title: Porcine circovirus (PCV) removal by Q sepharose fast flow chromatography.
abstract: The recently discovered contamination of oral rotavirus vaccines led to exposure of millions of infants to porcine circovirus (PCV). PCV was not detected by conventional virus screening tests. Regulatory agencies expect exclusion of adventitious viruses from biological products. Therefore, methods for inactivation/removal of viruses have to be implemented as an additional safety barrier whenever feasible. However, inactivation or removal of PCV is difficult. PCV is highly resistant to widely used physicochemical inactivation procedures. Circoviruses such as PCV are the smallest viruses known and are not expected to be effectively removed by currently-used virus filters due to the small size of the circovirus particles. Anion exchange chromatography such as Q Sepharose(®) Fast Flow (QSFF) has been shown to effectively remove a range of viruses including parvoviruses. In this study, we investigated PCV1 removal by virus filtration and by QSFF chromatography. As expected, PCV1 could not be effectively removed by virus filtration. However, PCV1 could be effectively removed by QSFF as used during the purification of monoclonal antibodies (mAbs) and a log10 reduction value (LRV) of 4.12 was obtained.
authors.affiliation: Purification Development, Genentech, Inc., One DNA Way, South San Francisco, CA, 94080.
authors.forename: Bin
authors.initials: B
authors.lastname: Yang
authors.forename: Hua
authors.initials: H
authors.lastname: Wang
authors.forename: Cintia
authors.initials: C
authors.lastname: Ho
authors.forename: Philip
authors.initials: P
authors.lastname: Lester
authors.forename: Qi
authors.initials: Q
authors.lastname: Chen
authors.forename: Florian
authors.initials: F
authors.lastname: Neske
authors.forename: Sally A
authors.initials: SA
authors.lastname: Baylis
authors.forename: Johannes
authors.initials: J
authors.lastname: Blümel
mesh_terms: D000818:Animals; D002845:Chromatography / Q000379:methods*; D017925:Circovirus / Q000737:chemistry / Q000302:isolation & purification* / Q000472:pathogenicity; D004279:DNA, Viral / Q000737:chemistry / Q000302:isolation & purification; D004340:Drug Contamination; D006801:Humans; D007231:Infant, Newborn; D012685:Sepharose / Q000737:chemistry*; D013552:Swine / Q000821:virology; D014611:Vaccination / Q000009:adverse effects
chemical_list: D004279:DNA, Viral; D012685:Sepharose
keywords: Q Sepharose Fast Flow); anion exchange chromatography; minute virus of mice; porcine circovirus type 1 and 2; viral clearance; virus chromatography
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