Target interference suppressed anti-drug antibody assay

US12174184B2 · kind B2 · utility

Assignee

• Hoffmann-La Roche Inc. · US

Inventors

• Uwe Dahl · Penzberg, DE
• Gregor Jordan · Penzberg, DE
• Roland Staack · Penzberg, DE
• Miriam Moheysen-Zadeh · Penzberg, DE

Key dates

• Filing date: Nov 27, 2018
• Grant date: Dec 24, 2024
• Expiry date: Jan 22, 2042

Classification

• Technology area (CPC G): Physics
• CPC primary: G01N2400/10
• WIPO field: Measurement
• WIPO sector: Instruments

Abstract

Herein is reported an immunoassay for quantifying the amount of anti-drug antibody, which anti-drug antibody can specifically bind to a drug antibody, which drug antibody can specifically bind to a therapeutic target, in a serum or plasma sample comprising the steps of a) incubating the serum or plasma sample at a pH value that is about the pI value of the target, and optionally removing formed precipitate after the incubation, b) incubating the serum or plasma sample obtained in step a) at a pH value of about 2, and optionally centrifuging the incubated sample to remove formed precipitate, c) adjusting the pH value to about 7.4, adding capture antibody conjugated to a first member of a binding pair and tracer antibody conjugated to a detectable label to the serum or plasma sample obtained in step b) and incubating the mixture to form a capture antibody-anti-drug antibody-tracer antibody-complex, d) quantifying the complex formed in step c) and thereby quantifying the amount of anti-drug antibody in the serum or plasma sample.