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
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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.
