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细胞库系统、建立及其在病毒研究、诊断和生物制药行业中的应用。

Cell bank system, establishment, and application in the virus research, diagnosis, and biopharmaceutical industries.

作者信息

Soleimani Sina, Ghorani Mohammadreza

机构信息

Razi Vaccine & Serum Research Institute, Agricultural Research Education and Extension Organization (AREEO), P.O. Box 31975-148, Karaj, Iran.

Department of Pathobiology, Faculty of Veterinary Medicine, University of Tabriz, Tabriz, Iran.

出版信息

Biotechnol Notes. 2025 Aug 15;6:209-221. doi: 10.1016/j.biotno.2025.08.001. eCollection 2025.

Abstract

BACKGROUND

The use of cells in research and diagnostic studies is important. This is of paramount importance in the biopharmaceutical product industry because cells are one of the most important platforms in the biopharmaceutical industry.

OBJECTIVE

The availability of highly efficient and suitable cells that can be continuously used for the mass production of biotechnological products is crucial for maintaining human health and hygiene. So, the cells used in this comprehensive system were studied, evaluated, documented, and stored for continuous and efficient use.

STUDY DESIGN

This review article discusses all aspects of cells involved in establishing this system as a Cell Bank System (CBS). Cell banking facilities, specialized laboratories, appropriate equipment, cold rooms, cryopreservation instruments, and cell authentication and characterization are mentioned. Cell handling, row materials tests, documentation, intellectual property registration, storage, backup, and transportation were explained. In addition, policies for cell retesting and revival are discussed.

RESULT

Based on the roadmap designed in this study, a comprehensive cell bank system can be formed for using in cell preparation, propagation, storage, and use of cells.

DISCUSSION

Considering that in the pharmaceutical industry, there is a need for a reliable, permanent, and uniform source of cells to produce and quality control the product, which can have significant effects on the products, by using this system and performing all of its aspects, diagnostic centers, researchers, and pharmaceutical manufacturers can access a reliable and persistent source of culture for related operations.

摘要

背景

细胞在研究和诊断研究中的应用至关重要。这在生物制药产品行业中尤为重要,因为细胞是生物制药行业最重要的平台之一。

目的

拥有高效且合适的细胞,能够持续用于大规模生产生物技术产品,这对维护人类健康和卫生至关重要。因此,对该综合系统中使用的细胞进行了研究、评估、记录和存储,以便持续高效使用。

研究设计

这篇综述文章讨论了将该系统建立为细胞库系统(CBS)所涉及的细胞的各个方面。提到了细胞库设施、专业实验室、适当的设备、冷藏室、冷冻保存仪器以及细胞鉴定和表征。解释了细胞处理、原材料测试、文件记录、知识产权注册、存储、备份和运输。此外,还讨论了细胞重新测试和复苏的政策。

结果

根据本研究设计的路线图,可以形成一个综合细胞库系统,用于细胞的制备、繁殖、存储和使用。

讨论

考虑到在制药行业中,需要可靠、永久且统一的细胞来源来生产产品并进行质量控制,这可能会对产品产生重大影响,通过使用该系统并执行其所有方面,诊断中心、研究人员和制药制造商可以获得用于相关操作的可靠且持久的培养物来源。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d296/12409320/6b57eb0ce635/gr1.jpg

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