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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 present work includes the preparation and characterization of{Co(II) , Ni(II), Pd(II), Fe(III) , Ru(III),Rh(III), Os(III) , Ir(III) , Pt(IV) and VO(IV)}complexes of a new ligand 4-[(1-phenyl-2,3-dimethyl-3-pyrozoline-5-one)azo]-N,N-dimethylanline (PAD). The product (PAD) was isolated,studies and characterized by phsical measurements,i.e., (FT-IR), (UV) Spectroscopy and elemental analysis(C.H.N). The prepared complexes were identified and their structural geometric were suggested in solid state by using flame atomic absorption, elemental analysis(C.H.N), (FT-IR) and (UV-Vis) Spectroscopy, as well as magnetic susceptibility and conductivity measurements . The study of the nature of the complexes formed in( ethanolic solution) following t
... Show MoreTo study the response of the celery plant to nitrogen fertilization and spray with salicylic acid in the leaves content of nutrients, the research was conducted in one of the fields of the Department of Horticulture and Gardening Engineering / College of Agriculture / University of Baghdad within the 2019-2018 season. The research was carried out as a global experiment and with the design of complete randomized sectors (RCBD) and with three replicates, the first factor included the addition of nitrogen with three levels and its symbol (N) (N1 control), (N2) g / m2 18 ), (N3) 37 g / m2 and the second factor spraying acid salicylic is denoted by
The study aims to identify the mechanical and electrical activities of the heart according to the energy systems of advanced players and to detect the differences between the energy systems in terms of the mechanical and electrical activities of the heart for advanced players. It was clear from the results of the significance of the differences between the three groups according to the energy systems of the advanced players in all research variables that (the non-oxygenic system "Lactic"), which represents the advanced players in the arches (800 m, 1500 m) was the first in most tests of mechanical and electrical activities of the heart, which is (Margaria-Kalamen, Wingate, systolic muscle strength of the heart FC, Stroke Volume SV
... Show MoreThe term ‘photometry’ refers to the accurate determination of the apparent brightness of an astronomical object. Until roughly 1980, nearly all astronomical photometry was done by means of analog measurements of photographic plates, or by analog or digital (photon-counting) techniques with photomultipliers. These photometers produced brightness readings which were typically displayed on dials, plotted on strip charts or printed on strips of paper, and it was often quite practical to analyse these raw data with pencil, paper and a slide rule or table of logarithms. However, during the late 1970s electronic area detectors for astronomy became more advanced: first, for a brief period, television-type cameras were employed, but these were s
... Show MoreThis paper includes the application of Queuing theory with of Particle swarm algorithm or is called (Intelligence swarm) to solve the problem of The queues and developed for General commission for taxes /branch Karkh center in the service stage of the Department of calculators composed of six employees , and it was chosen queuing model is a single-service channel M / M / 1 according to the nature of the circuit work mentioned above and it will be divided according to the letters system for each employee, and it was composed of data collection times (arrival time , service time, departure time)
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field of modern and contemporary Yemeni history, accomplished at Ibn Rushd College of Education, University of Baghdad. It was determined according to a time frame in the years 1989, which is the date of completion of the first master’s thesis in the field of modern and contemporary Yemeni history, which deals with the subject of “Iraqi-Yemeni relations 1932- 1962”, and the year 2020, which is the year of completion of a master’s thesis on the position of Iraqi public opinion on the Egyptian military intervention in Yemen (1962-1970). The study determined the nature of these studies, whether they were in the form of master’s theses or doctoral dissertations, or research and studies published in issues of the refereed scien
... Show MoreIn the ongoing series of our research, we prepared a new multifunctional azo-vanillin ligand (HL) and its Cu(II) complex to investigate their potential as versatile compounds for industrial/pharmaceutical purposes. Structural integrity was determined through spectroscopic analyses (FT-IR, NMR, Mass and UV-Vis), highlighting a distorted square planar geometry for the metal complex. The ligand was examined for its dyeing potential on wool and cotton with the latter showing better substantivity to cellulosic fibers and behaving as a good direct dye having excellent washing fastness. Furthermore, leveraging its surface-active properties, the ligand was tested as a green corrosion inhibitor for C-45 steel in a saline medium (3.5% NaCl) acr
... Show MoreBackground This in vitro study compares a novel calcium-phosphate etchant paste to conventional 37% phosphoric acid gel for bonding metal and ceramic brackets by evaluating the shear bond strength, remnant adhesive and enamel damage following water storage, acid challenge and fatigue loading. Material and Methods Metal and ceramic brackets were bonded to 240 extracted human premolars using two enamel conditioning protocols: conventional 37% phosphoric acid (PA) gel (control), and an acidic calcium-phosphate (CaP) paste. The CaP paste was prepared from β-tricalcium phosphate and monocalcium phosphate monohydrate powders mixed with 37% phosphoric acid solution, and the resulting phase was confirmed using FTIR. The bonded premolars were expo
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