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

Authors

  • David Pamies Center for Alternatives to Animal Testing, Johns Hopkins University, Baltimore, MD, USA
  • Anna Bal-Price European Commission, Joint Research Centre, Ispra, VA, Italy
  • Anton Simeonov National Center for Advancing Translational Sciences – National Institutes of Health, Rockville, MD, USA
  • Danilo Tagle National Center for Advancing Translational Sciences – National Institutes of Health, Rockville, MD, USA
  • Dave Allen Contractor supporting the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), Morrisville, NC, USA
  • David Gerhold National Center for Advancing Translational Sciences – National Institutes of Health, Rockville, MD, USA
  • Dezhong Yin ATCC Cell Systems, American Type Culture Collection (ATCC), Gaithersburg, MD, USA
  • Francesca Pistollato European Commission, Joint Research Centre, Ispra, VA, Italy
  • Takashi Inutsuka Pharmacological Evaluation Institute of Japan (PEIJ), Tokyo, Japan
  • Kristie Sullivan Physicians Committee for Responsible Medicine, Washington, DC, USA
  • Glyn Stacey National Institute for Biological Standardization and Control, South Mimms, Hertfordshire, UK
  • Harry Salem US Army Edgewood Chemical Biological Center, Aberdeen Proving Ground, MD, USA
  • Marcel Leist Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany
  • Mardas Daneshian Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany
  • Mohan C. Vemuri Life Sciences Solutions, Thermo Fisher Scientific, Carlsbad, CA, USA
  • Richard McFarland Center for Food Safety and Applied Nutrition/FDA, College Park, MD, USA
  • Sandra Coecke European Commission, Joint Research Centre, Ispra, VA, Italy
  • Suzanne C. Fitzpatrick Center for Food Safety and Applied Nutrition/FDA, College Park, MD, USA
  • Uma Lakshmipathy Life Sciences Solutions, Thermo Fisher Scientific, Carlsbad, CA, USA
  • Amanda Mack Cellular Dynamics International, Madison, WI, USA
  • Wen Bo Wang Cellular Dynamics International, Madison, WI, USA
  • Daiju Yamazaki Division of Pharmacology, National Institute of Health Sciences, Tokyo, Japan
  • Yuko Sekino Division of Pharmacology, National Institute of Health Sciences, Tokyo, Japan
  • Yasunari Kanda Division of Pharmacology, National Institute of Health Sciences, Tokyo, Japan
  • Lena Smirnova Center for Alternatives to Animal Testing, Johns Hopkins University, Baltimore, MD, USA
  • Thomas Hartung Center for Alternatives to Animal Testing, Johns Hopkins University, Baltimore, MD, USA; Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany

DOI:

https://doi.org/10.14573/altex.1607121

Keywords:

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

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.

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Published

2017-02-01

Issue

Vol. 34 No. 1 (2017)

Section

Articles

License

Articles are distributed under the terms of the Creative Commons Attribution 4.0 International license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is appropriately cited (CC-BY). Copyright on any article in ALTEX is retained by the author(s).

How to Cite

Pamies, D., Bal-Price, A., Simeonov, A., Tagle, D., Allen, D., Gerhold, D., Yin, D., Pistollato, F., Inutsuka, T., Sullivan, K., Stacey, G., Salem, H., Leist, M., Daneshian, M., Vemuri, M. C., McFarland, R., Coecke, S., Fitzpatrick, S. C., Lakshmipathy, U., … Hartung, T. (2017). Good Cell Culture Practice for stem cells and stem-cell-derived models. ALTEX - Alternatives to Animal Experimentation, 34(1), 95-132. https://doi.org/10.14573/altex.1607121

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