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|Title:||Good Cell Culture Practice for stem cells and stem-cell-derived models|
|Authors:||PAMIES David; PRICE Anna; SIMEONOV Anton; TAGLE Danilo; ALLEN Dave; GERHOLD David; YIN Dezhong; PISTOLLATO FRANCESCA; INUTSUKA Takashi; SULLIVAN Kristie; STACY Glynn; SALEM Harry; LEIST Marcel; DANESHIAN Mardas; VEMURI Mohan C; MCFARLAND Richard; COECKE Sandra; FITZPATRICK Suzanne C.; LAKSHMIPATHY Uma; MACK Amanda; WANG Wen Bo; YAMAZAKI Daiju; SEKINO Yuko; KANDA Yasunari; SMIRNOVA Lena; HARTUNG Thomas|
|Citation:||ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION|
|Publisher:||SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH|
|Type:||Articles in periodicals and books|
|Abstract:||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 to 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 as to the documentation and reporting of culture conditions. It is intended as guidance, which will facilitate 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, where it is necessary to divert from the principles of GCCP the risks to 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.|
|JRC Directorate:||Health, Consumers and Reference Materials|
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