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    Academic Journal

    Συνεισφορές: The study was conducted without sponsorship. The team of authors express their gratitude to the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya., Исследование проводилось без спонсорской поддержки. Коллектив авторов выражает благодарность ФГБУ «НИЦЭМ им. Н. Ф. Гамалеи» Минздрава России.

    Πηγή: Biological Products. Prevention, Diagnosis, Treatment; Том 21, № 4 (2021); 266-278 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 21, № 4 (2021); 266-278 ; 2619-1156 ; 2221-996X ; 10.30895/2221-996X-2021-21-4

    Περιγραφή αρχείου: application/pdf

    Relation: https://www.biopreparations.ru/jour/article/view/354/462; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/260; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/261; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/262; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/263; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/264; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/265; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/268; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/269; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/302; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/304; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/305; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/306; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/307; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/308; https://www.biopreparations.ru/jour/article/downloadSuppFile/354/312; Naso MF, Tomkowicz B, Perry WL, Strohl WR. Adeno-associated virus (AAV) as a vector for gene therapy. BioDrugs. 2017;31(4):317–34. https://doi.org/10.1007/s40259-017-0234-5; Samulski RJ, Muzyczka N. AAV-mediated gene therapy for research and therapeutic purposes. Annu Rev Virol. 2014;1(1):427–51. https://doi.org/10.1146/annurev-virology-031413-085355; Choi VW, McCarty DM, Samulski RJ. Host cell DNA repair pathways in adeno-associated viral genome processing. J Virol. 2006;80(21):10346–56. https://doi.org/10.1128/JVI.00841-06; Mays LE, Wang L, Lin J, Bell P, Crawford A, Wherry EJ, Wilson JM. AAV8 induces tolerance in murine muscle as a result of poor APC transduction, T cell exhaustion, and minimal MHCI upregulation on target cells. Mol Ther. 2014;22(1):28–41. https://doi.org/10.1038/mt.2013.134; Ahi YS, Bangari DS, Mittal SK. Adenoviral vector immunity: its implications and circumvention strategies. Curr Gene Ther. 2011;11(4):307–20. https://doi.org/10.2174/156652311796150372; Grieger JC, Soltys SM, Samulski RJ. Production of recombinant adeno-associated virus vectors using suspension HEK293 cells and continuous harvest of vector from the culture media for GMP FIX and FLT1 clinical vector. Mol Ther. 2016;24(2):287–97. https://doi.org/10.1038/mt.2015.187; Rajendra Y, Kiseljak D, Baldi L, Wurm FM, Hacker DL. Transcriptional and post-transcriptional limitations of high-yielding, PEI-mediated transient transfection with CHO and HEK-293E cells. Biotechnol Prog. 2015;31(2):541–9. https://doi.org/10.1002/btpr.2064; Wright JF. Transient transfection methods for clinical adeno-associated viral vector production. Hum Gene Ther. 2009;20(7):698–706. https://doi.org/10.1089/hum.2009.064; Keeler AM, Flotte TR. Recombinant adeno-associated virus gene therapy in light of Luxturna (and Zolgensma and Glybera): Where are we, and how did we get here? Annu Rev Virol. 2019;6(1):601–21. https://doi.org/10.1146/annurev-virology-092818-015530; Godakova SA, Noskov AN, Vinogradova ID, Ugriumova GA, Solovyev AI, Esmagambetov IB, et al. Camelid VHHs fused to human Fc fragments provide long term protection against botulinum neurotoxin A in mice. Toxins (Basel). 2019;11(8):464. https://doi.org/10.3390/toxins11080464; Froger A, Hall JE. Transformation of plasmid DNA into E. coli using the heat shock method. J Vis Exp. 2007;6:253. https://doi.org/10.3791/253; Birnboim HC, Doly J. A rapid alkaline extraction procedure for screening recombinant plasmid DNA. Nucleic Acids Res. 1979;7(6):1513–23. https://doi.org/10.1093/nar/7.6.1513; Merten OW. AAV vector production: state of the art developments and remaining challenges. Cell Gene Therapy Insights. 2016;2(5):521–51.; Sousa F, Prazeres DMF, Queiroz JA. Improvement of transfection efficiency by using supercoiled plasmid DNA purified with arginine affinity chromatography. J Gene Med. 2009;11(1):79–88. https://doi.org/10.1002/jgm.1272; Diogo MM, Queiroz JA, Prazeres DMF. Chromatography of plasmid DNA. J Chromatogr A. 2005;1069(1):3–22. https://doi.org/10.1016/j.chroma.2004.09.050; Stadler J, Lemmens R, Nyhammar T. Plasmid DNA purification. J Gene Med. 2004;6(Suppl 1):S54–S66. https://doi.org/10.1002/jgm.512; Cupillard L, Juillard V, Latour S, Colombet G, Cachet N, Richard S, et al. Impact of plasmid supercoiling on the efficacy of a rabies DNA vaccine to protect cats. Vaccine. 2005;23(16):1910–6. https://doi.org/10.1016/j.vaccine.2004.10.018; Zhao H, Lee KJ, Daris M, Lin Y, Wolfe T, Sheng J, et al. Creation of a high-yield AAV vector production platform in suspension cells using a design of experiment approach. Mol Ther Methods Clin Dev. 2020;18:312–20. https://doi.org/10.1016/j.omtm.2020.06.004; Nass SA, Mattingly MA, Woodcock DA, Burnham BL, Ardinger JA, Osmond SE, et al. Universal method for the purification of recombinant AAV vectors of differing serotypes. Mol Ther Methods Clin Dev. 2017;9:33–46. https://doi.org/10.1016/j.omtm.2017.12.004; Sommer JM, Smith PH, Parthasarathy S, Isaacs J, Vijay S, Kieran J, et al. Quantification of adeno-associated virus particles and empty capsids by optical density measurement. Mol Ther. 2003;7(1):122–8. https://doi.org/10.1016/s1525-0016(02)00019-9; Benskey MJ, Sandoval IM, Manfredsson FP. Continuous Collection of Adeno-Associated Virus from Producer Cell Medium Significantly Increases Total Viral Yield. Hum Gene Ther Methods. 2016;27(1):32–45. https://doi.org/10.1089/hgtb.2015.117; Hajba L, Guttman A. Recent Advances in the Analysis Full/Empty Capsid Ratio and Genome Integrity of Adeno-associated Virus (AAV) Gene Delivery Vectors. Curr Mol Med. 2020;20(10):806–13. https://doi.org/10.2174/1566524020999200730181042; Crosson SM, Dib P, Smith KJ, Zolotukhin S. Helper-free production of laboratory grade AAV and purification by iodixanol density gradient centrifugation. Mol Ther Methods Clin Dev. 2018;10:1–7. https://doi.org/10.1016/j.omtm.2018.05.001; https://www.biopreparations.ru/jour/article/view/354

