METHODOLOGICAL APPROACHES TO DEVELOPING AND CERTIFYING A STANDARD HUMAN IMMUNOGLOBULIN SAMPLE TO DETERMINE ANTICOMPLEMENTARY ACTIVITY

Introduction. The need to use standardized procedures for determining the specific safety of human immunoglobulin infusion formulations is due to the variability of critical parameters related to the use of biological reagents. Therefore, the problems with the development and certifying tests of standard samples are of particular relevance. Objective: to analyze methodological approaches to developing and certifying a standard sample to determine the anticomplementary activity of human immunoglobulin preparations. Material and methods. Standard samples of human immunoglobulin (foreign [Biological Reference Preparation (BRP) approved by the European Directorate for the Quality of Medicines and Healthcare (France)] and Russian batches) were used. Methods for systematic analysis and document examination were applied. Anticomplementary activity was determined by a method based on the ability of human immunoglobulins to bind complement, by preventing the lysis of sensitized sheep red blood cells in the complement binding reaction. Results. Comparative analysis and generalization of the experience in developing and certifying Russian and foreign standard human immunoglobulin samples for determining anticomplementary activity revealed the distinctive features of the Russian standard one. They lie in the two-component pattern and the presence of certified anticomplementary activity values for positive and negative controls, expressed as (Xmean±2Sx) with a 0.95 confidence interval, which makes it possible to use of this standard sample for confirming the stability of an analytical procedure and to evaluate possible trends to change the testing process. The advantage of the foreign standard sample of human immunoglobulin (BRP) is that several laboratories can be attracted to participate in certifying tests. Conclusion. Two approaches were identified in the methodology for the development and certifying tests of a standard human immunoglobulin sample to determine anticomplementary activity, and can also be used by the manufacturers of human immunoglobulin infusion formulations to develop and certify standard samples of their enterprise.

human immunoglobulin, anticomplementary activity, specific safety, standard samples