Guidance document on Good Cell and Tissue Culture Practice 2.0 (GCCP 2.0)

Pamies, David

doi:10.14573/altex.2111011

Cited by 47 publications

(61 citation statements)

References 119 publications

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“…Further guidance can be found in the review by Yao and Asayama 31 and in the Good Cell and Tissue Culture Practice 2.0 guidance document. 32 Despite the importance of these other products and protocols in terms of their need for replacement, within this brief report we will solely focus our discussion on the replacement of FBS. We highlight three different scenarios and provide some case studies of each, namely: i) the adaptation of single cell lines to animal component-free culture conditions by the replacement of FBS and trypsin; ii) the adaptation of multicellular models to FBS-free conditions; and iii) the replacement of FBS with hPL for the generation of primary stem/stromal cell cultures for clinical purposes.…”

Section: Xeno-free Aspects Beyond Fetal Bovine Serummentioning

confidence: 99%

Case Studies Exemplifying the Transition to Animal Component-free Cell Culture

Weber¹,

Wiest²,

Oredsson

2022

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Cell culture techniques are strongly connected with modern scientific laboratories and production facilities. Thus, choosing the most suitable medium for the cells involved is vital, not only directly to optimise cell viability but also indirectly to maximise the reliability of the experiments performed with the cells. Fetal bovine or calf serum (FBS or FCS, respectively) is the most commonly used cell culture medium supplement, providing various nutritional factors and macromolecules essential for cell growth. Yet, the use of FBS encompasses a number of disadvantages. Scientifically, one of the most severe disadvantages is the lot-to-lot variability of animal sera that hampers reproducibility. Therefore, transitioning from the use of these ill-defined, component-variable, inconsistent, xenogenic, ethically questionable and even potentially infectious media supplements, is key to achieving better data reproducibility and thus better science. To demonstrate that the transition to animal component-free cell culture is possible and achievable, we highlight three different scenarios and provide some case studies of each, namely: i) the adaptation of single cell lines to animal component-free culture conditions by the replacement of FBS and trypsin; ii) the adaptation of multicellular models to FBS-free conditions; and (iii) the replacement of FBS with human platelet lysate (hPL) for the generation of primary stem/stromal cell cultures for clinical purposes. By highlighting these examples, we aim to foster and support the global movement towards more consistent science and provide evidence that it is indeed possible to step out of the currently smouldering scientific reproducibility crisis.

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Section: Xeno-free Aspects Beyond Fetal Bovine Serummentioning

confidence: 99%

Case Studies Exemplifying the Transition to Animal Component-free Cell Culture

Weber¹,

Wiest²,

Oredsson

2022

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“…Succeeding, we present endpoints of a novel iNeurosphere Assay, which is based on human induced pluripotent stem cells. During method development, we proceeded according to the Guidance Document on Good In Vitro Method Practices (GIVIMP) principles, to ensure predictivity and reproducibility of the test methods ( OECD, 2018 ; Pamies et al, 2022 ). The description of each Neurosphere Assay endpoint follows the same rationale.…”

Section: Resultsmentioning

confidence: 99%

Scientific Validation of Human Neurosphere Assays for Developmental Neurotoxicity Evaluation

et al. 2022

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There is a call for a paradigm shift in developmental neurotoxicity (DNT) evaluation, which demands the implementation of faster, more cost-efficient, and human-relevant test systems than current in vivo guideline studies. Under the umbrella of the Organisation for Economic Co-operation and Development (OECD), a guidance document is currently being prepared that instructs on the regulatory use of a DNT in vitro battery (DNT IVB) for fit-for-purpose applications. One crucial issue for OECD application of methods is validation, which for new approach methods (NAMs) requires novel approaches. Here, mechanistic information previously identified in vivo, as well as reported neurodevelopmental adversities in response to disturbances on the cellular and tissue level, are of central importance. In this study, we scientifically validate the Neurosphere Assay, which is based on human primary neural progenitor cells (hNPCs) and an integral part of the DNT IVB. It assesses neurodevelopmental key events (KEs) like NPC proliferation (NPC1ab), radial glia cell migration (NPC2a), neuronal differentiation (NPC3), neurite outgrowth (NPC4), oligodendrocyte differentiation (NPC5), and thyroid hormone-dependent oligodendrocyte maturation (NPC6). In addition, we extend our work from the hNPCs to human induced pluripotent stem cell-derived NPCs (hiNPCs) for the NPC proliferation (iNPC1ab) and radial glia assays (iNPC2a). The validation process we report for the endpoints studied with the Neurosphere Assays is based on 1) describing the relevance of the respective endpoints for brain development, 2) the confirmation of the cell type-specific morphologies observed in vitro, 3) expressions of cell type-specific markers consistent with those morphologies, 4) appropriate anticipated responses to physiological pertinent signaling stimuli and 5) alterations in specific in vitro endpoints upon challenges with confirmed DNT compounds. With these strong mechanistic underpinnings, we posit that the Neurosphere Assay as an integral part of the DNT in vitro screening battery is well poised for DNT evaluation for regulatory purposes.

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“…The OECD developed also mainly three guidance documents, which define the standard on the quality of model reporting and by this set the basis for their the implementation into regulatory practise. The guidances Good Laboratory Practice (GLP) (OECD 1998) and the Good Cell Culture Practice (GCCP) (Coecke, Balls et al 2005;Pamies, Leist et al 2020;Pamies, Leist et al 2022) describe the individual relevant steps, whereas the Guidance Document on Good In vitro Method Practices (GIVIMP) integrates relevant aspects of both. GIVIMP thus comprise advice on the execution of the experimental assays, also specifying the use of reference materials and the development and setting of appropriate acceptance criteria for the assay (Ulrey, Kolle et al 2021), Table 88).…”

Section: Templates and Validation Framework For Reporting Of Cell Bas...mentioning

confidence: 99%

Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment

Escher

Partosch

Konzok

et al. 2022

EFS3

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While whole animal studies have their place in risk assessment of food and feed components, it is thought that more modern approaches such as human focused new approached methodologies (NAMs) would bring advantages including a greater focus to the human species, a focus on molecular mechanism and kinetics and the possibility of addressing susceptible populations. This report outlines the thinking from the authors and culminates in activity proposals in seven distinct but interacting scientific areas i.e. development of additional AOPs/AOP networks (AOPs), advanced cell culture models including Organ on a chip (OoC), toxicokinetic assessment with a focus on physiological based kinetic modelling (PBK), exposome, human susceptibility, data integration and new concepts in human risk assessment. Furthermore, the development of a Forum is proposed to facilitate the implementation of new approaches and concepts in risk assessment. The report was compiled by the project team, renowned experts in the various areas, and recommendations were discussed with EFSA and further refined following consultation with external experts via a dedicated workshop. The authors are convinced that if the recommendations are taken up, there will be a significant impact in the field, resulting in increasing the uptake and utilisation of these emerging technologies by all stakeholders involved.

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Guidance document on Good Cell and Tissue Culture Practice 2.0 (GCCP 2.0)

Cited by 47 publications

References 119 publications

Case Studies Exemplifying the Transition to Animal Component-free Cell Culture

Case Studies Exemplifying the Transition to Animal Component-free Cell Culture

Scientific Validation of Human Neurosphere Assays for Developmental Neurotoxicity Evaluation

Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment

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