Invention Grant
- Patent Title: Quantitation and modeling of quality attributes of therapeutic monoclonal antibodies
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Application No.: US16264044Application Date: 2019-01-31
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Publication No.: US11355217B2Publication Date: 2022-06-07
- Inventor: Xiaobin Xu , Yu Huang
- Applicant: Regeneron Pharmaceuticals, Inc.
- Applicant Address: US NY Tarrytown
- Assignee: Regeneron Pharmaceuticals, Inc.
- Current Assignee: Regeneron Pharmaceuticals, Inc.
- Current Assignee Address: US NY Tarrytown
- Agency: Kramer Levin Naftalis & Frankel LLP
- Main IPC: G01N33/48
- IPC: G01N33/48 ; G01N33/50 ; G16B5/20 ; G06F17/11 ; G01N33/68 ; C07K16/00 ; G16B20/20

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.
Public/Granted literature
- US20190237157A1 Quantitation and Modeling of Quality Attributes of Therapeutic Monoclonal Antibodies Public/Granted day:2019-08-01
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