Validation of model virus removal and inactivation capacity of an erythropoietin purification process |
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| Authors: | Mayté Pérez Elias Rodríguez María Rodríguez Rolando Paez Ignacio Ruibal Enrique Noa Osnel García Galina Moya Mayda Martínez José Marcelo Anazuria Martínez Marta Dubal Leonor Navea Rodolfo Valdés |
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| Institution: | aErythropoietin Production Department, Center for Genetic Engineering and Biotechnology, Ave 31/ 158 and 190, Cubanacán, Playa, PO Box 6162, Havana 10600, Cuba;bProcess Development Direction, Center for Genetic Engineering and Biotechnology, Ave 31/ 158 and 190, Cubanacán, Playa, PO Box 6162, Havana 10600, Cuba;cAIDS Reference Laboratory National Speedway and Jamaica Road, San José de las Lajas, PO Box 32700, Mayabeque, Cuba;dQuality Control Direction, Center for Genetic Engineering and Biotechnology, Ave 31/ 158 and 190, Cubanacán, Playa, PO Box 6162, Havana 10600, Cuba;eMonoclonal Antibody Production Department, Center for Genetic Engineering and Biotechnology, Ave 31/ 158 and 190, Cubanacán, Playa, PO Box 6162, Havana 10600, Cuba |
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| Abstract: | Human erythropoietin (hEpo) production requires mammalian cells able to make complex post-translational modifications to guaranty its biological activity. As mammalian cell can be reservoir of pathogenic viruses and several animal origin components are usually used in the cultivation of mammalian cells, hEpo contamination with viruses is something of great concern. As consequence, this study investigated the viral removal and inactivation capacity of a recombinant-hEpo (rec-hEpo) purification process. Canine parvovirus, Human poliovirus type-2, Bovine viral diarrhea virus and Human immunodeficiency virus type-1 were used for measuring process viral removal and inactivation capacities. In conclusion, this study corroborated that the assessed rec-hEpo purification process has enough capacity (5.0–19.4 Logs) for removing and inactivating these model viruses and sodium hydroxide demonstrated to be a robust sanitization solution for chromatography columns (5.0 (PV-2)-6.7 (CPV) Logs). |
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| Keywords: | Erythropoietin Viral inactivation Viral removal |
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