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ALTEX. 2018;35(3):353-378. doi: 10.14573/altex.1710081. Epub 2018 Apr 13.

Advanced Good Cell Culture Practice for human primary, stem cell-derived and organoid models as well as microphysiological systems.

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Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Baltimore, MD, USA.
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Biopredic sarl, St Gregoire, France.
Biotalentum Ltd, Godollo, Hungary.
Molecular Animal Biotechnology Laboratory, Szent Istvan University, Godollo, Hungary.
Services & Consultations on Alternative Methods (SeCAM), Magliaso, Switzerland.
University of Natural Resources and Life Sciences Vienna, Austria.
Evercyte GmbH, Vienna, Austria.
Medical University Innsbruck, Department of Physiology, Innsbruck, Austria.
CAAT-Europe, University of Konstanz, Konstanz, Germany.
Division of Molecular and Computational Toxicology, Amsterdam Institute for Molecules, Medicines and Systems, Vrije Universiteit Amsterdam, The Netherlands.
Leibniz Research Laboratories for Biotechnology and Artificial Organs, Department of Cardiothoracic, Transplantation and Vascular Surgery, REBIRTH - Cluster of Excellence, Hannover Medical School, Hannover, Germany.
Department of Applied Stem Cell Technologies, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands.
Department of Anatomy and Embryology, Leiden University Medical Center, Leiden, The Netherlands.
Luxembourg Centre for Systems Biomedicine (LCSB), University of Luxembourg, Belvaux, Luxembourg.
National Institute for Biological Standardization and Control, a center of the Medicines and Health-care Regulatory Agency, South Mimms, Hertfordshire, UK.
Toxicology, Bayer AG, Wuppertal, Germany.


A major reason for the current reproducibility crisis in the life sciences is the poor implementation of quality control measures and reporting standards. Improvement is needed, especially regarding increasingly complex in vitro methods. Good Cell Culture Practice (GCCP) was an effort from 1996 to 2005 to develop such minimum quality standards also applicable in academia. This paper summarizes recent key developments in in vitro cell culture and addresses the issues resulting for GCCP, e.g. the development of induced pluripotent stem cells (iPSCs) and gene-edited cells. It further deals with human stem-cell-derived models and bioengineering of organo-typic cell cultures, including organoids, organ-on-chip and human-on-chip approaches. Commercial vendors and cell banks have made human primary cells more widely available over the last decade, increasing their use, but also requiring specific guidance as to GCCP. The characterization of cell culture systems including high-content imaging and high-throughput measurement technologies increasingly combined with more complex cell and tissue cultures represent a further challenge for GCCP. The increasing use of gene editing techniques to generate and modify in vitro culture models also requires discussion of its impact on GCCP. International (often varying) legislations and market forces originating from the commercialization of cell and tissue products and technologies are further impacting on the need for the use of GCCP. This report summarizes the recommendations of the second of two workshops, held in Germany in December 2015, aiming map the challenge and organize the process or developing a revised GCCP 2.0.


quality control; cell culture; in vitro methods; gene editing; organotypic

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