"National BioService" launches technology platform to produce and implement tissue macrochips in humans

The RVC Biofund's portfolio company National bioservice has launched a service to produce tissue macrochips (TMA), designed to study cross- reactivity of antibodies to human tissues. These studies are a necessary step in developing therapeutic and diagnostic monoclonal antibodies and marketing domestic biosimilars.

The tissue macrochips designed by National BioService will become the first product in Russia and worldwide to correspond simultaneously to all major foreign and domestic regulatory requirements imposed on the way the cross-reactivity of antibodies should be tested.

Until now no company in the world ever produced tissue macrochips which would comply with the standards imposed by all the chief regulators(FDA, EMA, Health Ministry of the Russian Federation ) . Under this circumstance the manufacturers were forced to duplicate the studies required to register medical products in different countries. Russia does not produce similar products and the use of foreign counterparts is hindered by logistics and customs barriers on the one hand and their high cost on the other hand. Besides, the characteristics of TMA do not always comply with the requirements of Health Ministry of the Russian Federation.

"Today in the world more than 200 products undergo clinical tests and all of them are using biochips similar to ours. The market value of a single test ranges from 60 to 120 thousand dollars. For example, in the US the total market value of tissue microchips is 24 million dollars a year. Every year Russia gets closer to developing its own products based on monoclonal antibodies. So far the quantity of products can boast a dozen of titles only, nevertheless, the volume of the Russian market in the cross reactivity niche is already approaching the 50-75 mln. rubles. Within two years, the NBS plans to satisfy fully the demand of Russian manufacturers for TMA and TMA-related services " , commented Oleg Granstrem , Director of Business Development at National BioService"

The macrochip is a thin glass plate, on which up to 38 human tissues can be positioned. Besides, the TMA will have a unique design in terms of tissue composition. Since the production of TMA is compliant with these parameters, the product is universally applicable in situations when studies on cross-reactivity of antibodies are conducted by biopharmaceutical companies and contract research centers both in Russia and abroad.

When the research into cross — reactive antibodies is effected by home-made macrochips, its cost will be reduced two fold, the customs barriers will disappear so eventually the process of developing medical products will become less money-consuming and more energetic.

"National Bioservice has set the example of how to create high-tech products on the basis of the known technology platform and sparkle the interest of Russian developers . In future, we expect NBS to expand business towards the creation of new products and marketing them to companies engaged in R & D of innovative medical technologies not only in Russia but also abroad" — comments Egor Beketov, CEO of RVC Biofund.

The TMA technological service launched by National BioService will be used further to increase the range of tissue macrochips: focal TMA for cancer and other pathological tissues, TMA for various species used in the preclinical studies of antibodies.