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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Format: | Article |
Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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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). |
first_indexed | 2024-03-08T21:44:25Z |
format | Article |
id | doaj.art-c9ab5b3ce71e41b2ba20cfcaf1469840 |
institution | Directory Open Access Journal |
issn | 2221-996X 2619-1156 |
language | Russian |
last_indexed | 2024-04-24T19:12:12Z |
publishDate | 2018-02-01 |
publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
record_format | Article |
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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