Identification and characterization of a residual host cell protein hexosaminidase B associated with N‐glycan degradation during the stability study of a therapeutic recombinant monoclonal antibody product

Host cell proteins (HCPs) are process‐related impurities derived from host organisms, which need to be controlled to ensure adequate product quality and safety. In this study, product quality attributes were tracked for several monoclonal antibodies (mAbs) under the intended storage and accelerated...

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Detalles Bibliográficos
Autores principales: Li, Xuanwen, An, Yan, Liao, Jing, Xiao, Li, Swanson, Michael, Martinez‐Fonts, Kirby, Pavon, Jorge Alexander, Sherer, Edward C., Jawa, Vibha, Wang, Fengqiang, Gao, Xinliu, Letarte, Simon, Richardson, Douglas D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2021
Materias:
RESEARCH ARTICLES
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8365702/
https://www.ncbi.nlm.nih.gov/pubmed/33476097
http://dx.doi.org/10.1002/btpr.3128

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8365702/
https://www.ncbi.nlm.nih.gov/pubmed/33476097
http://dx.doi.org/10.1002/btpr.3128

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