Detecting human anti-therapeutic antibodies

Details Detecting human anti-therapeutic antibodies Detecting human anti-therapeutic antibodies

G - Physics

01

N

G01N 27/26 (2006.01) G01N 33/537 (2006.01)

Patent

CA 2543830

The invention provides a method for detecting the presence of anti-therapeutic antibody antibodies in a patient being treated with a therapeutic antibody. In one aspect of the invention, the invention is implemented by the following steps: (i) providing a first therapeutic antibody having a molecular tag attached thereto by a cleavable linkage, the molecular tag having one or more predetermined separation characteristics; (ii) providing a second therapeutic antibody having a cleavage-inducing moiety attached thereto, the cleavage- inducing moiety having an effective proximity; (iii) combining in an assay mixture the sample, the first therapeutic antibody, and the second therapeutic antibody under condition such that the first and second therapeutic antibodies form a complex with an anti-therapeutic antibody wherein the cleavable linkage of the first therapeutic antibody is within the effective proximity of the cleavage-inducing moiety of the second therapeutic antibody and molecular tags are released; and (iv) separating from the assay mixture and detecting the released molecular tags to determine the presence or absence of anti- therapeutic antibodies in the sample.

L'invention concerne un procédé de détection d'anticorps anti-anticorps thérapeutique chez un patient traité par anticorps thérapeutique. Selon un aspect, les étapes sont les suivantes: (i) fourniture d'un premier anticorps thérapeutique sur lequel est fixé une étiquette moléculaire via une liaison clivable, cette étiquette ayant une ou plusieurs caractéristiques de séparation préétablies; (ii) fourniture d'un second anticorps thérapeutique sur lequel est fixée une fraction à induction de clivage, laquelle a une proximité efficace; (iii) combinaison dans un mélange d'essai entre l'échantillon, le premier anticorps thérapeutique et le second anticorps thérapeutique, dans des conditions telles que les deux anticorps forment un complexe avec un anticorps antithérapeutique, sachant que la liaison clivable du premier anticorps est à proximité efficace de la fraction à induction de clivage du second anticorps et que des étiquettes moléculaires sont libérées; et (iv) séparation et détection, dans le mélange d'essai, de ces étiquettes libérées pour déterminer la présence ou l'absence d'anticorps antithérapeutique.

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