БИ Джаред (US),СЕНТЭКРОУК Пол (US),ДУ Цзяли (US),ДИМИТРОВА Мариана (US)
申请号：
RU2015119547
公开号：
RU2015119547A
申请日:
2013.10.23
申请国别(地区):
RU
年份:
2016
代理人:
摘要：
1. A stable low viscosity antibody formulation comprising: a. from about 150 mg / ml to about 400 mg / ml of an anti-IL-6 antibody； and b. more than about 150 mM arginine, where the antibody composition is in aqueous solution and has a viscosity of less than 20 cP at 23 ° C. 2. The antibody composition of claim 1, wherein the anti-IL-6 antibody comprises a heavy chain variable domain (VH) and a light chain variable domain (VL), where the VH domain contains complementarity determining regions (CDRs) containing SEQ ID NO: 7, 8 and 9, and the VL domain contains CDRs containing SEQ ID NO: 10, 11 and 12.3. The antibody composition of claim 2, wherein the anti-IL-6 antibody contains SEQ ID NO: 1 and SEQ ID NO: 2.4. Composition with antibody according to claims. 1-3, where the antibody is stable at a temperature of 2 ° C to 8 ° C for 12 months as determined by SEC HPLC. 5. Composition with antibody according to claims. 1-3, where the viscosity of the composition with the antibody is less than 14 cP at 23 ° C. 6. Composition with antibody according to claims. 1-3 containing more than 200 mM arginine. 7. Composition with antibody according to claims. 1-3, containing more than 220 mM arginine. 8. Composition with antibody according to claims. 1-3, containing from 150 mM to 400 mM arginine. 9. Composition with antibody according to claims. 1-3, additionally containing a surfactant. 10. The antibody composition of claim 7, wherein the surfactant is selected from the group consisting of polysorbate, pluronics, Brij, and other nonionic surfactants. The antibody composition of claim 8, wherein the surfactant is polysorbate 80.12. Composition with antibody according to claims. 1-3, where the composition further comprises histidine. 13. Composition with antibody according to claims. 1-3, where the composition contains virtually no trehalose. 14. Composition with antibody according to claims. 1-3, where the composition contains virtually no disaccharide. 15. Composition with antibody
