Εμφανίζονται 1 - 4 Αποτελέσματα από 4 για την αναζήτηση '"биоаналогичные (биоподобные) препараты"', χρόνος αναζήτησης: 0,53δλ Περιορισμός αποτελεσμάτων
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    Academic Journal

    Συνεισφορές: The study reported in this publication was carried out as part of publicly funded research project No. 056-00052-23-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D reporting No. 121022000147-4)., Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00052-23-00 на проведение прикладных научных исследований (номер государственного учета НИР 121022000147-4).

    Πηγή: Biological Products. Prevention, Diagnosis, Treatment; Том 23, № 4 (2023); 480-498 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 23, № 4 (2023); 480-498 ; 2619-1156 ; 2221-996X

    Περιγραφή αρχείου: application/pdf

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Trends Biotechnol. 2013;31(11):612–20. https://doi.org/10.1016/j.tibtech.2013.07.002; 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; Алпатова НА, Гайдерова ЛА, Яковлев АК, Мотузова ЕВ, Лысикова СЛ, Солдатов АА и др. Особенности определения специфической активности биотехнологических лекарственных средств. Биопрепараты. Профилактика, диагностика, лечение. 2017;17(1):13–26. EDN: YHSSGL; Mimura Y, Katoh T, Saldova R, O’Flaherty R, Izumi T, Mimura-Kimura Y, et al. Glycosylation engineering of therapeutic IgG antibodies: challenges for the safety, functionality and efficacy. Protein Cell. 2018;9(1):47–62. https://doi.org/10.1007/s13238-017-0433-3; 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; Láng JA, Balogh ZC, Nyitrai MF, Juhász C, Gilicze AKB, Iliás A, et al. In vitro functional characterization of biosimilar therapeutic antibodies. Drug Discov Today Technol. 2020;37:41–50. https://doi.org/10.1016/j.ddtec.2020.11.010; 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; Wild D, ed. The immunoassay handbook: theory and applications of ligand binding, ELISA and related techniques. 4th ed. Elsevier Science; 2013.; Lebakken CS, Riddle SM, Singh U, Frazee WJ, Eliason HC, Gao Y, et al. Development and applications of a broad-coverage, TR-FRET-based kinase binding assay platform. J Biomol Screen. 2009;14(8):924–35. https://doi.org/10.1177/1087057109339207; Noto A, Ngauv P, Trautmann L. Cell-based flow cytometry assay to measure cytotoxic activity. J Vis Exp. 2013;82:e51105. https://doi.org/10.3791/51105; Schasfoort RBM. Handbook of surface plasmon resonance. 2nd ed. RSC Publishing; 2017. https://doi.org/10.1039/9781788010283; Beyer B, Schuster M, Jungbauer A, Lingg N. Micro-heterogeneity of recombinant antibodies: analytics and functional impact. Biotechnol J. 2018;13(1). https://doi.org/10.1002/biot.201700476; Rosales C. Fcγ receptor heterogeneity in leukocyte functional responses. Front Immunol. 2017;8:280. https://doi.org/10.3389/fimmu.2017.00280; Branstetter E, Duff RJ, Kuhns S, Padaki R. Fc glycan sialylation of biotherapeutic monoclonal antibodies has limited impact on antibody-dependent cellular cytotoxicity. FEBS Open Bio. 2021;11(11):2943–9. https://doi.org/10.1002/2211-5463.13267; Velasco-Velázquez MA, Salinas-Jazmín N, HisakiItaya E, Cobos-Puc L, Xolalpa W, González G, et al. Extensive preclinical evaluation of an infliximab biosimilar candidate. Eur J Pharm Sci. 2017;102:35–45. https://doi.org/10.1016/j.ejps.2017.01.038; Eon-Duval A, Broly H, Gleixner R. Quality attributes of recombinant therapeutic proteins: an assessment of impact on safety and efficacy as part of a quality by design development approach. Biotechnol Prog. 2012;28(3):608–22. https://doi.org/10.1002/btpr.1548; Ishii-Watabe A, Kuwabara T. Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies. Drug Metab Pharmacokinet. 2019;34(1):64–70. https://doi.org/10.1016/j.dmpk.2018.11.004; Prior S, Metcalfe C, Hufton SE, Wadhwa M, Schneider CK, Burns C. Maintaining standards for biosimilar monoclonal antibodies. Nat Biotechnol. 2021;39(3):276–280. https://doi.org/10.1038/s41587-021-00848-0; Vezér B, Buzás Z, Sebeszta M, Zrubka Z. