Glycosylation Pattern and in vitro Bioactivity of Reference Follitropin alfa and Biosimilars.

ABSTRACT: Recombinant follicle-stimulating hormone (FSH) (follitropin alfa) and biosimilar preparations are available for clinical use. They have specific FSH activity and a unique glycosylation profile dependent on source cells. The aim of the study is to compare the originator (reference) follitropin alfa (Gonal-f®)- with biosimilar preparations (Bemfola® and Ovaleap®)-induced cellular responses in vitro. Gonadotropin N-glycosylation profiles were analyzed by ELISA lectin assay, revealing preparation specific-patterns of glycan species (Kruskal-Wallis test; p < 0.05, n = 6) and by glycotope mapping. Increasing concentrations of Gonal-f® or biosimilar (1 × 10^-3-1 × 10³ ng/ml) were used for treating human primary granulosa lutein cells (hGLC) and FSH recept

SUBMITTER: Riccetti L 

PROVIDER: S-EPMC6667556 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature