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filingDate 2019-01-31-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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publicationDate 2020-11-06-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-111902874-A
titleOfInvention Quantification and Modeling of Quality Attributes of Therapeutic Monoclonal Antibodies
abstract Methods are provided for predicting the in vivo serum concentration of an antibody having a target post-translational modification following administration of the antibody, as well as methods for predicting the exposure of a subject to post-translational variants of the antibody. The method comprises: using the determined in vivo rate constant for the post-translational modification to predict the percentage of the antibody with the target post-translational modification; and using the antibody with the target post-translational modification of the The predicted percentage is multiplied by the in vivo concentration of the antibody to determine the concentration of the antibody with the target post-translational modification.
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