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents. Curr Med Res Opin. 2016;32(5):829–34. https://doi.org/10.1185/03007995.2016.1145579; Acha V, Mestre-Ferrandiz J. Translating European regulatory approval into healthcare uptake for biosimilars: the second translational gap. Technol Anal Strateg Manag. 2017;29(3):263–75. https://doi.org/10.1080/09537325.2017.1285396; Alsamil AM, Giezen TJ, Egberts TC, Doevendans E, Leufkens HG, Gardarsdottir H. Nature and timing of post-approval manufacturing changes of tumour necrosis factor α inhibitor products: a 20-year follow-up study of originators and biosimilars. Eur J Pharm Sci. 2022;175:106227. https://doi.org/10.1016/j.ejps.2022.106227; 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; Thorpe R, Wadhwa M. Intended use of reference products & WHO international standards/ reference reagents in the development of similar biological products (biosimilars). Biologicals. 2011;39(5):262–5. https://doi.org/10.1016/j.biologicals.2011.06.005; Udpa N, Million RP. Monoclonal antibody biosimilars. Nat Rev Drug Discov. 2016;15(1):13–4. https://doi.org/10.1038/nrd.2015.12; Metcalfe С, Dougall Т, Bird С, Rigsby Р, Behr-Gross М-Е, Wadhwa М. The first World Health Organization International Standard for infliximab products: a step towards maintaining harmonized biological activity. MAbs. 2019;11(1):13–25. https://doi.org/10.1080/19420862.2018.1532766; Tebbey PW, Varga A, Naill M, Clewell J, Venema J. Consistency of quality attributes for the glycosylated monoclonal antibody Humira® (adalimumab). MAbs. 2015;7(5):805–11. https://doi.org/10.1080/19420862.2015.1073429; Kang HN, Thorpe R, Knezevic I. The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019. Biologicals. 2020;65:1–9. https://doi.org/10.1016/j.biologicals.2020.02.005; Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, et al. Maintaining consistent quality and clinical performance of biopharmaceuticals. Expert Opin Biol Ther. 2018;18(4):369–79. https://doi.org/10.1080/14712598.2018.1421169; Wadhwa M, Bird Ch, Dilger P, Rigsby P, Jia H, Behr-Gross ME. Establishment of the first WHO International Standard for etanercept, a TNF receptor II Fc fusion protein: Report of an international collaborative study. J Immunol Methods. 2017;447:14–22. https://doi.org/10.1016/j.jim.2017.03.007; Wadhwa M, Bird C, Atkinson E, Cludts I, Rigsby P. The first WHO international standard for adalimumab: dual role in bioactivity and therapeutic drug monitoring. Front Immunol. 2021;12:636420. https://doi.org/10.3389/fimmu.2021.636420; Jia H, Harikumar P, Atkinson E, Rigsby P, Wadhwa M. The first WHO international standard for harmonizing the biological activity of bevacizumab. Biomolecules. 2021;11(11):1610. https://doi.org/10.3390/biom11111610; Goffe B, Cather JC. Etanercept: an overview. J Am Acad Dermatol. 2003;49(2 Suppl):105–11. https://doi.org/10.1016/mjd.2003.554; Tracey D, Klareskog L, Sasso EN, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008;117(2):244–79. https://doi.org/10.1016/j.pharmthera.2007.10.001; Glennie MJ, French RR, Cragg MS, Taylor RP. Mechanisms of killing by anti-CD20 monoclonal antibodies. Mol Immunol. 2007;44(16):3823–37. https://doi.org/10.1016/j.molimm.2007.06.151; Smith MR. Rituximab (monoclonal anti-CD20 antibody): mechanisms of action and resistance. Oncogene. 2003;22(47):7359–68. https://doi.org/10.1038/sj.onc.1206939; Salinas-Jazmín N, Medina-Rivero E, Velasco-Velázquez MA. Bioassays for the evaluation of target neutralization and complement-dependent cytotoxicity (CDC) of therapeutic antibodies. Methods Mol Biol. 2022;2313:281–94. https://doi.org/10.1007/978-1-0716-1450-1_17; Marušič M, Klemenčič A. Adalimumab — general considerations. J Pharmacol Clin Toxicol. 2018;6(2):1104–11.; Roda G, Jharap B, Neeraj N, Colombel JF. Loss of response to anti-TNFs: definition, epidemiology, and management. Clin Transl Gastroenterol. 2016;7(1):e135. https://doi.org/10.1038/ctg.2015.63; Meager A, Leung H, Woolley J. Assays for tumour necrosis factor and related cytokines. J Immunol Methods. 