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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 work studies the impact of input machining parameters of Electrical Discharge Machining (EDM) on the machining process performance. Tool steel O1 was selected as the workpiece material, copper as the electrode material, and kerosene as the dielectric medium. Experimental runs have been carried out with a Design of Experiment (DOE) technique. Twenty tests are accomplished with the current range of (18 to 24 Ampere), a pulse duration range of (150 to 200 µs), and a pulse-off time range of (25 to 75 µs). Based upon the experimental study's output results, the EDM parameter's effect (voltage of power supply, discharge current, pulse duration, and pulse pause interval) on the responses of the process represented by sur
... Show MoreThe current study performed in order to detect and quantify epicatechin in two tea samples of Camellia sinensis (black and green tea) by thin layer chromatography (TLC) and high performance liquid chromatography (HPLC). Extraction of epicatechin from black and green tea was done by using two different methods: maceration (cold extraction method) and decoction (hot extraction method) involved using three different solvents which are absolute ethanol, 50% aqueous ethanol and water for both extraction methods using room temperature and direct heat respectively. Crude extracts of two tea samples that obtained from two methods were fractionated by using two solvents with different polarity (chloroform and
... Show MoreM. domestica is the most important insect that transmit pathogens for diseases in the world. The use of nanotechnology is eco-friendly method in control pests. The study aims to investigate the feasibility of bio-manufacturing nanocapsules of fungal secondary metabolites in order to improve the efficiency of metabolite and assess their inhibitory effect on the acetylcholine esterase enzyme in housefly larvae. An equal mixture of organic solvents, ethyl acetate and dichloromethane, was used to extract the metabolic products of the fungus M. anisopliae, (PEG4000) and chitosan was used in the preparation of nanocapsules. The results of the DLS granular size assay showed that the size of the extract particles and the size of the chitosan and
... Show MoreAbstract Background: This study is aimed to assess the maxillary incisors’ root position, angulation, and buccal alveolar bone thickness in both genders and different classes of malocclusion using cone‑beam computed tomography (CBCT). Materials and Methods: Two hundred and six CBCT images were gathered and analyzed by three‑dimensional On‑Demand software to measure the variables of 803 maxillary central and lateral incisors. Genders and class difference was determined by unpaired t‑test, one‑way ANOVA, and Chi‑square tests. Results: Buccal root position of the maxillary incisors accounted for in the majority of the cases followed by the middle and palatal positions. The thickness of alveolar bone appears to have nearly the sam
... Show Moreطريقة سهلة وبسيطة ودقيقة لتقدير السبروفلوكساسين في وجود السيفاليكسين او العكس بالعكس في خليط منهما. طبقت الطريقة المقترحة بطريقة الاضافة القياسية لنقطة بنجاح في تقدير السبروفلوكساسين بوجود السيفاليكسين كمتداخل عند الاطوال الموجية 240-272.3 نانوميتر وبتراكيز مختلفة من السبروفلوكساسين 4-18 مايكروغرام . مل-1 وكذلك تقدير السيفاليكسين بوجود السبروفلوكساسين الذي يتداخل باطوال موجية 262-285.7 نانوميتر وبتراكيز مخ
... Show MoreThis paper aims to propose a hybrid approach of two powerful methods, namely the differential transform and finite difference methods, to obtain the solution of the coupled Whitham-Broer-Kaup-Like equations which arises in shallow-water wave theory. The capability of the method to such problems is verified by taking different parameters and initial conditions. The numerical simulations are depicted in 2D and 3D graphs. It is shown that the used approach returns accurate solutions for this type of problems in comparison with the analytic ones.
Milling process is a common machining operation that is used in the manufacturing of complex surfaces. Machining-induced residual stresses (RS) have a great impact on the performance of machined components and the surface quality in face milling operations with parameter cutting. The properties of engineering material as well as structural components, specifically fatigue life, deformation, impact resistance, corrosion resistance, and brittle fracture, can all be significantly influenced by residual stresses. Accordingly, controlling the distribution of residual stresses is indeed important to protect the piece and avoid failure. Most of the previous works inspected the material properties, tool parameters, or cutting parameters, bu
... Show More