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.

    STABLE IgG4 ANTIBODIES
    5.
    发明申请
    STABLE IgG4 ANTIBODIES 审中-公开
    稳定的IgG4抗体

    公开(公告)号:US20170029521A1

    公开(公告)日:2017-02-02

    申请号:US15197496

    申请日:2016-06-29

    Applicant: GENMAB A/S

    Abstract: The present invention relates to stabilized IgG4 antibodies, to methods of producing such antibodies and to uses of such antibodies as a medicament. In a main aspect, the invention relates to a stabilized IgG4 antibody, comprising a heavy chain and a light chain, wherein said heavy chain comprises a human IgG4 constant region having a substitution of the Arg residue at position (409), the Phe residue at position (405) or the Lys residue at position (370).

    Abstract translation: 本发明涉及稳定的IgG4抗体,涉及产生此类抗体的方法以及此类抗体作为药物的用途。 在一个主要方面,本发明涉及一种稳定的IgG4抗体,其包含重链和轻链,其中所述重链包含具有在位置(409)处的Arg残基取代的人IgG4恒定区, 位置(405)或位置(370)处的Lys残基。

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