Research workpackages PDF Print E-mail

SCR&Tox research programme is organised in six workpackages, four of them are scientific, the fifth is in charge of training and dissemination, including workshops to regulatory bodies and the sixth workpackage that is involved in the SCR&Tox project management.

SCR&Tox research programme is organised in six work packages, four of them are scientific, the fifth is in charge of training and dissemination, including the workshops to regulatory bodies and the sixth workpackage is involved in project management.
Workpackage 1
Biological Resources- Leader: Johann Hyllner
Johan Hyllner is WP leader for the biological resources; his company, Cellartis, is a major industrial player worldwide with ten years expertise in the production of human pluripotent stem cell lines for industrial use.
This work package will be in charge of
Workpackage 2
Technological Resources- Leader:
By bringing proof of concept of predictive toxicology testing at industrial scale on the basis of cell-based assays using human pluripotent stem cell derivatives.
Healthcare policies and regulation
By entering into the validation process in vitro testing to replace or reduce animal experimentations in predictive toxicology for pharmaceutical compounds and cosmetic ingredients.
Next generation of toxicologists
Specific training experiences for the next generation of toxicologists involved in regulatory toxicology through the Implementation of the training and dissemination program of SCR&Tox, which specifically aims at technology transfer to stakeholders in the pharmaceutical and cosmetic industry, in particular through hand-on training at partners’ sites and assistance for setting-up laboratories in stakeholders’ plants

 

Biological Resources

 

Johan Hyllner is the leader for the biological resources workpackage; his company, Cellartis, is a major industrial player worldwide with ten years expertise in the production of human pluripotent stem cell lines for industrial use. Work package 1 will provide the necessary biological resources by amplifying and banking undifferentiated cells and by supplying protocols and production of differentiated cells, aiming specifically at :

 

  • Obtaining, preparing and banking all hES and iPS cell lines required for SCR&Tox and make them available to the SEURAT-1 cluster.
  • Designing and implementing conditions for scalable production of hES and iPS at the undifferentiated stage.
  • Identifying protocols for cell differentiation into 5 lineages (liver, CNS, heart, epidermis and muscle) at least at two stages – terminally differentiated and amplifiable precursors whenever technically sound - and make them available to the SEURAT-1 cluster.
  • Preparing “ready-to-screen” cell kits and plates for toxicology pathway assays.
 

 

Technological Resources

 

Catharina Ellerström is the leader for the technological resources workpackage; representing Cellectis Stem Cells a Cellectis business unit that combines two Cellectis Group companies dedicated to stem cell technology. These are Ectycell, based at the Evry Genopole (France), and Cellartis, based in Gothenburg (Sweden), which was acquired by Cellectis in October 2011.

The goal of the "Cellectis stem cells" Business Unit is to speed up the development of stem cell technology and in particular to find a robust and reproducible way of controlling stem cell production and differentiation, notably through the sharing of knowledge and expertise developed by the two companies, with a view to becoming a major, long-term and stable industrial player in the global marketplace.

Cellectis is a key player worldwide with ten years of expertise in genome engineering and delivery of engineered cells to the industry. Work Package 2 will explore cell functions, optimise cells for assays and prepare cells for high throughput screening platforms, by:

 

  • Designing and implementing technologies for defining cell profiles of gene and protein expression and for exploring cell functions at gene, protein and electrogenic levels, and transferring all protocols to the SEURAT-1 cluster.
  • Designing and implementing technologies for optimising cells for toxicity pathway assays through genomic engineering and protein transfer, and transferring all protocols to the SEURAT-1 cluster.
  • Designing and implementing technologies for introducing gene constructs facilitating cell selection at a particular differentiation stage or promotion of differentiation into a specific cell phenotype, and transferring all protocols to the SEURAT-1 cluster.

 

 

Assay Development

 

Susanne Bremer-Hoffmann is leader for the assay development workpackage. She has been responsible for more than 12 years at ECVAM for exploring and validating cell-based assays for toxicology, in particular using embryonic stem cells and, as such, has participated to the validation of the EST, the only test based on ES cells to-date which has been approved by regulatory bodies for reproductive toxicology testing. Workpackage 3 main objectives are the definition, implementation, normalisation and validation of assays by:

 

  • Applying relevant quality control measures on the presence and function of pluripotent stem cells derivatives of the toxicity pathway(s) selected collectively by the SEURAT-1 cluster and by demonstrating its relevant perturbation by the associated toxicant of reference.
  • Developing and implementing the assay of the selected toxicity pathway(s) at “low throughput scale”, as demonstrated by the identification of perturbators with toxic potential in the screening of a small-scale library of compounds selected by the SEURAT-1 cluster (proof-of concept) and
  • Entering the developed assay into the normalisation and validation process, ensuring that entering-into-prevalidation-criteria of the developed test assay are met.
 

 

Industrial Prototypes

 

Roy Forster is leader for the industrial-scale prototypes workpackage; his company, CIT, is one important CRO in the field of toxicology testing with major interest in the development of new approaches for testing cosmetic ingredients and pharmaceutical compounds.  Work package 4 main objectives are:

 

  • To establish standard operating procedures for preparing pluripotent stem cells derivatives for industrial-scale implementation of the developed prototype assay on high throughput screening platforms and make them available to the Data Warehouse
  • To transfer all technologies and methodologies design during the assay development phase and establish standard operating procedures made available to the Data Warehouse
  • To perform on industrial platforms the assay prototype using a test library of chemicals and cosmetic ingredients, and demonstrate successful implementation on parameters assessing robustness, sensitivity, specificity and reproducibility