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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Abstract:-
The approach maintenance and replacement one of techniques of operations research whom cares of the failure experienced by a lot of production lines which consist of a set of machines and equipment, which in turn exposed to the failure or work stoppages over the lifetime, which requires reducing the working time of these machines or equipment below what can or conuct maintenance process once in a while or a replacement for one part of the machine or replace one of the machines in production lines. In this research is the study of the failure s that occur in some parts of one of the machines for the General Company for Vege
... Show MoreThe purpose of this research is to find the estimator of the average proportion of defectives based on attribute samples. That have been curtailed either with rejection of a lot finding the kth defective or with acceptance on finding the kth non defective.
The MLE (Maximum likelihood estimator) is derived. And also the ASN in Single Curtailed Sampling has been derived and we obtain a simplified Formula All the Notations needed are explained.
The preparatory phase since it corresponds to adolescence are the most important stages of life , where the individual 's personality to take shape at this stage and start asking questions about the same , trying to discover the positive and negative traits hehas in order to form distinctive character and also is being he have Love Poll For everything that goes on around him.
And attention to cognitive motivation is important for students because the student who owns a motive cognitively looking for self - knowledge with conviction, and learning then be meaningful and lasts long. The motive of knowledge are common in which cognitive components does not mean exclusive knowledge on academic books and research in the narrow borders but a
Staphylococcus aureus is a common pathogenic agent due to its ability to cause various types of infections, ranging from mild skin infections to sever systemic diseases. One of the most virulence factors of this bacterium is its ability to from biofilms on solid surfaces by anchoring the planktonic cells and by producing a protective layer of extra polymeric substances. Biofilm formation is controlled through many genes. The most important ones are icaA and icaD. Dentures are prosthetic devices that are made of different materials to replace lost teeth. The aim of this study is to examine the ability of different types of denture materials to support the biofilm formation of S. aureus at phenotypic level by detecting ba
... Show MoreAn extensive program of laboratory testing was conducted on ring footing rested on gypseous soil brought from the north of Iraq (Salah El-Deen governorate) with a gypsum content of 59%. There are limited researches available, and even fewer have been done experimentally to understand how to ring footings behave; almost all the previous works only concern the behavior of ring footing under vertical loads, Moreover, relatively few studies have examined the impact of eccentric load and inclined load on such footing. In this study, a series of tests, including dry and wet tests, were carried out using a steel container (600×600×600) mm, metal ring footing (100 mm outer diameter and 40 mm inner diameter) was placed in the m
... Show MoreA field experiment was conducted during winter season of 2021 at a research station of college of agricultural engineering sciences, university of Baghdad to determine the response of active fertility percentage and seed yield and its components of faba bean (Vicia faba L. cv. Aguadulce) to distance between plants and spraying of nano and traditional boron. A Randomized Complete Block Design according to split-plots arrangement was used at three replicates. The main plots were three distances between plants (25, 35 and 45 cm), while the sub plots including spraying of distilled water only (control treatment), spraying of boron at a 100 mg L-1 and spraying of nano boron at two concentrations (1
... Show MoreArtificial Intelligence Algorithms have been used in recent years in many scientific fields. We suggest employing artificial TABU algorithm to find the best estimate of the semi-parametric regression function with measurement errors in the explanatory variables and the dependent variable, where measurement errors appear frequently in fields such as sport, chemistry, biological sciences, medicine, and epidemiological studies, rather than an exact measurement.
According to the importance of the subject of research, and the importance of the surveyed organization as a dynamic sector of the country in general , The research attempts to suggest to service organizations in general reconsidering the currently adopted mechanisms in the redesign of its functions , and in the services provided industry . The data was collected from (98) Director Mangers , head of department and head of division . The research tool is the questionnaire , which included (50) items . The results show Significant Effect & Correlation relationship between the two variables due to their dimensions . These lead to he application of job enrichment technology will increase the organization's ability to possess efficient hu
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