title: Comparative Biochemical and Functional Studies on a Branded Human Recombinant Factor VIIa and a Biosimilar Equivalent Product.
abstract: Recombinant factor VIIa (rFVIIa; NovoSeven, Novo Nordisk, Copenhagen, Denmark) is used to control bleeding in patients with hemophilia. A generic version of FVIIa was developed by AryoGen (Tehran, Iran). This study compared the composition and functional activities of AryoSeven and NovoSeven. Each product was compared at equigravimetric (1 mg/mL) stock solution for protein content. The proteomic profile was obtained using surface-enhanced laser desorption ionization mass spectrometry. Sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) analysis was carried out to determine the protein profile and Western blotting was performed using a polyclonal rabbit antihuman FVIIa antibody. The FVIIa-related antigen was also measured using a commercially available enzyme-linked immunosorbent assay method. Functional assay included the prothrombin time correction in FVII-deficient plasma. The protein content was comparable in 2 products and the mass spectra analysis showed a single peak at 50 kDa in all products. The SDS-PAGE and immunoblotting studies were comparable. Both products exhibited similar coagulant properties in different assays.
authors.affiliation: Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Nasiredin
authors.initials: N
authors.lastname: Sadeghi
authors.affiliation: Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Kahn
authors.affiliation: Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Daneyal
authors.initials: D
authors.lastname: Syed
authors.affiliation: Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Omer
authors.initials: O
authors.lastname: Iqbal
authors.affiliation: Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Schuharazad
authors.initials: S
authors.lastname: Abro
authors.affiliation: Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Reza
authors.initials: R
authors.lastname: Eshraghi
authors.affiliation: Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Hoppensteadt
authors.affiliation: Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA jfareed@lumc.edu.
authors.forename: Jawed
authors.initials: J
authors.lastname: Fareed
mesh_terms: D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000032:analysis* / Q000737:chemistry*; D004591:Electrophoresis, Polyacrylamide Gel; D015942:Factor VIIa / Q000032:analysis* / Q000737:chemistry*; D006801:Humans; D011517:Prothrombin Time; D011817:Rabbits; D011994:Recombinant Proteins / Q000032:analysis / Q000737:chemistry
chemical_list: D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa
keywords: AryoSeven; Innovin; NovoSeven; RecombiPlasTin 2G