FIELD: pharmacology.
SUBSTANCE: invention relates to compositions including duocarmycin-containing antibody-drug (ADC) conjugates and optionally a duocarmycin linker drug in an unconjugated form, which provide easy filtration of ADC and its separation from a duocarmycin linker drug in an unconjugated form, where the compositions contain a system of solvents from water and acetonitrile, with an acetonitrile content of 30 to 60 vol. %. A method is also proposed for detecting and/or quantifying the content of the free linker drug duocarmycin and isolating/approving a batch of duocarmycin-containing ADC.
EFFECT: expansion of the range of duocarmycin-containing drugs.
15 cl, 3 dwg, 2 tbl, 3 ex
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Authors
Dates
2022-06-21—Published
2019-11-04—Filed