1989;116(1):1–17. https://doi.org/10.1016/0022-1759(89)90306-2; Khabar KS, Siddiqui S, Armstrong JA. WEHI-13VAR: a stable and sensitive variant of WEHI 164 clone 13 fibrosarcoma for tumor necrosis factor bioassay. Immunol Lett. 1995;46(1–2):107–10. https://doi.org/10.1016/0165-2478(95)00026-2; Minafra L, Di Cara G, Albanese NN, Cancemi P. Proteomic differentiation pattern in the U937 cell line. Leuk Res. 2011;35(2):226–36. https://doi.org/10.1016/j.leukres.2010.07.040; Ferrara N, Hillan KJ, Gerber HP, Novotny W. Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer. Nat Rev Drug Discov. 2004;3(5):391–400. https://doi.org/10.1038/nrd1381; Apte RS, Chen DS, Ferrara N. VEGF in signaling and disease: Beyond discovery and development. Cell. 2019;176(6):1248–64. https://doi.org/10.1016/j.cell.2019.01.021; Wang Y, Fei D, Vanderlaan M, Song A. Biological activity of bevacizumab, a humanized anti-VEGF antibody in vitro. Angiogenesis. 2004;7(4):335–45. https://doi.org/10.1007/s10456-004-8272-2; Ebbers HC, van Meer PJ, Moors EH, Mantel-Teeuwisse AK, Leufkens HG, Schellekens H. Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab. Drug Discov Today. 2013;18(17–18):872–9. https://doi.org/10.1016/j.drudis.2013.05.004; Jefferis R. Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action. Trends Pharmacol Sci. 2009;30(7):356–62. https://doi.org/10.1016/j.tips.2009.04.007; Beck A, Wagner-Rousset E, Ayoub D, Van Dorsselaer A, Sanglier-Cianférani S. Characterization of therapeutic antibodies and related products. Anal Chem. 2013;85(2):715–36. https://doi.org/10.1021/ac3032355; Molina MA, Codony-Servat J, Albanell J, Rojo F, Arribas J, Baselga J. Trastuzumab (herceptin), a humanized anti-Her2 receptor monoclonal antibody, inhibits basal and activated Her2 ectodomain cleavage in breast cancer cells. Cancer Res. 2001;61(12):4744–9. PMID: 11406546; Collins DM, O’Donovan N, McGowan PM, O’Sullivan F, Duffy MJ, Crown J. Trastuzumab induces antibody-dependent cell-mediated cytotoxicity (ADCC) in HER-2-non-amplified breast cancer cell lines. Ann Oncol. 2012;23(7):1788–95. https://doi.org/10.1093/annonc/mdr484; Menard S, Pupa SM, Campiglio M, Tagliabue E. Biologic and therapeutic role of HER2 in cancer. Oncogene. 2003;22(42):6570–8. https://doi.org/10.1038/sj.onc.1206779; Vincenzi B, Schiavon G, Silletta M, Santini D, Tonini G. The biological properties of cetuximab. Crit Rev Oncol Hematol. 2008;68(2):93–106. https://doi.org/10.1016/j.critrevonc.2008.07.006; Kimura H, Sakai K, Arao T, Shimoyama T, Tamura T, Nishio K. Antibody-dependent cellular cytotoxicity of cetuximab against tumor cells with wild-type or mutant epidermal growth factor receptor. Cancer Sci. 2007;98(8):1275–80. https://doi.org/10.1111/j.1349-7006.2007.00510.x; Yazdi MH, Faramarzi MA, Nikfar S, Abdollahi M. A comprehensive review of clinical trials on EGFR inhibitors such as cetuximab and panitumumab as monotherapy and in combination for treatment of metastatic colorectal cancer. Avicenna J Med Biotechnol. 2015;7(4):134–44. PMID: 26605007; https://www.biopreparations.ru/jour/article/view/532

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    Academic Journal

    Πηγή: Biological Products. Prevention, Diagnosis, Treatment; Том 16, № 2 (2016); 67-77 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 16, № 2 (2016); 67-77 ; 2619-1156 ; 2221-996X ; undefined

    Περιγραφή αρχείου: application/pdf

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Динамика морфометрических показателей тромбоцитов периферической крови как критерий оценки тромбогенности диализных мембран. Урология 2011; (2): 36-41.; Ушакова АЮ, Феклисова ЛВ, Мескина ЕР, Тедер ЮГ, Волохович ТТ, Пожалостина ЛВ. Клинико-лабораторная эффективность применения различных схем аципола в лечении детей, больных острыми кишечными инфекциями. Биопрепараты 2008; (2): 19-21.; https://www.biopreparations.ru/jour/article/view/45; undefined

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