| 摘要 |
FIELD: medicine.SUBSTANCE: what is presented is a pharmaceutical formulation exhibiting neutralising activity on IL-6 receptor, having pH from 5.5 to 6.6 and containing histidine and/or citrate buffer, and at least one antibody specified in an antibody containing a heavy chain variable region including CDR1 comprising HDHAWS sequence, CDR2 comprising FISYSGITNYNPSLQG sequence, and CDR3 comprising SLARTTAMDY sequence, and a light chain variable region including CDR1 comprising QASTDISSHLN sequence, CDR2 comprising YGSHLLS sequence, and CDR3 comprising GQGNRLPYT sequence, and its versions containing the same hypervariable regions in the concentration of 10-240 mg/ml. What is presented is a method for stabilising the antibody in the process of cycles of freezing/thawing of an antibody-containing solution, wherein the above method involves adding arginine with arginine taken in the concentration of 1-1500 mM; the solution has pH from 5.0 to 6.6, wherein the above antibody is taken in the concentration of 10-240 mg/ml and is one of the antibodies specified above. What is disclosed is a method for stabilising the solution having pH from 5.5 to 6.6 and containing the antibody, wherein the above method involves adding arginine. Arginine is taken in the concentration of 1-1500 mM, wherein the above antibody is taken in the concentration of 10-240 mg/ml and is one of the antibodies specified above.EFFECT: invention enables producing the pharmaceutical solution of anti-IL-6 receptor antibody aggregation stable in storage.16 cl, 33 dwg, 12 tbl, 12 ex |
