title: Considerations in performing virus spiking experiments and process validation studies.
abstract: Virus safety of blood and plasma products produced on an industrial scale depends on several procedures including the ability of the production process to remove or inactivate potential virus contaminants. Because of the highly variable nature of the starting material it is essential to measure the viral clearance capacity of the production process in order to give a high degree of assurance that a particular product will not be contaminated with infectious virus.
authors.affiliation: Quality Biotech Ltd., Glasgow, UK.
authors.forename: A J
authors.initials: AJ
authors.lastname: Darling
mesh_terms: D001688:Biological Products / Q000592:standards*; D001769:Blood / Q000382:microbiology*; D001798:Blood Proteins / Q000302:isolation & purification*; D002845:Chromatography; D004340:Drug Contamination / Q000517:prevention & control; D006801:Humans; D008403:Mass Screening; D011786:Quality Control; D012015:Reference Standards; D012449:Safety; D014773:Virology / Q000379:methods*; D014776:Virus Cultivation; D014780:Viruses / Q000254:growth & development / Q000302:isolation & purification
chemical_list: D001688:Biological Products; D001798:Blood Proteins