Blood preparations of humans and animals in terms of their quality, efficacy and safety
The problems of quality and safety products derived from human blood plasma and hyperimmune animal sera as well as recombinant blood products resolved strict government regulation of their production processes. The risk of implications is minimized by plasma fractionation and purification of a speci...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
| Subjects: | |
| Online Access: | https://www.biopreparations.ru/jour/article/view/20 |
| _version_ | 1797244568903614464 |
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| author | M. V. Supotnitsky A. A. Elapov I. V. Borisevich E. Yu. Kudasheva V. I. Klimov E. V. Lebedinskaya L. V. Korsun E. V. Gorbunova V. G. Slobodayn V. A. Merkulov Yu. V. Olefir |
| author_facet | M. V. Supotnitsky A. A. Elapov I. V. Borisevich E. Yu. Kudasheva V. I. Klimov E. V. Lebedinskaya L. V. Korsun E. V. Gorbunova V. G. Slobodayn V. A. Merkulov Yu. V. Olefir |
| author_sort | M. V. Supotnitsky |
| collection | DOAJ |
| description | The problems of quality and safety products derived from human blood plasma and hyperimmune animal sera as well as recombinant blood products resolved strict government regulation of their production processes. The risk of implications is minimized by plasma fractionation and purification of a specific drugs from various impurities (immunoglobulin aggregates, protease, plasmin, plasminogen, prekallikrein activator, IgA and IgM etc.). Viral safety is achieved by multi-step manufacturing process that includes at least two independent methods (treatment with solvent/detergent + incubation at low pH or pasteurization, combined with polyethylene glycol processing). It was justified that for today the technological process of the development of plasma preparations and hyperimmune animal sera has reached its limit. Their further development is the most likely to refer to specific improvements. The improvements will relate to increasing the efficiency of manufacturing technologies and methods of clinical use (preparations for subcutaneous administration, combinations of different immunoglobulin preparations, etc.), viral safety, ways to eliminate component, that were previously not considered to be able to influence the outcome of clinical use (soluble molecules CD4, CD8, HLA, thrombin, trace amounts of blood clotting factors VIII, IX, X, XI, XII etc.). At the same time new genetic engineered preparations with well-characterized molecular composition and a high selectivity for target impact are expected to appear on the market because of these unsolved issues. These are recombinant blood factors with altered properties; cocktails of recombinant antibodies and Fab-fragments of IgG, highly affine for toxin epitopes, etc. Therefore, in the upcoming years it is necessary to create in Russia a new system for assessing the quality, efficacy and safety of blood products, taking into account the future course of their development. |
| first_indexed | 2024-03-08T21:44:06Z |
| format | Article |
| id | doaj.art-6648a807c76d4a3ba25057d041f10c7c |
| institution | Directory Open Access Journal |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| last_indexed | 2024-04-24T19:13:05Z |
| publishDate | 2018-02-01 |
| 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-6648a807c76d4a3ba25057d041f10c7c2024-03-26T09:10:51ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-02-0103334820Blood preparations of humans and animals in terms of their quality, efficacy and safetyM. V. Supotnitsky0A. A. Elapov1I. V. Borisevich2E. Yu. Kudasheva3V. I. Klimov4E. V. Lebedinskaya5L. V. Korsun6E. V. Gorbunova7V. G. Slobodayn8V. A. Merkulov9Yu. V. Olefir10Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииThe problems of quality and safety products derived from human blood plasma and hyperimmune animal sera as well as recombinant blood products resolved strict government regulation of their production processes. The risk of implications is minimized by plasma fractionation and purification of a specific drugs from various impurities (immunoglobulin aggregates, protease, plasmin, plasminogen, prekallikrein activator, IgA and IgM