title: Good Cell Culture Practice for stem cells and stem-cell-derived models.
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.
authors.affiliation: Center for Alternative to Animal Testing, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: David
authors.initials: D
authors.lastname: Pamies
authors.affiliation: European Commission, Joint Research Centre, Ispra, VA, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Bal-Price
authors.affiliation: National Center for Advancing Translational Sciences - National Institutes of Health, Rockville, MD, USA.
authors.forename: Anton
authors.initials: A
authors.lastname: Simeonov
authors.affiliation: National Center for Advancing Translational Sciences - National Institutes of Health, Rockville, MD, USA.
authors.forename: Danilo
authors.initials: D
authors.lastname: Tagle
authors.affiliation: Contractor supporting the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), Morrisville, NC, USA.
authors.forename: Dave
authors.initials: D
authors.lastname: Allen
authors.affiliation: National Center for Advancing Translational Sciences - National Institutes of Health, Rockville, MD, USA.
authors.forename: David
authors.initials: D
authors.lastname: Gerhold
authors.affiliation: ATCC Cell Systems American Type Culture Collection, Gaithersburg, MD, USA.
authors.forename: Dezhong
authors.initials: D
authors.lastname: Yin
authors.affiliation: European Commission, Joint Research Centre, Ispra, VA, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Pistollato
authors.affiliation: Pharmacological Evaluation Institute of Japan (PEIJ), Tokyo, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Inutsuka
authors.affiliation: Physicians Committee for Responsible Medicine, Washington, DC, USA.
authors.forename: Kristie
authors.initials: K
authors.lastname: Sullivan
authors.affiliation: National Institute for Biological Standardization and Control, South Mimms, Hertfordshire, UK.
authors.forename: Glyn
authors.initials: G
authors.lastname: Stacey
authors.affiliation: US Army Edgewood Chemical Biological Center, Aberdeen Proving Ground, MD, USA.
authors.forename: Harry
authors.initials: H
authors.lastname: Salem
authors.affiliation: Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany.
authors.forename: Marcel
authors.initials: M
authors.lastname: Leist
authors.affiliation: Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany.
authors.forename: Mardas
authors.initials: M
authors.lastname: Daneshian
authors.affiliation: Life Sciences Solutions, Thermo Fisher Scientific, Carlsbad, CA, USA.
authors.forename: Mohan C
authors.initials: MC
authors.lastname: Vemuri
authors.affiliation: Center for Food Safety and Applied Nutrition/FDA, College Park, MD, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: McFarland
authors.affiliation: European Commission, Joint Research Centre, Ispra, VA, Italy.
authors.forename: Sandra
authors.initials: S
authors.lastname: Coecke
authors.affiliation: Center for Food Safety and Applied Nutrition/FDA, College Park, MD, USA.
authors.forename: Suzanne C
authors.initials: SC
authors.lastname: Fitzpatrick
authors.affiliation: Life Sciences Solutions, Thermo Fisher Scientific, Carlsbad, CA, USA.
authors.forename: Uma
authors.initials: U
authors.lastname: Lakshmipathy
authors.affiliation: Cellular Dynamics International, Madison, WI, USA.
authors.forename: Amanda
authors.initials: A
authors.lastname: Mack
authors.affiliation: Cellular Dynamics International, Madison, WI, USA.
authors.forename: Wen Bo
authors.initials: WB
authors.lastname: Wang
authors.affiliation: Division of Pharmacology, National Institute of Health Sciences, Tokyo, Japan.
authors.forename: Daiju
authors.initials: D
authors.lastname: Yamazaki
authors.affiliation: Division of Pharmacology, National Institute of Health Sciences, Tokyo, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Sekino
authors.affiliation: Division of Pharmacology, National Institute of Health Sciences, Tokyo, Japan.
authors.forename: Yasunari
authors.initials: Y
authors.lastname: Kanda
authors.affiliation: Center for Alternative to Animal Testing, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Lena
authors.initials: L
authors.lastname: Smirnova
authors.affiliation: Center for Alternative to Animal Testing, Johns Hopkins University, Baltimore, MD, USA.|Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hartung
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods / Q000592:standards*; D000818:Animals; D018929:Cell Culture Techniques / Q000379:methods / Q000592:standards*; D003226:Congresses as Topic; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards; D011786:Quality Control; D013234:Stem Cells
keywords:  alternatives to animals;  induced pluripotent stem cells; Good Cell Culture Practices; in vitro methods