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

Дата
2022
Авторы
Eliseeva, O. A.
Kolganova, M. A.
Shokhin, I. E.
Dementyev, S. P.
Dubovik, N. S.
Savchenko, A. Y.
Journal Title
Journal ISSN
Volume Title
Издатель
Научные группы
Организационные подразделения
OrgUnit Logo
Организационная единица
Инженерно-физический институт биомедицины
Цель ИФИБ и стратегия развития – это подготовка высококвалифицированных кадров на базе передовых исследований и разработок новых перспективных методов и материалов в области инженерно-физической биомедицины. Занятие лидерских позиций в биомедицинских технологиях XXI века и внедрение их в образовательный процесс, что отвечает решению практикоориентированной задачи мирового уровня – диагностике и терапии на клеточном уровне социально-значимых заболеваний человека.
Выпуск журнала
Аннотация
Introduction. 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.
Описание
Ключевые слова
Цитирование
Development 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
URI
https://www.doi.org/10.33380/2305-2066-2022-11-4(1)-120-127
 https://www.scopus.com/record/display.uri?eid=2-s2.0-85144974576&origin=resultslist
 https://openrepository.mephi.ru/handle/123456789/28330
Коллекции
Публикации