title: Viral risk mitigation for Mammalian cell culture media.
abstract: Adventitious viral contamination in mammalian cell culture manufacturing facilities can lead to loss of product due to regulatory concerns regarding potential health risks. These events can also result in manufacturing shutdowns for extended periods of time. Numerous measures are currently taken to minimize these risks. Nonetheless, raw materials remain a high-risk entry point for viral contamination of mammalian cell cultures. Two virucidal technologies, ultraviolet radiation in the C band and high-temperature short-time pasteurization, were tested for the treatment of mammalian cell culture media. The results demonstrated no impact to the cell culture process or the quality of the products produced at the chosen dosage while providing robust viral protection.
authors.affiliation: Amgen, Inc., 4000 Nelson Road, Longmont, CO 80503.
authors.forename: Bob
authors.initials: B
authors.lastname: Weaver
authors.forename: Scott
authors.initials: S
authors.lastname: Rosenthal
mesh_terms: D000818:Animals; D001688:Biological Products; D018929:Cell Culture Techniques; D003470:Culture Media; D017077:Culture Media, Conditioned; D004340:Drug Contamination / Q000517:prevention & control; D006801:Humans; D012306:Risk; D018570:Risk Assessment; D014466:Ultraviolet Rays
chemical_list: D001688:Biological Products; D003470:Culture Media; D017077:Culture Media, Conditioned