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Please join us for KGI PhD Student, Terezie Cernosek, Senior Associate Scientist, Analytical Development, Catalent Pharma Solutions
Extensive analytical testing and characterization are critical throughout the lifecycle of a drug substance and drug product to evaluate and confirm appropriate quality. Multiple analytical methods to assess purity, potency, structure, size, and heterogeneity are required to demonstrate the quality and consistency of monoclonal antibody (mAb) products and are essential in establishing the critical quality attributes (CQAs) applied to confirm individual production lots conform to the product quality profile characteristics prior to release and to assess product stability. Liquid chromatography methods are used to assess purity, size associated heterogeneity, protein content, charge variants, and excipients. Electrophoretic approaches characterize primary structure and potential size and charge variants or impurities. Immunochemical methods are required to assess product identity and potency. Other methods generally applied to biological product lot release are utilized to extensively characterize unique molecular structure, by providing an aggregation assessment and information on tertiary structure and thermal stability. Development of an analytical method platform package will support standardization of operations across laboratories, improves demonstration and establishment of robust production processes, and ensures the confirmation of the quality and consistency of mAb products applied to address patient health needs.
Date: Wednesday, November 3, 2021
Time: 12:00 – 1:00 p.m.
Via Zoom: https://kgi.zoom.us/j/95854758377
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