Demonstrating analytical similarity of a biosimilar HLX04 to bevacizumab with a panel of state-of-the-art methods and tiering of quality attributes.

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作者： Lei,Zhang ^[1] ; Lu,Yu ^[1] ; Yanpeng,Xu ^[1] ; Peilan,Qin ^[1] ; Pengcheng,Shen ^[1] ; Kemeng,Liu ^[1] ; Mengdan,Fei ^[1] ; Hongya,Wang ^[1] ; Yanjing,Cao ^[1] ; Lihong,Lu ^[1] ; Wenyuan,Gao ^[1] ; Zhongli,Zhang ^[2]

作者单位： Department of Analytical Science and Development, Shanghai Henlius Biologics Co., Ltd, 5155 Guangfulin Road, Shanghai, 201600, China. ^[1] Department of Analytical Science and Development, Shanghai Henlius Biologics Co., Ltd, 5155 Guangfulin Road, Shanghai, 201600, China. zhongli_zhang@henlius.com. ^[2]

关键词 Analytical similarity Avastin?Bevacizumab Biosimilar HLX04

主题词糖基化(Glycosylation);中国(China);欧洲(Europe)

DOI 10.1007/s00216-023-04716-5

PMID 37162525

发布时间 2023-06-26

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