Predictive Modeling of Monoclonal Antibody Glycosylation and Critical Quality Attributes
Monoclonal antibodies are complex biological products, and glycosylation and other critical quality attributes (CQAs) can significantly influence their efficacy, stability, and pharmacokinetics. These attributes are sensitive to the metabolic state of the production cell and bioprocess conditions, making their prediction and control an important challenge in biomanufacturing. This project will develop mechanistic and data-driven models to predict mAb glycosylation and CQAs from cellular metabolism and process variables.