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

Abstract

SummaryThe 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.

The need for strategic development of safety sciences

“…-The Johns Hopkins Center for Alternatives to Animal Testing (CAAT) aims, outside of the pressures of regulating or being regulated, to be an engine of change in the safety sciences and other areas of animal use, overcoming the limitations of animal-based approaches and accelerating the uptake of new technologies by collaboration with all stakeholder groups. CAAT has started a number of collaborative programs to advance safety sciences, which include the Human Toxome Collaboration (see above), the Evidence-based Toxicology Collaboration (see below), the Good Cell Culture Practice Collaboration (Pamies et al, 2017) building on earlier work steered by ECVAM (Coecke et al, 2005), the Good ReadAcross Practice Collaboration (Patlewicz et al, 2014, Ball et al, 2016Zhu et al, 2016), the Refinement Collaboration (Zurlo and Hutchinson, 2014) and others. CAAT's transatlantic think tank for toxicology (t 4 ) has organized more than 30 workshops to advance concepts of toxicology such as integrated testing strategies (Hartung et al, 2013b;Rovida et al, 2015b), epithelial barrier models (Gordon et al, 2015), 3D cell cultures (Alépée et al, 2014), microphysiological systems (Marx et al, 2016), high-content imaging (van Vliet et al, 2014), and has commissioned a number of white papers.…”

Fetal bovine serum (FBS): Past – present – future

“…Recently, the presence of two clones in one cell line has been described, indicating clonal evolution within a cell culture population (Quentmeier et al, 2013 (ESAC, 2008). The drawbacks of using serum and advice to replace it with chemically-defined (serum-free) media are also mentioned in the Good Cell Culture Principles (GCCP) issued by EURL ECVAM in 2005 (Coecke et al, 2005), and more recently in the workshop report on GCCP for stem cells and stem-cell-derived models (Pamies et al, 2017). Also, the test guidelines no.…”

“…A recently published document expands these aspects, specifically addressing which standards and quality controls should be considered for the culture of stem cell-derived models (Pamies et al, 2017). This publication, which represents a first step towards a revised GCCP 2.0, comments on the need to preferentially apply serum-free media, (animal) protein-free media and chemically-defined media to avoid many disadvantages associated with the use of serum (Pamies et al, 2017). In this regard, as serum may induce spontaneous differentiation of iPSCs, fully chemically-defined media, supplemented with appropriate hormones and growth factors (van der Valk et al, 2004(van der Valk et al, , 2010, may be used.…”

“…Fortunately, guidelines such as the Good Cell Culture Practices discourage the use of FBS (Coecke et al, 2005;Pamies et al, 2017). In addition, because of contamination issues, the use of FBS during the production of biologicals is discouraged (EMA, 2013;USP, 2012).…”

OECD/EFSA workshop on developmental neurotoxicity (DNT): The use of non-animal test methods for regulatory purposes

“…Achieving the second aim will require testing of larger numbers of compounds (e.g., 200-300) as quickly as possible using the process-control strategy in multiple labs, in order to characterize assay performance and build confidence that the battery is suitable for regulatory purposes beyond prioritization and screening. In vitro testing must be transparent and standardized following guidance on good cell culture practice (Coecke et al, 2005), including stem cells and stem cell-derived models (Pamies et al, 2017), sharing of protocols and raw data.…”