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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
In the present research a new test rig has been proposed to be suitable for different cyclic loads such as cyclic bending, cyclic torsion, proportional and non proportional loads. In this work the efforts were concentrated on the cyclic bending loads concerning cracked pipes with or without internal pulsing pressure to study crack propagation in small bore pipes (up to 1'') for transverse or inclined cracks. The rig simulates the real service conditions under different stresses by means the least dangerous case will be suggested, so the experiments were considered for copper pipe, and the results have been tabulated and drawn to demonstrate the crack growth behavior as well as to justify the outcomes practically, consequently the durabil
... Show MoreThis study was done in green house of college of Agricultural engineering sciences during the season 2019-2020 to study the effect of the foliar spray with yeast suspension, nutrition solution (Foliartal) and their interaction on some leaf nutrients contents of (
The percent work was designed to determine the effect of ginger plant aqueous extract on function and histological structure of kidney in mice treated with carbon tetrachloride (CCl4). Ginger plant caused a protective effect against CCl4 induced kidney damage and improved the kidney weight and biochemical parameters including urea, uric acid and creatinine. The ginger plant has a protective effect against injury in the kidney of mice treated with CCL4, because the ginger plant protects the tissues of kidney from toxic effect of CCL4. The kidney of CCL4 treated mice showed many histological alterations in the kidney included: atrophy, vascular degeneration and hemorrhage, death cell, degeneration of epithelial cells, destruction of basement
... Show MoreInternational news websites, including Russia Today, pay special attention to the media image of Afghan women, especially after the Taliban movement took control of Afghanistan. Therefore, it was necessary to know the image of the Afghan woman, the fate of the rights she acquired in recent years, and the transformations that affected her after the Taliban took control of the government, and studied them on international news sites, specifically Russia Today.
The researcher summarized the problem of this study in the following question: What is the media image of the Afghan woman on the Russia Today news site?
... Show More
The news media material to any means of mass media, and increasingly
important in TV; what the associated word and image effects, which do different cover events (political, economic, sports, and social .... etc.) directly from the event site and gather the news and do prepared formulation and arranged within the framework provided by the newsletter, as it requires the viewer to provide the public with information about this news correlated; to achieve the greatest gravity following the shapes and styles and technical fees (Alkraveks) during the submission. What we are witnessing today from technological developments help existing staff to cover the news activity quickly and efficiently prohibitivel
... Show MoreMany international studies indicated that the polymorphisms of some genes disturbed the folate homocysteine (Hcy) metabolism and increased the vulnerability to Down syndrome (DS). We aimed to measure the serum levels of folate and Hcy in DS children and compare the levels with age and sex-matched apparently normal healthy children. We also aimed to study the A80G polymorphism of the gene reduced folate carrier (RFC1) in the DS children as a risk factor. Forty children with DS (24 were boys, and 16 were girls) with the age range between 5-13 years, and 26 normal healthy children (16 boys and ten girls) were included in this study. The results show that the highest genotype in the control group was AG (53.85%) followed by AA and GG (30.
... Show MoreABSTRACT This study developed two adsorbents for extracting salbutamol sulphate (SAS) from water and urine samples after derivatisation with 2-aminobenzothiazole as a colour reagent. These adsorbents include cetylpyridinium chloride surfactant (CPC) modified silica and alumina-coated magnetite nanoparticles (Fe3O4/SiO2/CPC and Fe3O4/Al2O3/CPC). The derivatisation of SAS with the colour reagent resulted in an orange azo dye with maximum adsorption wavelengths of 443.0 nm. UV–Vis spectroscopy was used to identify the target analyte following the magnetic solid-phase extraction (MSPE) method. Under optimal conditions, the concentration ranges of 0.03–5.00 µg/mL and 0.05–6.00 µg/mL with good linearity (˃ 0.99), the detection limi
... Show MoreAbstract
This research aims to define the roles of auditors by clarifying the concept and risks of cyber security in protecting information and financial data in economic units. Najaf, Babylon and Karbala, then the results were analyzed and the results were presented and analyzed to show that adopting cyber security improves the quality of reports Finance through what it achieves in displaying information with credibility and transparency, in a way that suits the needs of users, and cyber security has a role in managing economic resources more effectively to obtain benefits that would have been lost in the event of an
... Show MoreThe aim of this study is to shed light on the importance of biofuels as an alternative to conventional energy, in addition to the importance of preserving agricultural crops, which are the main source of this fuel, to maintain food security, especially in developing countries. The increase in global oil prices, in addition to the fear of global warming, are among the main factors that draw the world’s attention to searching for alternative sources of traditional energy, which are sustainable on the one hand, and on the other hand reduce carbon emissions. Therefore, the volume of global investment in renewable energy in general, and in liquid biofuels and biomass in particular, has increased. Global fears emerged that the excessive convers
... Show More