Quality control and evaluation concerns of recombinant glycoprotein hormones:"macro"and"micro"heterogeneity of glycosylation modifications
LI Yi-jun
HU Ying-ying
WEI Wei
Abstract：Glycoprotein hormones,including follicle-stimulating hormone,luteinizing hormone,chorionic gonadotropin,and thyroid stimulating hormone,are heterodimers consisting of non-convalently bound α and β subunits.Glycosylation complexity and structural heterogeneity are the focus of structural characterization and quality control of glycoprotein hormones.The modification sites,modification types,and sialic acid content of glycosylation are closely related to the receptor binding,signaling,biological function,and clearance rate of glycoprotein hormones in the body.In this paper,we summarize the marketed products of recombinant glycoprotein hormones,analyze the"macro"and"micro"complexity of glycosylation modification of these drugs,clarify the relationship between structural heterogeneity and biological function,sort out the analytical techniques used for structural confirmation and glycan chain identification,and put forward the relevant considerations of R&D pathway and CMC research based on their quality control difficulties.
Keywords：glycoprotein hormonefollicle-stimulating hormoneglycosylation modificationbiological potencyquality control
Publication Date：2023-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：10( 2467-2476 )