14.07.2025
The Experimental and Production Division of Advanced Plasma Processing, led by Evgeny Golubev, has confirmed compliance with international quality standards. The division's production site has successfully passed inspection and received the GMP certificate of the Eurasian Economic Union (EAEU).Additionally, the registration dossier for the drug “Agemfil A” (250 IU) has been brought into compliance with the requirements of the EAEU, and new dosages- 500IU and 1000IU- have been added to the state register of medicines, expanding its potential medical applications. The entire production volume of the drug is used for the needs of the NMRC for Hematology. The division is actively advancing its research and production activities. The division’s specialists have developed technologies for the production of key blood-derived medicines, including Fibrinogen, Thrombin, Prothrombin Complex, Albumin, and Normal Human Immunoglobulin. Two of these drugs, Albumin and Immunoglobulin, have already successfully completed preclinical trials.
Currently, preparations are underway to expand the division’s licensed activities and obtain approval for clinical trials, which will be a crucial step towards implementing these drugs into medical practice. Indications for the use of “Agemfil A” - treatment and prevention of bleeding in patients with classical hemophilia (hemophilia A), including during emergency or elective surgical interventions.
