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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
A design for a photovoltaic-thermal (PVT) assembly with a water-cooled heat sink was planned, constructed, and experimentally evaluated in the climatic conditions of the southern region of Iraq during the summertime. The water-cooled heat sink was applied to thermally manage the PV cells, in order to boost the electrical output of the PVT system. A set of temperature sensors was installed to monitor the water intake, exit, and cell temperatures. The climatic parameters including the wind velocity, atmospheric pressure, and solar irradiation were also monitored on a daily basis. The effects of solar irradiation on the average PV temperature, electrical power, and overall electrical-thermal efficiency were investigated. The findings i
... Show MoreThis study investigated the structural behavior of a beam–slab member fabricated using a steel C-Purlins beam carrying a profile steel sheet slab covered by a dry board sheet filled with recycled aggregate concrete, called a CBPDS member. This concept was developed to reduce the cost and self-weight of the composite beam–slab system; it replaces the hot-rolled steel I-beam with a steel C-Purlins section, which is easier to fabricate and weighs less. For this purpose, six full-scale CBPDS specimens were tested under four-point static bending. This study investigated the effect of using double C-Purlins beams face-to-face as connected or separated sections and the effect of using concrete material that contains different recycled
... Show MoreThis study Ajert to modify the chemical composition of milk fat cows and make it similar to the installation of milk fat mother through the addition of protein and soybean oil to be given Alkhltatnsp sensory protein that the best plan is the ratio of 1:1
The phenomenon of child labor, any activity performed by a child and represents a contribution to the production, this phenomenon had been rife in Iraqi society, after that the proportion of child labor for the age group (6-14 years) amounting to 3% in 2006, became for the same age group of 8% in 2008*.
It is recognized that each phenomenon reasons, the phenomenon which our atten
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Witness the current business environment changes rapidly reflected on the performance of the facility wishing to stay , which is no longer style reaction enough to handle installations with their environment , and quickly began to lose its luster with the emergence of a message and the vision of contemporary business environment from a set of parts interacting with each other and the concept of behavioral includes all dimensions of performance, it is imperative to adopt a system installations influence variables and positive interaction through the development of strategic plans and the use of implementation and follow-up strategies to ensure the effectiveness of the method for meas
... Show MoreThis research sheds light on one of the important and vital topics for the banking sectors (technical requirements for the application of economic intelligence) namely by (Hardware, equipment, communication networks, software, databases). And the dimensions of the strategic success of the banks represented by(Customer satisfaction, customer trust, quality of service, growth) In the three Iraqi private banks, namely(Assyria International Investment, Mansour Investment, International Development Investment and Finance). Its implementation is an urgent necessity in order to improve the quality of its banking services to win the satisfaction of its customers and their confidence and then grow to achieve stra
... Show MoreBackground: Thermocycling simulates the temperature dynamics in the oral environment. This in vitro study done to measure and compare the effect of thermocycling on the shear bond strength of stainless steel and sapphire brackets bonded to human enamel teeth using light cured orthodontic adhesive and debonded at various time, and to measure adhesive remnant index after debonding. Materials and Methods: one-hundred-twenty extracted upper first premolars for orthodontic reason were used in this study; depending on weather thermocycled or not, the sample was divided into two main groups, then within each group 30 teeth were used for stainless-steel brackets (Bionic®) and for sapphire brackets (Pure®). Both groups were subdivided into three
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