Immunological method
AssigneeGyros Patent AB
InventorsCecilia Bill, Ann-Charlott Steffen, Mats Inganäs
Life of this patent
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Abstract
The present invention relates to an in vitro method for the detection of an anti-drug antibody (ADA) against a therapeutic drug antibody (TDA) in a biological sample. The in vitro method comprises detecting and capturing said ADA using affinity moieties obtained from an intact therapeutic drug antibody, or a Fab fragment thereof, in a certain manner. Avoiding using only intact therapeutic drug antibodies or only Fab fragments thereof as reagents in such a method has been proven as an efficient way of increasing sensitivity, decreasing unspecific binding and the formation of large protein complexes. Such a method has great utility in therapeutic drug development or in the evaluation of a particular treatment of a patient.
Claims18
An in vitro method for the detection of an anti-drug antibody (ADA) against a therapeutic drug antibody (TDA) in a biological sample, said method comprising:
- capturing and attaching said ADA onto a solid phase via a capture reagent (1), said capture reagent comprising an affinity moiety (1a) for said ADA and a capturing moiety (1b) for attachment to a solid phase;
- and
- detecting ADA with a detection reagent (2), said detection reagent comprising an affinity moiety (2a) for said ADA and a detection moiety (2b) for detecting the presence of ADA in the sample, wherein said capture reagent (1) and said detection reagent (2) thereby forms a bridging complex with said ADA,
- wherein the method is characterized in that
- said affinity moiety (1a) of said capture reagent (1) and said affinity moiety (2a) of said detection reagent (2) are selected from the group consisting of an intact TDA and one or more Fab fragment(s) of said TDA;
- and
- a) when the affinity moiety (1a) of said capture reagent (1) is an intact TDA, the affinity moiety (2a) of said detection reagent (2) is one or more Fab fragment(s) of said TDA, and
- b) when the affinity moiety (1a) of said capture reagent (1) is one or more Fab fragment(s) of said intact TDA, the affinity moiety (2a) of said detection reagent (2) is an intact TDA.
Dependencies are inferred from the claim text.