Human anti-D immunoglobulin preparations: potency standardisation milestones
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 ingred...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2022-10-01
|
| Series: | Биопрепараты: Профилактика, диагностика, лечение |
| Subjects: | |
| Online Access: | https://www.biopreparations.ru/jour/article/view/410 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849342769783373824 |
|---|---|
| author | N. S. Vildanova E. S. Kormshchikova E. N. Kalinina K. A. Vorobiev I. V. Paramonov E. Yu. Kudasheva |
| author_facet | N. S. Vildanova E. S. Kormshchikova E. N. Kalinina K. A. Vorobiev I. V. Paramonov E. Yu. Kudasheva |
| author_sort | N. S. Vildanova |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-ad41b18bdf4c4eabbbc6794bb26da924 |
| institution | Kabale University |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| publishDate | 2022-10-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj-art-ad41b18bdf4c4eabbbc6794bb26da9242025-08-20T03:43:15ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562022-10-0122324124810.30895/2221-996X-2022-22-3-241-248288Human anti-D immunoglobulin preparations: potency standardisation milestonesN. S. Vildanova0E. S. Kormshchikova1E. N. Kalinina2K. A. Vorobiev3I. V. Paramonov4E. Yu. Kudasheva5Kirov Research Institute of Hematology and Blood TransfusionKirov Research Institute of Hematology and Blood TransfusionKirov Research Institute of Hematology and Blood TransfusionKirov Research Institute of Hematology and Blood TransfusionKirov Research Institute of Hematology and Blood TransfusionScientific Centre for Expert Evaluation of Medicinal ProductsHuman 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.https://www.biopreparations.ru/jour/article/view/410human anti-d immunoglobulinpotencyreference standardinternational standardreference standard development and certification |
| spellingShingle | N. S. Vildanova E. S. Kormshchikova E. N. Kalinina K. A. Vorobiev I. V. Paramonov E. Yu. Kudasheva Human anti-D immunoglobulin preparations: potency standardisation milestones Биопрепараты: Профилактика, диагностика, лечение human anti-d immunoglobulin potency reference standard international standard reference standard development and certification |
| title | Human anti-D immunoglobulin preparations: potency standardisation milestones |
| title_full | Human anti-D immunoglobulin preparations: potency standardisation milestones |
| title_fullStr | Human anti-D immunoglobulin preparations: potency standardisation milestones |
| title_full_unstemmed | Human anti-D immunoglobulin preparations: potency standardisation milestones |
| title_short | Human anti-D immunoglobulin preparations: potency standardisation milestones |
| title_sort | human anti d immunoglobulin preparations potency standardisation milestones |
| topic | human anti-d immunoglobulin potency reference standard international standard reference standard development and certification |
| url | https://www.biopreparations.ru/jour/article/view/410 |
| work_keys_str_mv | AT nsvildanova humanantidimmunoglobulinpreparationspotencystandardisationmilestones AT eskormshchikova humanantidimmunoglobulinpreparationspotencystandardisationmilestones AT enkalinina humanantidimmunoglobulinpreparationspotencystandardisationmilestones AT kavorobiev humanantidimmunoglobulinpreparationspotencystandardisationmilestones AT ivparamonov humanantidimmunoglobulinpreparationspotencystandardisationmilestones AT eyukudasheva humanantidimmunoglobulinpreparationspotencystandardisationmilestones |