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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
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2.

001-es BibID:BIBFORM092887
035-os BibID:(cikkazonosító)128200 (WoS)000600833700002 (Scopus)85092452389
Első szerző:Sárközy Dániel (PhD hallgató)
Cím:Ultrafast high-resolution analysis of human milk oligosaccharides by multicapillary gel electrophoresis / Daniel Sarkozy, Beata Borza, Apolka Domokos, Eszter Varadi, Marton Szigeti, Agnes Meszaros-Matwiejuk, Dora Molnar-Gabor, Andras Guttman
Dátum:2021
ISSN:0308-8146
Megjegyzések:There is recently growing interest towards synthesized human milk oligosaccharides (HMOs) as baby formula additives, and interestingly also as dietary supplements for adults. Currently quite a few manufacturers synthesize HMOs, however, their analysis is challenging, both in resolution and speed. In this paper an ultrafast high-resolution method is introduced for the separation of HMOs by multicapillary gel electrophoresis. Two gel compositions were evaluated with complementary resolving power. One was a conventionally used industrial standard carbohydrate separation matrix, resolving oligosaccharides according to their charge to hydrodynamic volume ratios. The other one was a borate-buffered dextran gel, which utilized the secondary equilibrium of the borate-vicinal diol complexation to enhance resolution. Considering the rapid analysis time and multiplexing (12-channel system), a 96 well sample plate can be analyzed in less than 80 min with the conventional type carbohydrate separation matrix and in less than one hour with the borate-buffered dextran gel. Exploiting the one fluorophore per molecule labeling stoichiometry, the limit of detection (S/N > 3) and limit of quantitation (S/N > 10) were determined as 0.025 and 0.100 mg/mL, respectively, with good linearity. Based on the calibration plot, the quantities of several low concentration HMOs were determined from a human milk sample.
Tárgyszavak:Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Food Chemistry. - 341 : 2 (2021), p. 1-8. -
További szerzők:Borza Beáta (1990-) (biomérnök) Domokos Apolka Váradi Eszter Szigeti Márton (1986-) (környezetmérnök) Mészáros-Matwiejuk Ágnes Molnár-Gábor Dóra Guttman András (1954-) (vegyészmérnök)
Pályázati támogatás:BIONANO_GINOP-2.3.2-15-2016-00017
GINOP
NKFIH NN 127062
NKFIH
ÚNKP-19-3-I-DE-356
ÚNKP
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DOI
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3.

001-es BibID:BIBFORM073869
035-os BibID:(Scopus)85045707414 (WOS)000444799300008
Első szerző:Szigeti Márton (környezetmérnök)
Cím:Quantitative assessment of mAb Fc glycosylation of CQA importance by capillary electrophoresis / Szigeti Marton, Chapman Jeff, Borza Beata, Guttman Andras
Dátum:2018
ISSN:0173-0835 1522-2683
Megjegyzések:The attached carbohydrates at the highly conserved asparagine?linked glycosylation site in the CH2 domain of the fragment crystallizable (Fc) region of monoclonal antibody therapeutics can play an essential role in their mechanism of action, including ADCC, CDC, anti?inflammatory functions, and serum half?life. Thus, this particular glycosylation represents one of the important critical quality attributes (CQA) of therapeutic monoclonal antibodies, which should be closely monitored and controlled during all stages of biopharmaceutical manufacturing. To study Fc glycosylation related quantitative critical quality attributes, the N?glycan pool of adalimumab (Humira?) was spiked with increasing amounts of mannose?5 oligosaccharide, a glycan with high CQA importance. The method enabled precise quantitative CQA assessment with high detection sensitivity.
Tárgyszavak:Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Electrophoresis. - 39 : 18 (2018), p. 2340-2343. -
További szerzők:Chapman, Jeff Borza Beáta (1990-) (biomérnök) Guttman András (1954-) (vegyészmérnök)
Pályázati támogatás:K 116263
NKFIH
BIONANO_GINOP-2.3.2-15-2016-00017
GINOP
Internet cím:Szerző által megadott URL
DOI
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