Aggregation Analysis And Beyond: Analytical Ultracentrifugation In The Biopharmaceutical Industry

October 14, 2014 -

AUC sedimentation velocity (SV) has a longstanding reputation as being the gold standard for the matrix free quantification of aggregates in biopharmaceuticals. The continuous c(S) distribution analysis as implemented in the software SEDFIT is the most commonly used data evaluation method in the biopharma environment due to regulatory requirements and the reliable reporting of very minor species by the algorithm. I will show how to set up such an analysis in order to achieve enhanced reproducibility during a study of many batches of one protein. Attention will be also paid to the recently developed calibration procedures regarding the temperature, scan time and the radial calibration of the centrifuge.

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