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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...

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Detalles Bibliográficos
Autores principales: Troxell, Bryan, Tsai, I-Wei, Shah, Kinjal, Knuckles, Christopher I., Shelton, Sarah, Lindsey, Kate, Cardenas, Selene M. Barbosa, Roberts, Taylor
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2023
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