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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
This work aimed to study the effect of laser surface treatment on the mechanical characteristics and corrosion behaviour of grey cast iron type A159. Many technical applications used conventional surface treatment, but laser surface hardening has recently been used to enhance the surface properties of many alloys. The mechanical characteristics, including microstructure, microhardness, and wear resistance of A159 grey cast iron, were studied, in addition to corrosion behaviour. The experimental laser parameters in this work were 0.9, 1.2, and 1.5 KW power with continuous wave carbon dioxide lasers with scanning speeds of 10 and 12 mm/s were used. The results found that phase-transitional alterations in microstructure were influenced by lase
... Show MoreAIM: To determine the value of the combination of thin-section 3 mm coronal and standard axial DWI and their impact in facilitating the diagnosis of acute brainstem infarction. METHODS: A cross-sectional study conducted from the 1st of April 2017 to the end of February 2018 on 100 consecutive patients (66% were male, and 34% were female) with isolated acute ischemic infarction in the brainstem. The abnormal MRI findings concerning the ischemic lesions were interpreted on standard axial 5 mm and thin-section coronal 3mm DWI. RESULTS: The mean age of the studied group was 69.2 ± 4.3 for male and 72.3 ± 2.5 years. The standard axial DWI can diagnose 20%, 6.7% and 6.7% of the infarctions in midbrain, pons an
... Show MoreOral squamous cell carcinoma (OSCC) is the most common malignant neoplasm of the oral mucosa. Human papillomavirus (HPV) virus cause a broad scope of diseases from benign to invasive tumors, types 16 and 18 classified as carcinogenic to humans. This study aimed to provide the first molecular characterization of HPV types in Iraq. Thirty-five unstimulated whole saliva samples were collected from histopathologically confirmed patients with oral cancer were enrolled in this study. Genomic DNA was extracted from exfoliating cells to amplify HPV-DNA using HPV-L1 gene sequence primers by polymerase chain reaction method (PCR), the viral genotyping was performed using direct sequencing method. HPV genotypes identified were deposited in Gen
... Show MoreOne of the important units in Sharq Dijla Water Treatment Plant (WTP) first and second extensions are the alum solution preparation and dosing unit. The existing operation of this unit accomplished manually starting from unloading the powder alum in the preparation basin and ending by controlling the alum dosage addition through the dosing pumps to the flash mix chambers. Because of the modern trend of monitoring and control the automatic operation of WTPs due to the great benefits that could be gain from optimum equipment operation, reducing the operating costs and human errors. This study deals with how to transform the conventional operation to an automatic monitoring and controlling system depending on a Programmable
... Show MoreThe question of word–formation motivation is one of the most urgent problems of morphological features of diminutive vocabulary in the languages of different structures, Arabic – Semitic and Russian - Slavic. The relevance of this question lies in the fact that the analysis of morphological elements of word-formation motivation plays an important role not only in identifying formal and semantic connections between different units of the same language, but also has an applied value in the comparative study of different languages. Taking in to account that word-formation motivation is usually considered sequentially in order to identify motivational relationships of this type of vocabulary, we will study motivation in comparative analy
... Show MoreThe specific activities of the natural radionuclides U-238 and Th-
232 and K-40 in 14 soil samples collected from different sites from
AL-Mustansiriyah university at two depths (topsoil "surface" and
20cm depth) were be investigated using gamma ray spectrometer
3"x3" NaI(Tl) scintillation detector.
The analysis of the energy spectra of the soil samples show that
these samples have specific activities ranging with (16.08-51.11)
Bq/kg for U-238, (14.79-52.29) Bq/kg for Th-232 and (191.08-
377.64) Bq/kg for K-40, with an average values of 29.37, 34.14 and
289.62 Bq/kg for U-238, Th-232, k-40 respectively. The radiation
hazard parameters of the natural radionuclides; radium equivalent
activity (Raeq), gamma a
Karbala province regarded one part significant zones in Iraq and considered an economic resource of vegetation such as trees of fruits, sieve and other vegetation. This research aimed to utilize Normalized Difference Vegetation index (NDVI) and Subtracted (NDVI) for investigating the current vegetation cover at last four decay. The Normalized Difference Vegetation Index (NDVI) is the most extensively used satellite index of vegetation health and density. The primary goals of this research are gather a gathering of studied area (Karbala province) satellite images in sequence time for a similar region, these image captured by Landsat (TM 1985, TM 1995, ETM+ 2005 and Landsat 8 OLI (Operational Land Imager) 2015. Preprocessing such gap filli
... Show MoreBackground: Calcium hydroxide and calcium-silicate materials used as direct pulp capping materials. The aims of this in vitro study is to compare among these materials in, the calcium ion release and pH change in soaking water after immersion of materials’ specimens in deionized water. Also Solubility and water sorption of materials’ specimens measured after soaking time. Calcium-silicate materials used were Biodentine, TheraCal and MTA Plus. Materials and methods: Four materials used in this study; Urbical lining (as control group), Biodentine, TheraCal and MTA Plus. Ten discs fabricated from each tested material, by using plastic moulds of 9 mm diameter and 1 mm thickness. Each specimen was immersed in 10 ml of d
... Show MoreIn the present paper, chitosan Schiff base has been synthesized from chitosan’s reaction with the salicyldehyde. The AuNPs was manufacture by extract of onion peels as a reducing agent. The Au NPs that have been prepared were characterized through the UV-vis spectroscopy, XRD analyses and SEM microscopy. The polymer blends of the chitosan Schiff base / PVP has been prepared through using the approach of solution casting. Chitosan Schiff base / PVP Au nano-composites was prepared. Nano composites and polymer blends have been characterized by FTIR which confirm the formation of Schiff base by revealing a new band of absorption at 1651cm-1 as a result of the (C=N) imine group. SEM, DSC and TGA confirms the thermal stability of the pr
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