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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 research work aims to the determination of molybdenum (VI) ion via the formation of peroxy molybdenum compounds which has red-brown colour with absorbance wave length at 455nm for the system of ammonia solution-hydrogen peroxide-molybdenum (VI) using a completely newly developed microphotometer based on the ON-Line measurement. Variation of responses expressed in millivolt. A correlation coefficient of 0.9925 for the range of 2.5-150 ?g.ml-1 with percentage linearity of 98.50%. A detection limit of 0.25 ?g.ml-1 was obtained. All physical and chemical variable were optimized interferences of cation and anion were studied classical method of measurement were done and compared well with newly on-line measurements. Application for the use
... Show MoreThis paper deals with constructing mixed probability distribution from mixing exponential
Recently, the application of geosynthetics in the reinforcement of weak subgrade is expanded dramatically. However, selection of the geo-material that fits site conditions and soil type is crucial to achieving the success of the overall performance of such improvement. Also, the road life and cost construction are significant keys for evaluating this type of ground treatment. This paper presents an overview of the subgrade strengthening with geosynthetics to acquire a better understanding of the technique and to provide a clear guide for transportation and geotechnical engineers. The rutting failure along with its main causes are highlighted briefly. The types of geosynthetics, their applications and
Cerium (III), Neodymium (III) and Samarium (III) Complexes existent a wide range of implementation that stretch from their play in the medicinal and pharmaceutical area because of their major significant pharmacological characteristic such as antifungal, anti-cancer, anti-bacterial ,anti-human immunodeficiency virus ,antineoplastic, anti-inflammation,inhibition corrosion,in some industrial (polymers, Azo dye).It is likely to open avenuesto research among various disciplines such as physics, electronics, chemistry and materials science by these complexes that contain exquisitely designed organic molecules.This paper reviews the definition, importance and various applications of Cerium (III), Neodymium (III) and Samarium (III) Complexes anddi
... Show MoreDiabetic foot ulcer (DFU) or Lower limb ulcers are one of the major complications caused by diabetes mellitus especially when patients fail to maintain tight glycemic control. DFU is linked to multiple risk factors along with the genetic factors and ethnicity which play a significant role in the development of DFUs through their effects on multiple aspects of the pathophysiological process. This narrative review aimed to summarize all the previous studies within the last ten years associating gene polymorphism and DFU. Polymorphism associated with vascular endothelial growth factor (rs699947), the G894T polymorphism of the endothelial nitric oxide synthase gene, interleukin-6–174 G>C gene polymorphism, heat shock protein 70 gene polymorph
... Show MoreLand snails constitute an important group of mollusks distributed worldwide. This study reports on land snails found in Iraq. A survey of terrestrial gastropods was performed during their activity seasons in gardens, agricultural lands and nurseries in Iraq from March 2022 to September 2023. Fifteen terrestrial snails belonging to seven families were documented. The species Euchondrus michonii (Bourguignat, 1853) was identified and recorded based on several distinct conchological characters for the first time in Iraq. The recently collected specimens, along with those previously recorded in Iraq, were included in this checklist. Essential information on each species is also presented. As there is no previous checklist or study that
... Show MoreIn this paper we proposed a new method for selecting a smoothing parameter in kernel estimator to estimate a nonparametric regression function in the presence of missing values. The proposed method is based on work on the golden ratio and Surah AL-E-Imran in the Qur'an. Simulation experiments were conducted to study a small sample behavior. The results proved the superiority the proposed on the competition method for selecting smoothing parameter.
Cerium (III), Neodymium (III) and Samarium (III) Complexes existent a wide range of implementation that stretch from their play in the medicinal and pharmaceutical area because of their major significant pharmacological characteristic such as antifungal, anti-cancer, anti-bacterial ,anti-human immunodeficiency virus ,antineoplastic, anti-inflammation,inhibition corrosion,in some industrial (polymers, Azo dye).It is likely to open avenuesto research among various disciplines such as physics, electronics, chemistry and materials science by these complexes that contain exquisitely designed organic molecules.This paper reviews the definition, importance and various applications of Cerium (III), Neodymium (III) and Samarium (III) Complexe
... Show MoreStatement of the Problem. The use of orthodontic fixed appliances may adversely affect oral health leading to demineralizing lesions and the development of gingival problems. Aims of the Study. The study aimed to coat orthodontic archwires with chlorhexidine hexametaphosphate nanoparticles (CHX-HMP NPs) and to evaluate the elusion of CHX from CHX-HMP NPs. Materials and Methods. A solution of CHX-HMP nanoparticles with an overall concentration of 5 mM for both CHX and HMP was prepared, characterized (using atomic force microscope and Fourier transformation infrared spectroscopy), and used to coat orthodontic stainless steel (SSW) and NiTi archwires (NiTiW). The coated segments were characterized (using scanning electron microscopy
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