FIELD: medicine.
SUBSTANCE: group of inventions relates to the field of medicine, namely to a pharmaceutical composition including (i) an antibody-drug conjugate, (ii) a histidine buffer, (iii) sucrose, and (iv) polysorbate 80 or polysorbate 20, where the antibody-drug conjugate is an antibody-drug conjugate, in which a drug-linker fragment represented by the following formula:
,
where A is a position of binding to the antibody, is conjugated with the antibody through a thioether bond, and where amount of polysorbate 80 or polysorbate 20 is 0.2-0.4 mg per 20 mg of the antibody-drug conjugate. The group of inventions also relates to a method for the production of a pharmaceutical composition, including stages of: (1) obtainment of an aqueous solution including (i) the antibody-drug conjugate, (ii) the histidine buffer, (iii) sucrose, and (iv) polysorbate 80 or polysorbate 20, and then, (2) lyophilization of the aqueous solution. The group of inventions also relates to a method for the production of a pharmaceutical composition, including stages of: (1) obtainment of an aqueous solution including (i) the antibody-drug conjugate, (ii) the histidine buffer, (iii) sucrose, and (iv) polysorbate 80 or polysorbate 20, (2) regulation of pH of the aqueous solution, and then, (3) lyophilization of the aqueous solution.
EFFECT: group of inventions provides reduction in a number of microparticles in a composition containing an antibody-drug conjugate.
49 cl, 18 ex, 17 tbl, 21 dwg
