Good cell culture practice for stem cells and stem-cell-derived models
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The first guidance on Good Cell Culture Practice dates back to 2005. This document expands this to 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 which 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, which will facilitate the generation of reliable data from cell culture systems, but 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 necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. This workshop report is considered as a first step toward a revised GCCP 2.0.
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PAMIES, David, Anna BAL-PRICE, Anton SIMEONOV, Danilo TAGLE, Dave ALLEN, David GERHOLD, Dezhong YIN, Francesca PISTOLLATO, Takashi INUTSUKA, Kristie SULLIVAN, Glyn STACEY, Harry SALEM, Marcel LEIST, Mardas DANESHIAN, Mohan C VEMURI, Richard MCFARLAND, Sandra COECKE, Suzanne C FITZPATRICK, Uma LAKSHMIPATHY, Amanda MACK, Wen Bo WANG, Yamazaki DAIJU, Yuko SEKINO, Yasunari KANDA, Lena SMIRNOVA, Thomas HARTUNG, 2017. Good cell culture practice for stem cells and stem-cell-derived models. In: Alternatives to Animal Experimentation : ALTEX. 2017, 34(1), pp. 95-132. ISSN 0946-7785. eISSN 1868-8551. Available under: doi: 10.14573/altex.1607121BibTex
@article{Pamies2017cultu-36724, year={2017}, doi={10.14573/altex.1607121}, title={Good cell culture practice for stem cells and stem-cell-derived models}, number={1}, volume={34}, issn={0946-7785}, journal={Alternatives to Animal Experimentation : ALTEX}, pages={95--132}, author={Pamies, David and Bal-Price, Anna and Simeonov, Anton and Tagle, Danilo and Allen, Dave and Gerhold, David and Yin, Dezhong and Pistollato, Francesca and Inutsuka, Takashi and Sullivan, Kristie and Stacey, Glyn and Salem, Harry and Leist, Marcel and Daneshian, Mardas and Vemuri, Mohan C and McFarland, Richard and Coecke, Sandra and Fitzpatrick, Suzanne C and Lakshmipathy, Uma and Mack, Amanda and Wang, Wen Bo and Daiju, Yamazaki and Sekino, Yuko and Kanda, Yasunari and Smirnova, Lena and Hartung, Thomas} }
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This document expands this to 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 which 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, which will facilitate the generation of reliable data from cell culture systems, but 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 necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. 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