Anti-drug antibody assay

Abstract

The invention provides an antibody binding specifically to Cynomolgus IgG characterized by not binding to Human IgG, and a method for the immunological determination of an immune complex (DA/ADA complex) of a drug antibody (DA) and an antibody against said drug antibody (anti-drug antibody, ADA) in a sample of a monkey species using a double antigen bridging immunoassay.

1 .- 16 . (canceled) 
   
   
       17 . A monoclonal antibody specifically binding to Cynomoglus IgG, wherein said monoclonal antibody does not bind to human IgG. 
   
   
       18 . The monoclonal antibody of  claim 17 , which is produced by a hybridoma cell line as deposited with the Deutsche Sammlung von Microorganismen und Zellkulturen GmbH under Accession Nos. DSM ACC2799, DSM ACC2800, DSM ACC 2801, DSM ACC 2802 or DSM ACC2803. 
   
   
       19 . A hybridoma cell line producing the monoclonal antibody of  claim 17 , which is deposited with the Deutsche Sammlung von Microorganismen und Zellkulturen GmbH under Accession Nos. DSM ACC2799, DSM ACC2800, DSM ACC 2801, DSM ACC 2802 or DSM ACC2803. 
   
   
       20 . A composition comprising a monoclonal antibody or a fragment thereof according to  claim 17 . 
   
   
       21 . The composition of  claim 21 , wherein the composition further comprises a mixture of the monoclonal antibody produced by the hybridoma cell line DSM ACC2799, DSM ACC2800, DSM ACC 2801, DSM ACC 2802 or DSM ACC2803. 
   
   
       22 . A method for the immunological determination of an immune complex (DA/ADA complex) of a drug antibody (DA) and an antibody against said drug antibody (ADA) in a monkey species sample using a double antigen bridging assay, said method comprising
 a) a capture antibody; and   b) a tracer antibody   
     wherein one of said capture or tracer antibody is a monoclonal antibody of  claim 17  and wherein the other capture or tracer antibody is an antibody specifically binding to human IgG, wherein the amount of immune complex formed is correlated to the concentration of DA, ADA and DA/ADA. 
   
   
       23 . The method of  claim 22 , wherein the monkey species sample is preincubated with a predetermined amount of the drug antibody. 
   
   
       24 . A method for the immunological determination of an antibody against a drug antibody (ADA) in a monkey species sample using a double antigen bridging immunoassay said method comprising
 a) a capture antibody, wherein said capture antibody is immobilized via a specific binding pair, and;   b) a tracer antibody   
     wherein one of said capture or tracer antibody is a monoclonal antibody of  claim 17  and wherein the other capture or tracer antibody is an antibody specifically binding to human IgG. 
   
   
       25 . The method of  claim 24 , wherein said capture antibody is conjugated to biotin and immobilized via Avidin or Streptavidin. 
   
   
       26 . A method for the immunological determination of an antibody against a drug antibody (ADA) in a monkey species sample using a double antigen bridging immunoassay said method comprising
 a) a capture antibody, wherein said capture antibody is immobilized via a specific binding pair, and;   b) a tracer antibody, wherein said tracer antibody is conjugated to a detectable level via a specific binding pair,   
     wherein one of said capture or tracer antibody is a monoclonal antibody of  claim 17  and wherein the other capture or tracer antibody is an antibody specifically binding to human IgG. 
   
   
       27 . The method of  claim 26 , wherein said tracer antibody is conjugated to digoxigenin and linking to a detectable level is performed via an antibody against digoxigenin.