Biomedical cell products – what’s new?

Federal Law No. 180 “On Biomedical Cell Products” is still in force in Russia. However, since 2016, registered products have not yet appeared on the market. In this article, we will try to figure out if there is any news in this area.

Two years ago, the Russian full-cycle research and production company Generium received the first license for the production of BMCP, but the company’s products have not been approved yet.

Not so long ago, another license for the production of autologous BMCPs in the Russian Federation was issued by Roszdravnadzor. It was received by the Burnazyan Center.

Federal State Budgetary Institution “State Scientific Center of the Russian Federation – Federal Medical Biophysical Center named after A.I. Burnazyan” is engaged in the manufacture of autologous BMCPs. In the future, the research center also plans to produce allogeneic and combined BMCPs. The Center for Biomedical and Additive Technologies has been actively working in the field of regenerative medicine for a long time and is developing unique technologies for the restoration of various damages to the skin and its appendages (with burns of various etiologies, trophic ulcers, postoperative scars and age-related changes), damaged tissues, ligaments and articular cartilage (with tears, fractures, osteoarthritis, and other conditions).

The Center conducts research on the creation of artificial organs and tissues using additive technologies (including a 3D bioprinter), tissue engineering structures with their subsequent introduction into clinical practice. Methods for obtaining a cell-free matrix for the subsequent reconstruction of tissue defects are being developed and tested.

In addition to the Burnazyan Center, from the fall of 2022, the Akrus BioMed pharmaceutical company plans to produce BMCP. It is planned to produce up to 70 thousand BMCPs per year at the facilities of the enterprise, which are used to treat long-term non-healing wounds, ulcers and extensive burns. In the future, the company’s products are planned to be supplied to Moscow clinics, burn centers and disaster medicine centers.

However, it should be noted that Akrus BioMed has not yet received a license from Roszdravnadzor for the production of BMCP. So far, only the Generium company and the Burnazyan Center have received licenses.