Potency assays for antibody drug substance binding to an fc...

Details Potency assays for antibody drug substance binding to an fc... Potency assays for antibody drug substance binding to an fc...

G - Physics

01

N

G01N 33/566 (2006.01) A61K 39/395 (2006.01)

Patent

CA 2615846

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.

L'invention concerne un procédé permettant de caractériser un anticorps et conçu comme une analyse de puissance destinée à une mise en vente en lots d'une composition pharmaceutique comprenant un anticorps, à utiliser plus précisément lors de la demande d'autorisation marketing pour ladite composition pharmaceutique. L'analyse selon l'invention consiste en un procédé permettant de déterminer la puissance d'un produit médicamenteux comprenant un peptide de liaison FcR, au moins un mécanisme d'action du peptide de liaison FcR du produit médicamenteux étant induit par le biais de la liaison du peptide de liaison FcR du produit médicamenteux à un récepteur Fc, le procédé consistant à déterminer la liaison du peptide de liaison FcR du produit médicamenteux à un récepteur Fc.

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