, and a light chain consisting of the amino acid sequence of SEQ ID NO: 3, and
(2) an anti-human TSLP receptor antibody consisting of amino acid sequences of an antibody generated by a post-translational modification of the anti-human TSLP receptor antibody of (1),
wherein the post-translational modification is a pyroglutamylation at the N-terminus of a heavy chain variable region and/or lysine deletion at the C-terminus of a heavy chain,
wherein a concentration of the arginine or a pharmaceutically acceptable salt thereof is 700 mmol/L or less,
wherein the pharmaceutical composition is a liquid preparation, or a lyophilized preparation or a spray-dried preparation,
wherein when the pharmaceutical composition is a liquid preparation, a content of the anti-human TSLP receptor antibody is 0.007 to 2 mmol/L, or when the pharmaceutical composition is a lyophilized preparation or a spray-dried preparation, a content of a solution after reconstituting the preparation in water is 0.007 to 2 mmol/L, and
wherein when the pharmaceutical composition is a liquid preparation, a pH of the liquid preparation is 5 to 6, or when the pharmaceutical composition is a lyophilized preparation or a spray-dried preparation, a pH of a solution after reconstituting the preparation in water is 5 to 6.
2. The pharmaceutical composition according to claim 1 , wherein the pharmaceutically acceptable buffer is one, or two or more selected from the group consisting of phosphoric acid, citric acid, acetic acid, succinic acid, histidine, ascorbic acid, glutamic acid, lactic acid, maleic acid, trometamol, and gluconic acid.
3. The pharmaceutical composition according to claim 1 , wherein the pharmaceutically acceptable buffer is phosphoric acid.
4. The pharmaceutical composition according to claim 1 , wherein the concentration of the pharmaceutically acceptable buffer is 5 to 100 mmol/L.
5. The pharmaceutical composition according to claim 1 , wherein the pharmaceutical composition is a liquid preparation.
6. The pharmaceutical composition according to claim 1 , wherein the surfactant is one, or two or more selected from the group consisting of polysorbates and poloxamer 188.
7. The pharmaceutical composition according to claim 1 , wherein the surfactant is polysorbate 80.
8. The pharmaceutical composition according to claim 1 , wherein a content of the surfactant is 0.001 to 1% (w/v).
9. The pharmaceutical composition according to claim 1 , wherein the content of the surfactant is 0.01 to 0.2% (w/V).
10. The pharmaceutical composition according to claim 1 , wherein when the pharmaceutical composition is stored, each content of a degradant and a multimer is 10% or less, or a content of a chemically modified substance is 50% or less.
11. The pharmaceutical composition according to claim 1 , comprising an anti-human TSLP receptor antibody comprising a heavy chain consisting of the amino acid sequence of SEQ ID NO: 1, and a light chain consisting of the amino acid sequence of SEQ ID NO: 3.
12. The pharmaceutical composition according to claim 1 , comprising an anti-human TSLP receptor antibody consisting of amino acid sequences of an antibody generated by a post-translational modification of an anti-human TSLP receptor antibody comprising a heavy chain consisting of the amino acid sequence of SEQ ID NO: 1, and a light chain consisting of the amino acid sequence of SEQ ID NO: 3.
13. The pharmaceutical composition according to claim 1 , comprising an anti-human TSLP receptor antibody comprising a heavy chain consisting of the amino acid sequence of amino acids 1-447 of SEQ. ID NO: 1, and a light chain consisting of the amino acid sequence of SEQ ID NO: 3.
14. The pharmaceutical composition according to claim 1 , comprising an anti-human TSLP receptor antibody comprising a heavy chain consisting of the amino acid sequence SEQ ID NO: 1, and a light chain consisting of the amino acid sequence of SEQ ID NO: 3, and an anti-human TSLP receptor antibody comprising a heavy chain consisting of the amino acid sequence of amino acids 1-447 of SEQ ID NO: 1, and a light chain consisting of the amino acid sequence of SEQ ID NO: 3.