Affiliation:
1. Scientific Centre for Expert Evaluation of Medicinal Products
Abstract
The evaluation of anticomplementary activity, being an obligatory component of the quality control ofhuman immunoglobulin preparations, requires the use of a number of reagents of biological origin that are difficult to standardise. In order to standardise the quality control method used for determination of antiсomplementary activity it is advisable to use a reference standard which demonstrates whether obtained results comply with the acceptance criteria, and helps to assess the stability of analytical performance. The aim of the study was to assess the stability of analytical performance of the test procedure used for determination of antiсomplementary activity of human immunoglobulin preparations using human immunoglobulin reference standards of various grades. Materials and methods: anticomplementary activity was determined by the complement fixation test in accordance with the general monograph of the State Pharmacopoeia of the Russian Federation (14th ed.) OFS.1.8.2.0007.15 using different batches of guinea pig complement and sheep red blood cells. The test procedure was standardised using the OSO 42-28-430-2018 human immunoglobulin reference standard and the human immunoglobulin BRP, batch 1 (cat. No. Y0001504). The obtained results of anticomplementary activity of the reference standards were used to construct Shewhart control charts, using the certified values as control limits. Results: the analysis of the constructed Shewhart charts helped to assess trends, and estimate the influence of different batches of guinea pig complement and sheep red blood cells on the stability of analytical performance of the test procedure used for determination of antiсomplementary activity of human immunoglobulin preparations. Conclusions: the use of the OSO 42-28-430-2018 reference standard in combination with Shewhart control charts for the quality control of human immunoglobulin preparations in terms of Anticomplementary activity makes it possible to control the testing process, and assess any of its changes associated with the replacement of the batch of the reagent. At the same time, the reference standard of the European Pharmacopoeia, which has a wide range of permissible values, can only be used to confirm the acceptance of the results. Further studies to determine the mean value of the anticomplementary activity of control samples, as well as the standard deviation, may increase the possibilities of using this reference standard for assessment of analytical performance stability.
Subject
General Earth and Planetary Sciences,General Environmental Science
Reference4 articles.
1. Buchacher A, Schluga P, Müllner J, Schreiner M, Kannicht C, Weinberger J. Anticomplementary activity of IVIG concentrates – important assay parameters and impact of IgG polymers. Vox Sang. 2010;98(3 Pt 1):209–18. https://doi.org/10.1111/j.1423-0410.2009.01271.x
2. Avertchenkov VM, Palagin IS. Intravenous immunoglobulins: mechanisms of action and possible clinical applications. Klinicheskaya mikrobiologiya i antimikrobnaya khimioterapiya = Clinical Microbiology and Antimicrobial Chemotherapy. 2004;6(3):273–81(In Russ.)
3. Krivykh MA, Kornilova OG, Bunyatyan ND, Kudasheva EYu. Development of pharmacopoeial methods for determining the anticomplementary activity of human immunoglobulin preparations. Khimiko-farmatsevticheskii zhurnal = Pharmaceutical Chemistry Journal. 2016;50(5):47–9 (In Russ.) https://doi.org/10.30906/0023-1134-2016-50-5-47-49
4. Krivykh MA, Kornilova OG, Kudasheva EYu. Method for producing positive control standard sample of human immunoglobulin to determine anticomplementary activity of preparations of human immunoglobulin, and standard sample of human immunoglobulin to determine anticomplementary activity of preparations of human immunoglobulin. Patent of the Russian Federation No. 2577703; 2016 (In Russ.)