The First WHO International Standard for Harmonizing the Biological Activity of Bevacizumab.

ABSTRACT: Several Bevacizumab products are approved for clinical use, with many others in late-stage clinical development worldwide. To aid the harmonization of potency assessment across different Bevacizumab products, the first World Health Organization (WHO) International Standard (IS) for Bevacizumab has been developed. Two preparations of a Bevacizumab candidate and comparator were assessed for their ability to neutralize and bind vascular endothelial growth factor (VEGF) using different bioassays and binding assays in an international collaborative study. Relative potency estimates were similar across different assays for the comparator or the duplicate-coded candidate sample. Variability in relative potency estimates was reduced when the candidate standard was used for calculation compared wit

SUBMITTER: Jia H 

PROVIDER: S-EPMC8615914 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature