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关于在生物制品生产中使用连续细胞系的理论考量与实际问题。

Theoretical considerations and practical concerns regarding the use of continuous cell lines in the production of biologics.

作者信息

Petricciani J C, Salk P L, Salk J, Noguchi P D

出版信息

Dev Biol Stand. 1981;50:15-25.

PMID:7341291
Abstract

The origin and history of continuous cell lines are discussed briefly in the context of their biological relationship to diploid and tumorigenic cells. The question of the potential tumorigenicity of continuous cell lines is examined from the points of view of the theoretical risks involved in the use of these cells for the production of biological products, and of practical approaches to risk assessment. Animal and in vitro tumorigenicity test systems are discussed, and published data on the transfer of tumorigenic properties by DNA are reviewed. Both animal and human experience with vaccines produced in tumor cells is discussed in relation to cancer risk. When the theoretical risks of using continuous cell lines as substrates to produce biological products are balanced against the available data, it would appear reasonable to proceed with the use of such cell lines for the development of biologics because the benefits of those products appear to exceed by far the potential risks associated with the use of these cell substrates.

摘要

本文简要讨论了连续细胞系的起源和历史,并探讨了它们与二倍体细胞和致瘤细胞之间的生物学关系。从使用这些细胞生产生物制品所涉及的理论风险以及风险评估的实际方法等角度,审视了连续细胞系潜在的致瘤性问题。讨论了动物和体外致瘤性测试系统,并回顾了关于DNA转移致瘤特性的已发表数据。还讨论了使用肿瘤细胞生产疫苗的动物和人类经验与癌症风险的关系。当将使用连续细胞系作为生产生物制品的底物的理论风险与现有数据进行权衡时,继续使用此类细胞系来开发生物制品似乎是合理的,因为这些产品的益处似乎远远超过了使用这些细胞底物所带来的潜在风险。

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