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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 analysis of Iraqi light oil (light naphtha) by capillary gas chromatography- mass spectrometry (GC-MS) was performed by the injection of whole naphtha sample without use of solvents. Qualitative analysis and the identification of the hydrocarbon constituents of light naphtha was performed and comparison had been done with American light oil (light naphtha). The obtained results showed a major difference between the two-light naphtha.
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 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 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 MoreThe current study was carried out at the Fields belongs of Horticulture Department, Collage of Agricultural Engineering Science, University of Baghdad, Al-Jadiriyah for the spring season 2016 -2017 to study the effect for inoculation mycorrhizae and folair application with bio stimulators and their interaction in the growth characters of (local okra ptera). A factorial experiment (2 in randomized complete block design (RCBD), the experiment included (12) treatment Distributed in three replicates. The three factors used in this experiment included . The inoculation with control (C) Mycorrhizae ( M ) , Biozyme (B ) ( B1 2cm3.L-1), ( B2 4cm1-.L-1) , Phosphalas (P) (P 2cm3.L-1), ( M + B1), ( M + B2), (P +
... Show MoreSocial determinants of health (SDH) profoundly influence diabetes outcomes; nevertheless, their impact on the Iraqi diabetic population remains under researched. The objectives of this study were To investigate the relationship between particular social determinants of health (SDH) variables namely food and housing insecurity, social support, income, and education and clinical outcomes, including HbA1c levels, medication adherence, and patient satisfaction among Iraqi diabetic patients. A cross-sectional study involving 212 diabetic patients in Iraq was conducted. Participants attending a healthcare facility in Iraq filled out validated questionnaires regarding social determinants of health, medication adherence, and satisfaction. HbA1c rea
... Show MoreThe present work included study of the effects of weather conditions such as solar radiation and ambient temperature on solar panels (monocrystalline 30 Watts) via proposed mathematical model, MATLAB_Simulation was used by scripts file to create a special code to solve the mathematical model , The latter is single –diode model (Five parameter) ,Where the effect of ambient temperature and solar radiation on the output of the solar panel was studied, the Newton Raphson method was used to find the output current of the solar panel and plot P-V ,I-V curves, the performance of the PV was determined at Standard Test Condition (STC) (1000W/m2)and a comparison between theoretical and experimental results were done .The best efficiency
... Show MoreBackground: Diabetes mellitus (DM) could be regarded as a set of chronic metabolic disorders which have a common aspect of hyperglycemia. The resistance in the peripheral actions of insulin or impaired insulin secretion could be the reason hepcidin which is a peptide hormone derived from liver, in systemic iron homeostasis is an essential regulator, and its lopsided production participates in the pathogenesis of iron disorders in spectrum. Osteoporosis often accompanies many diseases like ß-thalassemia, hemochromatosis, sickle liver diseases, cell disease and hemosiderosis featured by iron overload, evidences suggest that Iron overload and iron deficiency are suggested by evidences that they affect bone in a negative way, acting
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