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[期刊论文][Original Paper]
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Analysis of recombinant human follicle-stimulating hormone (FSH) by mass spectrometric approaches
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作 者:
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Josephine Grass;Martin Pabst;Martina Chang;Manfred Wozny;Friedrich Altmann;
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出版年:2011
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页 码:2427 - 2438
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出版社:Springer Nature
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摘 要:
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Recombinant human follicle stimulating hormone is an important drug in reproductive medicine. Thorough analysis of the heterodimeric heavily glycosylated protein is a prerequisite for the evaluation of production batches as well as for the determination of "essential similarity" of new biosimilars. The concerted application of different liquid chromatography-mass spectrometry methods enabled the complete depiction of the primary structure of this pituitary hormone. Sequence coverage of 100% for the α- as well as the β-chain was achieved with tryptic peptides. Most of these peptides could be verified by tandem mass spectrometry. Site-specific analysis of all four glycosylation sites was, however, not possible with tryptic but with chymotryptic peptides. Quantification of the glycoforms of each glycopeptide was accomplished with the software MassMap®. Both protein subunits gave interpretable mass spectra upon S-alkylation and separation on a C5 reversed-phase column. Glycan isomer patterns were depicted by separation on porous graphitic carbon, using mass spectrometric detection for the evaluation of the glycopeptide liquid chromatography-electrospray ionization data. The currently marketed product Gonal-f™ and a potential biosimilar were compared with the help of these procedures.
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关键字:
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Follicle-stimulating hormone; Follitropin; Glycoprotein; Biosimilar; Industry SectorsPharma ; Materials & Steel ; Automotive ; Chemical Manufacturing ; Finance, Business & Banking ; Health & Hospitals ; Biotechnology ; Electronics ; IT & Software ; Telecommunications ; Consumer Packaged Goods ; Energy, Utilities & Environment ; Aerospace ; Oil, Gas & Geosciences ; Engineering ;
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所属期刊
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ISSN: 1618-2642
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来自:Springer Nature
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