title: Validation of model virus removal and inactivation capacity of an erythropoietin purification process.
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).
authors: Erythropoietin Production Department, Center for Genetic Engineering and Biotechnology, Ave 31/ 158 and 190 Cubanacán, Playa, Havana, Cuba.
authors: Mayté
authors: M
authors: Pérez
authors: Elias
authors: E
authors: Rodríguez
authors: María
authors: M
authors: Rodríguez
authors: Rolando
authors: R
authors: Paez
authors: Ignacio
authors: I
authors: Ruibal
authors: Enrique
authors: E
authors: Noa
authors: Osnel
authors: O
authors: García
authors: Galina
authors: G
authors: Moya
authors: Mayda
authors: M
authors: Martínez
authors: José
authors: J
authors: Marcelo
authors: Anazuria
authors: A
authors: Martínez
authors: Marta
authors: M
authors: Dubal
authors: Leonor
authors: L
authors: Navea
authors: Rodolfo
authors: R
authors: Valdés
mesh_terms: D000818:Animals; D016466:CHO Cells; D002417:Cattle; D002850:Chromatography, Gel; D002852:Chromatography, Ion Exchange; D006224:Cricetinae; D003412:Cricetulus; D001908:Diarrhea Viruses, Bovine Viral / Q000187:drug effects / Q000302:isolation & purification; D004203:Disinfection / Q000379:methods*; D004285:Dogs; D004906:Erythrocyte Count; D004921:Erythropoietin / Q000302:isolation & purification* / Q000494:pharmacology; D005260:Female; D015497:HIV-1 / Q000187:drug effects / Q000302:isolation & purification / Q000648:ultrastructure; D006801:Humans; D007700:Kinetics; D051379:Mice; D046529:Microscopy, Electron, Transmission; D017993:Parvovirus, Canine / Q000187:drug effects / Q000302:isolation & purification; D017955:Poliovirus / Q000187:drug effects / Q000302:isolation & purification; D015203:Reproducibility of Results; D012156:Reticulocytes / Q000166:cytology / Q000187:drug effects; D012972:Sodium Hydroxide / Q000494:pharmacology; D038301:Virus Inactivation; D014780:Viruses / Q000187:drug effects / Q000302:isolation & purification*
chemical_list: D004921:Erythropoietin; D012972:Sodium Hydroxide