Date: September 29, 2020
Time: 7:00am PDT, 10:00am EDT
Analytical Ultracentrifugation (AUC) in the biopharmaceutical industry has traditionally been employed in the analysis of aggregation and higher order structure in protein drug products. More recently, gene delivery vectors have opened new avenues for AUC-based characterization and QC lot release methodologies. We discuss here the parameters of an AUC method which conform to the objectives of an ICH/cGMP validation and suggest gap-bridging strategies to maintain a high-quality AUC platform for use in AAV programs.
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