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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 Twelve isolates of bacteria were obtained from samples of different soils and water amended with 100µg/ml of five heavy metals chlorides (i.e: Aluminum Al+2, Iron Fe+2, Lead Pb+2, Mercury Hg+2 and Zinc Zn+2). Four isolates were identified as Bacillus subtilis and B. subtilis (B2) isolate was selected for this study according to their resistance to all five heavy metals chlorides. The ability of B. subtilis (B2) isolate for growing in different concentration of heavy metals chlorides ranging from 200-1200 µg/ml was tested. The highest conc. that B. subtilis (B2) isolate tolerate was 1000 µg/ml for Al+2, Fe+2, Pb+2, and Zn+2and 300 µg/ml for Hg+2 for 24hour. The effect of heavy metals chlorides on bacterial growth for 72 hrs was
... Show MoreThis paper analysed the effect of electronic internal auditing (EIA) based on the Control Objectives for Information and Related Technologies (COBIT) framework. Organisations must implement an up-to-date accounting information system (AIS) capable of meeting their auditing requirements. Electronic audit risk (compliance assessment, control assurance, and risk assessment) is a development by Weidenmier and Ramamoorti (2006) to improve AIS. In order to fulfil the study’s objectives, a questionnaire was prepared and distributed to a sample comprising 120 employees. The employees were financial managers, internal auditors, and workers involved in the company’s information security departments in the General Company for Electricity D
... Show MoreEvaluating the behavior of a ring foundation resting on multi-layered soil is one of the important issues facing civil engineers. Many researchers have studied the behavior of ring foundation rests on multi-layered soil with vertical loads acting on the foundation. In real life ring foundation can be subjected to both vertical and horizontal loads at the same time due to wind or the presence of soil. In this research, the behavior of ring footing subjected to inclined load has been studied using PLAXIS software. Furthermore, the effect of multi-layered soil has been simulated in the model. The results showed that both vertical and horizontal stresses are mainly affected when the inclination angle of the load exceeded 45 degrees with a reduc
... Show MoreCitizenship education is the effective educational tool in building a citizen who is able to participate in building his country. This can only come through the educational efforts that teachers make in the classroom. Such a step requires teachers to have knowledge of citizenship education, its principles, and the foundations for its development. Thus, the study aims to examine the degree of social studies teachers' knowledge of the dimensions of citizenship education at the basic education schools in the Sultanate of Oman. It also aims to examine its relationship with a set of variables. The researchers used the quantitative descriptive approach to achieve the objectives of the study. It further adopted a test tool, which consisted in i
... Show MoreFace recognition and identity verification are now critical components of current security and verification technology. The main objective of this review is to identify the most important deep learning techniques that have contributed to the improvement in the accuracy and reliability of facial recognition systems, as well as highlighting existing problems and potential future research areas. An extensive literature review was conducted with the assistance of leading scientific databases such as IEEE Xplore, ScienceDirect, and SpringerLink and covered studies from the period 2015 to 2024. The studies of interest were related to the application of deep neural networks, i.e., CNN, Siamese, and Transformer-based models, in face recogni
... Show MoreA land magnetic survey was carried out along regional profile, which is located at the north part of the Iraqi western desert. It starts from al –Qaam City (at north) toward Rutba City (at south) with a total length of 238km. The survey was carried out along the paved road between the two cities, About 113 measuring points were done with inter-station distance of 2 km (for 198 km) and 2 to 5km (for 40km). Two proton magnetometers were used in this survey. One of them is used for base station monitoring, which was fixed as of Salah Aldin field (Akkas). Its readings were used for diurnal corrections. All magnetic measurements were corrected for normal and topographic corrections. The readings were reduced to a certain base level. The resu
... Show MoreRutting has a significant impact on the pavements' performance. Rutting depth is often used as a parameter to assess the quality of pavements. The Asphalt Institute (AI) design method prescribes a maximum allowable rutting depth of 13mm, whereas the AASHTO design method stipulates a critical serviceability index of 2.5 which is equivalent to an average rutting depth of 15mm. In this research, static and repeated compression tests were performed to evaluate the permanent strain based on (1) the relationship between mix properties (asphalt content and type), and (2) testing temperature. The results indicated that the accumulated plastic strain was higher during the repeated load test than that during the static load tests. Notably, temperatur
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