biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Productsbiopreparat-108Research ArticleОБЗОРЫREVIEWSМеждународный опыт стандартизации препаратов аллергеновInternational practice of allergen products standardizationНевскаяЛ. В.NevskayaL. V.

Главный эксперт лаборатории иммунологии Испытательного центра экспертизы качества МИБП, канд. биол. наук

Chief expert of the Immunology Laboratory of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences

Nevskaya@expmed.ruЛавренчикЕ. И.LavrenchikE. I.

Ведущий эксперт управления экспертизы аллергенов, цитокинов и других иммуномодуляторов Испытательного центра экспертизы качества МИБП, канд. мед. наук

Leading expert of Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences

noemail@neicon.ruЖдановаМ. Ю.ZhdanovaM. Yu.

Эксперт 1 категории лаборатории иммунологии Испытательного центра экспертизы качества МИБП

1st professional category expert of the Immunology Laboratory of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality

noemail@neicon.ruФадейкинаО. В.FadeykinaO. V.

Главный технолог Испытательного центра экспертизы качества МИБП, канд. биол. наук

Chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences

noemail@neicon.ruКапитановаВ. К.KapitanovaV. K.

Эксперт 2 категории лаборатории иммунологии Испытательного центра экспертизы качества МИБП

2nd professional category expert of the Immunology Laboratory of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality

noemail@neicon.ruНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation201720022018174222229Copyright © Невская Л.В., Лавренчик Е.И., Жданова М.Ю., Фадейкина О.В., Капитанова В.К., 20182018Невская Л.В., Лавренчик Е.И., Жданова М.Ю., Фадейкина О.В., Капитанова В.К.Nevskaya L.V., Lavrenchik E.I., Zhdanova M.Y., Fadeykina O.V., Kapitanova V.K.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/108

Показано, что безопасное и эффективное применение препаратов аллергенов, используемых в диагностике и терапии аллергических заболеваний, зависит от стандартизации и методов контроля их качества. В статье рассмотрены различные подходы к стандартизации препаратов аллергенов, применяемые в США, Евросоюзе и России. Неоднородность исходного сырья, используемого при производстве природных препаратов аллергенов, необходимо учитывать при формировании требований для их стандартизации, поскольку экстракты нативных аллергенов представляют собой сложный белково-полисахаридный комплекс, состоящий из аллергенных (главных и второстепенных) и неаллергенных компонентов. Для стандартизации методов оценки активности препаратов аллергенов используют стандартные образцы. На сегодняшний день в стандартизации аллергенов существуют несколько подходов - в США внедряется система национальных стандартных образцов, биологическая активность которых определена одной методикой (метод внутрикожных разведений - ID50EAL), в Европе каждая фирма-производитель создает собственные внутренние стандарты (IHRS) со своими единицами активности. Препараты, выпускаемые в Российской Федерации, стандартизированы в единицах белкового азота.

The article demonstrates that safe and efficacious use of allergen products for detection and treatment of allergic diseases relies on standardization and quality control methods. The article summarises various approaches to allergen products standardization that are used in the United States, the European Union and the Russian Federation. Development of requirements for allergen products of natural origin must take account of the heterogeneity of raw materials used in their production, since native allergen extracts are complex protein-polysaccharide mixtures consisting of allergenic (primary and secondary) and non-allergenic components. Standardization of methods used for evaluation of allergen products potency is performed using reference standards. To date, there exist several approaches to allergens standardization. The United States introduced a system of national reference standards whose biological activity is determined by one technique (IntraDermal Dilution for 50 mm sum of Erythema determines bioequivalent Allergy Units - ID50EAL). In Europe each manufacturer establishes their own in-house reference standards (IHRS) and assigns them with units of activity. Products manufactured in the Russian Federation are standardized in protein nitrogen units (PNU).

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The authors declare that there are no conflicts of interest present.