HARMONIZATION OF REQUIREMENTS FOR THE SPECIFIC SAFETY OF HUMAN IMMUNOGLOBULIN PREPARATIONS WITH THE WORLD QUALITY STANDARDS

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DOI: https://doi.org/None
Issue: 
2
Year: 
2015

O.G. Kornilova, MD; M.A. Krivykh; E.Yu. Kudasheva, MD; Professor N.D. Bunyatyan, PhD; E.V. Lebedinskaya, PhD; A.V. Nechaev; E.V. Paramonova; Professor A.N. Mironov, MD Research Center for Examination of Medical Products, Ministry of Health of Russia, Moscow

Human immunoglobulin preparations are an integral part of therapy for immunodeficiencies and autoimmune diseases. In addition, they are used to prevent and treat viral and bacterial infections. Most treatment regimens involve the repeated administration of large-dose immunoglobulins. To activate the complement system to form anaphylatoxins, to activate the kallikrein-kinin, plasmin systems and the blood coagulation system, to change blood rheological properties, and to initiate intravascular hemolysis are an incomplete list of adverse effects that may be provoked by blood preparation infusions. High requirements for the specific safety associated with the effect of human immunoglobulin preparations on the hemostatic system are made to minimize possible complications due to their usage. The problems of evaluating the specific safety of human immunoglobulin preparations are analyzed. The paper provides an information and analytical review of the data of international experience in studying the specific safety of human immunoglobulin preparations and assesses Russian methods to determine the level of anticomplement activity. It presents principles in the harmonization of the requirements for the specific safety of human immunoglobulin preparations with the world quality standards.
Keywords: 
human immunoglobulins
specific safety
anti-A and anti-B hemagglutinins
anti-D antibodies
anticomplement activity
standard samples
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