etc.). Viral safety is achieved by multi-step manufacturing process that includes at least two independent methods (treatment with solvent/detergent + incubation at low pH or pasteurization, combined with polyethylene glycol processing). It was justified that for today the technological process of the development of plasma preparations and hyperimmune animal sera has reached its limit. Their further development is the most likely to refer to specific improvements. The improvements will relate to increasing the efficiency of manufacturing technologies and methods of clinical use (preparations for subcutaneous administration, combinations of different immunoglobulin preparations, etc.), viral safety, ways to eliminate component, that were previously not considered to be able to influence the outcome of clinical use (soluble molecules CD4, CD8, HLA, thrombin, trace amounts of blood clotting factors VIII, IX, X, XI, XII etc.). At the same time new genetic engineered preparations with well-characterized molecular composition and a high selectivity for target impact are expected to appear on the market because of these unsolved issues. These are recombinant blood factors with altered properties; cocktails of recombinant antibodies and Fab-fragments of IgG, highly affine for toxin epitopes, etc. Therefore, in the upcoming years it is necessary to create in Russia a new system for assessing the quality, efficacy and safety of blood products, taking into account the future course of their development.https://www.biopreparations.ru/jour/article/view/20иммуноглобулины для внутривенного введенияfc-фрагментiggполиклональное антителомономерные iggкорьиммуноглобулины для внутримышечного примененияизоагглютинины к антигенам а, в, dвич 1вич 2вирусы гепатитов а, в и спарвовирус в19hbsagкриопреципитатсепсисвозприонintravenous immunoglobulinfc-fragmentiggpolyclonal antibodymonomeric iggmeaslesimmunoglobulins for intramuscular administrationisoagglutinins to antigens a, b, dhiv-1hiv-2hepatitis a, b and cparvovirus b19hbsagcryoprecipitatesepsiswhoprion |
| spellingShingle | M. V. Supotnitsky A. A. Elapov I. V. Borisevich E. Yu. Kudasheva V. I. Klimov E. V. Lebedinskaya L. V. Korsun E. V. Gorbunova V. G. Slobodayn V. A. Merkulov Yu. V. Olefir Blood preparations of humans and animals in terms of their quality, efficacy and safety Биопрепараты: Профилактика, диагностика, лечение иммуноглобулины для внутривенного введения fc-фрагмент igg поликлональное антитело мономерные igg корь иммуноглобулины для внутримышечного применения изоагглютинины к антигенам а, в, d вич 1 вич 2 вирусы гепатитов а, в и с парвовирус в19 hbsag криопреципитат сепсис воз прион intravenous immunoglobulin fc-fragment igg polyclonal antibody monomeric igg measles immunoglobulins for intramuscular administration isoagglutinins to antigens a, b, d hiv-1 hiv-2 hepatitis a, b and c parvovirus b19 hbsag cryoprecipitate sepsis who prion |
| title | Blood preparations of humans and animals in terms of their quality, efficacy and safety |
| title_full | Blood preparations of humans and animals in terms of their quality, efficacy and safety |
| title_fullStr | Blood preparations of humans and animals in terms of their quality, efficacy and safety |
| title_full_unstemmed | Blood preparations of humans and animals in terms of their quality, efficacy and safety |
| title_short | Blood preparations of humans and animals in terms of their quality, efficacy and safety |
| title_sort | blood preparations of humans and animals in terms of their quality efficacy and safety |
| topic | иммуноглобулины для внутривенного введения fc-фрагмент igg поликлональное антитело мономерные igg корь иммуноглобулины для внутримышечного применения изоагглютинины к антигенам а, в, d вич 1 вич 2 вирусы гепатитов а, в и с парвовирус в19 hbsag криопреципитат сепсис воз прион intravenous immunoglobulin fc-fragment igg polyclonal antibody monomeric igg measles immunoglobulins for intramuscular administration isoagglutinins to antigens a, b, d hiv-1 hiv-2 hepatitis a, b and c parvovirus b19 hbsag cryoprecipitate sepsis who prion |
| url | https://www.biopreparations.ru/jour/article/view/20 |
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