A consensus rating method for small virus-retentive filters. I. Method development

PDA Journal of Pharmaceutical Science and Technology

Volumn 62, Issue 5, 2008, Pages 318-333

  Lute, Scott ^a   Riordan, William ^b   Pease III, Leonard F ^c   Tsai, De Hao ^c,i   Levy, Richard ^d   Haque, Mohammed ^e   Martin, Jerold ^e   Moroe, Ichiro ^f   Sato, Terry ^f,j   Morgan, Michael ^f   Krishnan, Mani ^g   Campbell, Jennifer ^g   Genest, Paul ^g   Dolan, Sherri ^h   Tarrach, Klaus ^h,j   Meyer, Anika ^h   Aranha, Hazel ^j   Bailey, Mark ^j   Bender, Jean ^j   Carter, Jeff ^j   Chen, Qi ^j   Dowd, Chris ^j   Jani, Raj ^j   Jen, David ^j   Kidd, Stanley ^j   Meltzer, Ted ^j   Remington, Kathryn ^j   Rice, Iris ^j   Romero, Cynthia ^j   Jornitz, Maik ^j   Sekura, Carol Marcus ^j   Sofer, Gail ^j   Specht, Rachel ^j   Wojciechowski, Peter ^j   Zachariah, Michael R ^c,i   Tarlov, Michael J ^c   Etzel, Mark ^b   Brorson, Kurt ^a   more..

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b University of Wisconsin Madison   (United States)

^c NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY   (United States)

^d Parenteral Drug Association (PDA) Global Headquarters   (United States)

^e PALL CORPORATION   (United States)

^f Asahi Kasei Medical Co   (United States)

^g MILLIPORE CORPORATION   (United States)

^h SARTORIUS STEDIM BIOTECH GMBH   (Germany)

ⁱ Bldg 142   (United States)

^j University of Maryland ^*

more..

Author keywords

Biopharmaceuticals; Bioprocessing standards; Plasma derived products; Virus retentive filtration; Virus safety

Indexed keywords

ARTICLE; BACTERIOPHAGE; BIOFILTER; BIOFILTRATION; ELECTROSPRAY; ELECTROSPRAY DIFFERENTIAL MOBILITY ANALYSIS; FEASIBILITY STUDY; LIGHT SCATTERING; NONHUMAN; NUCLEOTIDE SEQUENCE; PROCESS DEVELOPMENT; PRODUCT DEVELOPMENT; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SMALL VIRUS RETENTIVE FILTER; STANDARD; VIRUS FILTRATION; VIRUS STRAIN;

ADVISORY COMMITTEES; DNA, VIRAL; EQUIPMENT DESIGN; FEASIBILITY STUDIES; LEVIVIRUS; LIGHT; MATERIALS TESTING; MEMBRANES, ARTIFICIAL; MICROPORE FILTERS; PARTICLE SIZE; PROGRAM DEVELOPMENT; PROTEIN BINDING; REPRODUCIBILITY OF RESULTS; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; SCATTERING, RADIATION; SERUM ALBUMIN, BOVINE; STERILIZATION; VIRION;

EID: 57649212020     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

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