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The measurement and control of high-risk host cell proteins for polysorbate degradation in biologics formulation

Nonionic surfactant polysorbates, including PS-80 and PS-20, are commonly used in the formulation of biotherapeutic products for both preventing surface adsorption and acting as stabilizer against protein aggregation. Trace levels of residual host cell proteins (HCPs) with lipase or esterase enzymat...

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Detalles Bibliográficos
Autores principales: Li, Xuanwen, Wang, Fengqiang, Li, Hong, Richardson, Douglas D, Roush, David J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8826928/
https://www.ncbi.nlm.nih.gov/pubmed/35155990
http://dx.doi.org/10.1093/abt/tbac002