FIELD: pharmacy.
SUBSTANCE: group of inventions relates to an aqueous pharmaceutical composition containing adalimumab, also to pre-filled syringes or handles containing an aqueous pharmaceutical composition adalimumab. Composition contains (a) 45–55 mg/ml adalimumab; (b) 2–50 mM acetate buffer system; (c) 190–300 mM of stabilizer sugar, which is a non-reducing disaccharide selected from a group consisting of trehalose and sucrose; and (d) 0.9–1.1 mg/ml polysorbate 80; wherein composition has pH between 5.1 and 5.3; does not contain arginine; does not contain phosphate buffers; does not contain amino acids; does not contain surfactants, except polysorbate 80; and contains at least one stabilizer sugar.
EFFECT: group of inventions provides stability of biopharmaceutical protein during all stages of its production, storage, transportation and use.
16 cl, 22 dwg, 18 tbl, 3 ex
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