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[良好细胞培养规范(GCCP)——体外研究标准化与质量控制倡议。欧洲替代方法验证中心(ECVAM)GCCP特别工作组的成立]

[Good cell culture practice (GCCP)--an initiative for standardization and quality control of in vitro studies. The establishment of an ECVAM Task Force on GCCP].

作者信息

Hartung T, Gstraunthaler G, Coecke S, Lewis D, Blanck O, Balls M

机构信息

Biochemische Pharmakologie, Universität D-Konstanz.

出版信息

ALTEX. 2001;18(1):75-8.

Abstract

Cultured human and animal cells are increasingly used as the basis for simplified, direct test systems that have the potential to be more controllable and more reproducible than in vivo test systems. However, if a biological test system is simplified to fundamental levels then it is paramount that the essential components of such a reduced systems are closely defined and reproducible. Thus, minimal requirements for quality standards in cell and tissue culture have to be defined. It is the aim of this GCCP initiative to establish principles for standardisation, rationalisation, and international harmonisation of cell and tissue culture laboratory practices. Therefore, in analogy to Good Laboratory Practice (GLP), a Good Cell Culture Practice (GCCP) was initiated at the 3rd World Congress on Alternatives and Animal Use in the Life Sciences, Bologna, 29. August-2. September 1999. This "Bologna Statement on Good Cell Culture Practice" was presented, discussed, and refined in a Workshop, and a final version was approved at the closing ceremony of the Congress by the scientific audience. Based on the Bologna Statement, an ECVAM Task Force on GCCP was initiated, that is chaired by Thomas Hartung and Sandra Ceocke, in which experts in the field should elaborate minimal requirements for quality standards in cell culture. It is the intention of the GCCP Guidelines to encourage consensus among all concerned with the use of in vitro systems, in order to establish and maintain best laboratory practices, to promote effective quality control systems, to facilitate education and training, to support journal editors, and to help any authorities who need to interpret and apply conclusions based on in vitro data.

摘要

培养的人类和动物细胞越来越多地被用作简化的直接测试系统的基础,这些系统有可能比体内测试系统更易于控制和重复。然而,如果将生物测试系统简化到基本水平,那么至关重要的是,这种简化系统的基本组成部分必须得到严格定义且具有可重复性。因此,必须定义细胞和组织培养质量标准的最低要求。本良好细胞培养规范(GCCP)倡议的目的是建立细胞和组织培养实验室操作的标准化、合理化及国际协调原则。因此,类似于良好实验室规范(GLP),1999年8月29日至9月2日在博洛尼亚举行的第三届生命科学替代方法与动物使用世界大会上发起了良好细胞培养规范(GCCP)。这份“关于良好细胞培养规范的博洛尼亚声明”在一次研讨会上进行了介绍、讨论和完善,最终版本在大会闭幕式上得到了科学界听众的认可。基于博洛尼亚声明,启动了一个由托马斯·哈通和桑德拉·塞奥克主持的GCCP欧洲替代方法验证中心(ECVAM)特别工作组,该领域的专家应在其中详细阐述细胞培养质量标准的最低要求。GCCP指南旨在鼓励所有与体外系统使用相关的各方达成共识,以便建立和维持最佳实验室操作规范,促进有效的质量控制系统,推动教育与培训,支持期刊编辑,并帮助任何需要解释和应用基于体外数据得出的结论的当局。

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