Comparability strategy and demonstration for post-approval production cell line change of a bevacizumab biosimilar IBI305

High-producing cell line could improve the affordability and availability of biotherapeutic products. A post-approval production cell line change, low-titer CHO-K1S to high-titer CHO-K1SV GS-KO, was performed for a China marketed bevacizumab biosimilar IBI305. Currently, there is no regulatory guide...

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Detalles Bibliográficos
Autores principales: Wu, Zhouyi, Xu, Gangling, He, Wu, Yu, Chuanfei, Huang, Wanqiu, Zheng, Shirui, Kang, Dian, Xie, Michael H, Cao, Xingjun, Wang, Lan, Wei, Kaikun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10481892/
https://www.ncbi.nlm.nih.gov/pubmed/37680352
http://dx.doi.org/10.1093/abt/tbad017

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