A consensus rating method for small virus-retentive filters. I. Method development.
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.
Lute
Scott
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Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Blvd., Silver Spring, MD 20903, USA.
Riordan
William
W
Pease
Leonard F
LF
Tsai
De-Hao
DH
Levy
Richard
R
Haque
Mohammed
M
Martin
Jerold
J
Moroe
Ichiro
I
Sato
Terry
T
Morgan
Michael
M
Krishnan
Mani
M
Campbell
Jennifer
J
Genest
Paul
P
Dolan
Sherri
S
Tarrach
Klaus
K
Meyer
Anika
A
Zachariah
Michael R
MR
Tarlov
Michael J
MJ
EtzeL
Mark
M
Brorson
Kurt
K
Aranha
Hazel
H
Bailey
Mark
M
Bender
Jean
J
Carter
Jeff
J
Chen
Qi
Q
Dowd
Chris
C
Jani
Raj
R
Jen
David
D
Kidd
Stanley
S
Meltzer
Ted
T
Remington
Kathryn
K
Rice
Iris
I
Romero
Cynthia
C
Sato
Terry
T
Jornitz
Maik
M
Sekura
Carol Marcus
CM
Sofer
Gail
G
Specht
Rachel
R
Wojciechowski
Peter
P
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
D004279:DNA, Viral; D008567:Membranes, Artificial; D012710:Serum Albumin, Bovine