Method development and validation for determination of antihemolytic activity of eculizumab (Soliris)

Прудникова, Елена Юрьевна; Порошин, Григорий Николаевич; Кудина, Наталья Константиновна; Лягоскин, И. В.; Sazonova, Elena V.; Вишневский, Александр Юрьевич; Аббасова, Светлана Георгиевна

doi:10.19163/2307-9266-2016-4-6-54-71

Farm. farmakol. (Pâtigorsk)

2016

DOI: 10.19163/2307-9266-2016-4-6-54-71

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Method development and validation for determination of antihemolytic activity of eculizumab (Soliris)

Елена Юрьевна Прудникова¹,

Григорий Николаевич Порошин²,

Наталья Константиновна Кудина³

et al.

Abstract: V. 4 № 6, 2016V. 4 № 6, DOI: 10.19163/2307V. 4 № 6, -9266-2016

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Cited by 2 publications

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Phytochemical Profiling and Biological Activity of Achillea sintenisii Hub.‐Mor

Eruygur,

Buyukyildirim,

Tetik Rama

et al. 2023

Chemistry & Biodiversity

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Achillea (Asteraceae) species have been traditionally used for their different therapeutical properties. In this study, phytochemical composition of aerial parts of A. sintenisii which is endemic in Turkey was determined with Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS). To evaluate the wound healing potential, the cream formulation prepared from A. sintenisii was tested on the linear incision wound model in mice. In vitro enzyme inhibitory activity tests were performed on elastase, hyaluronidase, and collagenase. In the histopathological examination, angiogenesis and granulation tissue formation were significantly increased in A. sintenisii treatment groups compared to the negative control group. As a result of this study, it is thought that the enzyme inhibition and antioxidant activity of the plant may contribute to the wound healing process. According to LC/MS/MS analysis result, quinic acid (24.261 μg/mg extract) and chlorogenic acid (14.97 μg/mg extract) were identified as main constituents of the extract.

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Phytochemical Profiling and Biological Activity of Achillea sintenisii Hub.‐Mor

Eruygur,

Buyukyildirim,

Tetik Rama

et al. 2023

Chemistry & Biodiversity

View full text Add to dashboard Cite

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Analytical comparison of Soliris® and its biosimilar, PRK-001

Жученко¹,

Орлова

Зыбин³

et al. 2020

Biiotehnologiâ (Mosk.)

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Soliris® (Eculizumab) was approved by regulatory authorities as the first drag for treatment of orphan disease, paroxysmal nocturnal hemoglobinuria, in 2007. Later its use was extended for treatment of atypical hemolytic-uremic syndrome and myasthenia gravis. The high cost, the unavailability of therapy for a number of patients, as well as the expiration of the patent protection period for Soliris®, these factors became the prerequisite for the development of biosimilar medicinal products. Here, comparative analysis of PRK-001 (LLC «Pharmapark») and reference drag product, Soliris® (Alexion Pharmaceuticals, USA), was carried out. Physicochemical biosimilarity assessment has shown complete comparability of both products in terms of protein sequence as well as higher order structures. Post-translation modifications as well as impurity profile were the same too. Neither biosimilar nor reference product had impurity amount exceeding threshold. Biological properties of the reference product and biosimilar were the same. Since the comparability of the both drags has been proven, it can be assumed that PRK-001 is biosimilar of Soliris®. Eculizumab, Soliris, paroxysmal nocturnal hemoglobinuria, physicochemical comparison, post-translational modifications, biosimilar, drag product

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Method development and validation for determination of antihemolytic activity of eculizumab (Soliris)

Abstract: V. 4 № 6, 2016V. 4 № 6, DOI: 10.19163/2307V. 4 № 6, -9266-2016

Cited by 2 publications

References 6 publications

Phytochemical Profiling and Biological Activity of Achillea sintenisii Hub.‐Mor

Phytochemical Profiling and Biological Activity of Achillea sintenisii Hub.‐Mor

Analytical comparison of Soliris® and its biosimilar, PRK-001

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