Email this article Test systems for detecting residual amounts of host cell DNA and proteins for biopharmaceutical production
- Authors: Razumikhin M.V.1, Ryabova E.I.2, Esmagambetov I.B.3, Blinov A.A.4, Karpovich O.V.1
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Affiliations:
- GreenVan
- Immunobiotechnology Laboratory, N. F. Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation
- Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation
- National Research Center for Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya of the Ministry of Health of the Russian Federation
- Issue: Vol 15, No 5 (2025)
- Pages: 362-366
- Section: Analytical Methods and Instruments
- URL: https://journals.eco-vector.com/2227-572X/article/view/695448
- DOI: https://doi.org/10.22184/2227-572X.2025.15.5.362.366
- ID: 695448
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Abstract
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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About the authors
Mikhail Vadimovich Razumikhin
GreenVan
Author for correspondence.
Email: info@green-van.ru
ORCID iD: 0000-0002-7364-5235
Director of Science
Russian Federation, 125362, Moscow, Vodnikov St., Building 2, Bldg. 16, Office 6Ekaterina Igorevna Ryabova
Immunobiotechnology Laboratory, N. F. Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation
Email: info@green-van.ru
Junior Researcher
Russian Federation, 18 Gamaleya St., Moscow, 123098Ilyas Bulatovich Esmagambetov
Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation
Email: info@green-van.ru
PhD, Leading Researcher, Head of the Laboratory of Stromal Regulation of Immunity, Areas of professional interests: molecular biology, virology, biotechnology.
Russian Federation, Gamaleya Street, Building 18, Moscow, 123098Anton Anatolevich Blinov
National Research Center for Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya of the Ministry of Health of the Russian Federation
Email: info@green-van.ru
Research Assistant, Laboratory of Stromal Regulation of Immunity, Areas of professional interests: molecular biology, virology, biotechnology
Russian Federation, Gamaleya Street, Building 18, Moscow, 123098Oleg Vasilievich Karpovich
GreenVan
Email: info@green-van.ru
Development Director
Russian Federation, 25362, Moscow, Vodnikov St., Building 2, Bldg. 16, Office 6References
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