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Soleimani, Sina. (1403). Cell identification, characterization, and documentation for use in the production of biological products. سامانه مدیریت نشریات علمی, 79(3), 449-458. doi: 10.32592/ARI.2024.79.3.449
Sina Soleimani. "Cell identification, characterization, and documentation for use in the production of biological products". سامانه مدیریت نشریات علمی, 79, 3, 1403, 449-458. doi: 10.32592/ARI.2024.79.3.449
Soleimani, Sina. (1403). 'Cell identification, characterization, and documentation for use in the production of biological products', سامانه مدیریت نشریات علمی, 79(3), pp. 449-458. doi: 10.32592/ARI.2024.79.3.449
Soleimani, Sina. Cell identification, characterization, and documentation for use in the production of biological products. سامانه مدیریت نشریات علمی, 1403; 79(3): 449-458. doi: 10.32592/ARI.2024.79.3.449

Cell identification, characterization, and documentation for use in the production of biological products

Archives of Razi Institute
مقاله 3، دوره 79، شماره 3، مرداد و شهریور 2024، صفحه 449-458    اصل مقاله (308.98 K)
نوع مقاله: Review Article
شناسه دیجیتال (DOI): 10.32592/ARI.2024.79.3.449
نویسنده
Sina Soleimani*
Razi Vaccine & Serum Research Institute, Agricultural Research Education and Extension Organization (AREEO), P.O. Box 31975-148, Karaj, Iran
چکیده
There is always a concern about the quality of cell-based products in terms of the contamination of the cells and their lack of efficiency. Therefore, it is very important to ensure these cells' identity, purity, efficacy, and suitability for the production of biological products and diagnostic uses.
So, cells must be identified, evaluated, documented, and stored to be used consistently and efficiently. With these conditions, vaccine manufacturers have a suitable reserve of efficient and valuable cells for the production and quality control of biological products.
In this review article, a strategic plan for cell-substrate well-characterization and identification according to scientific principles, the author's work experience, and regulatory guidance for the optimal use of that cell in research and diagnostic studies especially for the biological product production process have been drawn. For this purpose, all aspects of cell identification, cell evaluation, and cell characterization are discussed. Because of the importance of cell identity in the competence of a cell substrate, in the cell identification section, all aspects of cell identification, including general cell information, and specific cell characteristics, especially in terms of cell passage history, cell storage conditions, and cell coding and labeling were studied. In the part of cell evaluation and determination of cell characteristics, all tests necessary to determine cell characteristics from various aspects including determination of cell identity, cell growth conditions, cell quality, and efficiency, and the possibility of cell contamination with adventitious agents, including cellular, viral, bacterial, mycoplasma, and mycobacterial agents were introduced. Due to the importance of endogenous virus contamination, this topic is specially discussed. Also, the stability of the cell both from the aspect of genetic stability and from the aspect of stability of cell efficiency, were discussed.
In the end, while reviewing the necessary documents to be under the control of the cell for use in the laboratory, based on the studies conducted, the certificate of the cell has been compiled.
Therefore, on this basis, the studied cell can be used for research and diagnostic studies of virology, and especially for the production and quality control of biological products.
کلیدواژه‌ها
Biological product؛ Cell culture؛ Characterization؛ Documentation
عنوان مقاله [English]
شناسایی، تعیین خصوصیات و مستند سازی سلول برای استفاده در تولید فراورده های بیولوژیک
چکیده [English]
همیشه نگرانی در مورد کیفیت محصولات سلولی از نظر آلودگی سلول ها و عدم کارایی آنها وجود دارد. بنابراین، اطمینان از هویت، خلوص، کارایی و مناسب بودن این سلول ها برای تولید محصولات بیولوژیکی و مصارف تشخیصی بسیار مهم است. لذا، سلول ها باید شناسایی، ارزیابی، مستندسازی و ذخیره شوند تا به طور مداوم و کارآمد مورد استفاده قرار گیرند. با این شرایط، سازندگان واکسن ذخیره مناسبی از سلول های کارآمد و ارزشمند برای تولید و کنترل کیفیت محصولات بیولوژیکی دارند.
در این مقاله مروری، یک برنامه راهبردی مناسب برای شناسایی و ارزیابی سلول با توجه به اصول علمی، تجربه کاری نویسنده و منابع معتبر برای استفاده بهینه از آن سلول در مطالعات تحقیقاتی و تشخیصی و به‌ویژه برای تولید محصول بیولوژیکی ارائه شده است. به این منظور تمام جنبه های شناسایی سلولی، ارزیابی سلولی و تعیین خصوصیات سلولی مورد بحث قرار می گیرد. به دلیل اهمیت هویت سلولی در مناسب بودن یک بستر سلولی، در بخش شناسایی سلول، تمام جنبه های شناسایی سلول، از جمله اطلاعات عمومی سلول، و ویژگی های خاص سلول، به ویژه از نظر تاریخچه پاساژ سلولی، شرایط ذخیره سازی سلول، کدگذاری و برچسب گذاری سلول مورد مطالعه قرار گرفت. در بخش ارزیابی سلولی و تعیین خصوصیات سلولی، کلیه آزمایشات لازم برای تعیین خصوصیات سلولی از جنبه های مختلف از جمله تعیین هویت سلولی، شرایط رشد سلولی، کیفیت و کارایی سلول و احتمال آلودگی سلولی با عوامل ناخواسته از جمله عوامل سلولی، ویروسی، باکتریایی، مایکوپلاسمایی و مایکوباکتریومی توضیح داده شده است. با توجه به اهمیت آلودگی ویروسی درون زا، این موضوع به طور ویژه مورد بحث قرار گرفته است. همچنین پایداری سلول هم از بعد پایداری ژنتیکی و هم از بعد پایداری کارایی سلول مورد بحث قرار گرفت.
