Determination of immunogenic proteins in biopharmaceuticals by UHPLC-MS amino acid analysis.
Amino acids
Biopharmaceuticals
Derivatization
Etanercept
Keyhole limpet hemocyanin
Mass spectrometry
Quality control
Ultra high-performance chromatography
Journal
BMC chemistry
ISSN: 2661-801X
Titre abrégé: BMC Chem
Pays: Switzerland
ID NLM: 101741142
Informations de publication
Date de publication:
Dec 2019
Dec 2019
Historique:
received:
17
01
2019
accepted:
02
05
2019
entrez:
7
8
2019
pubmed:
7
8
2019
medline:
7
8
2019
Statut:
epublish
Résumé
Nowadays, there is a growing interest in innovative and more efficient therapeutics-biopharmaceuticals, based on peptides or proteins. There are increased demands on quality control of such therapeutics. One of the methods usually used for characterization and quantification of biopharmaceuticals is amino acid analysis. In this work, a modern advanced analytical method based on precolumn derivatization and reversed-phase ultra high-performance liquid chromatography in combination with single quadrupole mass spectrometer was developed for amino acid analysis in different protein samples-model sample of bovine serum albumin, sample of strong immunogenic protein keyhole limpet hemocyanin, and sample of drug etanercept present in commercially available biopharmaceutical Enbrel. The method used isotopically labeled internal standards and was validated according to the International Council for Harmonisation guideline. The developed method was characterized by favorable performance and validation parameters, such as time of analysis (6 min), specificity, linearity (r
Identifiants
pubmed: 31384811
doi: 10.1186/s13065-019-0581-z
pii: 581
pmc: PMC6661756
doi:
Types de publication
Journal Article
Langues
eng
Pagination
64Déclaration de conflit d'intérêts
Competing interestsThe authors declare that they have no competing interests.
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