Center for Alternative to Animal Testing, Johns Hopkins University, Baltimore, MD, USA.
European Commission, Joint Research Centre, Ispra, VA, Italy.
ALTEX. 2017;34(1):95-132. doi: 10.14573/altex.1607121. Epub 2016 Aug 23.
The first guidance on Good Cell Culture Practice (GCCP) dates back to 2005. This document expands this to include aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice that can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times. This includes recommendations for the documentation and reporting of culture conditions. It is intended as guidance to facilitate the generation of reliable data from cell culture systems, and is not intended to conflict with local or higher level legislation or regulatory requirements. It may not be possible to meet all recommendations in this guidance for practical, legal or other reasons. However, when it is necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and the safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. This workshop report is considered a first step toward a revised GCCP 2.0.
《良好细胞培养实践(GCCP)指南》最早可追溯到 2005 年。本文件将其扩展到包括体外细胞培养质量保证的各个方面,重点是在研究、产品开发、测试和生物技术产品及基于细胞的药物制造中使用的日益多样化的细胞类型和培养方式。它提供了一套最佳实践的基本原则,可用于培训新人员、审查和改进当地程序,并有助于确保实验室之间数据的标准实践和条件,以及不同时间进行的实验。这包括对培养条件的记录和报告的建议。本指南旨在为细胞培养系统生成可靠数据提供便利,并不旨在与当地或更高层次的法规或监管要求相冲突。出于实际、法律或其他原因,可能无法满足本指南中的所有建议。但是,当有必要偏离 GCCP 原则时,应解决降低工作质量和实验室人员安全的风险,并证明任何结论或替代方法的合理性。本工作坊报告被视为修订版《GCCP 2.0》的第一步。