Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Wagner, C; Innthaler, B; Lemmerer, M; Pletzenauer, R; Birner-Gruenberger, R.
Biophysical Characterization of Adeno-Associated Virus Vectors Using Ion-Exchange Chromatography Coupled to Light Scattering Detectors.
Int J Mol Sci. 2022; 23(21):
Doi: 10.3390/ijms232112715
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- Co-Autor*innen der Med Uni Graz
- Birner-Grünberger Ruth
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- Abstract:
- Ion-exchange chromatography coupled to light scattering detectors represents a fast and simple analytical method for the assessment of multiple critical quality attributes (CQA) in one single measurement. The determination of CQAs play a crucial role in Adeno-Associated Virus (AAV)-based gene therapies and their applications in humans. Today, several different analytical techniques, including size-exclusion chromatography (SEC), analytical ultracentrifugation (AUC), qPCR or ELISA, are commonly used to characterize the gene therapy product regarding capsid titer, packaging efficiency, vector genome integrity, aggregation content and other process-related impurities. However, no universal method for the simultaneous determination of multiple CQAs is currently available. Here, we present a novel robust ion-exchange chromatography method coupled to multi-angle light scattering detectors (IEC-MALS) for the comprehensive characterization of empty and filled AAVs concerning capsid titer, full-to-total ratio, absolute molar mass of the protein and nucleic acid, and the size and polydispersity without baseline-separation of both species prior to data analysis. We demonstrate that the developed IEC-MALS assay is applicable to different serotypes and can be used as an orthogonal method to other established analytical techniques.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Dependovirus - genetics
- Chromatography, Ion Exchange - methods
- Chromatography, High Pressure Liquid - administration & dosage
- Chromatography, Gel - administration & dosage
- Capsid Proteins - genetics
- Genetic Vectors - genetics
- Light - administration & dosage
- Find related publications in this database (Keywords)
- adeno-associated virus vectors
- ion-exchange chromatography
- multi-angle light scattering
- dynamic light scattering
- protein characterization
- critical quality attributes