Review of methodological approaches to quality evaluation of recombinant interferon products

Abstract

The article summarises methods used to control the quality of recombinant interferon alpha and beta (IFNs) products. It demonstrates that currently used methodological approaches generally ensure proper quality control of this group of medicines. However, it is necessary to formulate basic requirements for the pharmacopoeial general chapters on interferon alpha-2 and beta-1 products in order to standardize the control procedures and increase the efficacy and safety of recombinant IFNs products. These requirements should be harmonized with requirements of both the European Pharmacopeia and pharmacopoeias of the Eurasian Economic Union member-states, and should take account of the current trends in the Russian pharmaceutical industry.

Keywords

• интерферон рекомбинантный
• субстанция
• оценка качества
• метод определения
• пегилированные формы
• recombinant interferon
• substance
• quality control
• test methods
• pegylated forms