Abstract
A major reason for the current reproducibility crisis in the life sciences is the poor implementation of quality control measures and reporting standards. Improvement is needed, especially regarding increasingly complex in vitro methods. Good Cell Culture Practice (GCCP) was an effort from 1996 to 2005 to develop such minimum quality standards also applicable in academia. This paper summarizes recent key developments in in vitro cell culture and addresses the issues resulting for GCCP, e.g. the development of induced pluripotent stem cells (iPSCs) and gene-edited cells. It further deals with human stem-cell-derived models and bioengineering of organo-typic cell cultures, including organoids, organ-on-chip and human-on-chip approaches. Commercial vendors and cell banks have made human primary cells more widely available over the last decade, increasing their use, but also requiring specific guidance as to GCCP. The characterization of cell culture systems including high-content imaging and high-throughput measurement technologies increasingly combined with more complex cell and tissue cultures represent a further challenge for GCCP. The increasing use of gene editing techniques to generate and modify in vitro culture models also requires discussion of its impact on GCCP. International (often varying) legislations and market forces originating from the commercialization of cell and tissue products and technologies are further impacting on the need for the use of GCCP. This report summarizes the recommendations of the second of two workshops, held in Germany in December 2015, aiming map the challenge and organize the process or developing a revised GCCP 2.0.
Highlights
The need for guidance on Good Cell Culture Practice (GCCP) especially for academic research was first recognized and the term GCCP was coined during a symposium of the German Association for Cell and Tissue Culture in Berlin 1996 organized by Thomas Hartung
The GCCP 2.0 collaboration was created to further promote GCCP, generate discussion and produce an updated guidance document on GCCP. These developments were fueled by individual experiences of irreproducibility of cell culture experiments, poor reporting standards and the fact that the principles enshrined in the overarching GLP2 were developed around animal studies and were not always directly applicable to in vitro work and academic environments (Cooper-Hannan et al, 1999)
For evaluation of cell differentiation under in vitro conditions, it is necessary to identify specific markers for different developmental windows of each cell type. The expression of these markers should be quantified and acceptable thresholds should be defined. These values can be used as quality control reference data to improve reproducibility of experiments, as the cells respond differently to a treatment depending on the stage of cell development, differentiation and maturation
Summary
The need for guidance on Good Cell Culture Practice (GCCP) especially for academic research was first recognized and the term GCCP was coined during a symposium of the German Association for Cell and Tissue Culture in Berlin 1996 organized by Thomas Hartung. A new guidance document on Good In Vitro Method Practices (GIVIMP), planned for 2018, aiming to reduce the uncertainties in cell and tissue-based in vitro method derived predictions in the regulatory implementation of in vitro methods for human safety assessment, is coordinated by the European validation body EURL ECVAM as a joint activity between the OECD Working Group on Good Laboratory Practice (GLP) and the OECD Working Group of the National Coordinators of the Test Guidelines Programme (WNT). It has adopted the principles of GCCP. Beyond that, such comparability increases the cost-efficiency of our spending in research and development, decreases the number of failures to reproduce results in other labs, and accelerates the process of generating knowledge and of innovation
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