FIELD: medicine.
SUBSTANCE: invention relates to a method for determination of a circulating conjugated anti-drug antibody comprising a therapeutic polypeptide and an endogenous anti-drug antibody formed in vivo to establish a correlation between the altered pharmacokinetics and a loss or decrease in efficacy including the steps of serum or cerebrospinal fluid exclusion chromatography from a mammal to which the drug is administered at least once, to determine the immunocomplex mass/size, and at least one heterogeneous immunoassay to detect a conjugated anti-drug antibody. Where the therapeutic polypeptide is a synthetic or non-natural therapeutic polypeptide.
EFFECT: invention provides a correlation with altered pharmacokinetics, loss or decrease in efficacy, neutralisation of natural analogues, as well as with general immune responses and hypersensitivity reactions including serum reaction, type III hypersensitivity, immune complex mediated disease.
7 cl, 3 ex, 6 dwg, 15 tbl
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