Head of the division- Evgeniy M. Golubev
The Experimental Production Division of Advanced Plasma Processing has been developing and manufacturing medicines for about 30 years, the raw material for which is human blood plasma. The beginning of our division is based on a decree of the government of the Russian Federation from the 24th of May 1995, on the allocation of funds to the Hematological Research Center for the purchase of instruments and equipment for the Laboratory of Blood Processing. The purpose of the laboratory was the development and production of domestic drugs for the treatment of hemophilia A and hemophilia B.
The most important role in the creation of the division was played by the Director of the Hematological Scientific Center of the Russian Academy of Medical Sciences, Academician A.I. Vorobyov, the Director of the Institute of Blood Transfusion of the Hematological Scientific Center of the Russian Academy of Medical Sciences M.A. Azhigirova, and researchers of the Hematological Scientific Center A.L. Berkovsky and T.L. Dereza.
In 2000, “clean rooms” for processing blood plasma and obtaining ready-made dosage forms were put into operation, and the first domestic chromatographically purified blood coagulation factors VIII and IX were obtained. At the beginning of the division’s operation, the volume of plasma processed per production cycle was 30 liters. Currently, a single plasma load for processing is 360 liters.
In 2003, the division received a license for the production of blood products. In 2002, the registration certificate for the drug “Agemfil B, 250 IU” was obtained, and in 2006, the registration certificate for the drug “Agemfil A, 250 IU”, used for the treatment of hemophilia B and hemophilia A, respectively.
In 2021, a certificate of compliance of the production site with the requirements of the rules of good manufacturing practice of the Eurasian Economic Union (GMP certificate) was obtained for the first time.
In 2023, additional dosages of Agemfil A (500 IU and 1000 IU) were added to the state register of medicines.
The division has developed a technology for the production of Fibrinogen, Thrombin, PPSB drugs (a drug similar to “FEIBA®”), Albumin and human normal Immunoglobulin. The Albumin and Immunoglobulin drugs are at the stage of preclinical trials.
Based on the research work in our division, a number of dissertations have been defended.
All responsible personnel of the division regularly undergo advanced training at the Department of Industrial Pharmacy at the I. M. Sechenov First Moscow State Medical University (Sechenov University).
The division is actively involved in the development of new medicines with strict adherence to the requirements of good manufacturing practice (GMP) for working in “clean” pharmaceutical production facilities. The employees of the division have compiled a number of production protocols and standard operating procedures (SOP) to ensure strict compliance with GMP requirements.
The Experimental Production Division of Advanced Plasma Processing of the NMRC for Hematology (hereinafter referred to as the Center) is the first Russian manufacturer of blood clotting factors from human blood plasma. The entire volume of the drug produced is used to meet the needs of the Center.
Thawing of plasma for fractionation
Site No. 1 — Plasma loading into the fractionation reactor
Plasma purification Site No. 2. Preparation of Cryoprecipitate for dilution and enrichment
Site of sterile filling of the drug solution into vials
Head of the Equipment and Instrumentation Operation Area, maintenance of the freeze-drying apparatus
Site No.3. Unloading of the finished medicinal product from the freeze-drying apparatus
Site No. 3. The finished product, Agemfil A, before labeling and packaging
Head of Site No. 3
Quality Control Laboratory. Determination of the content of substances by high-performance liquid chromatography
Quality Control Laboratory. The spectrophotometric method of protein measurement