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    Academic Journal

    Πηγή: Drug development & registration; № 1 (2016); 74-85 ; Разработка и регистрация лекарственных средств; № 1 (2016); 74-85 ; 2658-5049 ; 2305-2066

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    Relation: https://www.pharmjournal.ru/jour/article/view/225/222; Е.А. Савищенко, С.С. Илисавский, А.И. Гинак, Т.Д. Алейникова, М.М. Шавловский. Наночастицы на основе производных гидрокортизона в качестве векторов доставки генетического материала в эукариотические клетки in vivo // Биотехнология. 2009. Т. 1. С. 31-38.; Неоваскулген. URL: http://hsci.ru/produkty-i-uslugi/neovaskulgen (дата обращения 20.01.2016).; Ю.А. Жогина, Д.В. Глазкова, А.С. Ветчинова, Е.В. Богословская, Г.М. Цыганова, Г.А. Шипулин. Сравнительная оценка активности различных генетических конструкций, направленных на подавление репликации ВИЧ-1 // Биофармацевтический Журнал. 2014. Т. 6(5). С. 11-18.; П.В. Михайлов, Е.К. Курбанова, В.Д. Гусарова, А.М. Лящук, Ю.Н. Новиков, Д.А. Гусаров. Периодический режим культивирования бактериального продуцента E. coli с подпиткой для продукции генно-терапевтической суперскрученной плазмиды // Биофармацевтический Журнал. 2014. Т. 6(3). С. 31-35.; J. Sambrook, E. Fritsch, T. Maniatis. Gel electrophoresis of DNA. In Molecular Cloning: a Laboratory Manual. - N.Y.: Cold Spring Harbor Laboratory Press, Cold Spring Harbor, 1989. Chapter 6.; Потеря в массе при высушивании // Государственная фармакопея Российской Федерации. XII изд. Ч. 1. - М. 2007.; Государственная фармакопея Российской Федерации. XII издание. Ч. 1. - М. 2007.; ОФС 42-0075-07 // Государственная фармакопея XII, Ч.1. - М. 2007.; ОФС 42-0066-07 // Государственная фармакопея XII, Ч.1. - М. 2007.; Контроль стерильности методом прямого посева // Государственная фармакопея CCCP. XI издание. Ч. 2. - М. 1989.; M.J. Maltesen, M. van de Weert. Drying methods for protein pharmaceuticals // Drug Discovery Today: Technologies. 2008. V. 5. № 2-3. P. e81-e88.; S. Bhattacharya, R. Suryanarayanan. Local mobility in amorphous pharmaceuticals-characterization and implications on stability // J. Pharm. Sci. 2009. V. 98. № 9. P. 2935-2953.; M.J. Pikal. Freeze Drying // Encyclopedia of Pharmaceutical Technology / Ed. by J. Swabrick, J.S. Boyland. - N.Y.: Marcel Dekker, 2001.; S. Tsinontides, P. Rajniak, D. Pham, W. Hunke, J. Placek, S.D. Reynolds. Freeze Drying - Principles and Practice for Successful Scale-up to Manufacturing // Int. J. Pharm. 2004. V. 280. P. 1-16.; https://www.pharmjournal.ru/jour/article/view/225

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