Signatope is a new biotech company that has been offering innovative biomarker assays for application in drug discovery since August 2016. The company’s assays can be used in all phases of drug development to detect potential adverse drug effects on the kidneys, liver and other organs in any species whatsoever using minute amounts of sample.
The MammaScreen team from the University of Heidelberg Women’s Hospital has developed a blood test for diagnosing breast cancer. This new test can detect breast cancer at a very early stage. It works on women of all ages with tumours of any type and size.
Parkinson’s, Alzheimer’s and epilepsy are three prominent examples of neuronal conditions (disorders affecting the nerve cells) for which drugs for treatment are intensively sought. Paolo Cesare from the NMI in Reutlingen has developed an innovative 3D system for testing drugs that does not require animal testing. In 2015, the MEAFLUIT system was awarded first prize in BioRegio STERN Management GmbH's Science2Start idea competition.
The world of microorganisms is still largely unknown. Researchers such as Kai Sohn from the Fraunhofer IGB in Stuttgart are working on decoding, analysing and gradually gaining a better understanding of the microbial genome. In their search for new enzymes and other biomolecules, both biotechnologists and pharmacologists are interested in micoorganisms, and physicians are hoping that detailed insights into the microbial genome will lead to the development of more rapid methods for diagnosing infectious diseases.
What happens in tissues and organs and how do they react to pharmaceutical substances? Three-dimensional cell cultures can reproduce reality far better than a single-cell layer can. With good reason. Reality is far from two-dimensional. A company called 300MICRONS GmbH develops films with tiny indentations that provide optimal conditions for cells to grow into 3D cell aggregates.
Based on an accredited test method, the Fraunhofer IGB has developed an in vitro phototoxicity assay to measure the phototoxic potential of substances in medications and lotions used to protect the skin against environmental influences, which can become toxic when exposed to UV light. The assay uses human skin cells that have been grown into three-dimensional tissue as a human skin model.
Although the methods used to carry out amniocentesis are quite sophisticated, there is still a 0.5 percent risk of miscarriage following the intervention. Therefore, an EU-funded project called AngeLab is developing a rapid test that only requires a blood sample of the mother rather than amniotic fluid. The test yields information on the genetic health of the foetus within only a few hours. As part of the project, researchers from the Hahn-Schickard site in Freiburg have developed an innovative droplet PCR system.
Realistic alternatives to animal testing are more in demand than ever, especially in the drug development field. One possible solution is 3D cell cultures that possess the characteristics of the tissue from which they originate. Such systems were already developed at the Karlsruhe Institute of Technology (KIT) many years ago. Due to the huge demand for such systems, Prof. Dr. Eric Gottwald and two of his colleagues founded a company called 300MICRONS GmbH, which develops and markets 3D cell culture systems for different applications. The company will soon be able to produce large quantities of such cell culture systems.
At present, potential new drugs have to be tested on animals before they can be used on humans. However, results obtained from animals are not always transferrable to the situation in humans, which is why researchers around the world have long been seeking alternatives. Miniature human organs that can be used to test the efficacy of potential human drugs might provide a solution.
Quite a number of promising drug candidates for the treatment of diabetes are currently in the pharmaceutical pipeline, including innovative drugs that can stimulate the regeneration of insulin-producing pancreatic cells. However, they will have to be safety tested in animals. Scientists from Ulm University Hospital have now begun to develop a pancreatic chip from stem cells.
The most common and most successful system used for the experimental regulation of gene expression in eukaryotes is based on a gene switch that regulates the resistance of bacteria to tetracycline. The Tet technology also provides researchers with a tool that enables them to specifically, quantitatively and reversibly control the activity of individual genes in vivo and in vitro. The Heidelberg-based company TET Systems sells licences for the Tet technology that, since its inception, has been modified and optimised for a broad range of different functions.
Contact dermatitis is one of the most frequent occupational skin reactions resulting from exposure to allergens. Chronic allergic reactions to environmental allergens might sometimes become job- or life-threatening. Prof. Dr. Stefan Martin and his group of researchers in the Allergy Research Group of the Department of Dermatology at the Freiburg University Medical Centre are investigating the molecular mechanisms underlying the disease. One of their major objectives is to develop new therapies and in vitro test systems. The researchers have already clarified numerous molecular details associated with the development of contact dermatitis.
In the molecular biology laboratory at the Albstadt-Sigmaringen University of Applied Sciences a team led by Prof. Dr. Jörg Bergemann is developing and optimising assays that enable the quantitative determination of DNA damage and the investigation of repair mechanisms. The researchers exclusively use in vitro test systems. Using tissue engineering methods the researchers are developing a skin model for pharmacological efficacy and biocompatibility studies.
As of 2013 all cosmetic products containing a chemical with inherent skin sensitisation potential must be tested without the traditional animal testing. Prof. Dr. Stefan Martin from the Department of Dermatology at the University of Freiburg Medical Centre and his partners have been looking for alternatives to animal testing and have come up with the most specific in vitro test there has ever been. The researchers involved in the project have also been awarded a prize for their achievement by the Baden-Württemberg government.
The new drug screening and safety pharmacology laboratory at NMI Technologie Transfer GmbH NMI TT GmbH in Reutlingen with its standardised and special test systems complies fully with the requirements of safety pharmacology tests.
Between 20 and 30 million Germans suffer from allergies to house dust mites, pollen and many other allergens¹. The diagnosis of allergies is usually a rather time-consuming process as more than 20,000 potential allergens need to be tested in order to identify the allergen that causes a patient’s particular symptoms². Sensovation AG has developed a technology that allows the parallel analysis of 20 allergens and which has the potential to simplify and accelerate the diagnosis of allergies in the future. Founded in 2000, the Radolfzell-based company is focussed on the development and commercialisation of optical detection systems.
The new directive of the European Parliament and of the Council on the protection of animals used for scientific purposes was adopted on 22nd September 2010 and was implemented into the German Animal Welfare Act which came into force in February 2013. These regulations have implications for companies and researchers alike. In recent years a growing number of alternative methods to animal testing have been developed. Dr. Nina Hasiwa CEO of AtaX-Advice Alternatives to animal Xperiments based in Konstanz talks in an interview with Anna Weiß for BIOPRO about the impact and possible future prospects of the new legislation.
Since the beginning of the last century, fertilised chicken eggs have been an established model system and are nowadays often used as an alternative to animal experiments. The test model involves the use of the outer, strongly vascularised amnion (the so-called chorioallantoic membrane, CAM) which surrounds the embryo and is used for gas exchange during embryonic development.
The Commission welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.