Russia needs the new biomedical cell products that are the basis for the medicines production. The process of its manufacturing and registration could be much simpler. It was the core theme on the panel discussion at the “INNOPROM” international industrial exhibition’s venue. The need for the cell products is increasing every day: on the one hand, the scientists are looking for approaches to fight the complex diseases; on the other hand, they fix the resistance to the antimicrobial medicinal products. If in the end of 1980s, the antibiotics were very effective in fight with all the microbes, so now more than 25% of microbes developed resistance to the medicines. As a result, diseases, that were considered as defeated, began to return.

The University continues to develop the scientific field related to the new medicines development. After there was made a decision to hold the Universiade in Yekaterinburg there was put forward an idea to use a part of infrastructure, that will be related to the university after the Universiade will be completed, to develop biomedicine field in Ural region. As discussion on this topic continues, there is work organized on those scientific developments in this field that will be relevant and demand in coming decades. It is very important to give a tangible meaning to this idea, - First Vice-Rector of Ural Federal University Sergey Kortov said. 

“Here, in Ural, in Chemical and Pharmaceutical Center of Institute of Organic Synthesis, we are also working on creation of molecules of this type. We already have many “applicants” (biomedical cell products – ed. note), and we are ready to continue to move forward,” - Chairman of Ural regional office of Russian Academy of Sciences, Director of Institute of Organic Synthesis, Valery Charushin said. 

Problem is not a local one, limited by one region, it relates to all the scientific organizations working on medicine of future. Further step should be a creation of technological centers, where the work will be concerned with scaling up the scientific development results, i.e. preparation for industrial production. There is one such center in Ural: it recently received a license under the international GMP standard to work with veterinary pharmaceutical products. Mr. Charushin is sure that this is only the beginning. 

Scaling-up laboratories may be created on the Ural University’s basis, - says discussion participant, Member of State Duma committee on healthcare, Alexander Petrov. Moreover, pointed out Mr. Kortov, recently, the regional authorities together with the scientists decided that after the “Univrsiade-2023” that will be conducted in Ekaterinburg, the University will “inherit” a platform for creation of the University center.

In order to take to the next level, the pharmacology field needs a support from legislative establishment. The current legislative frameworks that regulate development results implementation process requires an essential modernization. Currently, the complex radionuclides and normal saline have to be registered under the same regulations, and it is not correct, - Mr. Petrov believes. Recently, at the first reading the State Duma adopted a law, according to which the experts will be able to send the registration dossier of pharmaceutical product for revision only once (for now the members of the Commission can do it many times). Now there is no certainty – will this law be fully adopted and will it start to work or not. In January 2017, the law on the biomedical materials has entered into the force, but it is not actually in use, because the implementing regulations have been not adopted. 

During two and a half years, there have been not constructed any production sites for manufacturing of the biomedical cell products, and as a result, there is few or no such products appeared, - Professor of Ural State Medical Academy Oleg Makeev tells. 

However, work on the regulatory frameworks goes on, Alexander Petrov assures. Moreover, the legislative establishment continues to work over the laws in several directions: both on the medicines registration issue, as well as making this field more attractive for business.

Chemists, in their turn, hope that the improvement of regulatory frameworks and development of the research centers will help to reduce the period between the molecule appearance and the serial production of pharmaceutical products. However, currently, it takes not years, but decades in the Russian Federation. For example, Ural researchers’ development result – one of those medicines, which in all cases should be in the first aid kits of military personnel, - has been getting to the pharmacy for almost 40 years.

Photo: Tatiana Andreeva / RG

Source: pharmapractice.ru