Email this article IMMUNOGENICITY AND SAFETY OF BIOTECHNOLOGICAL MEDICINES
- Authors: Soldatov A.A.1, Avdeeva Z.I.1, Bondarev V.P.1, Merkylov V.A.1
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Affiliations:
- Scientific Centre for Expert Evaluation of Medicinal Products
- Issue: Vol 22, No 2-1 (2019)
- Pages: 557-559
- Section: ORIGINAL ARTICLES
- Submitted: 18.05.2020
- Accepted: 18.05.2020
- Published: 15.04.2019
- URL: https://rusimmun.ru/jour/article/view/215
- DOI: https://doi.org/10.31857/S102872210006972-4
- ID: 215
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Abstract
The efficacy and safety of the use of biotechnological (biotherapeutic, genetic engineering) preparations are due to their targeted mechanism of action and low of toxicity, in contrast to traditional chemicals drugs. These features of biotherapeutic preparations also aff ect their safety profile. When treating with biotherapeutic preparations, the most major adverse reaction and the first developmental time is the so-called infusion reaction. The basis of the development of the reaction to the infusion of a biotherapeutic preparation may be one of the following reactions: cytokine release syndrome (CRS), type I hypersensitivity reaction (IgE-dependent allergic reaction) or IgG-mediated reaction. These reactions have a similar clinical picture, so it is difficult to clearly determine which mechanisms led to the development of the reaction to the infusion. The mechanisms of development of the reaction to the infusion are still poorly studied.
About the authors
A. A. Soldatov
Scientific Centre for Expert Evaluation of Medicinal Products
Author for correspondence.
Email: Patosold@mail.ru
DM, Chief Expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations,
Moscow
Russian FederationZh. I. Avdeeva
Scientific Centre for Expert Evaluation of Medicinal Products
Email: fake@neicon.ru
DM, professor, Chief Expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations,
Moscow
Russian FederationV. P. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products
Email: fake@neicon.ru
DM, professor, Director of Centre of expertise of the medical immunobiological preparations quality,
Moscow
Russian FederationV. A. Merkylov
Scientific Centre for Expert Evaluation of Medicinal Products
Email: fake@neicon.ru
DM, professor, Deputy Director General for the expertise of drugs of Center for examination and control of medical immunobiological preparations,
Moscow
Russian FederationReferences
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СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).