Good cell culture practice for stem cells & stem-cell-derived models

David Pamies, Anna Bal-Price, Anton Simeonov, Danilo Tagle, Dave Allen, David Gerhold, Dezhong Yin, Francesca Pistollato, Takashi Inutsuka, Kristie Sullivan, Glyn Stacey, Harry Salem, Marcel Leist, Mardas Daneshian, Mohan C. Vemuri, Richard Mcfarland, Sandra Coecke, Suzanne C. Fitzpatrick, Uma Lakshmipathy, Amanda MackWen Bo Wang, Daiju Yamazaki, Yuko Sekino, Yasunari Kanda, Lena Smirnova, Thomas Hartung

Research output: Contribution to journalArticlepeer-review

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 labo-ratories 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.

Original languageEnglish (US)
Pages (from-to)95-132
Number of pages38
JournalALTEX
Volume34
Issue number1
DOIs
StatePublished - 2017

Keywords

  • Alternatives to animals
  • Good cell culture practices
  • In vitro methods
  • Induced pluripotent stem cells

ASJC Scopus subject areas

  • Pharmacology
  • Medical Laboratory Technology

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