| abstract |
FIELD: medicine.SUBSTANCE: group of inventions refers to medicine and concerns stable pharmaceutical composition of antigen-binding protein containing 150 to 250 mg/ml of antigen-binding protein, from 1 to 100 mM of histidine buffer agent, from 70 to 170 mM of sodium chloride and from 20 to 30 mM of arginine, wherein said antigen-binding protein is a monoclonal antibody or fragment thereof, which bind to BLyS (SEQ ID NO: 1) or a hetero- or homotrimeric form of BLyS. Group of inventions also relates to a method of treating a disease or condition selected from a group consisting of systemic lupus erythematosus, vasculitis associated with antineutrophil cytoplasmic antibodies (ANCA), lupoid nephritis, primary Sjögren's syndrome, chronic immune thrombocytopenia, myasthenia gravis, symptomatic Waldenstrom's macroglobulinemia, immune desensitization in the patients awaiting kidney transplantation, membranous nephropathy, systemic sclerosis, rheumatoid arthritis, multiple myeloma, multiple sclerosis and renal insufficiency, in an individual comprising administering to the individual said composition in an amount effective for treating the disease or condition.EFFECT: group of inventions provides stable subcutaneous administration of the antibody in high concentration.21 cl, 20 dwg, 28 tbl, 11 ex |