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

Shvedova, E.V.; Kudasheva, É. Yu.; Климов, В. И.

doi:10.33029/0206-4952-2020-41-3-256-261

Cited by 3 publications

(1 citation statement)

References 5 publications

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“…Фармакологическое действие иммуноглобулина человека антирезус Rh 0 (D) обусловлено его специфической активностью, которая количественно выражается содержанием анти-D-антител [2,3,8,17]. Эта характеристика подлежит обязательной проверке при выпуске препарата и на этапе государственной экспертизы [18][19][20].…”

Section: Introductionunclassified

Determination of quality criteria for candidate standard for anti-D immunoglobulin

Kalinina,

Vildanova,

Kormshchikova

et al. 2024

Sibirskij nauchnyj medicinskij zhurnal

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Quality control of medicines is an integral part of the technological cycle, obligatory for the release of products into public distribution. Both in Russia and abroad, when carrying out of laboratory testing of the preparations, it is prescribed to use the reference materials – the certified standard samples. Currently, it is important for the Russian pharmaceutical industry to provide the methods for evaluating the specific activity of human anti-D immunoglobulin with a national standard sample. Its production is impossible without the production of stabilized concentrate of anti-D antibodies and verifying the suitability of each batch for sale. This requires the establishment of specification requirements and the development of regulatory documentation.Aim is to define the quality criteria for candidate standard for anti-D immunoglobulin.Material and methods. The national and foreign normative bases in the field of quality control of blood products, manufacturing and application of biological standards of medicines were analyzed. Three series of lyophilized concentrate of anti-D antibodies were obtained and a laboratory-experimental study of their properties was carried out.Results and discussion. As a result of the work done, technical specifications were approved, including a list of consumer characteristics, a description of the methods for their assessment and relevant norms.Conclusions. The established requirements can become the basis for the releasing quality control of the candidate standard for anti-D immunoglobulin during its serial production.

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Section: Introductionunclassified

Determination of quality criteria for candidate standard for anti-D immunoglobulin

Kalinina,

Vildanova,

Kormshchikova

et al. 2024

Sibirskij nauchnyj medicinskij zhurnal

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Human anti-D immunoglobulin preparations: potency standardisation milestones

Vildanova

Kormshchikova

Kalinina

et al. 2022

Biological Products. Prevention, Diagnosis, Treatment

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Human anti-D immunoglobulin preparations derived from human immune plasma are much needed and highly effective for specific anti-D prevention of perinatal complications and treatment of primary immune thrombocytopenia. The effectiveness of immune suppression is a direct function of the active ingredient dose received with the medicinal product. To improve the accuracy of anti-D antibody quantification, it is recommended to use certified reference materials with values assigned in international units (IUs). The aim of this study was to analyse the main stages in the development of the international standards (ISs) for human anti-D immunoglobulin potency testing and to substantiate the need for a national standard for anti-Rho(anti-D) antibody quantification. The article describes the creation of the first and subsequent ISs, the procedure for establishing the IU equivalent for the anti-Rho(anti-D) antibody concentration, the characteristics of the raw materials and preparations used, and the anti-Rho(anti-D) antibody assay methods applied to certify the ISs. According to the study conclusions, it is necessary to develop and certify a national standard for the content of anti-Rho(anti-D) antibodies that will meet the requirements of the corresponding Russian regulations.

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Development of acceptance criteria for the results of anti-D IgG quantification in human anti-D (Rh<sub>о</sub>) immunoglobulin preparations by enzyme immunoassay

Shvedova¹,

Leshina²,

Kudasheva³

et al. 2022

Biological Products. Prevention, Diagnosis, Treatment

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The competitive enzyme-linked immunosorbent assay (ELISA) used for the quantification of specific antibodies, anti-D (Rho) IgGs, in human anti-D (Rho) immunoglobulin preparations relies upon the competition between anti-D antibodies in the preparation and anti-D monoclonal antibodies (mAbs) for immunochemical binding to D-antigen epitopes of the immunosorbent, human erythrocytes of the ccDEE phenotype immobilised on a solid support. The immunosorbent is prepared in-house under laboratory conditions. The certification of the International Standard (IS) for anti-D immunoglobulin included attempts to use the CCDee phenotype, which is more common (16.01%) than the ccDEE phenotype (2.16%). It is possible to use the CCDee phenotype, as long as the user adheres to the acceptance criteria for the results, developed during method validation. The aim of this study was to develop the acceptance criteria for the results of anti-D IgG quantification in human anti-D immunoglobulin preparations by the ELISA method that would allow using CCDee erythrocytes to prepare the immunosorbent should there be no erythrocytes of the ccDEE phenotype available. Materials and methods: the study used human anti-D immunoglobulin preparations; anti-D IgG–spiked samples; the IS for anti-D immunoglobulin; the reference standard (RS) for anti-D IgG–free immunoglobulin; anti-D mAbs; and erythrocytes of the CCDee, ccDEE, and ccddee phenotypes. The authors quantified anti-D IgG antibodies by the competitive ELISA. The statistical analysis used parametric and nonpar ametric tests. Results: the study demonstrated the possibility of using CCDee erythrocytes for competitive immunochemical binding with anti-D mAbs and anti-D IgG of various human anti-D immunoglobulin preparations. The suitability of the analytical procedure with the CCDee phenotype was confirmed by validation parameters: trueness, intermediate precision, linearity, selectivity, specificity, and robustness of the method and comparability of the results obtained when using the CCDee and ccDEE phenotypes. The authors developed the acceptance criteria: the relative values of anti-D IgG content in the test sample should range within ±20% of the nominal value; the coefficient of determination (R2) should be at least 0.9; the relative standard deviation (RSD, %) of three absorbance values for each concentration should not exceed 20%. Conclusions: these acceptance criteria guarantee the reliability of assay results of anti-D IgG quantification by the ELISA, which allows them to be used by specialists of control and analytical laboratories to assess the quality of human anti-D immunoglobulin preparations.

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

Abstract: NOTE: This document has been prepared for the purpose of inviting comments and suggestions on the proposals contained therein, which will then be considered by the Expert Committee on Biological Standardization (ECBS). Comments MUST be received by

Cited by 3 publications

References 5 publications

Determination of quality criteria for candidate standard for anti-D immunoglobulin

Determination of quality criteria for candidate standard for anti-D immunoglobulin

Human anti-D immunoglobulin preparations: potency standardisation milestones

Development of acceptance criteria for the results of anti-D IgG quantification in human anti-D (Rh<sub>о</sub>) immunoglobulin preparations by enzyme immunoassay

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