TU Berlin and National Institutes for Food and Drug Control (NIFDC) China extend their cooperation in regulatory science.
Berlin, 4 October 2016 – Development cycles in the markets are accelerating. Regulatory authorities worldwide continuously face the challenge of declaring new drugs, cosmetic ingredients and food products as harmless to health. They make their decisions based on data provided by manufacturers. However, frequent setbacks in clinical studies prove how inadequate these data can be. Since 2014, the National Institutes for Food and Drug Control (NIFDC) China rely on regulatory science and early control in the approval process. TU Berlin now enables NIFDC to engage even more in the scientific aspect of the approval process as both organisations have extended their cooperation to six years. The first Chinese scientists recently finished their training in the operation of Multi-Organ-Chips (MOC) in Berlin. Now the technology will be transferred to China, where the scientists of the institute will be trained to independently execute tests.
“This makes NIFDC the first authority in the world to test the Multi-Organ-Chips independently and to use this technology with self-established assays to intervene in the development cycle”, explains Uwe Marx, inventor of the technology and CEO of TissUse GmbH founded as a spin-off of the TU Berlin in 2010.
The Multi-Organ-Chip technology currently makes it possible to replicate up to four human organs, scaled down 100,000 times, from cell tissue on a microscope slide. They are connected to each other with a system similar to blood vessels. Micro valves replicate the heart and the cell structures react to administered substances just like a human organism.
Experiments for testing new drugs, cosmetic ingredients and chemicals thereby do not need animal testing any more and developers as well as regulatory authorities can test how humans react to specific substances over longer periods of time. According to Marx, the use of human cells also allows the results to be transferred more easily than data from animal testing.
About TU Berlin
The Technische Universität Berlin (TU Berlin) is one of the oldest technical universities in Germany. With more than 32,000 students in 100 degree programmes, the university ranks among the largest universities in Germany. In addition to the university’s faculties and institutes, there are numerous collaborative research centres and major research networks. More than 177 million Euro in third-party funding were acquired by TU Berlin in 2015.
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National Institutes for food and drug Control (NIFDC), founded in 1950, is a subordinate agency of the China Food and Drug Administration (CFDA) and there are more than 50 departments and divisions within NIFDC. The main professional areas of NIFDC cover pharmaceutical products, biological products, medical devices, food, healthy food, Cosmetic, reference standards, laboratory animals, and drug safety evaluation etc. More than 800 different testing items could be performed in NIFDC. Each year, more than 13,000 batches of drugs are tested in NIFDC and more than 2,900 reference standards are distributed by NIFDC. Currently, there are more than 1000 employees including 800 technical staffs and more than 9800 modern testing instruments and equipment in NIFDC, with the total asset value of more than 400 million RMB.
TissUse is a Berlin, Germany-based, vibrant growth company who has developed a unique Multi-Organ-Chip platform that – for the first time ever – provides preclinical insight on the systemic level using human tissue. This enabling technology platform consists of a miniaturized construct that closely simulates the activity of multiple human organs in their true physiological context. TissUse's Multi-Organ-Chips provide a completely new approach to predict, for example, toxicity, ADME profiles and efficacy in vitro, reducing and replacing laboratory animal testing and streamlining human clinical trials.
TissUse is additionally applying its platform and know-how to develop spin-off programs in a variety of tissue and organ repair areas starting with the cosmetic market of hair transplants.
Dr Reyk Horland
VP Business Development
Oudenarder Str. 16
TissUse presents technologies at the WC9-congress in Prague
Spreenhagen (near Berlin), 13 August, 2014. TissUse is a German, Berlin-based, vibrant growth company providing high-value services in the area of tissue culture analysis of drug candidates, cosmetics and chemicals. TissUse is presenting its new products and prototypes based on its proprietary technology platform at the “9th World Congress on Alternatives and Animal Use in the Life Sciences” from August 24 to 28 in Prague. This “human-on-a-chip” platform enables the testing of drugs or chemicals on a set of miniaturized human organs emulating the biology of the human organism at the smallest possible biological scale. In the future, it will be possible, for example, to significantly reduce the number of animals used in pharmaceutical research and to substitute current alternative methods to animal testing.
Dr. Uwe Marx, founder and CEO of TissUse GmbH, is going to address the current developments and applications of the technology during a keynote speech at the WC9-Congress. TissUse launched its two-organ-chip in 2013. The platform has been successfully applied in more than 20 different academic and industrial research projects. One of the globally renowned collaboration partner is Beiersdorf . Any new chip design serving specific customer needs in organ arrangement can be prototyped and produced within two months due to a proprietary rapid prototyping procedure established at TissUse. The technology offers a broad range of commercial and scientific applications.
