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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Steady conjugate natural convection heat transfers in a two-dimensional enclosure filled with fluid saturated porous medium is studied numerically. The two vertical boundaries of the enclosure are kept isothermally at same temperature, the horizontal upper wall is adiabatic, and the horizontal lower wall is partially heated. The Darcy extended Brinkman Forcheimer model is used as the momentum equation and Ansys Fluent software is utilized to solve the governing equations. Rayleigh number (1.38 ≤ Ra ≤ 2.32), Darcy number (3.9 * 10-8), the ratio of conjugate wall thickness to its height (0.025 ≤ W ≤ 0.1), heater length to the bottom wall ratio (1/4 ≤ ≤ 3/4) and inclination angle (0°, 30° and 60°) are the main consid
... Show MoreTests in the sports field constitute an essential tool for achieving optimal results and evaluating player performance, particularly in competitive sports such as basketball. The importance of shooting emerges as it is the only means of direct scoring and the critical statistic that distinguishes victory from defeat. The researchers observed that previous tests of basic shooting types whether administered individually or in combination do not adequately reflect the complexities of actual game situations. Therefore, the problem lies in the need to address this gap by designing a composite test that simulates various playing conditions related to basic shooting skills. The descriptive approach was adopted, and the research community was delib
... Show MoreIn this research, the dynamics process of charge transfer from the sensitized D35CPDT dye to tin(iv) oxide( ) or titanium dioxide ( ) semiconductors are carried out by using a quantum model for charge transfer. Different chemical solvents Pyridine, 2-Methoxyethanol. Ethanol, Acetonitrile, and Methanol have been used with both systems as polar media surrounded the systems. The rate for charge transfer from photo-excitation D35CPDTdye and injection into the conduction band of or semiconductors vary from a to for system and from a to for the system, depending on the charge transfer parameters strength coupling, free energy, potential of donor and acceptor in the system. The charge transfer rate in D35CPDT / the syst
... Show MoreBootstrap is one of an important re-sampling technique which has given the attention of researches recently. The presence of outliers in the original data set may cause serious problem to the classical bootstrap when the percentage of outliers are higher than the original one. Many methods are proposed to overcome this problem such Dynamic Robust Bootstrap for LTS (DRBLTS) and Weighted Bootstrap with Probability (WBP). This paper try to show the accuracy of parameters estimation by comparison the results of both methods. The bias , MSE and RMSE are considered. The criterion of the accuracy is based on the RMSE value since the method that provide us RMSE value smaller than other is con
... Show Morehave suffered from deteriorating residential neighborhoods, poor economic, social and urban living conditions of the population and deteriorating the infrastructural and superior services. These problems were the secretions of these cities' rapid urbanization. Based on the principles of sustainable urban planning and in order to achieve adequate opportunities for the lives of the population and provide them with sustainable livelihoods, policies have emerged to upgrade along the lines of community participation and programmes to reform and develop those neighbourhoods, raise their efficiency and make them livable. Thus, the problem of research was identified "The absence of a comprehensive cognitive perception of the most prominent facto
... Show MoreObjectives: To assess the performance of a novel resin-modified glass-ionomer cement (pRMGIC) bonded to various tooth tissues after two-time intervals. Methods: 192 sound human molars were randomly assigned to 3 groups (n = 64): sound enamel, demineralised enamel, sound dentine. Sixty-four teeth with natural carious lesions including caries-affected dentine (CAD) were selected. All substrates were prepared, conditioned and restored with pRMGIC (30% ethylene glycol methacrylate phosphate (EGMP, experimental), Fuji II LC (control), Fuji IX, and Filtek™ Supreme with Scotchbond ™ Universal Adhesive. Shear bond strength (SBS) was determined after 24 h and three months storage in SBF at 37C. The debonded surfaces were examined using stereomi
... Show MoreAccording to the importance of the conveyor systems in various industrial and service lines, it is very desirable to make these systems as efficient as possible in their work. In this paper, the speed of a conveyor belt (which is in our study a part of an integrated training robotic system) is controlled using one of the artificial intelligence methods, which is the Artificial Neural Network (ANN). A visions sensor will be responsible for gathering information about the status of the conveyor belt and parts over it, where, according to this information, an intelligent decision about the belt speed will be taken by the ANN controller. ANN will control the alteration in speed in a way that gives the optimized energy efficiency through
... Show MoreRe-use of the byproduct wastes resulting from different municipal and industrial activities in the reclamation of contaminated water is real application for green projects and sustainability concepts. In this direction, the synthesis of composite sorbent from the mixing of waterworks and sewage sludge coated with new nanoparticles named “siderite” (WSSS) is the novelty of this study. These particles can be precipitated from the iron(II) nitrate using waterworks sludge as alkaline agent and source of carbonate. Characterization tests using X-ray diffraction (XRD), scanning electron microscopy (SEM) and energy dispersive spectroscopy (EDS) mapping revealed that the coating process was c
The study seeks to clarify the role of International Auditing Standard No. (320) of the relative importance in determining responsibility for planning and implementing the process of auditing financial statements and expressing neutral technical opinion through the analytical procedures of the auditor, whose responsibility is to obtain appropriate and reliable audit evidence that helps the auditor to form a general conclusion about whether The financial statements were consistent with the auditor's understanding of the entity. The relative importance contributes to defining the important accounts that help to set priorities for the auditor to set the necessary analytical procedures for these accounts. One of the most important co
... Show MoreER Abbas, AA Jasim, Journal of Physical Education, 2023 - Cited by 1