POTENCY ASSAYS FOR ANTIBODY DRUG SUBSTANCE BINDING 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

    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.

    Bispecific antibodies and methods for production thereof

    公开(公告)号:US10906991B2

    公开(公告)日:2021-02-02

    申请号:US14934956

    申请日:2015-11-06

    Applicant: GENMAB A/S

    Abstract: The invention relates to an ex vivo method for the generation of a bispecific antibody, comprising the steps of: a) providing a first antibody having a first binding specificity, wherein said first antibody comprises an IgG4-like CH3 region, b) providing a second antibody having a second binding specificity which differs from said first binding specificity, wherein said second antibody comprises an IgG4-like CH3 region, c) incubating said first and second antibodies together under reducing conditions which allow the cysteines in the core hinge region to undergo disulfide-bond isomerization, and d) obtaining a bispecific antibody. The invention furthermore relates to bispecific antibodies obtainable by the method of the invention.

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