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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
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آمار
تعداد مشاهده مقاله: 488
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