MODULATING ANTIBODY DEPENDENT CELLULAR PHAGOCYTOSIS

    公开(公告)号:US20210155710A1

    公开(公告)日:2021-05-27

    申请号:US16972298

    申请日:2019-06-05

    Applicant: Amgen Inc.

    Abstract: Provided herein are methods of modulating Antibody Dependent Cellular Phagocytosis (ADCP) activity of an antibody composition. In exemplary embodiments, the method comprises modulating the amount of (a) galactosylated glycans of the antibody, (b) afucosylated glycans of the antibody, (c) high mannose glycans of the antibody, or (d) a combination thereof, to modulate ADCP activity of the antibody, as further described herein.

    METHODS OF MODULATING ANTIBODY-DEPENDENT CELL-MEDIATED CYTOTOXICITY

    公开(公告)号:US20220033511A1

    公开(公告)日:2022-02-03

    申请号:US17275140

    申请日:2019-09-10

    Applicant: Amgen Inc.

    Abstract: The present disclosure provides a method of controlling the Antibody Dependent Cellular Cytotoxicity (ADCC) activity of a glycosylated and afucosylated IgG1 antibody composition. In exemplary embodiments, the method includes (1) determining the ADCC activity of a glycosylated and afucosylated IgG1 antibody composition; and (2) increasing or decreasing the ADCC activity of the IgG1 antibody composition by increasing or decreasing the amount of terminal β-galactose in the afucosylated glycan species at the consensus glycosylation site. Related methods of matching ADCC activity of a reference glycosylated and afucosylated IgG1 antibody composition and methods of engineering a specific target ADCC activity of a glycosylated and afucosylated IgG1 antibody composition are further provided herein.

    FC-GAMMA RECEPTOR II BINDING AND GLYCAN CONTENT

    公开(公告)号:US20250076309A1

    公开(公告)日:2025-03-06

    申请号:US18698098

    申请日:2022-10-04

    Applicant: AMGEN INC.

    Abstract: Provided herein are methods of determining product quality of an antibody composition, wherein the product quality is based on the Fcγ receptor II (FcγRI) binding level of the antibody composition. In exemplary embodiments, the method comprises (a) determining the afucosylated glycan content and/or β-galactosylated glycan content of a sample of the antibody composition; (b) optionally, calculating a predicted FcγRII binding level based on the afucosylated glycan content and/or β-galactosylated glycan content as determined in (a); and (c) determining the product quality of the antibody composition as acceptable when (i) the afucosylated glycan content and/or β-galactosylated glycan content is within a target range and/or (ii) the predicted FcγRII binding level is within a target range. Related methods of monitoring product quality and methods of producing an antibody composition are further provided herein.

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