SeCAM Services and Consultation on Alternative Methods, Switzerland.
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Toxicol In Vitro. 2017 Dec;45(Pt 3):272-277. doi: 10.1016/j.tiv.2017.04.022. Epub 2017 Apr 25.
Good Cell Culture Practices (GCCP) is of high relevance to in vitro toxicology. The European Society of Toxicology In Vitro (ESTIV), the Center for Alternatives for Animal Testing (CAAT) and the In Vitro Toxicology Industrial Platform (IVTIP) joined forces to address by means of an ESTIV 2016 pre-congress session the different aspects and applications of GCCP. The covered aspects comprised the current status of the OECD guidance document on Good In Vitro Method Practices, the importance of quality assurance for new technological advances in in vitro toxicology including stem cells, and the optimized implementation of Good Manufacturing Practices and Good Laboratory Practices for regulatory testing purposes. General discussions raised the duality related to the difficulties in implementing GCCP in an academic innovative research framework on one hand, and on the other hand, the need for such GCCP principles in order to ensure reproducibility and robustness of in vitro test methods for toxicity testing. Indeed, if good cell culture principles are critical to take into consideration for all uses of in vitro test methods for toxicity testing, the level of application of such principles may depend on the stage of development of the test method as well as on the applications of the test methods, i.e., academic innovative research vs. regulatory standardized test method.
良好的细胞培养实践（GCCP）与体外毒理学密切相关。欧洲毒理学学会体外毒理学分会（ESTIV）、动物替代方法中心（CAAT）和体外毒理学工业平台（IVTIP）联手，通过 ESTIV 2016 会前会议讨论了 GCCP 的不同方面和应用。涵盖的方面包括经合组织良好体外方法实践指南的现状、质量保证对于包括干细胞在内的体外毒理学新技术进步的重要性，以及为监管测试目的优化实施良好生产规范和良好实验室规范。一般性讨论提出了与在学术创新研究框架中实施 GCCP 相关的困难的双重性，以及为了确保体外毒性测试方法的重现性和稳健性而需要这些 GCCP 原则。事实上，如果良好的细胞培养原则对于所有用于毒性测试的体外测试方法的使用都至关重要，那么这些原则的应用程度可能取决于测试方法的发展阶段以及测试方法的应用，即学术创新研究与监管标准化测试方法。
