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Analytical Physicochemical and Functional Studies to Compare AryoTrust, a Follow-On Biologics, with the Originator Trastuzumab (Herceptin)
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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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.

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Publication Date
Thu May 05 2022
Journal Name
Karbala International Journal Of Modern Science
Nigella sativa Methanol Extract Inhibits PC-3 Cell Line Colonization, Induced Apoptosis, and Modulated LC3-based Autophagy
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Nigella sativa has various pharmacological properties and has been used throughout history for a variety of reasons. However, there is limited data about the effects of N. sativa (NS) on human cancer cells. This study aimed at observing the roles of methanolic extract of N. sativa on apoptosis and autophagy pathway in the Human PC3 (prostate cancer) cell line. The cell viability was checked by MTT assay. Clonogenic assay was performed to demonstrate clonogenicity and Western blot was used to check caspase-3, TIGAR, p53, and LC3 protein expression. The results demonstrated that PC3 cell proliferation was inhibited, caspase-3 and p53 protein expression was induced, and LC3 protein expression was modulated. The clonogenic assay showed that PC3

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Publication Date
Tue Oct 27 2015
Journal Name
International Journal Of Pharmacy And Pharmaceutical Sciences
EVALUATION OF CHEMOPREVENTIVE RESPONSE OF PENTOXIPHYLLINE AND SILDENAFIL INCOLORECTAL CARCINOMA EXPERIMENTALLY INDUCEDIN RATS: COMPARATIVE STUDYWITH 5-FLUOROURACIL
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Objective: This study was designed to investigate some possible therapeutic mechanisms of pentoxifylline and sildenafil in the treatment of colorectal carcinoma induced by 1, 2 dimethylhydrazines in rats. Methods: Rats were allocated into seven groups, negative control, colon cancer induced by 1,2,dimethylhydrazine, 5-fluorouracil (5-FU) (50 mg/kg)-treated, pentoxifylline (PTX) (50 mg/kg)-treated, sildenafil (0.7 mg/kg)-treated groups; the two other groups set as colon cancer induced group treated with PTX (50 mg/kg) plus 5-FU(50 mg/kg) and sildenafil (0.7 mg/kg) plus 5-FU (50 mg/kg), respectively. Results: Biochemical results revealed significant elevation of serum carcinoembryonic antigen (CEA) levels, carbohydrate19-9 antigen (CA19-9) as

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Publication Date
Tue Apr 01 2025
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Serological and Molecular Detection of Prevalence of Human Parvovirus (B19) in Beta Thalassemia Major Patients in Baghdad
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Background: Beta thalassemia major (β-TM) is an inheritable condition with many complications, especially in children. The blood-borne viral infection was proposed as a risk factor due to the recurrent blood transfusion regimen (hemotherapy) as human parvovirus B19 (B19V). Objective: This study investigated the B19V seroprevalence, DNA presence, B19V viral load, and B19V genotypes in β-TM patients and blood donors. Methods: This is a cross-sectional study incorporating 180 subjects, segregated into three distinct groups each of 60 patients, namely control, β-TM, and β-TM infected with Hepatitis C Virus (HCV).  For the B19V prevalence in the studied group, the ELISA technique and real-time PCR were used. The genotyping was follo

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Publication Date
Thu Dec 06 2018
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Formulation and In- Vitro Evaluation of Spherical Crystal Agglomerates of Ebastine by Quasi Emulsion Solvent Diffusion Method
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Ebastine (EBS) is a poorly water-soluble antihistaminic drug; it belongs to the class II group according to the biopharmaceutical classification system (BCS). The aim of the present work was to enhance the solubility, dissolution rate and micromeritic properties of the drug, by formulating it as spherical crystal agglomerates by Quasi Emulsion Solvent Diffusion (QESD) method.

Spherical crystal agglomerates (SCAs) were prepared in presence of three solvents dichloromethane (DCM), water and chloroform as a good solvent, poor solvent and bridging solvent respectively.  Agglomeration of EBS involved the use of some hydrophilic polymers like polyethylene glycol 4000 (PEG 4000), polyvinyl pyrrolidine K30 (PVP K30), D-?-tocopheryl

