| Abstract: |
Development of biologic pharmaceuticals requires characterization of aggregates, fragments, and purity as key critical quality attributes (CQAs) due to the immunogenicity risk to patients. Size exclusion chromatography (SEC) is the widely accepted workhorse in this space due to its utility and high sample throughput. However, AUC is frequently deployed by Catalent Biologics to address a myriad of issues encountered in process and formulation development where SEC is ineffective or not applicable. In this presentation, case studies from current drug development programs that were solved by AUC will be discussed. |
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