Current regulatory requirements for stability studies of biological medicinal products: a review
INTRODUCTION. The stability assessment of biological medicinal products (BMPs) requires special approaches and regulatory requirements. Therefore, BMPs require relevant national guidelines, which are an important prerequisite for the assurance of the safe and effective use of BMPs.AIM. This study ai...
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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»
2024-10-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/613 |
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| author | A. A. Soldatov A. K. Yakovlev Zh. I. Avdeeva D. V. Gorenkov A. S. Korovkin V. V. Kosenko |
| author_facet | A. A. Soldatov A. K. Yakovlev Zh. I. Avdeeva D. V. Gorenkov A. S. Korovkin V. V. Kosenko |
| author_sort | A. A. Soldatov |
| collection | DOAJ |
| description | INTRODUCTION. The stability assessment of biological medicinal products (BMPs) requires special approaches and regulatory requirements. Therefore, BMPs require relevant national guidelines, which are an important prerequisite for the assurance of the safe and effective use of BMPs.AIM. This study aimed to analyse national and international requirements for the stability assessment of BMPs in order to use the results to inform future development of a unified regulatory approach to estimating and confirming shelf-life periods for BMPs.DISCUSSION. Most biotechnological medicinal products (BTMPs) are proteins and are highly sensitive to environmental factors by nature. Therefore, the shelf life of a BTMP is established on the basis of real-time stability studies. Stability testing under accelerated and stress conditions is conducted to support shelf-life claims and to characterise the mechanism of protein structure degradation. The results of accelerated and stress studies can be used to select the most sensitive stability-indicating parameters and testing methods. National and international regulatory authorities have developed specialised guidelines for stability studies of BMPs of various origins, and the stability assessment approaches in the regulatory system of the Eurasian Economic Union (EAEU) are harmonised with international standards. Special considerations associated with the stability of vaccines imply that stability studies of vaccines should not only establish shelf life but also investigate stability after reconstitution and after short-term temperature excursions from the recommended cold-chain conditions.CONCLUSIONS. Special stability testing considerations for various groups of BMPs (including BTMPs and immunobiologicals) indicate the need to develop and improve the system of requirements for BMP stability assessment. This will facilitate the optimisation of the life cycle of BMPs in the Russian Federation and the other EAEU member states. |
| format | Article |
| id | doaj-art-a7794b50a9b84a0e9ce7418b155c8c81 |
| institution | Kabale University |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| publishDate | 2024-10-01 |
| 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-a7794b50a9b84a0e9ce7418b155c8c812025-08-20T03:59:39ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562024-10-0124333534710.30895/2221-996X-2024-24-3-335-347388Current regulatory requirements for stability studies of biological medicinal products: a reviewA. A. Soldatov0A. K. Yakovlev1Zh. I. Avdeeva2D. V. Gorenkov3A. S. Korovkin4V. V. Kosenko5Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsINTRODUCTION. The stability assessment of biological medicinal products (BMPs) requires special approaches and regulatory requirements. Therefore, BMPs require relevant national guidelines, which are an important prerequisite for the assurance of the safe and effective use of BMPs.AIM. This study aimed to analyse national and international requirements for the stability assessment of BMPs in order to use the results to inform future development of a unified regulatory approach to estimating and confirming shelf-life periods for BMPs.DISCUSSION. Most biotechnological medicinal products (BTMPs) are proteins and are highly sensitive to environmental factors by nature. Therefore, the shelf life of a BTMP is established on the basis of real-time stability studies. Stability testing under accelerated and stress conditions is conducted to support shelf-life claims and to characterise the mechanism of protein structure degradation. The results of accelerated and stress studies can be used to select the most sensitive stability-indicating parameters and testing methods. National and international regulatory authorities have developed specialised guidelines for stability studies of BMPs of various origins, and the stability assessment approaches in the regulatory system of the Eurasian Economic Union (EAEU) are harmonised with international standards. Special considerations associated with the stability of vaccines imply that stability studies of vaccines should not only establish shelf life but also investigate stability after reconstitution and after short-term temperature excursions from the recommended cold-chain conditions.CONCLUSIONS. Special stability testing considerations for various groups of BMPs (including BTMPs and immunobiologicals) indicate the need to develop and improve the system of requirements for BMP stability assessment. This will facilitate the optimisation of the life cycle of BMPs in the Russian Federation and the other EAEU member states.https://www.biopreparations.ru/jour/article/view/613biological medicinal productsbiotechnological medicinal productsstability studiesvaccine stabilityaccelerated stability studiesstability studies under stress conditionslong-term stability studiesshelf lifethermal stabilityphotostability |
| spellingShingle | A. A. Soldatov A. K. Yakovlev Zh. I. Avdeeva D. V. Gorenkov A. S. Korovkin V. V. Kosenko Current regulatory requirements for stability studies of biological medicinal products: a review Биопрепараты: Профилактика, диагностика, лечение biological medicinal products biotechnological medicinal products stability studies vaccine stability accelerated stability studies stability studies under stress conditions long-term stability studies shelf life thermal stability photostability |
| title | Current regulatory requirements for stability studies of biological medicinal products: a review |
| title_full | Current regulatory requirements for stability studies of biological medicinal products: a review |
| title_fullStr | Current regulatory requirements for stability studies of biological medicinal products: a review |
| title_full_unstemmed | Current regulatory requirements for stability studies of biological medicinal products: a review |
| title_short | Current regulatory requirements for stability studies of biological medicinal products: a review |
| title_sort | current regulatory requirements for stability studies of biological medicinal products a review |
| topic | biological medicinal products biotechnological medicinal products stability studies vaccine stability accelerated stability studies stability studies under stress conditions long-term stability studies shelf life thermal stability photostability |
| url | https://www.biopreparations.ru/jour/article/view/613 |
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