公开(公告)号：US20170362319A1

公开(公告)日：2017-12-21

申请号：US15414254

申请日：2017-01-24

Applicant: GENMAB A/S

Inventor： Catharina Emanuele GERARDA HAVENITH ,  Tom VINK ,  Patrick VAN BERKEL ,  Paul PARREN

IPC: C07K16/28 ,  G01N33/566

CPC classification number: C07K16/2812 ,  C07K16/2863 ,  C07K2317/21 ,  C07K2317/34 ,  C07K2317/41 ,  C07K2317/732 ,  C07K2317/76 ,  G01N33/566 ,  G01N2333/70535

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.

公开(公告)号：US20220177585A1

公开(公告)日：2022-06-09

申请号：US17349482

申请日：2021-06-16

Applicant: GENMAB A/S

Inventor： Catharina Emanuele GERARDA HAVENITH ,  Tom VINK ,  Patrick VAN BERKEL ,  Paul PARREN

IPC: C07K16/28 ,  G01N33/566

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.