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).
O2 stable hydrogenases for applications
23.07.2018 | Max-Planck-Institut für Chemische Energiekonversion
Scientists uncover the role of a protein in production & survival of myelin-forming cells
19.07.2018 | Advanced Science Research Center, GC/CUNY
A new manufacturing technique uses a process similar to newspaper printing to form smoother and more flexible metals for making ultrafast electronic devices.
The low-cost process, developed by Purdue University researchers, combines tools already used in industry for manufacturing metals on a large scale, but uses...
For the first time ever, scientists have determined the cosmic origin of highest-energy neutrinos. A research group led by IceCube scientist Elisa Resconi, spokesperson of the Collaborative Research Center SFB1258 at the Technical University of Munich (TUM), provides an important piece of evidence that the particles detected by the IceCube neutrino telescope at the South Pole originate from a galaxy four billion light-years away from Earth.
To rule out other origins with certainty, the team led by neutrino physicist Elisa Resconi from the Technical University of Munich and multi-wavelength...
For the first time a team of researchers have discovered two different phases of magnetic skyrmions in a single material. Physicists of the Technical Universities of Munich and Dresden and the University of Cologne can now better study and understand the properties of these magnetic structures, which are important for both basic research and applications.
Whirlpools are an everyday experience in a bath tub: When the water is drained a circular vortex is formed. Typically, such whirls are rather stable. Similar...
Physicists working with Roland Wester at the University of Innsbruck have investigated if and how chemical reactions can be influenced by targeted vibrational excitation of the reactants. They were able to demonstrate that excitation with a laser beam does not affect the efficiency of a chemical exchange reaction and that the excited molecular group acts only as a spectator in the reaction.
A frequently used reaction in organic chemistry is nucleophilic substitution. It plays, for example, an important role in in the synthesis of new chemical...
Optical spectroscopy allows investigating the energy structure and dynamic properties of complex quantum systems. Researchers from the University of Würzburg present two new approaches of coherent two-dimensional spectroscopy.
"Put an excitation into the system and observe how it evolves." According to physicist Professor Tobias Brixner, this is the credo of optical spectroscopy....
13.07.2018 | Event News
12.07.2018 | Event News
03.07.2018 | Event News
23.07.2018 | Health and Medicine
23.07.2018 | Earth Sciences
23.07.2018 | Science Education