Head of the testing laboratory- Doctor of Biological Sciences, Professor, Laureate of the State Prize of the Russian Federation, Alexander V. Karyakin .
By Order of the Ministry of Health of the USSR, No. 721, dated 31 December 1964, a special state control service was established for the quality of blood products and blood substitutes produced by industrial enterprises and blood service institutions, which included the Central Laboratory for State Control and Study of the Quality of Blood Products and Blood Substitutes of the Central Order Lenin Institute of Hematology and Blood Transfusion of the Ministry of Health of the USSR.
The first head and organizer of the Central Laboratory was Doctor of Medical Sciences, Professor Lyudmila N. Pushkar, a participant in the Great Patriotic War, holder of many orders and medals, author of a number of inventions and many fundamental documents of the country's blood service.
From 1992 to 2005, the head of the laboratory was Doctor of Chemical Sciences, Professor Valery Petrovich Panov, Chairman of the Commission on Blood Products, Blood Substitutes and Preservative Solutions of the State Pharmacopoeial Committee.
As part of the Central Laboratory of State Control in the 80-90s, there were groups for the physical and chemical analysis of blood products, the physical and chemical analysis of blood substitutes, and specialists from other departments of the institute who were also involved in biological tests and microbiological studies.
In 1994, on the instructions of the Ministry of Health of the Russian Federation, a Commission for standardization of regulatory documentation in the field of circulation of transfusion and infusion therapy was established at the Central Laboratory of the State Control, including groups of experts - leading specialists. The Commission carried out the examination of draft regulatory and regulatory-technical documentation upon its approval (pharmacopoeia articles, technological instructions, pilot, start-up and industrial regulations for the production of blood products, blood substitutes and preservative solutions, instructions for the medical use of transfusion and infusion therapy, technical specifications, industry standards for medical devices and medical equipment, used in the blood service).
In order to strengthen control over the viral safety of drugs and blood components, at the initiative of the Central Laboratory of State Control, by joint Order No. 262/67 of the Ministry of Health of the Russian Federation and the Russian Academy of Medical Sciences in 1997, as an integral part of the control and licensing system for ensuring the quality, effectiveness and safety of medicines, the Central Laboratory of State Control of Viral Safety of Drugs and Blood Components was established at the Hematological Scientific Center. Its creator and leader was Doctor of Biological Sciences, Professor Alexander V. Karyakin.
In order to improve and ensure the independence of the system of state control of transfusion and infusion therapy drugs in accordance with the Law of the Russian Federation "On Medicines" in 2001, the Division of State Control and Study of the Quality, effectiveness, Safety of Transfusion and Infusion Therapy Drugs was established in the State Scientific Research Center of the Russian Academy of Medical Sciences, which included the Central Laboratory of State Control and Study of the Quality of Blood Products, Blood Substitutes and Preservative Solutions and the Central Laboratory for Monitoring the Viral Safety of Blood Components and Preparations.
Since 2005, the department has been headed by Professor Alexander V. Karyakin. Under his leadership, a testing laboratory was established on the basis of the department, which in 2006 received accreditation from the Federal Agency for Technical Regulation and Metrology to carry out work on confirming the conformity of medicines as a testing laboratory of the Federal State Budgetary Institution "NMRC for Hematology" of the Ministry of Health of the Russian Federation (certificate of accreditation № РОСС RU.0001.21ФЛ24). The accreditation of the testing laboratory of the department is confirmed by the Federal Accreditation Service.
In accordance with the scope of accreditation, the testing laboratory of the Division of Examination, on a contractual basis, performs work on testing blood drugs, blood substitutes, hemoconservants, recombinant proteins, drugs based on monoclonal antibodies and orphan drugs for the purpose of their introduction into civil circulation at the request of the Federal State Budgetary Institution "Information and Methodological Center for Examination, Accounting and Analysis of Circulation of Medical Products" Roszdravnadzor, regional blood transfusion stations, domestic manufacturers of medicines, representative offices of foreign companies and distributors.
The testing laboratory of the examination department is equipped with all the necessary modern equipment and highly qualified personnel to conduct analyses of medicines designated in the field of its accreditation.
