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Volume 7, Issue 2 (Suppl)
J Biotechnol Biomater
ISSN: 2155-952X JBTBM, an open access journal
Biomaterials 2017
March 27-28, 2017
2
nd
Annual Conference and Expo on
March 27-28, 2017 Madrid, Spain
J Biotechnol Biomater 2017, 7:2 (Suppl)
http://dx.doi.org/10.4172/2155-952X.C1.074Development of an
in vitro
testing battery to assess biocompatibility of medical devices
Elisabeth Mertl
1
, Gabriele Ettenberger
1
, Christian Kirchnawy
1
, Magdalena Haller
1
, Daniela Neubert
1
and
Thomas Czerny
2
1
OFI Technology & Innovation GmbH, Austria
2
University of Applied Sciences, Austria
I
n order to guarantee safety for the end-users of medical devices, they have to be tested for adverse reactions on the skin before market
authorization. Animal testing is still state of the art, but ethically questionable and expensive. During the last years, socio-political
pressure has led to the development of alternatives. One of the key aspects of our recent research is to establish an
in vitro
testing
battery to examine the biocompatibility of medical devices in contact with the skin or mucosa. The first task was the development of
an appropriate extraction method in order to cover a wide range of substances migrating from the device. As skin models and various
assays have already been developed for testing pure chemicals, the focus was on the establishment of such methods to assess extracts
for cytotoxicity, irritation and sensitization. To identify a possible sensitization potential, a screening method to cover different steps
of the skin sensitization process was developed. The molecular initiation event, the binding of haptens to peptides can be assessed by
chromatographic methods. The molecular and cellular responses include the activation of an antioxidant pathway in keratinocytes
and hence, activating the phenotypical deformation of dendritic cells. So far, various samples have been examined in the different
assays. Spiking of sample extracts was used to prevent false negative results. Additionally, samples were examined with animal testing
in order to compare the results which showed more sensitive responses in the
in vitro
assays. Further, it could be shown that not only
materials themselves but also the manufacturing process plays an important role for biocompatibility. In this context, production
processes of medical devices were improved. Summarizing, these assays are developed not only with a sufficient sensitivity, but also
to be robust, simple to use, ethically responsible and inexpensive in comparison to current animal testing.
elisabeth.mertl@ofi.at