Development and certification of a pharmacopoeial reference standard for primary structure identification of purified recombinant interferon beta-1b by peptide mapping

Development and certification of a pharmacopoeial reference standard for primary structure identification of purified recombinant interferon beta-1b by peptide mapping

Medicines based on recombinant human interferons (rhIFNs) beta-1a and beta-1b are used as first-line treatment of multiple sclerosis. Meanwhile, rhIFN beta-1a and beta-1b have structural differences associated with the eukaryotic or prokaryotic expression systems, respectively. Pharmacopoeias requir...

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Main Authors: E. O. Goloshchapova, O. B. Rounova, A. S. Minero, O. V. Fadeikina, R. A. Volkova, M. B. Degterev, S. A. Taran, R. R. Shukurov, O. B. Ustinnikova
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2022-04-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
recombinant interferon beta-1b
identification
peptide mapping
high performance liquid chromatography
mass spectrometry
pharmacopoeial reference standard (phrs)
Online Access:https://www.biopreparations.ru/jour/article/view/415
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