FIELD: medicine, pharmaceutics.
SUBSTANCE: invention refers to biotechnology. What is presented is a composition of an antibody for treating HER2-positive cancer containing an active antibody presented by an antibody characterised by the fact that it has a variable light and heavy chain domain, and its acidic variants, namely: glycosilated, deaminated variants, as well as a variant with a reduced disulphide bond, a syalylated variant and a irreducible variant. A number of acidic variants makes less than approximately 25%. There are described a pharmaceutical composition containing this composition, for treating HER2-positive cancer and a method for preparing the composition involving the evaluation of the acidic variants and verification of the fact that their number makes at least than approximately 25%.
EFFECT: using the invention provides the new composition, wherein the antibody and its acidic variants have the pharmacokinetic parameters that can find application in treating HER2-positive cancer.
14 cl, 17 dwg, 1 tbl, 1 ex
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Authors
Dates
2015-03-10—Published
2009-01-28—Filed