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US 12,178,881 B2Granted
Filterable duocarmycin-containing antibody-drug conjugate compositions and related methods
AssigneeByondis B.V.
InventorCarolus Johannes Edgar Van Den Hoef
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Abstract
Duocarmycin-based antibody-drug conjugates can be readily separated from non-conjugated duocarmycin linker-drug in a composition that contains a solvent system of water and acetonitrile and that has 30% to 60% acetonitrile.
Claims15
A method, which comprises:
- (a) combining (i) an aqueous solution or a lyophilized product of an antibody-drug conjugate of formula (I):
- Ab-(L-D)m (I),
- wherein Ab is an IgG antibody, L-D is a duocarmycin linker-drug, wherein the duocarmycin linker-drug in non-conjugated form is represented by formula (IV):
- wherein n is 0-3;
- R5 is selected from
- y is 1-16;
- and
- R6 is selected from
- m represents an average DAR of from 1 to 12, and optionally further comprising the duocarmycin linker-drug in non-conjugated form, with (ii) a dilution medium that comprises water, acetonitrile, and acid to form a filterable composition, wherein said filterable composition comprises 30% to 60% (v/v) of said acetonitrile;
- and
- (b) filtering said filterable composition across a filter having a molecular weight cutoff within the range of 3 kDa to 50 kDa to form a filtrate.
8 more elements
Dependencies are inferred from the claim text.