Открытый доступ
Доступ платный или только для подписчиков
Оптимизация маннозных гликанов при культивировании продуцента моноклонального антитела к фактору некроза опухоли альфа
Аннотация
Проведена коррекция маннозных гликанов в биосимилярном рекомбинантном моноклональном антителе к фактору некроза опухолей альфа при культивировании клеток линии СНО. Показана эффективность внесения в среду 20 нМ ионофорного антибиотика монензина для повышения доли высокоманнозной гликоформы Man5, что сочеталось с ухудшением роста и продуктивностью клеточной линии. Подтверждено, что содержание гликоформы Man5 в профиле гликозилирования биосимилярного моноклонального антитела может быть приведено в соответствие с содержанием гликозилированных форм в оригинальном препарате путем внесения сахарозы в концентрации 60 мМ, как наиболее предпочтительного агента, который позволяет сохранить культуральные характеристики и продуктивность клеточной линии.
Ключевые слова
Ссылки
den Broeder A., van de Putte L., Rau R., et al. A single dose, placebo controlled study of the fully human anti-tumor necrosis factor-alpha antibody adalimumab (D2E7) in patients with rheumatoid arthritis / J. Rheumatol. 2002. V. 29. No. 11, P. 2288 – 2298.
Chew A., Bennett A., Smith C., et al. Successful treatment of severe psoriasis and psoriatic arthritis with adalimumab / B. J, Dermatol. 2004. V. 151. No. 2. P. 492 – 496.
Papadakis K., Shaye O., Vasiliauskas E., et al. Safety and efficacy of adalimumab (D2E7) in Crohn’s disease patients with an attenuated response to infliximab / Am. J. Gastroenterol. 2005. V. 100. No. 1. P. 75 – 79.
Jaffe G., Dick A., Br?zin A., et al. Adalimumab in patients with active noninfectious uveitis / New Eng. J. Med. 2016. V. 375. No. 10. P. 932 – 943.
Maini R., Elliott M., Brennan F., et al. Targeting TNF alpha for the therapy of rheumatoid arthritis / Clin. Exp. Rheumatol. 1994. V. 12. Suppl. 11. P. 63 – 66.
Maini R., Elliott M., Brennan F., et al. Beneficial effects of tumour necrosis factor-alpha (TNF-alpha) blockade in rheumatoid arthritis (RA) / Clin. Exp. Immunol. 1995. V. 101. No. 2. P. 207 – 212.
Kempeni J. Update on D2E7: A fully human anti-tumour necrosis factor alpha monoclonal antibody / Ann. Rheum. Dis. 2000. V. 59. Suppl. 1. P. i44 – 45.
Scallon B., Cai A., Solowski N., et al. Binding and functional comparisons of two types of tumor necrosis factor antagonists / J. Pharmacol. Exp. Ther. 2002. V. 301. No. 2. P. 418 – 426.
Van den Brande J. M., Braat H., van den Brink G. R., et al. / Infliximab but not etanercept induces apoptosis in lamina propria T-lymphocytes from patients with Crohn’s disease / Gastroenterology. 2003. V. 124. No. 7. P. 1774 – 1785.
Shen C., Assche G. V., Colpaert S., et al. Adalimumab induces apoptosis of human monocytes: A comparative study with infliximab and etanercept / Aliment. Pharmacol. Ther. 2005. V. 21. No. 3. P. 251 – 258.
Mitoma H., Horiuchi T., Tsukamoto H., et al. Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: Comparison among infliximab, etanercept, and adalimumab / Arthritis Rheum. 2008. V. 58. No. 5. P. 1248 – 1257.
Goncalves J., Ara?jo F., Cutolo M., et al. Biosimilar monoclonal antibodies: Preclinical and clinical development aspects / Clin. Exp. Rheumatol. 2016. V. 34. No. 4. P. 698 – 705.
Danese S., Gomollon F. Governing Board and Operational Board of ECCO. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). / J Crohns. Colitis. 2013. V. 7. No. 7. P. 586 – 589.
Kurki P., Bielsky M. Working party on similar biological (biosimilar) medicinal products (BMWP) of Committee for Medicinal Products for Human Use (CHMP). ECCO position challenged by European drug regulators / J Crohns Colitis. 2014. V. 8. No. 3. P. 258.
Beck A., Debaene F., Diemer H., et al. Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies / J. Mass Spectrom. 2015. V. 50. No. 2. P. 285 – 297.
Brady L., Velayudhan J., Visone D., et al. The criticality of high-resolution N-linked carbohydrate assays and detailed characterization of antibody effector function in the context of biosimilar development / Monoclon. Antibod. 2015. V. 7. No. 3. P. 562 – 570.
Воронина Е. В., Лобанова Н. В., Сухоженко А. В. и др. Оптимизация питательных сред для культивирования клеточной линии СНО — продуцента моноклонального антитела Адалимумаб против фактора некроза опухолей альфа / Биотехнология. 2016. Т. 32. С. 60 – 67.
