Patent ID: 8313913

Claim:
A method for detecting the antibody-dependent cell-mediated cytotoxic (ADCC) activity of an antibody composition, said antibody molecules having a sugar chain, wherein at least part of the antibody molecule has a no-fucose sugar chain in which fucose is not bound to N-acetylglucosamine in the reducing end of the sugar chain of the antibody molecule, the method comprising: (a) preparing a standard curve from the binding activities of three or more reference antibody compositions to a Fcγ receptor IIIa, wherein the no-fucose sugar chain ratio and the ADCC activity of each reference antibody composition is known, comprising (i) contacting each reference antibody composition, separately, with an antigen which binds to the variable regions of the antibodies in each reference antibody composition, to form a reference antibody-antigen complex for each reference antibody composition; (ii) contacting each reference antibody-antigen complex with Fcγ receptor IIIa; and (iii) measuring the binding activity of each reference antibody-antigen complex to the Fcγ receptor IIIa; (b) determining the binding activity of a test antibody composition, comprising (i) contacting a test antibody composition with said antigen, wherein said antigen bindgs to the variable regions of the antibodies in said test antibody composition, to form a test antibody-antigen complex; (ii) contacting the test antibody-antigen complex to the Fcγ receptor IIIa; and (iii) measuring the binding activity of the test antibody-antigen complex to the Fcγ receptor IIIa; and (c) determining an ADCC activity for the test antibody composition by comparing the binding activity of the test antibody-antigen complex to the Fcγ receptor IIIa with a standard curve of the binding activities of the reference antibody-antigen complexes to the Fcγ receptor IIIa.