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    Academic Journal

    Source: Chemistry; Том 17, № 2 (2025): Вестник Южно-Уральского государственного университета. Серия: Химия; 116–168 ; Химия; Том 17, № 2 (2025): Вестник Южно-Уральского государственного университета. Серия: Химия; 116–168 ; 2412-0413 ; 2076-0493

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  18. 18
    Academic Journal

    Contributors: This study was conducted by the Scientific Centre for Expert Evaluation of Medicinal Products as part of the applied research funded under State Assignment No. 056-00001-25-00 (R&D Registry No. 124022200103-5)., Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00001-25-00 на проведение прикладных научных исследований (номер государственного учета НИР 124022200103-5).

    Source: Regulatory Research and Medicine Evaluation; Том 15, № 1 (2025); 44-56 ; Регуляторные исследования и экспертиза лекарственных средств; Том 15, № 1 (2025); 44-56 ; 3034-3453 ; 3034-3062 ; 10.30895/1991-2919-2025-15-1

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    Relation: https://www.vedomostincesmp.ru/jour/article/view/733/1801; https://www.vedomostincesmp.ru/jour/article/downloadSuppFile/733/823; https://www.vedomostincesmp.ru/jour/article/downloadSuppFile/733/825; https://www.vedomostincesmp.ru/jour/article/downloadSuppFile/733/831; Халимова АА, Орлов АС, Таубэ АА. Анализ локализации производства биотехнологических лекарственных препаратов в России с учетом происхождения активных фармацевтических субстанций. Ведомости Научного центра экспертизы средств медицинского применения. Регуляторные исследования и экспертиза лекарственных средств. 2024;14(1):53–61. https://doi.org/10.30895/1991-2919-2024-14-1-53-61; Gogesch P, Dudek S, van Zandbergen G, Waibler Z, Anzaghe M. The role of Fc receptors on the effectiveness of therapeutic monoclonal antibodies. Int J Mol Sci. 2021;22(16):8947. https://doi.org/10.3390/ijms22168947; Wang X, An Z, Luo W, Xia N, Zhao Q. Molecular and functional analysis of monoclonal antibodies in support of biologics development. Protein Cell. 2018;9(1):74–85. https://doi.org/10.1007/s13238-017-0447-x; Alt N, Zhang TY, Motchnik P, Taticek R, Quarmby V, Schlothauer T, et al. Determination of critical quality attributes for monoclonal antibodies using quality by design principles. Biologicals. 2016;44(5):291–305. https://doi.org/10.1016/j.biologicals.2016.06.005; Gao X, Wang W, Tesar D, Wei B, Eschelbach J, Kelley RF, Jiang G. An approach to bioactivity assessment for critical quality attribute identification based on antibody-antigen complex structure. J Pharm Sci. 2021;110(4):1652–60. https://doi.org/10.1016/j.xphs.2020.12.027; Joshi S, Rathore AS, Krull IS. Analytical characterization of biotherapeutic products, Part II: The analytical toolbox. LCGC North Am. 2018;36(11):814–22.; Rathore AS, Dash R. Tools for functional assessment of biotherapeutics. LCGC North Am. 2021;39(6):272–77.; Cedeño-Arias M, Sánchez-Ramírez J, Blanco-Santana R, Rengifo-Calzado E. Validation of a flow cytometry based binding assay for evaluation of monoclonal antibody recognizing EGF receptor. Sci Pharm. 2011;79(3):569–81. https://doi.org/10.3797/scipharm.1104-18; Kamen L, Myneni S, Langsdorf C, Kho E, Ordonia B, Thakurta T, et al. A novel method for determining antibody-dependent cellular phagocytosis. J Immunol Methods. 2019;468:55–60. https://doi.org/10.1016/j.jim.2019.03.001; Dash R, Singh SK, Chirmule N, Rathore AS. Assessment of functional characterization and comparability of biotherapeutics: a review. AAPS J. 2021;24(1):15. https://doi.org/10.1208/s12248-021-00671-0; Heinrich L, Tissot N, Hartmann DJ, Cohen R. Comparison of the results obtained by ELISA and surface plasmon resonance for the determination of antibody affinity. J Immunol Methods. 