PROTEIN COMPOSITIONS AND METHODS FOR PRODUCTION THEREOF Russian patent published in 2018 - IPC A61K38/00 A61K39/395 A61P37/00 A61P19/02 

FIELD: medicine; pharmacology.

SUBSTANCE: group of inventions relates to the field of medicine, specifically to pharmacology and immunology, and is intended to treat a subject having an autoimmune disease. In order to treat a subject having an autoimmune disease, said subject is administered a therapeutically effective amount of an aqueous pharmaceutical composition comprising adalimumab at a concentration, of at least 50 mg/ml, and water. Composition has conductivity of less than about 2.5 mS/cm. In another embodiment, said composition has osmolality not higher than about 30 mOsmol/kg. In yet another embodiment, in said composition adalimumab has a hydrodynamic diameter (D_h), which is at least about 50% less than D_h of adalimumab in a buffer solution at a given concentration. Alternatively, in said composition adalimumab has a hydrodynamic diameter (D_h) of less than 4 nm. Also for the treatment of a subject having an autoimmune disease, a therapeutically effective amount of an aqueous pharmaceutical composition is administered, containing mannitol, polysorbate 80, adalimumab at a concentration of at least 50 mg/ml, and water. Composition has conductivity of less than about 2.5 mS/cm. In said composition adalimumab has a hydrodynamic diameter (D_h), which is at least about 50% less than D_h of adalimumab in a buffer solution at a given concentration. In an alternative embodiment, adalimumab has a hydrodynamic diameter (D_h) of less than 4 nm. Another embodiment comprises an aqueous pharmaceutical composition which contains adalimumab at a concentration of 50 to 200 mg/ml, and does not contain a tonicity modifier or a buffer system. Aqueous pharmaceutical composition is also provided which consists of 50 mg/ml of adalimumab, a polyol and a surfactant.

EFFECT: use of the group of inventions makes it possible to increase the effectiveness of treatment of an autoimmune disease by using a composition having low aggregation, low opalescence, low viscosity and high solubility.

54 cl, 36 dwg, 77 tbl, 31 ex, 5 app.