“Design and development of new Chips are ongoing. Our latest research focus is based on the four-organ-chip prototype”, says Uwe Marx. This means that four independent organs on a chip interact on a physiological level. “The development of a ten-organ-chip is expected to be completed by 2017. Our approach could revolutionize drug development.” In addition to the keynote lecture, the technology platform will be prominently featured in a further presentation and seven posters. Visitors will have the opportunity to meet the development team at the TissUse exhibition booth or at the various posters. Furthermore, a four-organ-chip prototype will be exhibited at the booth.
About the technology
A dynamic two-organ-chip has been established for the simultaneous cultivation of two different cell types in a common media perfusion circuit at a miniaturized scale. Cells or tissues can be applied both into the two culture spaces on standard Transwell inserts to model biological barriers, such as intestine epithelia, or onto matrix supports to mimic the three-dimensional environment of parenchymal organs, such as the liver. The on-chip micropump and microfluidic channels interconnect these organs and provide lifelike behaviour. This enables the direct prediction of effects of chemicals and their metabolism on near real-life models.
TissUse, a 2010 spin-off from the Technische Universität Berlin, has developed a unique chip-based tissue culture platform, enabling the testing of drugs or chemicals on a set of miniaturized human organs (organoids) simulating the biology of the human organism. The TissUse management reflects a mixture of industry experience and deep scientific know-how in the many areas of science underlying the multidisciplinary micro-organoid technology. The company collaborates extensively with the Technische Universität Berlin, Fraunhofer IGB, Fraunhofer IWS, University of Würzburg, and other academic institutions. TissUse is additionally applying its platform and know-how to develop spin-off programmes in a variety of tissue and organ repair areas, starting with the cosmetic market of hair transplants.
Dr. Uwe Marx
Oudenarder Str. 16
Ownership of patent portfolio enables commercial production of multi-organ-chips
Spreenhagen (near Berlin), 30 August, 2013. TissUse GmbH today announced the signing of a transfer agreement with the Technische Universität (TU) Berlin. With this, five patent families for the production, application and automation of multi-organ chips are fully transferred to TissUse GmbH, the TU Berlin spin-off company founded in 2010. The biotech company produces models of human organs for preclinical drug testing based on this patented technology. The patent transfer allows TissUse the unlimited full development of the multi-organ chips and their commercial application.
“We thank the TU Berlin for the constructive negotiations for the transfer of the patents,” said Dr. Uwe Marx, CEO of TissUse GmbH. “The collaboration with the TU Berlin has proven to be excellent for our young company and will continue.” The patents were developed within the framework of the Federal Ministry of Education and Research (BMBF) funded GO-Bio Project at the TU Berlin. TissUse has had access to the technology since 2010 through an option and license agreement with ipal Gesellschaft für Patentverwertung Berlin mbH (Association for Patent Exploitation).
The multi-organ chip technology makes it possible to carry out chemical and pharmaceutical tests on individual or related human mini organs (organoids). In this way, the validity of preclinical testing can be increased in the future compared to the current animal experimentation conducted, and the failure rate in clinical trials on humans in the pharmaceutical industry can be reduced. So far, about 20 academic and industrial research institutions have tested the two-organ chip, which is ready for production. Within two months, TissUse will be producing tailor-made two-organ models to fulfil the needs of specific research projects. The potential applications, however, range much further: “As a next step, we have embarked on the development of a four-organ chip,” commented Uwe Marx. “Our development has a bright future – especially with the full use of the patents within TissUse.”
TissUse has also, at the same time, received an exclusive license for a promising cell therapy to combat hair loss, which was developed by the same department of the TU Berlin. “We are carrying out first clinical testing of this therapy with hair transplant centres worldwide,” said Marx.
TissUse GmbH is a spin-off company from the TU Berlin founded in 2010. It has developed a unique chip-based tissue culture platform enabling the testing of drugs or chemicals using a series of miniaturised and interconnected human organs (organoids) simulating the biology of the human organism. TissUse’ management team reflects a mixture of industry expertise and in-depth multidisciplinary scientific know-how concerning micro-organoid technology. The company works closely with the TU Berlin, Fraunhofer IGB, Fraunhofer IWS, Würzburg University and other academic institutions. TissUse is also applying its platform and industry-specific knowledge to develop other spin-off programmes in a variety of tissue and organ repair areas, beginning with the cosmetic market for hair transplants.
Dr. Uwe Marx
Oudenarder Str. 16