Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry

The article describes a new method for measurement of monoclonal antibody Eculizumab concentration in human plasma in a range of 3-250 μg/ml. In this method we used an antibody Fab fragment, capable of binding to eculizumab specifically in human plasma. The method uses the biolayer interferometry fo...

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Main Authors: V. M. Simonov, M. S. Pantushenko, A. A. Kazarov, O. A. Markova, G. N. Poroshin
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
Online Access:https://www.biopreparations.ru/jour/article/view/98
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author V. M. Simonov
M. S. Pantushenko
A. A. Kazarov
O. A. Markova
G. N. Poroshin
author_facet V. M. Simonov
M. S. Pantushenko
A. A. Kazarov
O. A. Markova
G. N. Poroshin
author_sort V. M. Simonov
collection DOAJ
description The article describes a new method for measurement of monoclonal antibody Eculizumab concentration in human plasma in a range of 3-250 μg/ml. In this method we used an antibody Fab fragment, capable of binding to eculizumab specifically in human plasma. The method uses the biolayer interferometry for determination of Eculizumab concentration without additional tag in the analyzing substances. This method was comparatively validated along with the traditional ELISA. Comparative validation demonstrated that the biolayer interferometry based method has an advantage to the ELISA in such important statistical criteria as an analytical range, accuracy, precision, specificity and selectivity (matrix effect).
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publisher Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
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series Биопрепараты: Профилактика, диагностика, лечение
spelling doaj.art-c9ab5b3ce71e41b2ba20cfcaf14698402024-03-26T09:10:52ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-02-0117315816498Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometryV. M. Simonov0M. S. Pantushenko1A. A. Kazarov2O. A. Markova3G. N. Poroshin4International Biotechnology Center «Generium»International Biotechnology Center «Generium»International Biotechnology Center «Generium»JSC «Generium»International Biotechnology Center «Generium»The article describes a new method for measurement of monoclonal antibody Eculizumab concentration in human plasma in a range of 3-250 μg/ml. In this method we used an antibody Fab fragment, capable of binding to eculizumab specifically in human plasma. The method uses the biolayer interferometry for determination of Eculizumab concentration without additional tag in the analyzing substances. This method was comparatively validated along with the traditional ELISA. Comparative validation demonstrated that the biolayer interferometry based method has an advantage to the ELISA in such important statistical criteria as an analytical range, accuracy, precision, specificity and selectivity (matrix effect).https://www.biopreparations.ru/jour/article/view/98моноклональное антителоэкулизумаббиослойная интерферометриявалидацияmonoclonal antibodyeculizumabbiolayer interferometryvalidation
spellingShingle V. M. Simonov
M. S. Pantushenko
A. A. Kazarov
O. A. Markova
G. N. Poroshin
Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry
Биопрепараты: Профилактика, диагностика, лечение
моноклональное антитело
экулизумаб
биослойная интерферометрия
валидация
monoclonal antibody
eculizumab
biolayer interferometry
validation
title Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry
title_full Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry
title_fullStr Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry
title_full_unstemmed Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry
title_short Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry
title_sort development and validation of a method for determination of eculizumab concentration in human plasma by biolayer interferometry
topic моноклональное антитело
экулизумаб
биослойная интерферометрия
валидация
monoclonal antibody
eculizumab
biolayer interferometry
validation
url https://www.biopreparations.ru/jour/article/view/98
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