System-Biotech: Technology for the Production of Recombinant Therapeutic Proteins

2023: Development of recombinant therapeutic protein manufacturing technology

The scientific laboratory engaged in developments in the field of molecular biology, genetics and cellular technologies, Sistema-Biotech, on April 5, 2023, announced the development of technology for the production of recombinant therapeutic proteins that are used to produce biotechnological drugs, including those based on monoclonal antibodies. The company is ready to introduce technology on an industrial scale at the sites of Russian manufacturers of biotechnological drugs, which could potentially ensure Russia's independence from imports in this area.

Based on recombinant therapeutic proteins, a significant part of pharmaceuticals in the world is produced. On an industrial scale, such proteins are grown in bioreactors using special cellular systems, under certain physicochemical conditions. We have created a technology that allows a CHO-based cell system to produce many times more protein per liter of cell fluid in comparison with most analogues used in Russia, "said Natalia Pozdnyakova, director of science at Sistema-BioTech.

Most Russian pharmaceutical companies produce therapeutic recombinant proteins based on imported technologies that allow cell systems to produce approximately 1.5-2 g of protein per liter of fluid. The technology we developed when transferring to the industrial level shows significantly better results and is optimal in price. In addition, the use of domestic technology by Russian pharmaceutical companies guarantees Russia's import independence in this area, "said Artem Sirazutdinov, General Director of Sistema-BioTech. - Some Russian companies with R&D laboratories have similar developments, but they use them only in their own production facilities. Our technology is the first available to the entire market.

The technology developed by Sistema-BioTech made it possible to obtain a highly effective producer (cell line) of Adalimumab, a monoclonal antibody that underlies drugs for the therapy of diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis and a number of autoimmune diseases. Adalimumab is one of more than 30 monoclonal antibodies on the list of vital and essential drugs (VEDs). Any recombinant therapeutic proteins, including bispecific antibodies, etc. can be prepared in a similar manner.