Background: Trastuzumab is a blockbuster monoclonal antibody that has revolutionized the treatment of HER2-positive breast and gastric cancers. With the increasing availability of biosimilar monoclonal antibodies in clinical practice, independent verification of biosimilarity using products sampled from a real-world supply chain is important to assure clinicians and the patients to use these products confidently. Objective: The aim of this study is to assess the biosimilarity of AryoTrust, a trastuzumab biosimilar, in comparison with the reference product Herceptin. AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings. Methods: AryoTrust and Herceptin were compared using an extensive set of orthogonal analytical techniques which included SDS-PAGE, ion-exchange chromatography, capillary isoelectric focusing, peptide mapping, N-glycan profiling, circular dichroism, differential scanning calorimetry, and surface plasmon resonance. In addition to these teste, functional comparability was also tested using an HER2-dependent cell-based proliferation inhibition bioassay. Results: The results showed that both products have highly comparable profiles in all assessed attributes. The analysis showed similar molecular integrity and purity, identical primary structure, comparable charge heterogeneity, similar isoelectric points (pI) of the main isoform, close glycosylation patterns (mainly, by core-fucosylated complex-type glycans), similar higher-order structural features, and thermal stability. The receptor binding studies exhibited comparable binding affinities with Fcγ receptors and FcRn. Finally, the cell-based bioassay revealed comparable dose–response curves with similar EC50 values and relative potency. Conclusions: The integrated analytical and functional data support the biosimilarity of AryoTrust to the reference product Herceptin, which has been marketed and used in Iraq. This study provides real-world scientific evidence supporting confidence in the quality and comparability of this trastuzumab biosimilar and reduces any doubt in the product and at the same time emphasizes the value of independent post-marketing biosimilarity assessments.
Cutaneous leishmaniasis is one of endemic diseases in Iraq. It is considered as widely health problem and is an uncontrolled disease. The aim of the study is to identify of Leishmania species that cause skin lesions among patients in Thi-Qar Province, South of Iraq, also to detect some virulence factors of L. tropica. This study includes three local locations, Al-Hussein Teaching, Suq Al-Shyokh General and Al-Shatrah General Hospitals in Province for the period from the beginning of December 2018 to the end of September 2019. The samples were collected from 80 patients suffering from cutaneous leishmaniasis, both genders, different ages, various residence places and single and multiple lesions. Nested-PCR technique was
... Show MoreA theoretical and protection study was conducted of the corrosion behavior of carbon steel surface with different concentrations of the derivative (Quinolin-2-one), namly (1-Amino-4,7-dimethyl-6-nitro-1H-quinolin-2-one (ADNQ2O)). Theoretically, Density Functional Theory (DFT) of B3LYP/ 6-311++G (2d, 2p) level was used to calculate the optimized geometry, physical properties and chemical inhibition parameters, with the local reactivity to predict both the reactive centers and to locate the possible sites of nucleophilic and electrophilic attacks, in vacuum, and in two solvents (DMSO and H2O), all at the equilibrium geometry. Experimentally, the inhibition efficiencies (%IE) in the saline solution (of 3.5%) NaCl were studied using potentiomet
... Show MoreAu nanoparticle-functionalized (TiO2)1−x(ZnO:MgO)x nanocomposite thin films (0≤x≤0.3) were effectively produced by chemical spray pyrolysis and annealed at 600 °C. The effects of ZnO incorporation and Au nanoparticle modification on the films' structural, optical, and antibacterial properties were studied using X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FTIR), UV–Vis spectroscopy, and field-emission scanning electron microscopy (FESEM). XRD analysis confirms the formation of polycrystalline anatase TiO2 and shows a composition-dependent structural develop- ment with increasing ZnO concentration. The optical experiments revealed increased transmittance and a progressive wid- ening of the optical band gap f
... Show MoreThe aim of this study is to screen the phytochemicals found in Populus euphratica leaves since this type of trees are used traditionally by many villagers as treatment for eczema and other skin disease and also this plant is poorly investigated for their phytochemicals especially in Iraq. Phytochemical screening of the extracts obtained from the n-hexane and chloroform fraction of leaves of Populus euphratica was done by Thin-layer chromatography and various spraying reagents to test if alkaloids, sterols and other compounds are present. UPLC-electrospray ionization –tandem mass spectroscopy along with GC-MS and HPTLC are used to identify the phytochemicals present in the plant leaves.UPLC-ESI-MS/MS method 20 compound
... Show MoreGel polymer electrolytes (GPEs) have drawn a lot of interest due to their special qualities, which include high conductivity that is comparable to liquid electrolytes, excellent mechanical stability, and high flexibility. Using the solution casting approach, we have synthesized copper ion conducting gel polymer electrolyte (GPE) films made of polyvinyl alcohol (PVA) as the polymer host. An ionic salt, copper sulphate (CuSO 4 ), and a plasticizing solvent, PANI/ [BMIM] [BF 4 ] polyionic liquid, were employed. The structural, electrical, and electrochemical properties of the GPE films were carefully examined. The significant XRD crystalline peak decreased and disappeared upon the addition of PANI/[BMIM] [BF 4 ] polyionic liquid, suggesting th
... Show MoreIn this study, thin flms containing titanium dioxide (TiO₂), iron (III) oxide (Fe2O3) and cerium oxide (CeO2), with varying Fe2O3:CeO2 concentrations ranging from 0 to 30 wt% and 10 wt% gold nanoparticles (AuNPs), were prepared on glass using chemical spray pyrolysis. The structural, morphological, and sensing properties of the prepared thin flms were examined. XRD analysis revealed that a phase transformation occurred based on the dopant concentration: flms with x = 0 or 0.1 formed a polycrystalline anatase structure, whereas those with intermediate concentrations (x = 0.15 or 0.20) were amorphous. At higher doping concentrations (x = 0.25, 0.30), the structure developed a hematite Fe2O3, CeO2 and Au phase. Morphologicall
... Show More