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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
When exercising their authority in the jurisprudence, judges are subject to a set of restrictions that they must adhere to, as they do not want their jurisprudence to be accepted and welcomed by law practitioners in general, and legal scholars in particular, and in contrast to it, the arrows of criticism and defamation will extend to that jurisprudence, and then they will have to reverse them . Perhaps the most important of those restrictions imposed on judges is their observance of justice between the parties to the lawsuit through their lack of bias for one of the parties at the expense of the other, in addition to their observance of public order and public morals, as well as their observance of the legal texts that they work under its u
... Show MoreSemiconductor-based metal oxide gas detector of five mixed from zinc chloride Z and tin chloride S salts Z:S ratio 0, 25, 50, 75 and 100% were fabricated on glass substrate by a spray pyrolysis technique. With thickness were about 0.2 ±0.05 μm using water soluble as precursors at a glass substrate temperature 500 ºC±5, 0.05 M, and their gas sensing properties toward CH4, LPG and H2S gas at different concentration (10, 100, 1000 ppm) in air were investigated at room temperature which related with the petroleum refining industry.
Furthermore structural and morphology properties were scrutinize. Results shows that the mixing ratio affect the composition of formative oxides were (ZnO, Zn2SnO4, Zn2SnO4+ZnSnO3, ZnSnO3, SnO2) ratios ment
Background: This study was performed to determine the effect of aging of different types of composite material restorations on: Shear bond strength (SBS) to light cure and no mix chemical cure orthodontic adhesives with sapphire bracket and the debonding failure sites. Materials and methods: One hundred forty four composite disks were made from three different composite resin materials which are: 3M Filtek Z250, 3M filtek Z350 and 3M Valux plus, each group with (48) disks each, then according to the duration of storage each group was subdivided into two equal groups one of them stored for one day and the other was stored for one month, then each group was further subdivided into two equal subgroups with (12) disks each one bonded with ligh
... Show MoreMultiple sclerosis (MS) is a chronic, inflammatory demyelinating disease of central nervous system with complex etiopathogenesis that impacts young adults (Lee et al., 2015), and MS impacts younger and middle aged character and leads to a range of disabilities that can alter their daily routines (Yara et al, 2010). Although, the exact cause of MS is still undetermined, the disease is mediated by adaptive immunity through the infiltration of T cells into the central nervous system (Bjelobaba et al, 2017). MS causes the Focal neurological symptomsand biochemical changes in the molecular level and the variation of neural cells such as loss or alteration of sensation, motor function, visible signs such as blurred vision or transient blindness,
... Show MoreA survey of haemoproteids among the eight species of Iraq rallids were carried out in the
middle, south, and west of Iraq. Two haemoproteods were recorded, Haeomproteus porzanae
(Galli-Valerio, 1907) as a new record for Iraq and the new species H. baghdadensis described
from Fulica atra L. collected in the middle of Iraq.
Shumblan (SH) is one of the most undesirable aquatic plants widespread in the irrigation channels and water bodies. This work focuses on boosting the biogas potential of shumblan by co-digesting it with other types of wastes without employing any chemical or thermal pretreatments as done in previous studies. A maximum biogas recovery of 378 ml/g VS was reached using shumblan with cow manure as inoculum in a ratio of 1:1. The methane content of the biogas was 55%. Based on volatile solid (VS) and C/N ratios, biogas productions of 518, 434, and 580 ml/g VS were obtained when the shumblan was co-digested with food wastes (SH:F), paper wastes (SH:P), and green wastes (SH:G) respectively. No significant changes of methane contents were observ
... Show MoreAcademic Entitlement (AE) is the expectation by students to receive high grades or preferential treatment without significant effort. Exploring AE from faculty perspective has not been investigated in Arab colleges of pharmacy. The aim of this study was to explore experiences and perceptions towards student AE among pharmacy faculty in the Arab World. A cross-sectional, self-administered, anonymous, electronic survey was sent to pharmacy faculty across pharmacy colleges in Arab countries. The survey collected demographic data, an AE measure including 17 items reflecting seven AE components, and faculty perceptions and perceived reasons for AE. A total of 345 responses were collected. The AE level wa
Background Bilateral cleft lip deformity is much more difficult to correct than unilateral cleft lip deformity. The complexity of the deformity and the sensitive relationships between the arrangement of the muscles and the characteristics of the external lip necessitate a comprehensive preoperative plan for management. The purpose of this study was to evaluate the repair of bilateral cleft lip using the Byrd modification of the traditional Millard and Manchester methods. A key component of this repair technique is focused on reconstruction of the central tubercle.
Methods Fourteen patients with mean age of 5.7 months presented with bilateral cleft lip deformity and were operated on using a mod
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