Development of a robust bioassay of monoclonal antibodies and biosimilars against TNF-α by NF-κB-inducible lentiviral reporter gene

•The U937-NFκB-Luc cell line was generated by lentivirus encoding NFκB-driven luciferase.•A RGA for measuring bioactivities of the TNF-α antagonists was established.•The RGA was validated according to ICH Q2 (R1) guidelines. The tumor necrosis factor alpha (TNF-α)/nuclear factor-kappa B (NF-κB) sign...

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Veröffentlicht in:	International immunopharmacology 2021-04, Vol.93, p.107418-107418, Article 107418
Hauptverfasser:	Huang, Jing, Wang, Lan, Yu, Chuanfei, Fu, Zhihao, Liu, Chunyu, Wu, Gang, Guo, Luyun, Guo, Xiao, Chen, Shiyu, Liu, Xumei, Wang, Junzhi
Format:	Artikel
Sprache:	eng
Schlagworte:	Biopharmaceuticals ICH(Q2) Lentiviral vector NF-κB Reporter gene assay TNF-α
Online-Zugang:	Volltext
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