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Risk control of host cell proteins in one therapeutic antibody produced by concentrated fed‐batch (CFB) mode

Multiple control strategies, including a downstream purification process with well‐controlled parameters and a comprehensive release or characterization for intermediates or drug substances, were implemented to mitigate the potential risk of host cell proteins (HCPs) in one concentrated fed‐batch (C...

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Detalles Bibliográficos
Autores principales: Lu, Yiling, Lin, Jun, Bian, Tianze, Chen, Jin, Liu, Dan, Ma, Mingjun, Gao, Zhen, Chen, Jiemin, Ju, Dianwen, Wang, Xing
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9978904/
https://www.ncbi.nlm.nih.gov/pubmed/36874608
http://dx.doi.org/10.1002/elsc.202200060