BMCP — problems and prospects of development in Russia

In April 2019, within the framework of the IPhEB Russia exhibition, held in St. Petersburg, a thematic session “Development of biotechnological direction in the pharmaceutical industry” was held. The session was devoted to various aspects of the life cycle of biomedical cell products (BMCP) and prospects of such products entering the Russian market.

Currently, in Russia there is no registered BMCP and no factory site that has obtained a license for the production of such type of products. However, it is known that the company “Generium” is a pioneer in obtaining a license for the production of BMCP and has already launched this process. It is hoped that soon “Generium” will be able to successfully pass this path and put into production the first Russian cellular products.

However, it is worth noting that the path of the domestic BMCP to the Russian market is quite long, labor-intensive and expensive. According to the experts' realistic forecasts, BMCP can enter the market only after 9-11 years of pre-clinical (PCT) and clinical trials (CT), as well as a successful scaling up of the production process. For example, it takes about 2 years to deliver the necessary equipment for production. The personnel issue also remains unresolved. In fact, qualified personnel is the basis of any process, including biotechnological one. Currently, many companies and research centers offer training programs to improve the level of professionals in this field. Thus, the FGBU Institute of Toxicology of the FMBA conducts cycles for the organization and carrying out of PCT in accordance with good laboratory practice GLP.

Maria Zaitseva, the leading researcher of the FGBU Institute of Toxicology of the FMBA also notes that there are a large number of questions regarding the PCT for BMCP. How reasonable is the use of standard animals when it comes to the use of human cells? It is obvious that the crucial task is the development of alternative methods of PCT, such as computer modeling (in silico) and in vitro methods, as well as improvement of the legal and regulatory framework base.

According to Alexei Martynov, President of the Association of Manufacturers of BMCP, the company “X-Biocell”, together with the Institute of FMBA in Moscow, is currently developing the design of preclinical research for a biomedical cell product. The expert hopes that soon these studies can be carried out. Then there will be needed a center where the product tested in the pre-clinic can be manufactured already for the clinical trials. “Such a production center, or better several ones, should be created as soon as possible,” says Alexey Martynov. “Only after that will it be possible to develop a product for clinical trials of BMCP” [1]

To sum up, the following steps can accelerate the market entry of BMCP: improvement of the legal and regulatory framework, quality training of specialists at all stages of work, creation of associations of manufacturers and preparation of necessary infrastructure.  In addition, it will be useful to refer to foreign experience in the development and implementation of BMCP, because there are already about 30 registered drugs on the basis of cellular technologies on the world market.