Title: Good Cell Culture Practice for stem cells and stem-cell-derived models
Authors: PAMIES DavidPRICE AnnaSIMEONOV AntonTAGLE DaniloALLEN DaveGERHOLD DavidYIN DezhongPISTOLLATO FRANCESCAINUTSUKA TakashiSULLIVAN KristieSTACY GlynnSALEM HarryLEIST MarcelDANESHIAN MardasVEMURI Mohan CMCFARLAND RichardCOECKE SandraFITZPATRICK Suzanne C.LAKSHMIPATHY UmaMACK AmandaWANG Wen BoYAMAZAKI DaijuSEKINO YukoKANDA YasunariSMIRNOVA LenaHARTUNG Thomas
Citation: ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
Publisher: SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH
Publication Year: 2016
JRC N°: JRC102901
ISSN: 1868-596X
URI: http://dx.doi.org/10.14573/altex.1607121
http://publications.jrc.ec.europa.eu/repository/handle/JRC102901
DOI: 10.14573/altex.1607121
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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