در پایان ضمن بررسی مستندات لازم جهت قرار گرفتن تحت کنترل سلول برای استفاده در آزمایشگاه، بر اساس مطالعات انجام شده، شناسنامه سلول تدوین گردیده است.
بنابراین، بر این اساس، سلول مورد مطالعه می تواند برای تحقیقات و مطالعات تشخیصی ویروس شناسی و به ویژه برای تولید و کنترل کیفیت محصولات بیولوژیکی مورد استفاده قرار گیرد.
کلیدواژه‌ها [English]
کشت سلول, فراوده های بیولوژیک, تعیین خصوصیات, مستند سازی
سایر فایل های مرتبط با مقاله
مراجع
  1. Acceptability of cell substrates for production of biologicals. Report of a WHO Study Group on Biologicals. World Health Organization technical report series. 1987;747:1-29.
  2. WHO. Requirements for Poliomyelitis Vaccine (Inactivated). In Requirements for Biological Substances: 1. General Requirements for Manufacturing Establishments and Control Laboratories; 2. Requirements for Poliomyelitis Vaccine (Inactivated). WHO Technical Report Series No 178. 1959.
  3. WHO. Requirements for Poliomyelitis Vaccine (Inactivated). In Requirements for Biological Substances. Manufacturing and Control Laboratories. . WHO Technical Report Series No 323. 1966.
  4. Hayflick L, Plotkin S, Stevenson R. History of the acceptance of human diploid cell strains as substrates for human virus vaccine manufacture. Developments in biological standardization. 1987;68:9-17.
  5. Hayflick L. A brief history of cell substrates used for the preparation of human biologicals. Developments in biologicals. 2001;106:5-23.
  6. Perkins FT. Suggested methods for the management and testing of a passaged diploid cell culture used for virus vaccine production. Japanese journal of medical science & biology. 1971;24(5):342-4.
  7. WHO. equirements for Poliomyelitis Vaccine (Oral). In Requirements for Biological Substances WHO Technical Report Series No 486. 1962.
  8. WHO. Requirements for continuous cell lines used for biologicals production. In: WHO Expert Committee on Biological Standardization. World Health Organization, Annex 3 (WHO Technical Report Series, No 745. 1987.
  9. Ziyaeifar F, Soleimani S, Lotfi M. Identification of Iranian BHK-21-C5 Cell Line by Two Steps Polymerase Chain Reaction. Arch Razi Inst. 2021;76(2):193-201.
  10. Schiff LJ. Review: Production, characterization, and testing of banked mammalian cell substrates used to produce biological products. In Vitro Cellular & Developmental Biology - Animal. 2005;41(3):65-70.
  11. Ziyaeifar F, Soleimani S. Characterizing the BHK-21 C5 cell line and determining cellular sensitivity to rubella virus compared with the routine cell (RK13). Arch Razi Inst. 2021;76(3):461-9.
  12. Ziaiifar F, Soleimani S, Lotfi M. Characterization of the BHK-21C5 Cell line and Its Introduction for use in Research, Diagnostics and Production of Biological Products. Alborz University Medical Journal. 2020;9(4):405-14.
  13. Ziayaeifar F, Soleimani S. Evaluation of BHK-21 Cell Line for Specific Viruses by Two Different PCR Methods. Archives of Razi Institute. 2022;77(5):1631-7.
  14. Weiskirchen S, Schröder SK, Buhl EM, Weiskirchen R. A Beginner’s Guide to Cell Culture: Practical Advice for Preventing Needless Problems. 2023;12(5):682.
  15. Masters JR, Stacey GN. Changing medium and passaging cell lines. Nature protocols. 2007;2(9):2276-84.
  16. Soleimani S. A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance. Arch Razi Inst. 2022;77(6):2023-35.
  17. Kwist K, Bridges WC, Burg KJL. The effect of cell passage number on osteogenic and adipogenic characteristics of D1 cells. Cytotechnology. 2016;68(4):1661-7.
  18. Heidemann R, Lünse S, Tran D, Zhang C. Characterization of cell-banking parameters for the cryopreservation of mammalian cell lines in 100-mL cryobags. Biotechnology progress. 2010;26(4):1154-63.
  19. Sinha J, Inan M, Fanders S, Taoka S, Gouthro M, Swanson T, et al. Cell bank characterization and fermentation optimization for production of recombinant heavy chain C-terminal fragment of botulinum neurotoxin serotype E (rBoNTE(Hc): Antigen E) by Pichia pastoris. Journal of Biotechnology. 2007;127(3):462-74.
