Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation
To ensure the safety and to secure the approval of injectable medicinal products based on antigen-specific immunoglobulins of animal origin, it is necessary to exclude their contamination with adventitious human pathogens. Ensuring the viral safety of heterologous immunoglobulins presents a major ch...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2022-07-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
| Subjects: | |
| Online Access: | https://www.biopreparations.ru/jour/article/view/385 |
| _version_ | 1797244526521221120 |
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| author | V. V. Mashin A. N. Sergeev N. N. Martynova T. V. Antipina E. I. Sakanyan V. V. Kataeva N. V. Zagidullin |
| author_facet | V. V. Mashin A. N. Sergeev N. N. Martynova T. V. Antipina E. I. Sakanyan V. V. Kataeva N. V. Zagidullin |
| author_sort | V. V. Mashin |
| collection | DOAJ |
| description | To ensure the safety and to secure the approval of injectable medicinal products based on antigen-specific immunoglobulins of animal origin, it is necessary to exclude their contamination with adventitious human pathogens. Ensuring the viral safety of heterologous immunoglobulins presents a major challenge, because the State Pharmacopoeia of the Russian Federation, 14 edition, lacks production stage-specific viral safety requirements for such medicinal products. The aim of the study was to analyse the requirements set forth in general and individual monographs of the State Pharmacopoeia of the Russian Federation, the European Pharmacopoeia, (10th edition), the British Pharmacopoeia (2019), the United States Pharmacopoeia (USP 43–NF 38), the Japanese Pharmacopoeia (17th edition), as well as the recommendations of the European Medicines Agency and the World Health Organisation concerning the viral safety of medicinal products for human use based on heterologous antigen-specific immunoglobulins. The authors analysed regulatory requirements for the following: serum/plasma-producing animals; immunisation antigens for the animals; quarantine of the animals; viral contamination tests for immune animal serum/plasma pools; model viruses to validate viral inactivation/removal processes at different stages of vaccine production; viral load reduction at each inactivation/ removal step; testing of materials obtained at critical production stages. The authors drafted sections for quality standards on production stage-specific measures to minimise the viral contamination risk of medicinal products for human use based on heterologous immunoglobulins, which they proposed for inclusion to the State Pharmacopoeia of the Russian Federation. |
| first_indexed | 2024-03-08T21:43:34Z |
| format | Article |
| id | doaj.art-f2096a613d76412da147fb6e6c3a7d3c |
| institution | Directory Open Access Journal |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| last_indexed | 2024-04-24T19:12:25Z |
| publishDate | 2022-07-01 |
| 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-f2096a613d76412da147fb6e6c3a7d3c2024-03-26T09:10:53ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562022-07-0122211212310.30895/2221-996X-2022-22-2-112-123275Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian FederationV. V. Mashin0A. N. Sergeev1N. N. Martynova2T. V. Antipina3E. I. Sakanyan4V. V. Kataeva5N. V. Zagidullin6Scientific and Production Association for Immunological Preparations “Microgen”Scientific and Production Association for Immunological Preparations “Microgen”Scientific and Production Association for Immunological Preparations “Microgen”Scientific and Production Association for Immunological Preparations “Microgen”Scientific and Production Association for Immunological Preparations “Microgen”Scientific and Production Association for Immunological Preparations “Microgen”Scientific and Production Association for Immunological Preparations “Microgen”To ensure the safety and to secure the approval of injectable medicinal products based on antigen-specific immunoglobulins of animal origin, it is necessary to exclude their contamination with adventitious human pathogens. Ensuring the viral safety of heterologous immunoglobulins presents a major challenge, because the State Pharmacopoeia of the Russian Federation, 14 edition, lacks production stage-specific viral safety requirements for such medicinal products. The aim of the study was to analyse the requirements set forth in general and individual monographs of the State Pharmacopoeia of the Russian Federation, the European Pharmacopoeia, (10th edition), the British Pharmacopoeia (2019), the United States Pharmacopoeia (USP 43–NF 38), the Japanese Pharmacopoeia (17th edition), as well as the recommendations of the European Medicines Agency and the World Health Organisation concerning the viral safety of medicinal products for human use based on heterologous antigen-specific immunoglobulins. The authors analysed regulatory requirements for the following: serum/plasma-producing animals; immunisation antigens for the animals; quarantine of the animals; viral contamination tests for immune animal serum/plasma pools; model viruses to validate viral inactivation/removal processes at different stages of vaccine production; viral load reduction at each inactivation/ removal step; testing of materials obtained at critical production stages. The authors drafted sections for quality standards on production stage-specific measures to minimise the viral contamination risk of medicinal products for human use based on heterologous immunoglobulins, which they proposed for inclusion to the State Pharmacopoeia of the Russian Federation.https://www.biopreparations.ru/jour/article/view/385heterologous sеrumheterologous immunoglobulinviral contaminationstate pharmacopoeia of the russian federationeuropean pharmacopoeiaunited states pharmacopeiabritish pharmacopoeiajapanese pharmacopoeiaeuropean medicines agencyworld health organisation |
| spellingShingle | V. V. Mashin A. N. Sergeev N. N. Martynova T. V. Antipina E. I. Sakanyan V. V. Kataeva N. V. Zagidullin Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation Биопрепараты: Профилактика, диагностика, лечение heterologous sеrum heterologous immunoglobulin viral contamination state pharmacopoeia of the russian federation european pharmacopoeia united states pharmacopeia british pharmacopoeia japanese pharmacopoeia european medicines agency world health organisation |
| title | Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation |
| title_full | Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation |
| title_fullStr | Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation |
| title_full_unstemmed | Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation |
| title_short | Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation |
| title_sort | minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the state pharmacopoeia of the russian federation |
| topic | heterologous sеrum heterologous immunoglobulin viral contamination state pharmacopoeia of the russian federation european pharmacopoeia united states pharmacopeia british pharmacopoeia japanese pharmacopoeia european medicines agency world health organisation |
| url | https://www.biopreparations.ru/jour/article/view/385 |
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