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Quality by Design-Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira (R)

Zhang, EH; Xie, LQ; Qin, PL; Lu, LH; Xu, YP; Gao, WY; Wang, LL; Xie, MHW; Jiang, WD; Liu, S

Xie, MHW (corresponding author), Shanghai Henlius Biotech Inc, Shanghai Engn Res Ctr Antitumor Biol Drugs, Shanghai, Peoples R China.

AAPS JOURNAL, 2020; 22 (3):

Abstract

Quality by design (QbD) is an efficient but challenging approach for the development of biosimilar due to the complex relationship among process, qual......

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