FIELD: biotechnology; pharmaceutics.
SUBSTANCE: disclosed is a pharmaceutical composition containing an anti-IL-5 antibody and use thereof. Pharmaceutical composition contains from 80 mg/ml to 120 mg/ml of antibodies to IL-5, from 10 mm to 30 mm buffer of acetic acid-sodium acetate or succinic acid-sodium succinate, wherein pH ranges from 5.0 to 5.8, from 0.1 mg/ml to 0.6 mg/ml of polysorbate 80 and from 50 mg/ml to 80 mg/ml of sucrose. Anti-IL-5 antibody contains a heavy chain as shown in SEQ ID NO: 83, and a light chain as shown in SEQ ID NO: 84. Also disclosed is a lyophilised formulation and a reconstituted solution containing an IL-5 antibody and said buffer and a surfactant for treating an IL-5 mediated disease.
EFFECT: inventions provide anti-IL-5 antibody formulations stable at 2–8 °C or at 25 °C for at least 6 months.
14 cl, 5 dwg, 28 tbl, 19 ex
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