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Development and Validation of the ELISA Method for Anti-trastuzumab Antibodies Determination in Human Serum

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dc.contributor.authorEliseeva, O. A.
dc.contributor.authorKolganova, M. A.
dc.contributor.authorShokhin, I. E.
dc.contributor.authorDementyev, S. P.
dc.contributor.authorDubovik, N. S.
dc.contributor.authorSavchenko, A. Y.
dc.contributor.authorДубовик, Наталья Сергеевна
dc.contributor.authorСавченко, Алла Юрьевна
dc.date.accessioned2024-12-25T17:56:59Z
dc.date.available2024-12-25T17:56:59Z
dc.date.issued2022
dc.description.abstractIntroduction. One of the widely used specific anti-HER 2 (human epidermal growth factor receptor 2) MAb drugs is trastuzumab. Trastuzumab is highly effective for malignant HER 2 hyperexpression reduction, which results in HER 2 oncogenicity decrease. As any other biotherapeutics trastuzumab can cause immunological adverse reactions, e.g. immunogenicity or anti-drug antibodies (ADAs) production. Aim. The aim of this study was to develop and validate the analytical method for anti-trastuzumab antibodies determination in human blood serum. Materials and methods. The semi-quantitative anti-trastuzumab antibody determination was carried out by the ELISA method combined with ACE technique, using spectrophotometric detection in the visible range of the spectrum. Results and discussion. The developed method was validated for cut point, selectivity, sensitivity, hook effect, drug tolerance, precision and stability (short-term and long-term). To decrease the background noise from non-specific binding of sera components, the minimum required dilution value was determined at 10 % serum. The calculated values for screening cut point (normalization factor) and confirmatory cut point were 0.004 and 34.59 %, respectively. The sensitivity of the developed method was estimated at 99.5 ng/mL of anti-trastuzumab antibodies. Conclusion. The obtained results allow us to use the developed ACE ELISA method for the determination of anti-trastuzumab antibodies in human serum during trastuzumab safety clinical trials.
dc.format.extentС. 120-127
dc.identifier.citationDevelopment and Validation of the ELISA Method for Anti-trastuzumab Antibodies Determination in Human Serum / Eliseeva, O. A. [et al.] // Drug Development and Registration. - 2022. - 11. - № 4. - P. 120-127. - 10.33380/2305-2066-2022-11-4(1)-120-127
dc.identifier.doi10.33380/2305-2066-2022-11-4(1)-120-127
dc.identifier.urihttps://www.doi.org/10.33380/2305-2066-2022-11-4(1)-120-127
dc.identifier.urihttps://www.scopus.com/record/display.uri?eid=2-s2.0-85144974576&origin=resultslist
dc.identifier.urihttps://openrepository.mephi.ru/handle/123456789/28330
dc.relation.ispartofDrug Development and Registration
dc.titleDevelopment and Validation of the ELISA Method for Anti-trastuzumab Antibodies Determination in Human Serum
dc.typeArticle
dspace.entity.typePublication
oaire.citation.issue4
oaire.citation.volume11
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relation.isAuthorOfPublication4a7fa818-55bb-479d-9b8f-d8f52b55ef9a
relation.isAuthorOfPublication.latestForDiscovery5978d292-8499-4dce-8409-2c198da332e3
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