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ALTEX. 2017;34(1):95-132. doi: 10.14573/altex.1607121. Epub 2016 Aug 23.

Good Cell Culture Practice for stem cells and stem-cell-derived models.

Author information

1
Center for Alternative to Animal Testing, Johns Hopkins University, Baltimore, MD, USA.
2
European Commission, Joint Research Centre, Ispra, VA, Italy.
3
National Center for Advancing Translational Sciences - National Institutes of Health, Rockville, MD, USA.
4
Contractor supporting the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), Morrisville, NC, USA.
5
ATCC Cell Systems American Type Culture Collection, Gaithersburg, MD, USA.
6
Pharmacological Evaluation Institute of Japan (PEIJ), Tokyo, Japan.
7
Physicians Committee for Responsible Medicine, Washington, DC, USA.
8
National Institute for Biological Standardization and Control, South Mimms, Hertfordshire, UK.
9
US Army Edgewood Chemical Biological Center, Aberdeen Proving Ground, MD, USA.
10
Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany.
11
Life Sciences Solutions, Thermo Fisher Scientific, Carlsbad, CA, USA.
12
Center for Food Safety and Applied Nutrition/FDA, College Park, MD, USA.
13
Cellular Dynamics International, Madison, WI, USA.
14
Division of Pharmacology, National Institute of Health Sciences, Tokyo, Japan.

Abstract

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 laboratories 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.

KEYWORDS:

alternatives to animals; induced pluripotent stem cells; Good Cell Culture Practices; in vitro methods

PMID:
27554434
DOI:
10.14573/altex.1607121
[Indexed for MEDLINE]
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