FIELD: medicine.
SUBSTANCE: group of inventions refers to medicine, namely to obtaining a lyophilised composition containing an antibody-drug conjugate of formula
a buffer agent, a lyoprotector and a surfactant. Molar ratio of the lyoprotector to the antibody-drug conjugate is 1400–3200 to 1, where the buffer agent is histidine or succinate, where the lyoprotector is sucrose, trehalose or a mixture thereof, where surfactant is polysorbate. When reconstituted with water, the antibody-drug conjugate is present in amount of 5–15 mg/ml, buffer agent is present in concentration of 3–10 mM, amount of polysorbate is 0.005–0.02% (w/v), pH is 5.3–6.0 and, besides, the composition does not include a bulky agent. Group of inventions also relates to a method of producing said lyophilised composition.
EFFECT: use of this group of inventions enables to obtain improved stability and appearance of the powder.
6 cl, 4 tbl, 4 dwg
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