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

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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 Mack
Wen Bo Wang
Daiju Yamazaki
Yuko Sekino
Yasunari Kanda
Lena Smirnova
Thomas Hartung

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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How to Cite
[1]
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., McFarland, R., Coecke, S., Fitzpatrick, S., Lakshmipathy, U., Mack, A., Wang, W., Yamazaki, D., Sekino, Y., Kanda, Y., Smirnova, L. and Hartung, T. 2017. Good Cell Culture Practice for stem cells and stem-cell-derived models. ALTEX - Alternatives to animal experimentation. 34, 1 (Feb. 2017), 95-132. DOI:https://doi.org/10.14573/altex.1607121.
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