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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
The research aims to reveal the recent trends used in providing information and to know the persuasive methods used in designing the content of the infographic as well as the nature of persuasive design methods and the topics presented by the infographic in the research sample. The researcher used the survey method, specifically the survey, by using the content analysis method to analyze the infographic material from the sample selected from the press and news sites that are the subject of the research, based on the method of what was said? How was it said? The researcher relied on the intentional sample, and this sample depends on the researcher selecting the vocabulary of the sample based on experiences and evaluating the c
... Show MoreOver application courier company (DHL) to keep the quality of service to achieve customer satisfaction the adoption of precedence delivery time - A prospective study))
Become attention to quality is a global phenomenon, and I took organizations and governments around the world attaches special attention, but we can say that quality has become the first function for many organizations, and has become a management philosophy
The adsorption of Cr (VI) from aqueous solution by spent tea leaves (STL) was studied at different initial Cr (VI) concentrations, adsorbent dose, pH and contact time under batch isotherm experiments The adsorption experiments were carried out at 30°C and the effects of the four parameters on chromium uptake to establish a mathematical model description percentage removal of Cr (VI). The
analysis results showed that the experimental data were adequately fitted to second order polynomial model with correlation coefficients for this model was (R2 = 0.9891). The optimum operating parameters of initial Cr (VI) concentrations, adsorbent dose, pH and contact time were 50 mg/l, 0.7625 g, 3 and 100 min, respectively. At these conditions, th
In this work we used the environmentally friendly method to prepared ZrO2 nanoparticles utilizing the extract of Thyms plant In basic medium and at pH 12, the ZrO2 NPs was characterized by different techniques such as FTIR, ultraviolet visible, Atomic force microscope, Scanning Electron Microscopy, X-ray diffraction and Energy dispersive X-ray. The average crystalline size was calculated using the Debye Scherres equation in value 7.65 nm. Atomic force microscope results showed the size values for ZrO2 NPs were 45.11nm, and there are several distortions due to the presence of some large sizes. Atomic force microscope results showed the typical size values for ZrO2 NPs were 45.11 nm, and there are several distortions due to the presence of so
... Show MoreThe present work deals with five species of parasitic Hymenoptera belonging to Pteromalidae, Eupelmidae and Eurytornidae which have been reared from brachid beetles. A new species, Eurytoma irakensis is described and the species, Bruchocida orientalis Crawford is recorded for the first time from Iraq.
The research study is important since it establishes predicted rates for various nervous system functional indicators.In terms of performing the skill of Dribbling in basketball for young players in Baghdad Governorate in order to reach scientific results that serve researchers, coaches, and players uniformly. The study's goal is to create predictive equations for specific functional indicators of the nervous system in relation to the Dribbling skill performance of young basketball players in Baghdad Governorate. The researchers used a descriptive approach with a survey method on (8) youth basketball league clubs in Baghdad Governorate for the 2022-2023 sports season, totaling (96) players . Three tests were used to measure the nervous sy
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