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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 importance of this study lies in shedding the light on the impact of Islam and Prophet Mohammed (peace be upon him) on the western culture and English literature in particular. While some writers were looking at Islam as a dangerous element, others were completely taken by the oriental spirit of Arabic and Islamic culture and glorifying it. Writers from Chaucer to later ones mostly make references to this impact showing how vast was the gap of misunderstanding between the east and the West. Thus, this study aims at breaking the barrier between East and West in its three sections as it introduces the meaning of Islam and its common features with other religions in the first section. The second section briefly presents writers’ reflecti
... Show MoreTransgenic plants offer advantages for the manufacture of recombinant proteins with terminal
mannose residues on their glycan chains. So plants are chosen as source of pharmaceutical products and for
the development of alternative expression systems to produce recombinant lysosomal enzymes. In the
present study the sequence of the natural cDNA encoding for the human lysosomal enzyme
glucocerebrosidase (GCD) was modified to enhance its expression in soybean plants. The glucocerebrosidase
gene signal peptide was substituted with that signal peptide for the Arabidopsis thaliana basic endochitinase
gene to support the co-translational translocation into the endoplasmic reticulum (ER), and the storage
vacuol
This study discusses the semiotic of the Islamic blazon - a related analytical study between the Islamic blazon and its visual publicity message. The aim of the current study is to explore the related relationship between the Islamic blazon and its visual publicity message. The sample is contained Five of Islamic blazon in the Mamelukes period which is between 1250 to 1517. The methodology is descriptive-analytical, and the result is that there is a clear relation between the Islamic blazon with its visual publicity message. This study's recommendation is to go towards analyzing the meanings of the cultural legacies of the Islamic civilization, and researching the implicit meanings accompanying these features leads to a deeper understand
... Show MoreThe electronic characteristics, including the density of state and bond length, in addition to the spectroscopic properties such as IR spectrum and Raman scattering, as a function of the frequency of Sn10O16, C24O6, and hybrid junction (Sn10O16/C24O6) were studied. The methodology uses DFT for all electron levels with the hybrid function B3-LYP (Becke level, 3-parameters, Lee–Yang-Parr), with 6-311G (p,d) basis set, and Stuttgart/Dresden (SDD) basis set, using Gaussian 09 theoretical calculations. The geometrical structures were calculated by Gaussian view 05 as a supplementary program. The band gap was calculated and compared to the measured valu
... Show MoreThis research aims to study the influence of organizational power on the achievement of entrepreneurship for business organizations. It is an analytical study of the views of a sample of managers in the Iraqi Ministry of Education. The research highlights the contribution that can be made from the knowledge of the theory of business organizations in achieving organizational success. The organizational power of the organization contributes to achieving entrepreneurship in the business environment and achieving a competitive position in the work environment. The research dealt with two variables: the first is the independent variable, the organizational power in its dimensions (Expend Power, Structural Power, Prestige Power). And t
... Show MoreThe dynamical behavior of a two-dimensional continuous time dynamical system describing by a prey predator model is investigated. By means of constructing suitable Lyapunov functional, sufficient condition is derived for the global asymptotic stability of the positive equilibrium of the system. The Hopf bifurcation analysis is carried out. The numerical simulations are used to study the effect of periodic forcing in two different parameters. The results of simulations show that the model under the effects of periodic forcing in two different parameters, with or without phase difference, could exhibit chaotic dynamics for realistic and biologically feasible parametric values.
The serum protein test includes measurement of the level of total protein(albumin, globulin). Fetuin-A is a blood protein made in liver. It can inhibit insulin receptor, enhance insulin sensitivity and make the individuals more likely to develop type 2 diabetes, then disorder in lipid profile (Total cholesterol(TC), low density lipoprotein cholesterol (LDL-c), high density lipoprotein cholesterol (HDL-c), Triglyceride(TG) and very low density lipoprotein cholesterol (VLDL-c) . To evaluate Fetuin-A, total protein, albumin, globulin, HbAlc and lipid profile in 200 adult and elderly Iraqi patients with type 2 Diabetes Mellitus were taken and compare them with 200 subjects as a healthy control. The laboratory analysis(for patients and
... Show MoreTo evaluate the Interaction of Mn(II), Fe(II), Co(II), Ni(II),Cu(II), Zn(II) And Cd(II) Mixed- Ligand Complexes of cephalexin mono hydrate (antibiotics) And Furan-2-Carboxylic Acid To The Different DNA Sources. All the metal complexes were observed to cleave the DNA. A difference in the bands of complexes .The cleavage efficiency of the complexes compared with that of the control is due to their efficient DNA-binding ability and the other factors like solubility and bond length between the metal and ligand may also increase the DNA-binding ability. The ligands (Cephalexin mono hydrate (antibiotics) and Furan-2- Carboxylic acid and there newly synthesized metal complexes shows good antimicrobial activities and Binding DNA , thus, can be used
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