title: [Prion safety of medicinal products using the example of an influenza vaccine produced in a cell line].
abstract: Prions are pathogenic proteins and are the cause for spongiform encephalopathies. Pathogenic prions differ from physiologically common non-pathogenic prions only in their sterical structure. Upon infection by a pathogenic prion protein, a series of reactions is initiated in which common non-pathogenic prion proteins are transformed into pathogenic prions. Animals, mainly ruminants like cattle, sheep and goats are susceptible to prions, but also man. Prions are very robust and it is difficult to inactivate them. During the production processes of pharmaceuticals, the risk for contamination by infectious prions can be reduced by careful choice of animal material, the replacement of animal material and by appropriate production procedures. For instance biologicals like influenza vaccines can be produced by a permanent canine cell line, whose prion safety has been proven by useful methods (standard scrapy cell assay). Mandatory guidelines ensure that the risk for contamination by pathogenic prions has to be considered and excluded in the production of bio-pharmaceuticals.
authors.affiliation: Novartis Vaccines and Diagnostics GmbH, Marburg. heidi.trusheim@novartis.com
authors.forename: Heidi
authors.initials: H
authors.lastname: Trusheim
authors.forename: Jens-Peter
authors.initials: JP
authors.lastname: Gregersen
authors.forename: Heinz-Josef
authors.initials: HJ
authors.lastname: Schmitt
authors.forename: Michael
authors.initials: M
authors.lastname: Bröker
mesh_terms: D000818:Animals; D002417:Cattle; D004340:Drug Contamination / Q000517:prevention & control*; D006041:Goats; D006801:Humans; D007252:Influenza Vaccines / Q000032:analysis*; D017096:Prion Diseases / Q000517:prevention & control*; D011328:Prions / Q000737:chemistry; D012449:Safety; D012756:Sheep
chemical_list: D007252:Influenza Vaccines; D011328:Prions