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Analytical comparability to evaluate impact of manufacturing changes of ARX788, an Anti-HER2 ADC in late-stage clinical development

ARX788 is an anti-HER2 antibody drug conjugate (ADC) developed using Ambrx proprietary Engineered Precision Biologics technology. The manufacturing process of ARX788 has been optimized during the course of early to late-phase clinical development. A comprehensive evaluation of side-by-side comparabi...

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Detalles Bibliográficos
Autores principales:	Yu, Wayne, Ramprasad, Mysore P., Pal, Manoj, Chen, Chris, Paruchuri, Shashi, Skidmore, Lillian, Knudsen, Nick, Allen, Molly, Buechler, Ying
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Public Library of Science 2023
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10332591/ https://www.ncbi.nlm.nih.gov/pubmed/37428761 http://dx.doi.org/10.1371/journal.pone.0284198

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