FIELD: medicine.
SUBSTANCE: subjects 1 and 2 are a pharmaceutical composition of pembrolizumab for the treatment of malignant neoplasm or infectious disease, containing: 5-50 mg/ml pembrolizumab; 0.087-0.432 mg/ml histidine; 0.464-0.931 mg/ml histidine hydrochloride monohydrate; 1-2 mg/ml glycine; trehalose 70-130 mg/ml and poloxamer 188 0.8-1.2 mg/ml or proline 20-34 mg/ml; and water for injection up to 1 ml, as well as obtained by lyophilization of the specified composition. Subjects 3 and 4 are using the pharmaceutical composition of pembrolizumab for the treatment of a malignant neoplasm or an infectious disease and for obtaining a drug. EFFECT: stability of the pharmaceutical composition of pembrolizumab and the preservation of the activity of the protein molecule in the composition.
26 cl, 6 dwg, 34 tbl, 7 ex
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