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July 2011: 3D replaces animal experiments
Measuring the toxicity of a product without requiring animal experiments – this could soon become reality. Recent advance in cell-research at the Heinz Nixdorf - Lehrstuhl für Medizinische Elektronik at the TU München, show how the experiments could be avoided in the future.
In 2007 the EU REACH regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals came into effect. Now the European industry has been obliged to intensify the analysis concerning risks of substances for humans and the environment. Extensive toxicological tests have become indispensable and animal experiments still play an unavoidable role. The implementation of toxicity tests on cell cultures could be an important step away from the controversial experiments.
New and very promising scientific findings concerning toxicity tests on cell cultures have been recently made through electrochemical measurements (by application of electrochemical sensors). With the help of the label-free IMOLA-IVD technology, 3-dimensional liver micro tissues have been - for the very first time - immobilized on a BioChip and then analyzed. In most previous tests, 2-dimensional cells had been immobilized, a process in which cell cultures do not maintain all of their specific functions, what makes these experiments less predictive for toxicological effects on humans.
In the latest experiments, 3-dimensional hepatocytes were observed on IMOLA-IVD systems. The 3-dimensional micro tissue was examined in detail and in real time on toxicological reactions. During the experiment, SDS (Sodium Dodecyl Sulphate) was added and then removed from the cell culture. Adding toxicological substances repeatedly is only possible with IMOLA-IVD systems because of their label free capacity. They allow to continuously observe the vitality of cell cultures during a long term and to add, remove and then re-add active agents through their fluidic-systems. This kind of long-term measurement allows a very precise measurement for the vitality of cells and hence, the toxicity of correspondingly applied chemicals. The improved prognosis for humans is given through the structure of the micro tissue that is close to reality. Liver micro tissues are particularly revealing, because the liver is a central organ for the degradation of toxicological substances in the human body.
The 3- dimensional cell cultures from InSphero AG are thus ideal for examining the basic research on toxicity within the REACH-inspections. With the aid of this kind of examination, detailed insight about the toxicity of substances could be detected without the use of bioassays.
The scientific findings concerning these new possibilities of measurement are significant. According to Dr. Joachim Wiest, CEO of cellasys GmbH, a milestone has been achieved. Through the successful combination of a commercially available measurement technique and the 3-dimensional micro tissue, the REACH-regulation can be implemented without conducting innumerable animal experiments.
Karolin Herzog
The experiments have been carried out with the IMOLA-IVD technology of cellasys GmbH and 3 dimensional micro tissue from InSphero AG.
Mai 2011: ISO certificates from cellasys available
Since 16.05.2011 cellasys – a spin-off from Heinz-Nixdorf Lehrstuhl für Medizinische Elektronik, Technische Universität München – has certified its quality management system by TÜV Süd referring the international standards ISO 9001:2008 and ISO 13485:2009. Founded in 2007, cellasys sells cell-based assays for live cell monitoring to national and international laboratories. Applications range from environmental monitoring via medicine and research to animal welfare.
Dr. Joachim Wiest, CEO of the company expects an „increased use of the chip-based, label-free, continuous live cell monitoring technology in industrial and medical applications” caused by the certificate in the field of in-vitro diagnostics.
The certificates enable the use of cellasys’s innovative products for diagnostic and therapeutic use in europe. For example the “intelligent mobile lab for in-vitro diagnostic” (IMOLA-IVD) – the main product of cellasys – can now be applied to check the quality of transplants in the field of regenerative medicine. With the IMOLA-IVD the metabolic activity and changes in bioimpedance of various cell-types can be measured. So, it is possible to investigate the impact of different substances toward living cells. With that, optimized strategies in the clinical practice can be determined. In an ongoing project the therapy of cancer patients is improved by identification of the matching drug. It is a promising device which will certainly improve the therapy of cancer in many disciplines.
Beside the motivation of Dr. Wiest to “assure the high quality of all products and processes of cellasys GmbH in an enduring manner” the certificate may also be crucial for the market position.
Karolin Herzog
The scope of the certification includes:
Design and Development, Production, Distribution, Servicing and Installation of Cell-based Assays for In-vitro Diagnostic use as well as Design and Development, Production and distribution of Biochips for Cell Culture Techniques.
BI Life Science 1/2010 (page 7):
... Future projects include implants of sensor chips for controlled drug release ...
BIOforum Europe 3/2009 (page 24):
Genetic Engineering & Biotechnology News:
E.ON Bayern Umweltpreis 2008: