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Soleimani, S. (1401). A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance. سامانه مدیریت نشریات علمی, 77(6), 2023-2035. doi: 10.22092/ari.2022.358890.2327
S Soleimani. "A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance". سامانه مدیریت نشریات علمی, 77, 6, 1401, 2023-2035. doi: 10.22092/ari.2022.358890.2327
Soleimani, S. (1401). 'A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance', سامانه مدیریت نشریات علمی, 77(6), pp. 2023-2035. doi: 10.22092/ari.2022.358890.2327
Soleimani, S. A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance. سامانه مدیریت نشریات علمی, 1401; 77(6): 2023-2035. doi: 10.22092/ari.2022.358890.2327

A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance

Archives of Razi Institute
مقاله 3، دوره 77، شماره 6، بهمن و اسفند 2022، صفحه 2023-2035    اصل مقاله (408.66 K)
نوع مقاله: Review Article
شناسه دیجیتال (DOI): 10.22092/ari.2022.358890.2327
نویسنده
S Soleimani*
Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975-148, Karaj, Iran
چکیده
Today, due to the importance of diseases controlled by vaccination, the production of biological products is of great importance in ensuring public health, so producing high-quality biological products plays an important role in maintaining public health. One of the most important principles of manufacturing high-quality and efficient biological products is using suitable seeds based on standard principles. To produce a suitable seed for continuous use for mass production of biological products, the seed must be defined according to certain principles and foundations. These principles are formed in the form of a seed lot system. In this review article, all the requirements for the establishment of a seed to produce a biological product include general seed information, including basic and seed information and microorganisms, seed-specific information including seed passage levels, propagation method, seed storage conditions, coding and labeling, identification information and design of suitable laboratories for passage, seed propagation, and storage, determination of seed characteristics including all necessary tests to determine seed identity, purity, potency, efficacy, stability, safety and also all the necessary information for documenting and storing seeds has been studied. Also, this study discusses the method of preparing all the necessary information for establishing a seed lot system, especially determining the characteristics of seeds. Based on the study's results, a complete and comprehensive seed lot system has been formed that can be used to prepare, propagate, passage, and store seeds used in the production of biological products.
کلیدواژه‌ها
Vaccine؛ Seed؛ Lot؛ System؛ Characterization
عنوان مقاله [English]
مروری بر نحوه استقرار سامانه بذر در تولید فراورده های بیولوژیک و مطالعه اهمیت آن
چکیده [English]
امروزه با توجه به اهمیت بیماری های قابل کنترل با واکسیناسیون، صنعت تولید فراورده های بیولوژیک از اهمیت به سزایی در تامین سلامت جامعه دارد، به طوریکه تولید فراورده های بیولوژیک با کیفیت بالا در حفظ سلامت جامعه نقش به سزایی دارد. از مهمترین مبانی تولید فراورده های بیولوژیک با کیفیت بالا و مناسب، استفاده از بذر مناسب و بر اساس اصول استاندارد می باشد. برای ایجاد یک بذر مناسب جهت استفاده مداوم برای تولید انبوه فراورده های بیولوژیک، باید بذر بر اساس اصول و مبانی خاصی تعریف شده باشد. این اصول در قالب سیستمی به نام سامانه بذر شکل می گیرد.
در این مقاله مروری، کلیه موارد مورد نیاز برای قرار گرفتن یک بذر برای تولید یک فراورده بیولوژیک شامل، اطلاعات عمومی بذر شامل اطلاعات اولیه و اطلاعات بذرشناسی و میکروارگانیسمی، اطلاعات اختصاصی بذر شامل سطوح پاساژ بذر، نحوه تکثیر، شرایط ذخیره سازی بذر، کدگذاری و لیبل گذاری، اطلاعات شناخت و طراحی آزمایشگاه های مناسب برای پاساژ، تکثیر و نگهداری بذر، تعیین خصوصیات بذر شامل کلیه آزمایش های لازم برای تعیین هویت بذر، خلوص بذر، توانمندی بذر، اثر گذاری بذر، پایداری بذر، بی ضرری بذر و همچنین کلیه اطلاعات لازم برای مستندسازی و ذخیره سازی بذر، مورد مطالعه و بررسی قرار گرفته است.
همچنین در این مطالعه، روش تهیه کلیه اطلاعات لازم برای استقرار سامانه بذر به ویژه تعیین خصوصیات بذر، بحث شده است. بر اساس نتایج مطالعه انجام گرفته، یک سامانه بذر کامل و جامع شکل گرفته است که می تواند برای تهیه، تکثیر، پاساژ و نگهداری بذرهای مورد استفاده در تولید فراورده های بیولوژیک، مورد استفاده قرار گیرد.
کلیدواژه‌ها [English]
واکسن, بذر, سامانه, تعیین خصوصیات, آزمایش
سایر فایل های مرتبط با مقاله
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