3 . 2020

Methods for evaluating the specifi c activity of preparations of human antirhesus Rho(D): current status of the problem

Abstract

Preparations of immunoglobulin human antirhesus Rh_o(D) are unique means of specific perinatal prevention of Rh-immunization of women with Rh-negative blood affiliation. The pharmacological effect of the drugs is realized by means of antirhesus Rh_o(D) IgG antibodies (Ab) (anti-D-Ab) that can neutralize Rh-positive fetal red blood cells that have entered the mother’s bloodstream. The choice of a method for evaluating the specific activity (content of anti-D-Ab) in human immunoglobulin preparations plays a key role in ensuring their potential therapeutic effectiveness. Methods of automatic continuous analysis of hemagglutination, enzyme-linked immunoassay and flow cytofluorimetry are used in the world practice to assess the specific activity of human immunoglobulin antirhesus Rh_o(D), whereas in our country these methods are not implemented in domestic immunobiological drug production. This research analyzes the stages of improvement of methods for evaluating specific activity, features of their reproduction, as well as advantages and disadvantages. Quantitative assessment of the content of anti-D-Ab in International units of activity or micrograms in comparison with the International standard sample of activity of immunoglobulin antirhesus by instrumental method has been established as a necessary condition for obtaining high-quality human immunoglobulin antirhesus Rh_o(D). The discussion provides the knowledge obtained at the moment, as a result, is justified a conclusion about the prospects for improving the methods for evaluating the specific activity of domestic human immunoglobulin antirhesus Rh_o(D) preparations in accordance with modern requirements for bioanalytical methods. Scopus, Web of Science, Pubmed, WHO, Global Health, elibrary, EMA, FDA, and the State Pharmacopoeia of the Russian Federation were used to search for literature.

Keywords:preparations of Immunoglobulin human antirhesus Rho(D); modern methods of quantitative assessment; specific activity; red blood cell phenotype; anti-D-antibodies

For citation: Shvedova E.V., Kudasheva E.Yu., Klimov V.I. Methods for evaluating the specific activity of preparations of human antirhesus Rh_o(D): current status of the problem. Immunologiya. 2020, 41 (3): 256-61. DOI: 10.33029/0206-4952-2020-41-3-256-261 (in Russian)

Funding. The study was carried out as part of a publicly funded research project No. 056-00003-20-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D public accounting No. AAAA-A18-118021590046-9).

Conflict of interests. The authors declare no conflict of interests.

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