For twenty years the Experimental and Production Department of Advanced Plasma Processing has been developing and manufacturing medicines, the raw material of which is human blood plasma. The beginning of our department is based on a decree of the government of the Russian Federation of May 24, 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 department is headed by Evgeniy M. Golubev (pictured left).
Tatyana I. Shirokova - Deputy Head of the Experimental and Production Department of Advanced Plasma Processing (authorized person). Graduated from the Mendeleev University of Chemical Technology (1997).
In 2010, Shirokova completed advanced training at the I.M. Sechenov First Moscow State Medical University of Higher Education in the cycle "Advanced training of specialists responsible for the production of medicines."
In 2012, she completed advanced training at the I.M. Sechenov First Moscow State Medical University in the cycle "Advanced training of specialists responsible for the quality, packaging and labeling of medicines, including Authorized persons."
In 2013, she passed training at the I.M. Sechenov Moscow State Medical University under the program, “Advanced Training of Authorized Persons” and was certified as an Authorized Person (Order of the Ministry of Health of Russia No. 134 dated 26.03.2014).
She has been working in her position since 2004.
The most important role in the creation of the department 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, the researchers of the Hematological Scientific Center of the Russian Academy of Medical Sciences: A.L. Berkovsky, T.L. Dereza, engineers: T.P. Azarovskaya, E.E. Moiseenko
In 2000, "clean" rooms for processing blood plasma and obtaining ready-made dosage forms were put into operation. In the beginning of the department’s operations, the volume of processed plasma in one production cycle was 30 liters. Currently, the one-time loading of plasma for processing is 180 liters. Over time, there was a transition from the batch method of protein isolation to chromatography. The first domestic chromatographically purified blood coagulation factors VIII, IX were obtained in this department. The drugs passed preclinical and clinical trials, and in 2003, the department received a license for the production of blood products. In 2002 the registration certificate for the drug "Agemfil B" for the treatment of hemophilia B was obtained, and in 2006, the the department received the registration certificate for the drug "Agemfil A" used for the treatment of hemophilia A.
To date, the laboratory and production facilities of the department are located on an area of 800 m 2 . It is planned to increase the volume of plasma processing up to 20 tons per year. Fibrinogen, thrombin, P.P.S.B. preparations have all been developed at the department. Albumin, immunoglobulin preparations, a preparation similar to FEIBA® are currently under development.
A number of dissertations have been defended based on the research work of our department.
Currently, the staff of the department consists of 43 people. Employees of the department have completed advanced training courses and scientific training in such educational centers such as SKIF, Moscow Medical Academy named after I.M. Sechenov, and St. Petersburg State University of Refrigeration and Food Processing Technologies.
The department strictly complies with the requirements of Good Manufacturing Practice (GMP) for working in "clean" rooms. Employees of the department have compiled a number of production protocols and standard operating procedures (SOP) contributing to strict compliance with GMP requirements.
The Experimental and Production Department of Advanced Plasma Processing of the NMRC for Hematology is the only Russian manufacturer of blood clotting factors from human blood plasma. The Department regularly supplies “Agemfil A” and “Agemfil B” drugs to the clinic of the NMRC for Hematology.
DEPARTMENT TEAM
Tatyana I. Shirokova - Deputy Head of Department (authorized person). Graduated from the Mendeleev University of Chemical Technology (1997). Certified as an authorized person by the Ministry of Health of Russia (Order No. 134 dated 26.03. 2014). She has been in this position since 2004.
Maria A. Buyanova — Head of the Quality Assurance Department
Anna S. Gurishkina — Deputy Head of the Quality Control Department
Nadezhda A. Gumaneva — Head of the Quality Control Department
Elizaveta A. Golubeva — Head of the Intrashop Laboratory.
Tamara V. Tolkacheva — Bacteriologist, Candidate of Biological Sciences
Dmitry V. Shalnev - Chief Technologist. Graduated from the Faculty of Ecology of the Mendeleev University of Chemical Technology, Department of Biotechnology (2006). He has held this position since 2008.
Zoya A. Sakharova - Technologist
Sergey A. Manuylov - Head of Workshop No. 1
Nina M. Nikitina - Head of Workshop No. 2.
Tatyana P. Azarovskaya - Head of Workshop No. 3.
Alexander A. Kornyshov - Chief Engineer
Tatyana L. Nazarova — Head of the Logistics Department
Workshop No. 1 - plasma cutting for fractionation. From left to right: head of workshop No. 1 S.A. Manuilov, head of department E.M. Golubev, engineer T.M. Akimkin
Lead engineer Elizaveta A. Safronova. Measurement of the level of bacterial endotoxins in antihemophilic preparations.
The process of chromatographic fractionation. Head of Workshop No. 2, N.M. Nikitina
Sitting: Deputy Head of the Department (authorized person) Tatyana I. Shirokova. Standing, 1st row: Chief Technologist, Dmitry V. Shalnev; Leading Engineer, Evgeny E. Moiseenko; Head of Workshop No. 2, Nina M. Nikitina; Head of the Quality Assurance Depar
Authorized person ,Tatyana I. Shirokova. Control and registration of archival samples of the finished dosage form.
Head of the Intrashop Laboratory, Nadezhda A. Gumaneva. Measurement of specific activity in the finished dosage form of the drug.
Preparation of plasma for fractionation .Head of Workshop No. 3, T.P. Azarovskaya
