Taking prescription drugs during pregnancy can be harmful to the unborn child. Therefore, identifying the embryotoxic potential of a new drug candidate is an essential part of any preclinical study. These studies are currently conducted in animals according to OECD guidelines.
In Europe, 11 Million animals are tested annually. About 50 percent of these tests are performed to explore the bone harming and thus the embryotoxic potential of such drug candidates. Dr. Nicole zur Nieden, leader of the stem cell group at the Fraunhofer Institute, is developing a method to identify the bone harming potential in vitro.
This shall be enabled by simulating and monitoring the multi-phase differentiation process of pluripotent stem cells in a controlled bioreactor system. By adding compounds with known in vivo osteotoxic potential, adverse effects on the differentiation will be identified. Non human embryonic primate stem cells will be compared to human progenitor cells to study varying molecular reactions compared to the established test organisms (mice).
DASGIP, leading manufacturer of parallel bioreactor systems, will contribute its bioreactor system to the project. Through further improvements Dr. Matthias Arnold, CSO DASGIP, and the scientists at the Fraunhofer IZI plan to establish and automate a multi-step cultivation process covering the different phases of differentiating stem cells in drug testing.
The German government subsidizes the research project, acting on behalf of international organizations such as OECD and the EU. Since 1986 the EU commission has stressed its interest in new methods to minimize, replace or optimize animal testing. Recently, the demand to accelerate these processes has been increasing due to the EU Cosmetics and Chemicals Legislation and the desire to avoid complications associated with drug development. To date, only the embryonic stem cell test (EST) could prove as reliable ex vivo alternative to animal testing, which builds the basis for the planned improvements. The EU commission will publish its new ideas on how to reduce the need for animal testing and how to promote alternative methods sometime in April.
Not only politicians, but also industry representatives strongly appreciate the development of alternative methods as it can make drug development and approval faster and more cost-effective: In contrast to existing processes the stem cell approach promoted by Fraunhofer IZI is characterized by a high predictability for human effects, by cost-efficiency and by short testing periods. Therefore, Thomas Drescher, President of DASGIP, looks forward to providing the industry with a bioreactor system, which could help replacing up to 50 percent of the animal tests required in bone toxicity test for drugs, chemicals, plant protecting agents and cosmetics.
Further project partners are the ZEBET - Centre for Documentation and Evaluation of Alternatives to Animal Experiments - at the Federal Institute for Risk Assessment (http://www.bfr.bund.de/cd/1591) and the contract research organization RCC Ltd. (www.rccltd.ch).
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02.12.2016 | IMBA - Institut für Molekulare Biotechnologie der Österreichischen Akademie der Wissenschaften GmbH
A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.
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The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.
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The efficiency of power electronic systems is not solely dependent on electrical efficiency but also on weight, for example, in mobile systems. When the weight of relevant components and devices in airplanes, for instance, is reduced, fuel savings can be achieved and correspondingly greenhouse gas emissions decreased. New materials and components based on gallium nitride (GaN) can help to reduce weight and increase the efficiency. With these new materials, power electronic switches can be operated at higher switching frequency, resulting in higher power density and lower material costs.
Researchers at the Fraunhofer Institute for Solar Energy Systems ISE together with partners have investigated how these materials can be used to make power...
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