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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
This paper deals the prediction of the process of random spatial data of two properties, the first is called Primary variables and the second is called secondary variables , the method that were used in the prediction process for this type of data is technique Co-kriging , the method is usually used when the number of primary variables meant to predict for one of its elements is measured in a particular location a few (because of the cost or difficulty of obtaining them) compare with secondary variable which is the number of elements are available and highly correlated with primary variables, as was the&nbs
... Show MoreLinguistic research according to modern curricula:
It is one of the important matters that occupy the ideas of those concerned with linguistic studies, whether Arabic or otherwise. Recent years have witnessed the advancement of this methodological approach, and books and studies in Arabic have been written on important, multifaceted issues, of grammatical and linguistic origins, and their balance with new developments and ideas attracted mostly from Western studies.
The comparative approach - as they call it - is one of the modern approaches that is based on balancing a language with other sisters belonging to its family, to reach similarities and differences between them, and to know the c
Calcium carbonate is predominantly present in aqueous systems, which is
commonly used in industrial processes. It has inverse solubility characteristics
resulting in the deposition of scale on heat transfer surface. This paper focuses on
developing methods for inhibition of calcium carbonate scale formation in cooling
tower and air cooler system where scaling can cause serious problems, ZnCl 2 and ZnI
2 has been investigated as scale inhibitor on AISI 316 and 304. ZnCl 2 were more
effective than ZnI 2 in both systems, and AISI 316 show more receptivity to the
chlorides salt compared to AISI 304. The inhibitors were more effective in cooling
tower than air cooler system. AISI 316 show more constant inhibition effic
The inhibitory action of four lactobacilli isolates Lactobacillus bulgaricus, L. acidophilus, L. plantarum and L. fermentum, isolated from four different samples; yoghurt, vinegar, saliva and vagina respectively, on Escherichia coli and Staphylococcus aureus adhesion to uroepithelial cells were investigated. Results showed that all Lactobacillus isolates or their supernatant were able to reduce the number of the uropathogens attached to uroepithelial cells. However, inhibition level of lactobacilli cells was higher than their supernatant. Nevertheless, the human indigenous lactobacilli (L. fermentum and L. plantarum) were more competitive than food lactobacilli (L. acidophilus and L. bulgaricus).
Abstract: The issue of rebuilding the strategiccapacity of Iraq after the occupation and the US invasion in 2003 has been oneof the most contentious issues of debate and debate. It raises a number ofpolitical, social, economic, military and security problems. We say politicalprimarily because the climate and political conditions play a large and activerole along with other factors complementary to them. The important questionthat arises here is: How can the ruling political blocs move to the stage ofreconstruction without reservations? In order to answer this question, wedivided the study into three main axes. The first deals with the concept ofpower and its types. The second axis deals with the relationship betweenstrategic capa
... Show MoreIt is an analytical study carried out at university of Basra using a sample included the dean ,assistants and managers of scientific dept. in the university for about(63)managers .The study aimed at discovering a model of crises management in the university.The researcher adopted the descriptive survey methodology.To achieve the objective of the study ,a questionnaire of (41)statements was developed covering five main variables like ,signal detection, prevention and preparedness, response, recovery and learning .The validity of the questionnaire was done by a group of referees .Its stability was determined by Cronbach,s Alfa .The questionnair,s stability coefficient was(0.
... Show MoreThe Results Of Interest In Capitals And Major Cities Have Become Major Attraction Centers For People In Rural Areas And Different Regions, Especially With The Concentration Of Industrial And Commercial Establishments And Public Services, Which Helped To Find The Wide Differences Between Them. Recently, The Trend To Develop Small Urban Centers In Rural Back Areas Great And Serious Attempt To Reduce Inflation. The Suburb Of Abu Ghraib Is One Of The Important Suburbs Near The City Of Baghdad And Through The Study Of The Reality Of The Suburb Shows That The Outcome Of Its Career And Urban Development Lies In Its Mutual Relationship With The City Of The Mother In The Light Of Considerations And Measures Of The Most Important Accessibility And
... Show More