Continuous monitoring of a monoclonal antibody by size exclusion chromatography reveals a correlation between system suitability parameters and column aging

Wu, KW; Chen, TH; Yang, TC; Wang, SC; Shameem, M; Graham, KS

Chen, TH (通讯作者),Regeneron Pharmaceut Inc, Formulat Dev Grp, 777 Old Saw Mill River Rd, Tarrytown, NY 10591 USA.

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2023; 235 ():

Abstract

Size exclusion chromatography (SEC) is a foundational analytical method to assess product purity of biological molecules. To ensure accurate and repro......

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