TY - JOUR
T1 - Good cell culture practice for stem cells & stem-cell-derived models
AU - Pamies, David
AU - Bal-Price, Anna
AU - Simeonov, Anton
AU - Tagle, Danilo
AU - Allen, Dave
AU - Gerhold, David
AU - Yin, Dezhong
AU - Pistollato, Francesca
AU - Inutsuka, Takashi
AU - Sullivan, Kristie
AU - Stacey, Glyn
AU - Salem, Harry
AU - Leist, Marcel
AU - Daneshian, Mardas
AU - Vemuri, Mohan C.
AU - Mcfarland, Richard
AU - Coecke, Sandra
AU - Fitzpatrick, Suzanne C.
AU - Lakshmipathy, Uma
AU - Mack, Amanda
AU - Wang, Wen Bo
AU - Yamazaki, Daiju
AU - Sekino, Yuko
AU - Kanda, Yasunari
AU - Smirnova, Lena
AU - Hartung, Thomas
N1 - Funding Information:
The work on this article was supported by the EU-ToxRisk Project (European Union's Horizon 2020 research programme grant agreement No 681002, to Marcel Leist and Thomas Hartung), and the German BMBF grant NeuriTox (to Marcel Leist). The contribution of Yuko Sekino was supported by Japan Agency for Medical Research and Development grants (ID: 15mk0104053h0101 and 16mk0104027j0002).
PY - 2017
Y1 - 2017
N2 - 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 labo-ratories 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.
AB - 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 labo-ratories 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.
KW - Alternatives to animals
KW - Good cell culture practices
KW - In vitro methods
KW - Induced pluripotent stem cells
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U2 - 10.14573/altex.1607121
DO - 10.14573/altex.1607121
M3 - Article
C2 - 27554434
AN - SCOPUS:85012027021
SN - 1868-596X
VL - 34
SP - 95
EP - 132
JO - ALTEX
JF - ALTEX
IS - 1
ER -