Man in the palm of your hand
The unique technology will accelerate the development of pharmaceuticals and make them safe
Yuri Drize (photo by Andrey Moiseev), newspaper "Search" No. 28-2013
The box is smaller than a mobile phone with tubes extending from it in my hands – nothing more or less than a cellular model of human organs created for the first time in the country in one millionth of the size. Different human cells live in this chip – each mini-cell has its own organ. In one, for example, the liver, in others the intestines, the brain... The culture medium washes them instead of blood – it ensures the life of cells for four weeks. A compact control unit is responsible for its movement through microchannels, it provides adjustment and automatic maintenance of the necessary parameters of cell cultivation. In fact, no matter how fantastic it sounds, a portable device is a kind of homunculus. And it was made at the Scientific and Technical Center "BioClinicum".
– Of course, everything is conditional, – explains the general director of the center Dmitry Sakharov (pictured), – human organs and tissues are much more complicated. However, today our development allows us to create, perhaps, their most adequate cellular model.
– The main thing is, what was the device created for?
– The possibilities of its application are very wide. For example, using such cellular models, it is possible to develop pharmaceuticals, study their effect on the body, and much more. Before the advent of such a device, these tasks were solved only in experiments on laboratory animals.
However, the effect of pharmaceutical drugs and their toxicity in humans and animals may be different. For example, a new drug for the treatment of diabetes mellitus, troglitazone, had to be withdrawn from sale due to side effects on liver cells (hepatotoxicity), which could not be detected in animal studies. As a result, there were cases of death of patients from acute liver damage, as well as the development of hepatitis. Needless to say, the company that put the drug on the market suffered significant financial losses.
Meanwhile, as joint research with our foreign partner, the Berlin Technical University, has shown, the toxicity of the drug is clearly established during testing on our device. This is its uniqueness: it is able to assess the effect of the drug on human organs and tissues. And another very important advantage. When developing new medicines, for the first time, it becomes possible to significantly reduce the use of laboratory animals. This is a kind of revolution. Last year, the Ministry of Health gave permission for 650 clinical trials of new drugs. This means that initially there were about 5-6 thousand of them. And all these substances had to be tested on animals. But the Russian market for the creation of medicines is small. In Europe and the USA, it is an order of magnitude larger. And to test the safety of one drug, you need from 5 to 20 thousand laboratory animals. Now their number will gradually decrease.
– What prevents you from speeding up this process?
– There is no hurry. It is necessary to conduct additional research to understand the possibilities of the new testing technology, to compare the results of studies on laboratory animals and cellular models of human organs. So far, we can say that this technology allows us to obtain important and more accurate data on the toxicity of drugs for humans. Now it is necessary to prove its effectiveness and usefulness to pharmaceutical companies, submit a new method of testing drugs to the Ministry of Health, give it the status of a regulatory document. But already today the device can be successfully used in the creation of new cosmetic products. Animal testing is completely prohibited in the European cosmetics industry, and violators of this requirement cannot bring their goods to the market. Our device allows us to assess the safety of cosmetic products for humans, as well as provide unique data on their effect on skin cells at the molecular level. We are confident that the technology will accelerate the promotion of new products to the market, make them safer and cheaper.
– How did the idea of creating such devices come about?
– The pioneers of these studies were scientists from Germany and the USA. Initially, cell biologists and geneticists studied the possibilities of testing various substances on cell monocultures. Over time, it became clear that in such studies it is necessary to recreate the complex relationships of various organs and systems of the human body, where the tested substance falls. So gradually the unique biotechnology "man on a chip" was born. Today this direction is developing rapidly. A specialized international journal "Laboratory on a Chip" is published – it concentrates the main results of scientific research. Major thematic conferences and congresses are held in different countries, in which our team also participates. Foreign patents protect the design features of microbioreactors and the technology of co-cultivation of cells in them.
– Is it possible to use this device in basic research?
– Absolutely. This is another important area of its application. And here it is difficult to overestimate the capabilities of our device. Realizing that the tasks of research in the field of biology and medicine on models of human tissues and organs can be very different, we offer options for adapting the device to a specific range of tasks, develop special chip designs, and assist in the preparation of protocols for joint cell culture of interest to specific scientists. In fact, we become participants in such studies. As it turned out, our biotechnology has extensive capabilities for environmental monitoring, allows us to obtain various cellular models of the development of human diseases, such as cancer. Personalized medicine is a very important and promising direction. We believe that chips can be useful in selecting the most effective combination of drugs for the treatment of a particular patient. It is in these areas that extensive fundamental research is conducted abroad. This is a breakthrough technology of the future.
– What about today?
– We have successfully completed the "man on a chip" project, organized and launched a pilot production of the device, working at full capacity, because the chips are disposable, their service life is 2-3 weeks, and a lot of them are needed. The device aroused interest in Russia and abroad. Its prototypes are already working at the Berlin Technical University (8 devices), the Siberian Branch of the Russian Academy of Medical Sciences, and MSU is next in line.
– Is this technology available, does it require special training of personnel? And, of course, is the price high?
– Our equipment is designed for research institutes and large medical centers. The staff, of course, must be prepared, as well as during the operation of any high-tech device. The price of the prototype is about 4 million rubles. This is significantly cheaper than the cost of equivalent foreign equipment. During mass production, it will be reduced at least four times.
– However, the Ministry of Health has the last word. What will it be like?
– Of course, there are always problems with the approval of any new product, but we are sure that they can be solved. Recently, our technology was discussed at a government commission discussing the prospects for the development of biotechnologies, and it received positive feedback. It is supported by the Ministry of Education and Science, which partially financed the experimental design development of the device, and the funds were allocated on a competitive basis. Now the device is undergoing the necessary approvals, after which it will be handed over to the Ministry of Health. At the same time, our team is actively conducting post-marketing research to develop standardized methods of its application in various fields. Thanks to cooperation with foreign partners, we have a good chance of a quick start of sales in the EU market.
– But they have their own chips – after all, they are the discoverers...
– Yes, but our development turned out to be better than foreign ones. Only our device allows us to provide different variants of the flow of the culture medium in the chip, simultaneously cultivating six different types of cells. This determines its versatility and wide application possibilities. Over the past two years, we have improved the technology so successfully that the Berlin Technical University, with which we have very good relations, recognized the superiority of our device and, as they say, put their samples on the shelf.
– How did you manage it?
– The center has been in existence for only about five years, about four years since we took up this project. The term is short, but we have a strong team headed by the corresponding member of the Russian Academy of Sciences Alexander Grigorievich Tonevitsky. The average age of researchers is 25 years. They are mainly graduates of the chemical, biological, and medical faculties of Moscow State University and Baumanka. A full cycle of pilot production is located under one roof: from development to release of the finished device. We have a modern cell research unit, new methods of using the device are being developed on its basis. We conduct pilot trials of pharmaceutical products and joint experimental studies in the interests of users.
It remains only to be happy for the NTC "BioClinicum". It very quickly turned into a modern scientific and production innovative company, well-known in Russia and abroad. Today, the center's team has 36 employees, it occupies a separate three-story building in the technopark and is equipped "to the nines". Applicants who want to get here to work are strictly selected. There are only two requirements: you need to be a great specialist and be able to work in a team with full dedication.
Portal "Eternal youth" http://vechnayamolodost.ru12.07.2013