title: A consensus rating method for small virus-retentive filters. I. Method development.
abstract: Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.g., parvoviruses) from products by a size exclusion mechanism. In 2002, the Parenteral Drug Association (PDA) organized the PDA Virus Filter Task Force to develop a common nomenclature and a standardized test method for classifying and identifying viral-retentive filters. One goal of the task force was to develop a test method for small virus-retentive filters. Because small virus-retentive filters present unique technical challenges, the test method development process was guided by laboratory studies to determine critical variables such as choice of bacteriophage challenge, choice of model protein, filtration operating parameters, target log10 reduction value, and filtration endpoint definition. Based on filtration, DLS, electrospray differential mobility analysis, and polymerase chain reaction studies, a final rating based on retention of bacteriophage PP7 was chosen by the PDA Virus Filter Task Force. The detailed final consensus filter method was published in the 2008 update of PDA Technical Report 41. Virus Filtration.
authors.affiliation: Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Blvd., Silver Spring, MD 20903, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Lute
authors.forename: William
authors.initials: W
authors.lastname: Riordan
authors.forename: Leonard F
authors.initials: LF
authors.lastname: Pease
authors.forename: De-Hao
authors.initials: DH
authors.lastname: Tsai
authors.forename: Richard
authors.initials: R
authors.lastname: Levy
authors.forename: Mohammed
authors.initials: M
authors.lastname: Haque
authors.forename: Jerold
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authors.lastname: Martin
authors.forename: Ichiro
authors.initials: I
authors.lastname: Moroe
authors.forename: Terry
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authors.lastname: Sato
authors.forename: Michael
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authors.lastname: Morgan
authors.forename: Mani
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authors.lastname: Krishnan
authors.forename: Jennifer
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authors.lastname: Campbell
authors.forename: Paul
authors.initials: P
authors.lastname: Genest
authors.forename: Sherri
authors.initials: S
authors.lastname: Dolan
authors.forename: Klaus
authors.initials: K
authors.lastname: Tarrach
authors.forename: Anika
authors.initials: A
authors.lastname: Meyer
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zachariah
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Tarlov
authors.forename: Mark
authors.initials: M
authors.lastname: EtzeL
authors.forename: Kurt
authors.initials: K
authors.lastname: Brorson
authors.forename: Hazel
authors.initials: H
authors.lastname: Aranha
authors.forename: Mark
authors.initials: M
authors.lastname: Bailey
authors.forename: Jean
authors.initials: J
authors.lastname: Bender
authors.forename: Jeff
authors.initials: J
authors.lastname: Carter
authors.forename: Qi
authors.initials: Q
authors.lastname: Chen
authors.forename: Chris
authors.initials: C
authors.lastname: Dowd
authors.forename: Raj
authors.initials: R
authors.lastname: Jani
authors.forename: David
authors.initials: D
authors.lastname: Jen
authors.forename: Stanley
authors.initials: S
authors.lastname: Kidd
authors.forename: Ted
authors.initials: T
authors.lastname: Meltzer
authors.forename: Kathryn
authors.initials: K
authors.lastname: Remington
authors.forename: Iris
authors.initials: I
authors.lastname: Rice
authors.forename: Cynthia
authors.initials: C
authors.lastname: Romero
authors.forename: Terry
authors.initials: T
authors.lastname: Sato
authors.forename: Maik
authors.initials: M
authors.lastname: Jornitz
authors.forename: Carol Marcus
authors.initials: CM
authors.lastname: Sekura
authors.forename: Gail
authors.initials: G
authors.lastname: Sofer
authors.forename: Rachel
authors.initials: R
authors.lastname: Specht
authors.forename: Peter
authors.initials: P
authors.lastname: Wojciechowski
mesh_terms: D026683:Advisory Committees; D004279:DNA, Viral / Q000302:isolation & purification; D004867:Equipment Design; D005240:Feasibility Studies; D017909:Levivirus / Q000235:genetics / Q000302:isolation & purification / Q000378:metabolism; D008027:Light; D008422:Materials Testing; D008567:Membranes, Artificial; D008851:Micropore Filters / Q000592:standards; D010316:Particle Size; D016730:Program Development; D011485:Protein Binding; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012542:Scattering, Radiation; D012710:Serum Albumin, Bovine / Q000378:metabolism; D013242:Sterilization / Q000295:instrumentation / Q000592:standards; D014771:Virion / Q000302:isolation & purification
chemical_list: D004279:DNA, Viral; D008567:Membranes, Artificial; D012710:Serum Albumin, Bovine