Abstract
The glycosylation profile of recombinant human FSH (r-hFSH) is an important attribute of this molecule, defining its net biological effect, safety and efficacy. The most recently developed r-hFSH (r-hFSH-delta) is produced in a human cell line and has a distinct pharmacokinetic/pharamcodynamic (PK/PD) profile versus r-hFSH-alfa, which is produced in a hamster cell line: r-hFSH-delta had a higher elimination half-life and produced a higher ovarian response and higher serum concentrations of inhibin B and estradiol. This PK/PD profile was attributed to the higher proportion of tri- and tetra-sialylated glycans and the presence of both α2,3- and α2,6-linked sialic acid in r-hFSH-delta. The aim of the current study was to compare the glycosylation profiles of r-hFSH-alfa (Gonal-f, Merck KGaA) and r-hFSH-delta (Rekovelle, Ferring Pharmaceuticals) with endogenous pituitary-derived human FSH (p-hFSH).
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call