AUC 2022

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AUC in Pharmaceutical development: Sweet spots in the methods’ universe
Submitter: Klaus Richter
Authors: Richter Klaus,
Corresponding Author: Richter Klaus
Title: AUC in Pharmaceutical development: Sweet spots in the methods’ universe
Contribution Type: Full Talk
Selected for Presentation Yes
Abstract: Analytical ultracentrifugation is a prominent method utilized in academic research and pharmaceutical development. Major applications of SV-AUC in pharmaceutical development can be found in comparability studies of proteins to support lot similarity and in stability studies. The versatile adaptation of SV-AUC allows to likewise support studies of peptides, and complex large biopharmaceuticals, such as LNPs, AAVs, larger viruses, nucleic acid containing complexes and VLPs. Beyond that interaction studies with SV-AUC can confirm the potency of pharmaceuticals based on their interaction affinity. We find that complex studies with multiple species may benefit from a restricted fitting approach to predefined species and thereby obtain precision and robustness more in line with the requirements of analytical method development.