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Publication Date
Mon Sep 01 2025
Journal Name
Journal Of Engineering
Theoretical and Experimental Investigation of an Acetone-Filled Pulsating Heat Pipe Heat Exchanger for Waste Heat Recovery
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In this work, a vertical pulsating heat pipe heat exchanger (PHPHE)  was designed for waste heat recovery, exchanging thermal energy between two air streams in a counterflow configuration. The heat exchanger consists of six rows, each row consists of one pulsating heat pipe (PHP), and each PHP has six turns. The working fluid used in the heat pipe was acetone with fill ratios of 50%, 60%, and 70%. The effect of evaporator inlet temperature at 40, 45, and 50°C and air velocity at 0.5, 0.7, and 0.9 m/s on the pulsating heat pipes consisting of three sections- evaporator, condenser, and adiabatic, whose dimensions were 25 x 25 x 10 cm, was studied. At the same time, the condenser temperature was maintained at 26°C. The system’s th

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Publication Date
Wed Jul 02 2025
Journal Name
Scientific Reports
N-Homocysteinylation of lysine residues in α-Synuclein enhances aggregation propensity and cytotoxicity in SH-SY5Y cells
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Publication Date
Thu Dec 01 2022
Journal Name
Baghdad Science Journal
Synthesis, Spectral Identification, Antibacterial Evaluationand Theoretical Study of Co, Fe, Rh and Pd Complexes for 2-benzoylthiobenzimidazol
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A new novel series of metalcomplexes are prepared from reactions between 2-benzoylthiobenzimidazole (L) with metal salts of Co (II) , Fe(III) and Rh (III) , while Pd(II) complex was obtained by mixing ligandsof 2-benzoylthiobenzimidazole (L) as primary ligand and bipyridine (L/ )as secondary ligand as well as palladium chloride as metal salt in an ethanoic medium. The geometry of these compounds were identified using C.H.N.microanalysis, Ultraviolet–visible, Fourier transforms infrared, magnetic susceptibility, molar conductivity and flame atomic absorption (A.A). From the dataobtained by these spectral analyses, the molecular structures for Rh and Fe complexes were proposed to be octahedral geometry. A square planar construction is propo

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Publication Date
Thu Nov 14 2024
Journal Name
Journal Of Emergency Medicine, Trauma And Acute Care
Isolation, optimization, and redesigning of phages of methicillin-resistant Staphylococcus aureus from clinical hospital isolates in Baghdad
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Background: A global health concern is methicillin-resistant Staphylococcus aureus (MRSA). The use of bacteriophages is one of the many novel control strategies against MRSA that are frequently sought. However, it is quite challenging to isolate enough lytic anti-MRSA phages. In order to extract, optimize, and remodel anti-MRSA phages, this study sought novel approaches.

Methods: Two ATCC MRSA strains and nine clinical MRSA isolates were used to isolate wild anti-MRSA phages from hospital settings, dirt, and sewage. The wild phages were optimized using plaque-based biokinetic techniques. Usi

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Publication Date
Sun Jun 07 2009
Journal Name
Baghdad Science Journal
Compatibility between Pseudomonas fluorescens and Trichoderma harzianum in disease control of Fusarium tomato wilt under greenhouse condition .
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This study was conducted to evaluate the efficacy of 6 isolates of Pseudomonas fluorescens and Trichoderma harzianum and there combination against Fusarium tomato wilt disease caused by Fusarium oxysporum F.sp. Lycopersisi under green house condition .The isolates of bacteria (B3) and Trichoderma (T1) were found to be highly effective in reducing the disease incidence to 13.3% , 21% respectively , compared to control treatment (40%).Furthermore, disease severity was reduced to 28 and 30% respectively in comparison to control (90%) .Colonization of the roots (cfu /g fresh root weight )by the two isolates whether alon or together was extremely high . The combination treatment had a high ability in reducing disease incidenece and sev

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Publication Date
Tue Sep 08 2020
Journal Name
Baghdad Science Journal
Radiological Impact Assessment of Farm Soils and Ofada rice (Oryza sativa japonica) from Three Areas in Nigeria
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Oryza sativa japonica (ofada rice) is largely grown in Aramoko, Abakaliki and Ofada are communities and consumed by both the poor and rich in Nigeria. A total of twenty ofada rice farmlands were identified in each study area and rice samples were randomly collected, thoroughly mixed to make a representative sample from each farmland. Soil samples were collected in each farm to a depth of 5-15cm from at least eight different points and thoroughly mixed together to form a representative sample. The samples were thereafter taken to the laboratory for preparation and spectroscopic analysis. A well-calibrated NaI(Tl) gamma-ray detector was used in spectrometric analysis of the samples and descriptive statistics was used to analyze th

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