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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 aimed at studying the inhibitive effect of the hot watery dry and ethanolic ginger(85%) and fragrant oil which are added in concentrates of o.o25, o.o5o and 0.1g / 100g respectively in the growth of bacteria and molds. The results of the initial chemical diagnosis showed containment of ginger roots extract on. Alkaloids, Glycosides, Flavonoids and Suponins. The highest inhibitive effect of the bacteria reached the concentrate . 0.1% of the oil extract then the concentrate 0.050% of the ethanolic hot extract follows it. While 0.1% was the least inhibitive concentrate for the hot watery extract. But the inhibitive effect of the hot oily and alcoholic extracts in the numbers of molds colonies was 0.025%, when the concentrate 0.1%
... Show MoreThe aim of this work is to explore the thermal performance of a tracked tubular solar still (TSS) with a parabolic trough concentrator in Baghdad (33.27° N, 44.37° E) in September 2022. The present tubular still is distinguished by its hexagonal glass cover. The effect of integrating the TSS with a heat pipe, the still tilt angle (10°, 15°), and the depth of saline water inside the still partitions on the productivity of freshwater are investigated. The results showed that using heat pipe enhances the freshwater productivity by 25%–40% and the efficiency by 25%. For the still integrated with heat pipe, as the water depth is increased from 5.5 to 6.5 cm the productivity of freshwater is incre
Objectives: This study aims to assess and compare the micro-shear bond strength (μSBS) of a novel resin-modified glass-ionomer luting cement functionalized with a methacrylate co-monomer containing a phosphoric acid group, 30 wt% 2-(methacryloxy) ethyl phosphate (2-MEP), with different substrates (dentin, enamel, zirconia, and base metal alloy). This assessment is conducted in comparison with conventional resin-modified glass ionomer cement and self-adhesive resin cement. Materials and methods: In this in vitro study, ninety-six specimens were prepared and categorized into four groups: enamel (A), dentin (B), zirconia (C), and base metal alloys (D). Enamel (E) and dentin (D) specimens were obtained from 30 human maxillary first premolars e
... Show MoreThis study was based on the determination of aphid species that infested Chrysanthemum sp. (Asterales, Asteraceae) in the middle of Iraq; five aphid species belong to subfamily Aphidinae were recorded: Aphis fabae Scopoli, 1763, Aphis gossypii Glover, 1877, Coloradoa rufomaculata (Wilson, 1908), Macrosiphoniella sanborni (Gillette, 1908) and Myzus persicae (Sulzer, 1776). A. gossypii was the most dominant species throughout the study period while M. persicae is the lesser species.
A summary of the main taxonomic characters is presented here and a pictorial key which was designed to separate aphi
... Show MoreAryl hydrocarbon receptor (AhR) is a ligand-activated transcription factor that regulates T cell function. The aim of this study was to investigate the effects of AhR ligands, 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD), and 6-Formylindolo[3,2-b]carbazole (FICZ), on gut-associated microbiota and T cell responses during delayed-type hypersensitivity (DTH) reaction induced by methylated bovine serum albumin (mBSA) in a mouse model. Mice with DTH showed significant changes in gut microbiota including an increased abundance of
In this review, previous studies on the synthesis and characterization of the metal Complexes with paracetamol by elemental analysis, thermal analysis, (IR, NMR and UV-Vis (spectroscopy and conductivity. In reviewing these studies, the authors found that paracetamol can be coordinated through the pair of electrons on the hydroxyl O-atom, carbonyl O-atom, and N-atom of the amide group. If the paracetamol was a monodentate ligand, it will be coordinated by one of the following atoms O-hydroxyl, O-carbonyl or N-amide. But if the paracetamol was bidentate, it is coordinated by atoms (O-carbonyl and N-amide), (O-hydroxyl and N-amide) or (O-carbonyl and O-hydroxyl). The authors also found that free paracetamol and its complexes have antimicrobial
... Show MoreIn this review, previous studies on the synthesis and characterization of the metal Complexes with paracetamol by elemental analysis, thermal analysis, (IR, NMR and UV-Vis (spectroscopy and conductivity. In reviewing these studies, the authors found that paracetamol can be coordinated through the pair of electrons on the hydroxyl O-atom, carbonyl O-atom, and N-atom of the amide group. If the paracetamol was a monodentate ligand, it will be coordinated by one of the following atoms O-hydroxyl, O-carbonyl or N-amide. But if the paracetamol was bidentate, it is coordinated by atoms (O-carbonyl and N-amide), (O-hydroxyl and N-amide) or (O-carbonyl and O-hydroxyl). The authors also found that free paracetamol and its complexes have antimicrobial
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