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Evaluation of TD-NMR for the detection of protein aggregation in liquid biopharmaceuticals.
Rel. Roberto Pisano, Gerhard Winter. Politecnico di Torino, Corso di laurea magistrale in Ingegneria Chimica E Dei Processi Sostenibili, 2023
Abstract
Monitoring of protein aggregation is crucial to avoid the administration of an altered drug substance to a patient. The techniques that are currently used to detect the formation of protein aggregates, e.g., Size Exclusion - High Performance Liquid Chromatography SE–HPLC = SEC) and Flow Imaging Microscopy (FIM), require a certain sample preparation and the destructive use of the protein drug product to perform the measurement. Furthermore, multiple orthogonal or complementary techniques need to be used in order to characterize the sample completely, e.g., to characterize aggregates in every possible size range such as the nanometer (<100 nm), submicrometer (100-1000 nm), subvisible (1-100 µm), visible (>100 µm) range.
In this work, the readouts obtained from established techniques for the analysis of protein aggregates were compared to the one obtained from a new approach, Time Domain Nuclear Magnetic Resonance (TD-NMR)
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