Employees of the department take part in the work of the Council of the Ministry of Health of the Russian Federation on the State Pharmacopoeia and the commissions of the Pharmacopoeia Committee of the Federal State Budgetary Institution " Scientific Center for the Examination of Medical Products.” They prepared, edited and are included in the State Pharmacopoeia of the XIII edition:
- GMP.1.8.1.0001.15,18 "Medicinal products from Human Plasma"
- GMP.1.8.1.0003.15 "Human immunoglobulins"
- GMP.1.8.1.0007.18 "Viral safety of medicines from human blood plasma"
- GMP.1.8.2.0003.15,18 "Determination of blood coagulation factor activity"
- PM.3.3.2.0001.15,18 "Human plasma for fractionation"
- PM.3.3.2.0002.15 "Human coagulation factor VII"
- PM.3.3.2.0003.15 "Human coagulation factor VIII"
- PM.3.3.2.0004.15 "Human coagulation factor IX"
- PM.3.3.2.0005.15 "Von Willebrand factor"
- PM.3.3.2.0006.15,18 "Human albumin"
- PM.3.3.2.0007.15 "Normal human immunoglobulin"
- PM.3.3.2.0008.15 "Normal human immunoglobulin for intravenous administration"
The main areas of the laboratory's work:
- testing of medicines for compliance with regulatory documents
- approbation and validation of analytical techniques used for quality control of blood medicines, blood substitutes and preservative solutions; preparation and revision of their descriptions for inclusion in regulatory documents for substances and medicines
- preclinical studies of blood products and blood substitutes (general toxicological studies)
- study of stability and establishment of expiration dates of blood drugs, blood substitutes and preservative solutions
The price list for testing one series of drugs and their individual indicators.
Photo 2015: Sitting (from left to right): technician, T. O. Zemskova; senior researcher, Cand. Sci. (Biol.), L. N. Ermakova; Head of the Department, Dr. Sci. (Biol.), Professor A. V. Karyakin; leading engineer, G. M. Khromova; Head of the Laboratory for Monitoring the Viral Safety of Components and Products, Cand. Sci. (Biol.)., Associate Professor E. D. Skotselyas; engineer O. N. Charykova; laboratory assistant, A. V. Ignatieva;
Standing: researcher, L.A. Terentyeva; researcher, N.N. Panova; senior researcher, Cand. Sci. (Biol.), V. S. Ivanova; leading engineer, T. A. Grigorieva; senior laboratory assistant, N. V. Shlychkova; researcher, Y. A. Kotova; researcher, Cand. Sci. (Chem.), L. P. Grineva; senior researcher, Cand. Sci. (Chem.), T. A. Dolotova; senior researcher, Cand. Sci. (Chem.), N. E. Ivanova; researcher, G. N. Kryukova; laboratory assistant, S. S. Stepanova; senior researcher, Cand. Sci. (Chem.), E. V. Mikhailova; senior researcher, Cand. Sci. (Chem.), S. G. Beksaev; engineer, S. S. Nekhaevskaya
LABORATORY STAFF
Lyudmila N. Ermakova- leading biotechnologist, Candidate of Biological Sciences. She graduated from the Moscow Technological Institute of Food Industry with a degree in Chemical Technology of Vitamins and Enzyme Protein Preparations (1968), received the degree of Candidate of Biological Sciences in 1980 and has been working at the NMRC for Hematology since 1973. She is the author of 50 publications and 2 patents.
Valentina S. Ivanova - leading biotechnologist, Candidate of Biological Sciences. She graduated from the Moscow Technological Institute of Food Industry with a degree in Chemical Technology of Vitamins and Enzyme Protein Preparations (1974). She received the degree of Candidate of Biological Sciences in 1988 and has been working at the NMRC for Hematology since 1965. She is the author of 50 printed works and 1 copyright certificate.
Elena V. Mikhailova - leading chemist, Candidate of Chemical Sciences. She graduated from the Faculty of Chemical Technology of Polymers of the D.I. Mendeleev Russian University of Chemical Technology in 1993, with the specialty "Chemist-technologist.” In 1999 she received the degree of Candidate of Chemical Sciences. She has been working at the NMRC for Hematology since 2000 and is the author of 10 publications.
