6 . 2021

Problems associated with the manifestation of immunogenicity of biotherapeutic proteins and ways to solve them

Abstract

The clinical effectiveness of the use of biotechnological medicines (therapeutic/biotherapeutic proteins) is due to the high selectivity of action on certain links in the pathogenesis of the disease due to the specificity of their interaction with a significant target antigen. However, their use is accompanied by the development of serious side effects, in some cases due to the manifestation of unwanted immunogenicity. One of the main clinical manifestations of the formation of an immune response to a medicine is the development of the patient’s non-response to the therapy. The review analyzes the mechanisms of development of primary and secondary nonresponsiveness to the medicine, approaches to elucidating the cause of the manifestations of responsiveness and choosing a strategy for further treatment of patients with this condition. A critical analysis of methodological techniques for assessing the immunogenicity of a medicinal product and detecting anti-drug antibodies (ADA) in blood serum samples from patients is presented.

Keywords:immunogenicity; antibodies to the medicine, biotechnological medicines; biotechnological (therapeutic) proteins; monoclonal antibodies; primary and secondary nonresponsiveness to the medicine; pharmacokinetics; efficacy; safety

For citation: Avdeeva Zh.I., Soldatov A.A., Bondarev V.P, Mosyagin V.D., Merkulov V.A. Problems associated with the manifestation of immunogenicity of biotherapeutic proteins and ways to solve them. Immunologiya. 2021; 42 (6): 706-19. DOI: https://doi.org/10.33029/0206-4952-2021-42-6-706-719. (in Russian)

Funding. The study was carried out at the framework of the State task of the Scientific Centre for Expert Evaluation of Medicinal Products of the MOH of Russia No. 056-00005-21-00 for the applied researches investigations (R&D State registration No. 121022000147-4).

Conflict of interests. The authors declare no conflict of interests.

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