The results of testing kits manufactured by Hyasen Biotech (China) for detecting residual amounts of DNA and proteins of the producer strain are presented. The study was carried out by the Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation (Moscow) in collaboration with GreenVan (Moscow). The article presents testing and validation data for the HCP1046B HEK293 HCP ELISA kit for detecting residual proteins and the HCP1044B HEK293 Residual DNA Detection Kit for detecting residual HEK293 DNA using polymerase chain reaction (PCR). Hyasen Biotech”s reagents for detecting residual proteins and DNA of the producer strain have been shown to provide reliable results for measuring impurities associated with the producer strain, and to be used for routine analysis during the production and release of pharmaceuticals.

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Разработка: студия Green Art