FIELD: medicine.
SUBSTANCE: group of inventions relates to the field of medicine and pharmaceuticals. First invention of the group: an aqueous liquid pharmaceutical composition of the fusion protein TACI-Fc for treating an autoimmune disease or a lymphoma, containing the fusion protein TACI-Fc, a non-reducing sugar, and an amino acid; wherein the fusion protein TACI-Fc has the amino acid sequence SEQ ID NO.1, the non-reducing sugar constitutes 90 to 120 mmol/l mannitol and/or 35 to 45 mmol/l sucrose, the amino acid constitutes 75 to 125 mmol/l arginine hydrochloride and/or 8 to 12 mmol/l histidine hydrochloride, and the concentration of the fusion protein TACI-Fc is 80 to 100 mg/ml. Group of inventions also relates to a lyophilised composition produced from said aqueous composition; to an application of pharmaceutical formulations in the manufacture of a medicinal product for treating an autoimmune disease or a lymphoma; to a method for producing a pharmaceutical composition of the fusion protein TACI-Fc.
EFFECT: group of inventions provides high solubility of the fusion protein TACI-Fc before and after lyophilisation, compliance with the human injection standards with respect to the content of insoluble microparticles and visible foreign inclusions, stability in the process of lyophilisation and storage without polymerisation or degradation after re-dissolving while preserving the biological activity.
16 cl, 9 tbl, 9 ex, 3 dwg
