Method of stabilizing antibody and stabilized solution-type antibody preparation
The present invention provides a method of suppressing the formation of a soluble association of an antibody in a solution; a method of suppressing the formation of a chemically degraded product of an antibody in a solution; and a method of stabilizing an antibody in a solution. The present invention also provides a solution-type antibody preparation in which the formation of a soluble association is suppressed; a solution-type antibody preparation in which the formation of a chemically degraded product is suppressed; a solution-type antibody preparation in which the formation of a soluble association, the formation of a chemically degraded product and the formation of an insoluble aggregate are suppressed; an agent for suppressing the formation of a soluble association of an antibody; an agent for suppressing the formation of a chemically degraded product of an antibody; and a stabilizing agent for an antibody.
1. A method for inhibiting the formation of soluble dimers and trimers of an antibody in a solution, comprising adding glycine and citric acid to an antibody in a solution so that the solution comprises an antibody, 10-30 mg/ml glycine and 0.1-50 mmol/L citric acid.
2. The method according to claim 1 , wherein the concentration of the antibody in said solution is 0.01 to 150 mg/mL, and wherein, said solution further comprises a nonionic surfactant.
3. The method according to claim 2 , wherein the pH of the solution is within the range of 4 to 7.
4. The method according to claim 3 , wherein the antibody is a humanized antibody or a human antibody.
5. The method according to claim 4 , wherein the antibody is an antibody to ganglioside GD3 or an antibody to CCR4.
6. A solution-type antibody preparation comprising an antibody, 10 to 30 mg/mL glycine, and 0.1 to 50 mmol/L citric acid, wherein the formation of soluble dimers and trimers of said antibody is inhibited in said preparation.
7. The preparation according to claim 6 , wherein the antibody concentration is 0.01 to 150 mg/mL.
8. The preparation according to claim 7 , wherein said preparation further comprises a nonionic surfactant.
9. The preparation according to claim 8 , wherein said preparation has a pH of between 4 and 7.
10. The preparation according to claim 9 , wherein the antibody is a humanized antibody or a human antibody.
11. The preparation according to claim 10 , wherein the antibody is an antibody to ganglioside GD3 or an antibody to CCR4.
12. The preparation according to claim 6 , wherein the antibody is an IgG antibody.
13. The preparation according to claim 6 , wherein the antibody is an IgG antibody, wherein the antibody concentration is 0.01 to 150 mg/mL, and wherein said preparation has a pH of between 4 and 7.
14. The preparation according to claim 13 , wherein the antibody concentration is 0.1 to 50 mg/ml.
15. The preparation according to claim 14 , wherein the antibody concentration is 1 to 20 mg/ml.