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Application of Size Exclusion Chromatography with Multiangle Light Scattering in the Analytical Development of a Preclinical Stage Gene Therapy Program
To provide safe recombinant adeno-associated viruses (rAAV) to patients, scalable manufacturing processes are required. However, these processes may introduce impurities that impact the performance and quality of the final drug product. Empty rAAV capsids are product-related impurities. Regulatory g...
Autores principales: | Troxell, Bryan, Tsai, I-Wei, Shah, Kinjal, Knuckles, Christopher I., Shelton, Sarah, Lindsey, Kate, Cardenas, Selene M. Barbosa, Roberts, Taylor |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Mary Ann Liebert, Inc., publishers
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10125404/ https://www.ncbi.nlm.nih.gov/pubmed/36927085 http://dx.doi.org/10.1089/hum.2022.218 |
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