Abstract
Anti-complement activity is a measure of the specific safety of human immunoglobulins characterizing one of the unwanted effect - spontaneous activation of the complement system. In compliance with the specifications of the European Pharmacopeia and WHO recommendations, the anti-complement activity of human immunoglobulin preparations must not be greater than 50%, which corresponds to a maximum of 1 CH50/mg of immunoglobulin. The measurement method was based on the ability of human immunoglobulins to produce “nonspecific” (in the absence of an antigen-antibody complex) binding of complement, preventing lysis of sensitized sheep red blood cells. We present here the results of analysis of the critical parameters of the method for measuring anti-complement activity, along with assessment of existing methodological approaches to its optimization. We report experimental studies of the effects of components of the hemolytic system and complement in guinea pigs on the results of measurements of anti-complement activity. The optimum conditions for the method of measuring the anti-complement activity of human immunoglobulins are based in evidence and the anti-complement properties of human immunoglobulin preparations for intravenous use of Russian origin are evaluated.
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