2010;352(1–2):13–22. https://doi.org/10.1016/j.jim.2009.10.002; Register AC, Tarighat SS, Lee HY. 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Development of a robust reporter gene assay to measure the bioactivity of anti-PD-1/anti-PD-L1 therapeutic antibodies. J Pharm Biomed Anal. 2017;145:447–53 https://doi.org/10.1016/j.jpba.2017.05.011; Alhazmi HA, Albratty M. Analytical techniques for the characterization and quantification of monoclonal antibodies. Pharmaceuticals (Basel). 2023;16(2):291. https://doi.org/10.3390/ph16020291; Bansal R, Dash R, Rathore AS. Impact of mAb aggregation on its biological activity: Rituximab as a case study. J Pharm Sci. 2020;109(9):2684–98. https://doi.org/10.1016/j.xphs.2020.05.015; Tada M, Ishii-Watabe A, Suzuki T, Kawasaki N. Development of a cell-based assay measuring the activation of FcγRIIa for the characterization of therapeutic monoclonal antibodies. PLoS One. 2014;9(4):e95787. https://doi.org/10.1371/journal.pone.0095787; Geigert J. Quality attributes of a biopharmaceutical. In: Geigert J. The challenge of CMC regulatory compliance for biopharmaceuticals. Switzerland: Springer; 2019. P. 311–29.; Алпатова НА, Гайдерова ЛА, Яковлев АК, Мотузова ЕВ, Лысикова СЛ, Солдатов АА, Авдеева ЖИ. Особенности определения специфической активности биотехнологических лекарственных средств. Биопрепараты. Профилактика, диагностика, лечение. 2017;17(1):13–26. EDN: YHSSGL; Prior S, Hufton SE, Fox B, Dougall T, Rigsby P, Bristow A. International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab. MAbs. 2018;10(1):129–42. https://doi.org/10.1080/19420862.2017.1386824; Rižner TL, Adamski J. It is high time to discontinue use of misidentified and contaminated cells: Guidelines for description and authentication of cell lines. J Steroid Biochem Mol Biol. 2018;182:1–3. https://doi.org/10.1016/j.jsbmb.2017.12.017; Мельникова ЕВ, Меркулова ОВ, Меркулов ВА, Олефир ЮВ, Ручко СВ, Бокованов ВЕ. Идентификация клеточных линий человека с использованием метода генотипирования короткими тандемными повторами: мировая практика. Биофармацевтический журнал. 2015;7(6):3–10. EDN: VRRBXF; Хорольский МД, Семенова ИС, Мельникова ЕВ, Олефир ЮВ. Применение метода коротких тандемных повторов для аутентификации клеточных линий. БИОпрепараты. Профилактика, диагностика, лечение. 2019;19(4):251–60. https://doi.org/10.30895/2221-996X-2019-19-4-251-260; White JR, Abodeely M, Ahmed S, Debauve G, Johnson E, Meyer DM, et al. Best practices in bioassay development to support registration of biopharmaceuticals. Biotechniques. 2019;67(3):126–37. https://doi.org/10.2144/btn-2019-0031; Zimmermann H, Gerhard D, Dingermann T, Hothorn LA. Statistical aspects of design and validation of microtitre-plate-based linear and non-linear parallel in vitro bioassays. Biotechnol J. 2010;5(1):62–74. https://doi.org/10.1002/biot.200900146; Surowka M, Klein C. A pivotal decade for bispecific antibodies? 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J Immunol Methods. 2017;448:74–9. https://doi.org/10.1016/j.jim.2017.05.011; Головинская ОВ, Лысикова СЛ, Лебедева ЮН, Алпатова НА, Мовсесянц АА, Меркулов ВА. Рекомендации по изложению методики оценки биологической (специфической) активности биотехнологических лекарственных препаратов в нормативной документации. БИОпрепараты. Профилактика, диагностика, лечение. 2018;18(3):168–74. https://doi.org/10.30895/2221-996X-2018-18-3-168-174; https://www.vedomostincesmp.ru/jour/article/view/733

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