Multiplexed chromatography-immunoassay method for the characterization of circulating immune complexes

US9797900B2 · kind B2 · utility

Assignee

• F. Hoffmann-La Roche AG · CH

Inventors

• Uwe Dahl · Penzberg, DE
• Gregor Jordan · Penzberg, DE
• Roland Staack · Penzberg, DE

Key dates

• Filing date: Sep 5, 2014
• Grant date: Oct 24, 2017
• Expiry date: Sep 5, 2034

Classification

• Technology area (CPC G): Physics
• CPC primary: G01N33/94
• WIPO field: Measurement
• WIPO sector: Instruments

Abstract

Thus, herein is reported a method for analyzing/characterizing circulating immune complexes (CICs) formed in vivo comprising a size-exclusion chromatography of a sample obtained from a mammal to which the drug had been administered at least once for determining the weight/size of the immune complexes, optionally a second non-SEC chromatography, and at least one immunoassay, whereby the immune complex is characterized by the correlation of the immune complex size and the immunoassay result/read-out. Also reported herein is the use of a method as reported herein for determining a correlation to altered pharmacokinetics, for determining loss or reduction of efficacy, for determining neutralization of natural counterparts of the drug, for determining immune and hypersensitivity reactions, including serum sickness/type III hypersensitivity reaction/immune complex-mediated disease.