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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Forty five wound specimens were collected from patients suffering from wound infections and taken from various hospitals in Ibb city, Yemen. The study was to determine synergic antibacterial activity of between mountain honey and Argemone mexicana plant. Isolation, identification of bacterial isolates and antibiotic sensitivity test were done. Agar-disc and agar-well diffusion method were carried to determine antibacterial activity of honey, Argemone mexicana plant and a mixture of them against bacterial isolates. Out of 45 specimens, 29 (64.4%) gave positive cultures. Staphylococcus aureus was the predominant bacterial pathogens with percentage (72.4%) followed by Pseudomonas aeruginosa (17.2%) and Staphylococcus epidermidis (10.4%).
... Show MoreLet h is Γ−(λ,δ) – derivation on prime Γ−near-ring G and K be a nonzero semi-group ideal of G and δ(K) = K, then the purpose of this paper is to prove the following :- (a) If λ is onto on G, λ(K) = K, λ(0) = 0 and h acts like Γ−hom. or acts like anti–Γ−hom. on K, then h(K) = {0}.(b) If h + h is an additive on K, then (G, +) is abelian.
The presented work shows a preliminary analytic method for estimation of load and pressure distributions on low speed wings with flow separation and wake rollup phenomena’s. A higher order vortex panel method is coupled with the numerical lifting line theory by means of iterative procedure including models of separation and wake rollup. The computer programs are written in FORTRAN which are stable and efficient.
The capability of the present method is investigated through a number of test cases with different types of wing sections (NACA 0012 and GA(W)-1) for different aspect ratios and angles of attack, the results include the lift and drag curves, lift and pressure distributions along the wing s
... Show MoreTwo different composite materials were prepared by stir casting method of AA 6061 alloy as a matrix reinforced with two addition different ceramic materials Al2O3 and B4C of grain size 20 µm by 2.5, 5, 7.5 and10% in weight. The composite material with aluminum alloy as a matrix possesses a unique mechanical properties such as: high specific strength and hardness, low density, and high resistance to corrosion and friction wear. This composite is widely used in automotive parts space and marine applications.
Pin-on-disc technique was used to calculate the wear rate for each addition of Al2O3 and B4C particles. Rockwell hardness test and
... Show MoreWellbore stability is considered as one of the most challenges during drilling wells due to the
reactivity of shale with drilling fluids. During drilling wells in North Rumaila, Tanuma shale is
represented as one of the most abnormal formations. Sloughing, caving, and cementing problems
as a result of the drilling fluid interaction with the formation are considered as the most important
problem during drilling wells. In this study, an attempt to solve this problem was done, by
improving the shale stability by adding additives to the drilling fluid. Water-based mud (WBM)
and polymer mud were used with different additives. Three concentrations 0.5, 1, 5 and 10 wt. %
for five types of additives (CaCl2, NaCl, Na2S
In this paper, an experimental study was conducted to enhance the thermal performance of a double-pass solar air heater (SAH) using phase change material (PCM) for thermal storage at climatic conditions of Baghdad city - Iraq. The double-pass solar air heater integrated with thermal storage system was manufactured and tested to ensure that the air heating reserved after the absence of the sun. The rectangular cavity filled with paraffin wax was used as a latent heat storage and incorporated into the lower channel of solar air heater. Experiments were carried out to evaluate the charging and discharging characteristics of two similar designed solar air collectors with and without using phase change material at a constant
... Show MoreIn this research, rabbit femurs were implanted with CP Ti screws coated with a combination of CaCO3 and nanohydroxyapatite, and the effect on osseointegration was assessed using histological and histomorphometric examination at 2 and 6 weeks. CaCO3 and nanohydroxyapatite were combined with the EPD to coat the surfaces of the CP Ti screws. The femurs of five male rabbits were implanted with coated and uncoated implant screws. Healing time was divided into two groups (2 and 6 weeks). After 2 and 6 weeks of implantation, the histological examination revealed an increase in the growth of bone cells for coated screws, and the histomorphometric analysis revealed an increase in the percentage of ne
... Show MoreThe effect of 532nm Diode Pumped Solid State (DPSS) laser at power density of 5.234 W/cm2 on the growth of Gram-negative Pseudomonas aeruginosa and Gram-positive Staphylococcus aureus was evaluated. These bacteria were isolated from samples taken from burn and infected wound areas of 55 patients admitted to the burn-wound unit in Al-Kindy teaching hospital in Baghdad during the period from October 2012 to March 2013. Each isolate was identified using microscopic, cultural and biochemical methods. A standard bacterial suspension was prepared for each isolate. Serial dilutions were then prepared and a dilution of 10-5 was selected. Irradiation experiments included four groups: (L-P-) bacterial suspension in saline solution, (L-P+) bacteria
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