  20. Weiskirchen S, Schröder SK, Buhl EM, Weiskirchen R. A Beginner’s Guide to Cell Culture: Practical Advice for Preventing Needless Problems. 2023;12(5):682.
  21. Ziayaeifar F, Soleimani S. Evaluation of BHK-21 Cell Line for Specific Viruses by Two Different PCR Methods. Arch Razi Inst. 2022;77(5):1631-7.
  22. Uno Y, Nozu R, Kiyatake I, Higashiguchi N, Sodeyama S, Murakumo K, et al. Cell culture-based karyotyping of orectolobiform sharks for chromosome-scale genome analysis. Communications biology. 2020;3(1):652.
  23. Cooper JK, Sykes G, King S, Cottrill K, Ivanova NV, Hanner R, et al. Species identification in cell culture: a two-pronged molecular approach. In vitro cellular & developmental biology Animal. 2007;43(10):344-51.
  24. Ziyaeifar F, Soleimani S, Lotfi M. Identification of Iranian BHK-21-C5 Cell Line by Two Steps Polymerase Chain Reaction. Archives of Razi Institute. 2021;76(2):193-201.
  25. Patil R, Kale AD, Mane DR, Patil D. Isolation, culture and characterization of primary cell lines of human buccal mucosal fibroblasts: A combination of explant enzamytic technique. Journal of oral and maxillofacial pathology: JOMFP. 2020;24(1):68-75.
  26. Yashwanth BS, Goswami M, Kooloth Valappil R, Thakuria D, Chaudhari A. Characterization of a new cell line from ornamental fish Amphiprion ocellaris (Cuvier, 1830) and its susceptibility to nervous necrosis virus. Scientific Reports. 2020;10(1):20051.
  27. Kamiloglu S, Sari G, Ozdal T, Capanoglu E. Guidelines for cell viability assays. 2020;1(3):332-49.
  28. Xu N, Chen X, Rui J, Yu Y, Gu D, Ruan JJ, et al. Cell growth measurement. 2020:37.
  29. Zhao C. Cell culture: in vitro model system and a promising path to in vivo applications. Journal of Histotechnology. 2023;46(1):1-4.
  30. Oh S, Gu EY, Han JS, Lee BS, Moon KS, Kim YB, et al. Tumorigenicity Assessment of Human Cancer Cell Lines Xenografted on Immunodeficient Mice as Positive Controls of Tumorigenicity Testing. International journal of toxicology. 2022;41(6):476-87.
  31. Gutiérrez-Martínez A, Sew WQG, Molano-Fernández M, Carretero-Junquera M, Herranz H. Mechanisms of oncogenic cell competition-Paths of victory. Seminars in cancer biology. 2020;63:27-35.
  32. Di Marco MV, Voena CJPCM. Review: biological implications of oncogenic rearrangements in non-small cell lung cancer. 2022. 2022;5.
  33. Ingram D, Stan G-B. Modelling genetic stability in engineered cell populations. Nature Communications. 2023;14(1):3471.
  34. Feng F, Huang C, Xiao M, Wang H, Gao Q, Chen Z, et al. Establishment and characterization of patient-derived primary cell lines as preclinical models for gallbladder carcinoma. 2020;9(3):1698-710.
  35. Young L, Sung J, Stacey G, Masters JR. Detection of Mycoplasma in cell cultures. Nature protocols. 2010;5(5):929-34.
  36. Manohar M, Orrison B, Peden K, Lewis AM, Jr. Assessing the tumorigenic phenotype of VERO cells in adult and newborn nude mice. Biologicals. 2008;36(1):65-72.
  37. Torabi S, Soleimani S, Mahravani H, Ebrahimi MM, Shahsavandi S. Mouse Fibroblast L929 Cell Line as a Useful Tool for Replication and Adaptation of Infectious Bursal Disease Virus. Archives of Razi Institute. 2023;78(3):863-71.
  38. Nikfarjam L, Farzaneh P. Prevention and detection of Mycoplasma contamination in cell culture. Cell journal. 2012;13(4):203-12.
  39. Soleimani S, Abedi Kiasari B. Evaluation and comparison of Hela, Hep2C and Vero cell lines sensitivity to polio vaccinal virus using micro and macro vaccine potency tests. Archives of Razi Institute. 2012;67(2):125-31.
  40. Ghanemi A. Cell cultures in drug development: Applications, challenges and limitations. Saudi pharmaceutical journal: SPJ: the official publication of the Saudi Pharmaceutical Society. 2015;23(4):453-4.
  41. Chaudhary SS, Pandey KD, Singh RP, Verma PC, Gupta PK. A vero cell derived combined vaccine against sheep pox and Peste des Petits ruminants for sheep. Vaccine. 2009;27(19):2548-53.
  42. Stacey G. Risk Assessment of Cell Culture Procedures. 2007. p. 567-87.
  43. WHO. Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. Replacement of Annex 1. WHO Technical Report Series, No 878 Annex 3. 2013.
آمار
تعداد مشاهده مقاله: 678
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