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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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
This study was conducted in the poultry field of the department of animal production, college of agricultural engineering sciences, university of Baghdad for the period from 10/15/2021 to 11/25/2021 with the aim of showing the effect of adding different levels of dill seeds to the diet on productive and carcass traits For broiler meat. In this study, 200 unsexed broiler chicks of breed (Ross 308) were used, one day age, with a starting weight of 41.46 g. The chicks were randomly distributed to 5 treatments, and each treatment included 4 replicates, 10 birds for each replicate. The birds were fed three diets: the starter diet, the growth diet and the final diet. The experiment treatments were T1,
... Show MoreThis study showed that the lens in baloot muluki fish Chondrostoma regium is transparent, spherical shape, and solid in textures, while in the tree frog Hyla arborea savignyi, freshwater turtles Clemmys caspia caspia, white–eared bulbul Pycnonotus leucotis and brown rat Rattus norvegicus are transparent, soft and biconvex, it is very soft in white–eared bulbul. There are many significant differences have been recorded between the average weight lens and the total concentration of the protein in the lens all studied animals. Electrical migration process for lens proteins showed that there is one bundle of crystalline –? and one bundle also crystalline–? in all studied species, either crystalline–? may represent one bundle character
... Show MoreBackground: Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic process often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. The physics forceps is one of those innovations in dental extraction technologies that claim to provide an efficient means for atraumatic dental extractions. Materials and method: A randomized clinical trial was conducted to compare the physics forceps with the conventional forceps for the removal of 28 mandibular single rooted teeth under the following parameters: incidence of crown, root, b
... Show MoreStudent performance may influence by several factors in all his study levels such as primary school, intermediate school and even in his college; some of these factors are psychological factors, social factors, and the factors which correlate with student environment.
In this paper we study some of these factors to discover their influence by using canonical correlation analysis to analyze the data. Many conclusions are discovered to help who focuses student performance or to make it pest in future.
The aim of this research is to construct a three-dimensional maritime transport model to transport nonhomogeneous goods (k) and different transport modes (v) from their sources (i) to their destinations (j), while limiting the optimum quantities v ijk x to be transported at the lowest possible cost v ijk c and time v ijk t using the heuristic algorithm, Transport problems have been widely studied in computer science and process research and are one of the main problems of transport problems that are usually used to reduce the cost or times of transport of goods with a number of sources and a number of destinations and by means of transport to meet the conditions of supply and demand. Transport models are a key tool in logistics an
... Show MoreThis paper aimed to investigate the effect of the height-to-length ratio of unreinforced masonry (URM) walls when loaded by a vertical load. The finite element (FE) method was implemented for modeling and analysis of URM wall. In this paper, ABAQUS, FE software with implicit solver was used to model and analysis URM walls subjected to a vertical load. In order to ensure the validity of Detailed Micro Model (DMM) in predicting the behavior of URM walls under vertical load, the results of the proposed model are compared with experimental results. Load-displacement relationship of the proposed numerical model is found of a good agreement with that of the published experimental results. Evidence shows that load-displacement curve obtained fro
... Show MoreChallenges facing the transition of traditional cities to smart: Studying the challenges faced by the transition of a traditional area such as Al-Kadhimiya city center to the smart style
BACKGROUND: Hepatocyte growth factor (HGF) is a proangiogenic factor that exerts different effects over stem cell survival growth, apoptosis, and adhesion. Its impact on leukemogenesis has been established by many studies. AIM: This study aimed to determine the effect of plasma HGF activity on acute myeloid leukemia (AML) patients at presentation and after remission. PATIENTS AND METHODS: This was a cross-sectional prospective study of 30 newly-diagnosed, adult, and AML patients. All patients received the 7+3 treatment protocol. Patients’ clinical data were taken at presentation, and patients were followed up for 6 months to evaluate the clinical status. Plasma HGF levels were estimated by ELISA based methods in the pa
... Show MoreObjectives: To study the prevalence of rs1799964 (-1031 T/C) and rs361525 (- 238 G/A) SNPs and their effect on the disease activity, severity, and cytokines production in newly diagnosed Iraqi rheumatoid arthritis patients. Patients and Methods: sixty-three patients were diagnosed by a specialist physician while attending the rheumatology unit and twenty control participated. The inflammatory markers were measured and PCR amplification and sequencing were performed to demonstrate TNF-α SNPs. Results: Regarding (-1031 C/T) SNP, the TT genotype and allele C were significantly present in the controls, and the CT genotype was distributed significantly in the patients. The TT genotype was mostly distributed in the mild-moder
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