ФГБУ «Научный центр экспертизы средств медицинского применения» Минздрава России
Публикация

Проблемы, связанные с проявлением иммуногенности лекарственных препаратов моноклональных антител при клиническом использовании

Примечания:
The clinical use of drugs monoclonal antibodies (MA) may be a manifestation of their junk immunogenicity that is the cause of a number of side effects and reduce the clinical effectiveness. The frequency and severity of immune response is influenced by factors related to the structure of MA, the presence of impurities, the peculiarities of the disease, the patient’s condition. Drugs MA with minimal presence of the amino acid sequences of the mouse origin (humanized) or their complete absence (recombinant), are less expressed antigenic activity. However, only the results of clinical studies that allow to assess the true immunogenicity of a medicinal product MA. When developing clinical research programs and follow-up of security application MA should make provision for the use of appropriate analytical procedures for determining the induced antibodies and assessment of their properties - binding or neutralizing antibodies. You must also consider the possibility of detention in the sera samples of substances affecting the results of the analysis, including the components of protein, the range of medicines, included in the accompanying therapy and other All of the above factors should be taken into account to obtain adequate results on the evaluation of the immunogenicity of medicines MA in their clinical use.
Авторы: Алпатова Н.В., Авдеева Ж.И., Солдатов А.А., Медуницын Н.В., Бондарев В.П., Миронов А.Н., Меркулов В.А.
Подразделение/организация:  ФГБУ «НЦЭСМП» Минздрава России
Дата публикации на сайте: 22.08.2017
Источники:
  • "Иммунология" 2014; 35(1): 28–32.





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