PhD Dissertation Defense Presentation - Keck Graduate Institute April 12, 2024, 10:00 am Skip to main content
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terezie cernosek
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..



April 12
10:00 am - 11:00 am PDT
Event Category:


KGI 535 Building – Room 109
535 Watson dr
Claremont, CA 91711 United States


Open To
General Public, Faculty and Staff, KGI Students