STABLE PHARMACEUTICAL PREPARATION BASED ON THE PD-1 ANTIBODY AND ITS USE IN MEDICINE Russian patent published in 2020 - IPC A61K39/395 A61K9/08 A61K9/19 A61K47/12 A61K47/26 C07K16/28 A61P35/00 

FIELD: biotechnology; medicine.

SUBSTANCE: group of inventions relates to a stable pharmaceutical preparation of PD-1 antibody and use thereof. Disclosed is a stable pharmaceutical preparation of PD-1 antibody containing 1 mg/ml to 60 mg/ml of PD-1 antibody or antigen-binding fragment thereof, from 30 mg/ml to 120 mg/ml α,α-trehalose dihydrate, from 0.01 mg/ml to 1 mg/ml polysorbate 20, from 2 mM to 30 mM acetate buffer. PH of the preparation ranges from 4.5 to 6.0. Antibody to PD-1 contains amino acid sequence of heavy chain with SEQ ID NO: 7 and light chain amino acid sequence with SEQ ID NO: 8. Also disclosed is a lyophilised powder prepared by lyophilisation of a pharmaceutical preparation at a drying temperature of −10 °C to −5 °C.

EFFECT: obtained preparation is applicable in a method of preventing or treating a PD-1-mediated disease or disorder; invention provides effective inhibition of aggregation and deamidation of PD-1 antibody, thereby preventing antibody degradation, producing a stable pharmaceutical preparation for injections; antibody to PD-1 remains stable even after re-dissolution after lyophilisation.

14 cl, 2 dwg, 5 tbl, 8 ex