Potency assays for antibody drug substance binding to an fc receptor

Abstract

The invention relates to a method of characterizing an antibody, which method is suitable as a potency assay for batch release of a pharmaceutical composition comprising an antibody, specifically for use when applying for marketing authorization for said pharmaceutical composition. The assay provided is a method for determining the potency of a drug product comprising an FcR binding peptide, wherein at least one mechanism of action of the FcR binding peptide of the drug product is mediated through the binding of the FcR binding peptide of the drug product to a Fc receptor, wherein said method comprises determining the binding of the FcR binding peptide of the drug product to an Fc receptor.

1 - 161 . (canceled) 
     
     
         162 . A method for determining the potency of a drug product comprising an FcR binding peptide, wherein at least one mechanism of action of the FcR binding peptide of the drug product is mediated through the binding of the FcR binding peptide of the drug product to a Fc receptor, wherein said method comprises determining the binding of the FcR binding peptide of the drug product to an Fc receptor, wherein said method is part of an application for marketing authorization for selling said drug product as a pharmaceutical composition. 
     
     
         163 . A method for applying for marketing authorization for a drug product comprising an FcR binding peptide, which method comprises describing a method for determining the potency of a drug product comprising an FcR binding peptide, wherein at least one mechanism of action of the FcR binding peptide of the drug product is mediated through the binding of the FcR binding peptide of the drug product to a Fc receptor, wherein said method comprises determining the binding of the FcR binding peptide of the drug product to an Fc receptor. 
     
     
         164 . The method of  claim 162 , wherein the method for determining the potency of a drug product comprising an FcR binding peptide is used as a potency assay for batch release. 
     
     
         165 . The method of  claim 162 , wherein the binding of the FcR binding peptide to the Fc receptor is determined by use of a method comprising (i) bringing a sample of the drug product into contact with an Fc receptor for a time period sufficient for allowing the FcR binding peptide to bind to the Fc receptor, and (ii) detecting the amount of FcR binding peptide bound to the Fc receptor. 
     
     
         166 . The method of  claim 165 , wherein the detection is performed by use of a detecting antibody directed at the FcR binding peptide. 
     
     
         167 . The method of  claim 166 , wherein the detecting antibody is a labeled antibody. 
     
     
         168 . The method of  claim 162 , wherein the binding of the FcR binding peptide to the Fc receptor is determined by use of an ELISA. 
     
     
         169 . The method of  claim 162 , wherein the binding of the FcR binding peptide to the Fc receptor is determined by use of an AlphaScreen™ assay. 
     
     
         170 . The method of  claim 162 , wherein the binding of the FcR binding peptide to the Fc receptor is determined by use of a radioimmunoassay. 
     
     
         171 . The method of  claim 162 , wherein the binding of the FcR binding peptide to the Fc receptor is determined by use of a Biacore assay.