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ATERA: Advanced 3D human tissue models and exclusive testing services for cosmetic, consumer product and pharmaceutical industry

 
: Wever, Bart de; Varlet, Beatrice le; Groeber, Florian; Ginosian, Anna; Guillon, Fabien; Walles, Heike

ALTEX Proceedings 5 (2016), No.1, pp.44
ISSN: 2194-0479
European Society for Alternatives to Animal Testing (EUSAAT Congress) <17, 2016, Linz>
English
Abstract
Fraunhofer IGB ()

Abstract
In line with industrial innovation and many EU regulatory encouragements or requirements (EC 1223/2009, 2010/63/EU, EC 1272/2008, EC 1907/2006, 98/8/EC), the need for reconstructed human tissue models is still increasing. Advanced Tissue Engineering for Research Applications (ATERA) is a new tissue engineering company specialized in the development, validation, manufacturing and commercialization of “advanced” human tissue models. These models can be used as a reliable, cost-effective, and predictive alternative to animal experimentation in product evaluation, industrial safety and efficacy testing as well as medical research. ATERA is currently marketing a portfolio of 3D human tissue models including 3 types of reconstructed human epidermis, ocular models, oral mucosal epithelial models, vaginal, bladder and colon mucosa. To show the capacity of the ATERA – RHE skin irritation test method to replace the in vivo Draize test for regulatory accepted testing, a catch up validation study was performed. Results with an overall accuracy of 85% and reproducibility of 93% are currently under assessment by EURL-ECVAM’s Scientific Advisory Committee. All human tissue models are produced in a ISO 9001/V2008 certified state-of-the-art production facility. In addition to these models several advanced models are available or will become available. These including full thickness skin models, a human intestine model, a model to mimic the Blood Brain Barrier (BBB) and corneal epithelial models. A variety of highly specialised in vitro testing services are offered by ATERA and its partnering laboratories such as standardized in vitro test protocols for efficacy and safety testing but also sophisticated assays based on impedance spectroscopy to assess compounds and formulations for sub-clinical irritation, epidermal barrier regeneration and wound-healing. Testing services are also performed on tissue models that are currently not mass produced. A perfused vascularised skin model allows to evaluate both systemic efficacy and toxicity of test compounds, in the presence or absence of circulation of other cell types (e.g. different immune cells) thus providing a new in vitro tool helpful to develop candidate methods assessing potential systemic toxicity. Advanced Tissue Engineering for Research Applications now provides new opportunities to promote alternative methods and to develop predictive tools more relevant to human health.

: http://publica.fraunhofer.de/documents/N-426274.html