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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 current research aims to identify the level of partnership between school and community agencies to improve secondary school outcomes for students with intellectual disabilities and develop strategies that help enhance community partnerships between schools and agencies. The researcher used the qualitative research approach; he utilized the interviews as a tool for data collection. The sample of research included (12) participants: three female school leaders, three male-school leaders, three female-school supervisors, and three male-school supervisors in schools that have programs for students with intellectual disabilities in Riyadh. The results of the study showed that the level of partnership bet
... Show More: Cervical malignancy positioned as the fourth most prevalent disease among women around the world. HPVs especially HPV16 are the causative agent of cervical cancer, responsible of about 5% of all human cancers worldwide. Some researchers found that the fibronectin is repressed by the papillomavirus (HPV) type 16 E7 oncoprotein in both HPV-positive nontumorigenic and tumorigenic cell lines, while others found that the HPV oncoprotein increase the levels of fibronectin. The aim is to study the effect of HPV infection on Fibronectin expression and their correlation onthe development of Cervicalcancinoma. The current retrospective study enrolled paraffinized blocks of two groups. The research included 30 cervical carcinomatous tissues as well
... Show MoreAccording to grammarians In ( نإ) and Itha (اذإ) are conditionals and sometimes they may be used interchangeably. However, when they are mentioned in the Holy Qur’an, they have their own specific use. This paper attempts to investigate their meanings in the source language as well as investigate their translations and find out any differences or similarities. The translations that are adopted in this research are as follows: Pickthall, Al-Hilali & Khan, and Shakir.
The present paper addresses one of the most challenging topics in translation; namely legal translation in the framework of two different approaches; the classical (formal) and the more recent (functional). The latter approach is the outcome of the process of simplifying legal language known technically as Plain Language Movement. The advent of this movement dates back to the 1950s, in response to the widely-held complain about the awkwardness of the legal register. Within this framework, the salient features of legal language, at the various linguistic and textual levels, underwent reconsideration in favor of more publicly digested expressions. The paper then subjects two translations of a lease contract to analysis in the ligh
... Show MoreConstruction of artificial higher order protein complexes allows sampling of structural architectures and functional features not accessible by classical monomeric proteins. Here, we combine in silico modelling with expanded genetic code facilitated strain promoted azide-alkyne cycloaddition to construct artificial complexes that are structurally integrated protein dimers and demonstrate functional synergy. Using fluorescent proteins sfGFP and Venus as models, homodimers and heterodimers are constructed that switched ON once assembled and display enhanced spectral properties. Symmetrical crosslinks are found to be important for functional enhancement. The determined molecular structure of one artific
In this research, a simple experiment in the field of agriculture was studied, in terms of the effect of out-of-control noise as a result of several reasons, including the effect of environmental conditions on the observations of agricultural experiments, through the use of Discrete Wavelet transformation, specifically (The Coiflets transform of wavelength 1 to 2 and the Daubechies transform of wavelength 2 To 3) based on two levels of transform (J-4) and (J-5), and applying the hard threshold rules, soft and non-negative, and comparing the wavelet transformation methods using real data for an experiment with a size of 26 observations. The application was carried out through a program in the language of MATLAB. The researcher concluded that
... Show MoreKE Sharquie, AA Noaimi, E Abdulqader, WK Al-Janabi, J Dermatol Venereol, 2020 - Cited by 6
Postcolonial reading for any text aroused a great controversy that deserves to be studied it give more dimensions with the awareness that it can be interpreted in numerous ways. Postcolonialism is a challenging field as it covers variety of political, psychological, cultural, and economical activities often called ‘postcolonial’. The concept of culture worked effectively in shaping and mapping postcolonial struggles, which have so profoundly reshaped our world. Man's sense of cultural displacement is the core of this project. Man's quest for cultural adaptation forms a kind of equilibrium and compromise to the vision of human liberation. It is very important to minimize disadvantages and to internalize the logic of Western colonization.
... Show MoreThe analytical results of the failure types of six limestone islands in the Ha Long bay of Vietnam have been identified. The calculated results of safety factor for 03 plane failure blocks lie within 0.9 and 2, have high potential failure. The analytical results have been also simulated these islands in three-dimensional space and have been also analyzed their potential failure on the fracture surfaces. The results obtained in this paper have important significance for planning and development of the Ha Long bay area, as World Natural Heritage, Quang Ninh province of Vietnam.
Leuciscidae species are the abundant and widely distributed fish species in Iraq's inland waters. They are complex species, and morphology makes them difficult to identify. Molecular analysis achieved and confirmed the morphological characters. Twenty specimens of Acanthobrama marmid were collected from two localities at Tigris River, in the middle of Iraq; 15 specimens from the Al-Zubaydia sub-district and five specimens from Al-Tharthar Lake. We used the mitochondrial DNA cytochrome b (cytb) gene to sequence the DNA of A. marmid. The following analysis are compared the sequences with those of other fish genera and species found in the Gene Bank. The barcoding result (DNA sequencing) in fishes found in the same family (Leuciscidae) showed
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