QUANTITATION AND MODELING OF QUALITY ATTRIBUTES OF THERAPEUTIC MONOCLONAL ANTIBODIES

    公开(公告)号:US20220367001A1

    公开(公告)日:2022-11-17

    申请号:US17824098

    申请日:2022-05-25

    Inventor: Xiaobin Xu Yu Huang

    Abstract: Methods of predicting an in vivo serum concentration of an antibody with a post-translational modification of interest after administration of the antibody are provided, as are methods for predicting a subject's exposure to post-translational variants of the antibody. The methods include predicting a percentage of the antibody with the post-translational modification of interest using an in vivo rate constant determined for the post-translational modification, and multiplying the predicted percentage of the antibody with the post-translational modification of interest by the in vivo concentration of the antibody to determine the concentration of the antibody with the post-translational modification of interest.

    Quantitation and modeling of quality attributes of therapeutic monoclonal antibodies

    公开(公告)号:US11355217B2

    公开(公告)日:2022-06-07

    申请号:US16264044

    申请日:2019-01-31

    Inventor: Xiaobin Xu Yu Huang

    Abstract: Methods of predicting an in vivo serum concentration of an antibody with a post-translational modification of interest after administration of the antibody are provided, as are methods for predicting a subject's exposure to post-translational variants of the antibody. The methods include predicting a percentage of the antibody with the post-translational modification of interest using an in vivo rate constant determined for the post-translational modification, and multiplying the predicted percentage of the antibody with the post-translational modification of interest by the in vivo concentration of the antibody to determine the concentration of the antibody with the post-translational modification of interest.

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