Shields R., Lai J., Keck R., O’Connell L., et al. Lack of fucose on human IgG1 N-linked oligosaccharide improves binding to human Fcgamma RIII and antibody-dependent cellular toxicity / J. Biol. Chem. 2002. V. 277. No. 30. P. 26733 – 26740.
Kanda Y., Yamada T., Mori K., et al. Comparison of biological activity among nonfucosylated therapeutic IgG1 antibodies with three different N-linked Fc oligosaccharides: the high-mannose, hybrid, and complex types / Glycobiology. 2007. V. 17. No. 1. P. 104 – 118.
Elbein A., Tropea J., Mitchell M., et al. Kifunensine, a potent inhibitor of the glycoprotein processing mannosidase I / J. Biol. Chem. 1990. V. 265. No. 26. P. 15599 – 15605.
Zhou Q., Shankara S., Roy A., et al. Development of a simple and rapid method for producing non-fucosylated oligomannose containing antibodies with increased effector function / Biotechnol. Bioeng. 2008. V. 99. No. 3. P. 652 – 665.
Pande S., Rahardjo A., Livingston B., et al. Monensin, a small molecule ionophore, can be used to increase high mannose levels on monoclonal antibodies generated by Chinese hamster ovary production cell-lines / Biotechnol. Bioeng. 2015. V. 112. No. 7. P. 1383 – 1394.
Mollenhauer H., Morre D., Rowe L. Alteration of intracellular traffic by monensin; mechanism, specificity and relationship to toxicity / Biochim. Biophys. Acta. 1990, V. 1031. No. 2. P. 225 – 246.
Paroutis P., Touret N., Grinstein S. The pH of the secretory pathway: Measurement, determinants, and regulation / Physiology. 2004. V. 19. P. 207 – 215.
Machamer C., Cresswell P. Monensin prevents terminal glycosylation of the № and O-linked oligosaccharides of the HLA-DR-associated invariant chain and inhibits its dissociation from the alpha-beta chain complex / Proc. Natl. Acad. Sci. 1984. V. 81. No. 5. P. 1287 – 1291.
Kousoulas K., Bzik D., Person S. Effect of the iono¬phore monensin on herpes simplex virus type 1-induced cell fusion, glycoprotein synthesis, and virion infectivity / Intervirology. 1983. V. 20. No. 1. P. 56 – 60.
Chatterjee S., Bradac J., Hunter E. Effect of monensin on Mason-Pfizer monkey virus glycoprotein synthesis / J. Virol. 1982. V. 44. No. 3. P. 1003 – 1012.
Hossler P., McDermott S., Racicot C., et al. Cell culture media supplementation of uncommonly used sugars sucrose and tagatose for the targeted shifting of protein glycosylation profiles of recombinant protein therapeutics / Biotechnol. Prog. 2014. V. 30. No. 6. P. 1419 – 1431.
Hossler P., Racicot C., Chumsae C. Cell culture media supplementation of infrequently used sugars for the targeted shifting of protein glycosylation profiles / Biotechnol. Prog. 2017. V. 33. No. 2. P. 511 – 522.
Huang C., Lin H., Yang J. A robust method for increasing Fc glycan high mannose level of recombinant antibodies / Biotechnol. Bioeng. 2015. V. 112. No. 6. P. 1200 – 1209.
Wong D., Wong K., Goh L., et al. Impact of dynamic online fed-batch strategies on metabolism, productivity and N-glycosylation quality in CHO cell cultures / Biotechnol. Bioeng. 2005. V. 89. No. 2. P. 164 – 177.
Pacis E., Yu M., Autsen J., et al. Effects of cell culture conditions on antibody N-linked glycosylation-what affects high mannose 5 glycoform / Biotechnol. Bioeng. 2011. V. 108. No. 10. P. 2348 – 2358.
Robinson D., Chan C., Yu L., et al. Characterization of a recombinant antibody produced in the course of a high yield fed-batch process / Biotechnol. Bioeng. 1994. V. 44. No. 6. P. 727 – 735.
Voronina E., Seregin Y., Litvinova N., et al. Design of a stable cell line producing a recombinant monoclonal anti-TNF? antibody based on a CHO cell line / Springer Plu. 2016. V. 5. No. 1. P. 1584.
Ссылки
- Ссылки не определены.
** ** ** ** ** **
ISSN: 2073-8099
** ** ** ** ** **
Подписаться на наши издания Вы можете через почтовые каталоги Объединенный каталог «Пресса России» «Урал Пресс», «Ивис», «Прессинформ» и «Профиздат».
Наши партнеры:
iIPhEB - Международная выставка и форум по фармацевтике и биотехнологиям, 2–4 апреля 2024