FIELD: biotechnology.
SUBSTANCE: invention relates to biotechnology, particularly to a method of producing a conjugate of a cell-binding agent and a cytotoxic agent. Cytotoxic agent is brought into contact with a bifunctional cross-linking reagent represented by structural formula or its salt in a buffer solution containing a buffer agent, wherein the buffer solution has a high buffer capacity and the molar ratio of the buffer to the bifunctional cross-linking reagent ranges from 2:1 to 8:1. Mixture containing a cytotoxic agent compound with a linker is obtained. Obtained compound is brought into contact with a cell-binding agent in a solution having pH from 4 to 9. Second mixture containing a conjugate of a cell-binding agent and a cytotoxic agent are obtained.
EFFECT: invention leads to considerable reduction of antibody fragmentation and increases stability of prepared conjugates.
70 cl, 2 tbl, 2 ex
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Authors
Dates
2020-01-23—Published
2015-11-18—Filed