Roszdravnadzor issued a license for the production of autologous biomedical cell products to FSBI “State Research Center of the Russian Federation – Federal Medical Biophysical Center named after A. I. Burnazian”. This is reported on the official website of the department.
“The production of autologous biomedical cell products will be a breakthrough in the treatment of patients,” the report says.
Biomedical cell products (BMCP) are new promising drugs for prevention, diagnosis and treatment of diseases (pathological conditions), preservation of pregnancy, and medical rehabilitation of patients.
An autologous biomedical cell product contains a cell line (cell lines) obtained from the biological material of a person who is to be administered the therapy.
The first license for the production of biomedical cell products in the Russian Federation was issued two years ago, in April 2020, to Generium, a Russian full-cycle company.