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001-es BibID:	BIBFORM073661
Első szerző:	Borza Beáta (biomérnök)
Cím:	Glycosimilarity assessment of biotherapeutics 1 : quantitative comparison of the N-glycosylation of the innovator and a biosimilar version of etanercept / Borza Beata, Szigeti Marton, Szekrenyes Akos, Hajba Laszlo, Guttman Andras
Dátum:	2018
ISSN:	0731-7085
Megjegyzések:	The carbohydrate moieties on the polypeptide chains in most glycoprotein based biotherapeutics and their biosimilars play essential roles in such major mechanisms of actions as antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, anti-inflammatory functions and serum clearance. In addition, alteration in glycosylation may influence the safety and efficacy of the product. Glycosylation, therefore, is considered as one of the important critical quality attributes of glycoprotein biotherapeutics, and consequently for their biosimilar counterparts. Thus, the carbohydrate moieties of such biopharmaceuticals (both innovator and biosimilar products) should be closely scrutinized during all stages of the manufacturing process. In this paper we introduce a rapid, capillary gel electrophoresis based process to quantitatively assess the glycosylation aspect of biosimilarity (referred to as glycosimilarity) between the innovator and a biosimilar version of etanercept (Enbrel? and Benepali?, respectively), based on their N-linked carbohydrate profiles. Differences in sialylated, core fucosylated, galactosylated and high mannose glycans were all quantified. Since the mechanism of action of etanercept is TNF? binding, only mannosylation was deemed as critical quality attribute for glycosimilarity assessment due to its influence on serum half-life.
Tárgyszavak:	Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Journal of Pharmaceutical and Biomedical Analysis. - 153 (2018), p. 182-185. -
További szerzők:	Szigeti Márton (1986-) (környezetmérnök) Szekrényes Ákos (1983-) (vegyészmérnök) Hajba László Guttman András (1954-) (vegyészmérnök)
Pályázati támogatás:	K 116263 NKFIH GINOP-2.3.2-15-2016-00017 GINOP
Internet cím:	Szerző által megadott URL Intézményi repozitóriumban (DEA) tárolt változat
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