PhD Dissertation Defense Presentation

Terezie Cernosek
Senior Associate Scientist, Analytical Development Catalent Biologics

Analytical Quality by Design applied to platform method development for the characterization of monoclonal antibody-based therapeutics

Monoclonal antibody (mAb) therapeutics have emerged as a leading modality in the biopharmaceutical space for the treatment of a variety of diseases which are difficult to treat. mAbs are complex and heterogenous in nature, requiring monitoring of primary structure, higher order structure, charge variants, and glycosylation. These heterogeneities may arise during bioprocessing or storage due to susceptibility to chemical modifications, degradation, or self-association. Properly characterizing mAbs is critical to ensuring their quality, safety, and efficacy, with Critical Quality Attributes (CQAs) defining their physical, chemical, and biological properties. Analytical Quality b Design (AQbD) principles, incorporating statistical methodologies and risk-based strategies, are recommended for developing robust and reliable analytical procedures. This presentation reports on the development of platform analytical procedures for mAb products, to ensure procedure quality, consistency, and efficiency. This work focused on methods for analytical size exclusion chromatography (SEC), Protein A (ProA), capillary electrophoresis-sodium dodecyl sulfate (CE-SDS), and imaged capillary isoelectric focusing (icIEF). The robustness and reproducibility of the analytical procedures demonstrate the utility of adopting AQbD principles, leading to standardized and efficient processes for mAb CQA analyses..

Zoom: https://kgi.zoom.us/j/95206540349