Results of studies devoted to determination of the anticomplementary activity of human immunoglobulin preparations in various formulations were presented. The optimal conditions for developing a positive control, i.e., a reference standard of human immunoglobulin that can be used for determining the anticomplementary activity, were defined. The first domestic reference sample of human immunoglobulin was developed. This standard is intended to be used for quality assessment of human immunoglobulin preparations for intravenous administration in terms of an anticomplementary activity parameter. Use of the proposed reference standard of human immunoglobulin for determination of anticomplementary activity will improve the evaluation accuracy of commercial human immunoglobulin preparations for intravenous administration.Reference standards (RS) play an important role in immunological drug (ID) quality assurance systems according to an analysis of pharmacopoeial requirements imposed on ID quality control methods. RS are widely used in practice as indicators of the certified compositions and properties of the samples [1, 2].Currently, the anticomplementary activity (ACA) of human immunoglobulin (IG) preparations is determined in international practice using RS of human immunoglobulin (RS IG) [Human Immunoglobulin (ACA and molecular size), BRP batch 1] with certified ACA values of a negative control in the range 10 -40% and of a positive control in the range 60 -100% [3,4]. The positive and negative controls confirm the reliability of the results in the different ACA ranges. The WHO recommends strongly the use of national RS, the application of which is more economically advantageous for manufacturing and quality assessment [5].The goal of the present work was to develop a RS for determining the ACA of human IG preparations.
EXPERIMENTAL PARTVarious IG formulations with protein contents >45 mg/mL in addition to samples of human IG preparations that were heat treated on a water bath (56 ± 1°C) were used to develop the RS. Ampuls were treated for 5 -7 min; vials, 15 min.
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