Determination of antibody production against administered therapeutic glycoproteins, especially monoclonal antibodies

Abstract

Disclosed are a composition and method for determining the levels of specific immune responsiveness to a glycoprotein in an individual being treated therewith by (i) contacting a body fluid sample obtained from the individual prior to glycoprotein treatment with glycoprotein that has been modified to have an oxidized carbohydrate portion; (ii) contacting a body fluid sample obtained from the individual subsequent to glycoprotein treatment with the glycoprotein that has been modified to have an oxidized carbohydrate portion; and (iii) observing the degree of difference in the specific immune response to the oxidized glycoprotein in the pre- and post-treatment samples.

Dependencies are inferred from the claim text.