Dev. Biol. Stand
v.2
The effect of freeze-drying on the potency and stability of live varicella virus vaccine
Bennett, P. S.;R. Z. Maigetter;M. G. Olson;P. J. Provost;E. M. Scatergood;T. L. Schfield
Blood Rev.
v.2
Infectious complications of blood transfusion
Berkman, S. A.
Biologicals
v.26
Virus validation of pH 4-treated human immunoglobulin products produced by the Cohn fractionation process
Bos, O. J. M.;D. G. J. Sunye;C. E. F. Nieuweboer;F. A. C. van Engelenburg;H. Schuitemaker;J. Over
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Preparation and properties of serum and ;lasma proteins. Ⅳ. A system for the separation into fractions of the proteins and lipoprotein components of biological tissues and fluids
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Blood separation and plasma fractionation
Viral contamination of human plasma and procedures for preventing virus transmission by plasma products
Cuthbertson, B.;K. G. Reid;P. R. Foster;J. R. Harris(ed.)
Biologicals
v.24
Improvement of virus safety of a S/D-treated factor Ⅷ concentrate by additional dry heat treatment at 100℃
Dichtelmuller, H.;D. Rudnick;B. Breuer;R. Kotitschke;M. Kloft;A. Darling;E. Watson;B. Flehmig;S. Lawson;G. Frosner
Pharmacotherapy
v.16
Viral infectivity of albumin and plasma protein fraction
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Bundesanzeiger
v.84
Notice on the registration of drugs: requirements for validation studies to demomstrate the virus safety of drugs derived from human blood or plasma
Federal Health Office;Paul Ehrlich Institute Federal Office for Sera and Vaccines
Vox Sang.
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Removal and inactivation of hepatitis a Virus(HAV) during processing of factor Ⅷ concentrates
Hamman, J.;J. Zou;B. Horowitz
Curr. Stud. Hematol. Blood Transfus
v.56
Strategies to produce virus-safe blood derivatives
Heimburger, N.;H. E. Karges
Dev. Bio. Stand
v.81
Theroretical and technical concerns in inactivation/elimination of viruses in plasma derivatives
Hilfenhause, J.;M. Niedrig;T. Nowak
Dev. Biol. Stand
v.75
Introductory remark: viral safety of biologicals
Horaud, F.
Yale J. Med
v.63
Blood protein derivative viral safety: observations and analysis
Horowitz, B.
Vox Sang.
v.74
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Virus inactivation by solvent/detergent treatment and the manufacture of SD-plasma
Horowitz, B.;A. Lazo;H. Grossberg;G. Page;A. Lippin;G. Swan
Lancet
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Virus safety of solvent/detergent treated antihaemophiliac factor concentrates
Horowitz, M. S.;C. Rooks;B. Horowitz;M. W. Hilgartner
Federal Resister
v.63
no.185
Guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin;Availability
International Conference on Harmonisation
Biologicals
v.28
Inactivation and clearance of viruses during the manufacturing of high purity factor Ⅸ
Johnston, A.;A. MacGregor;S. Borovec;M. Hattarki;K. Stuckly;D. Anderson;N. H. Goss;A. Oates;E. Uren
J. Microbiol. Biotechnol
v.10
Partitioning and inactivation of viruses by cold ethanol fractionation and pasteurization during manufacture of albumin from human plasma
Kim, I. S.;H. G. Eo;C. E. Chang;S. Lee
Biotechnol. Bioprocess Eng.
v.6
Removal and inactivation of human immunodeficiency virus(HIV-1) by cold ethanol fractionation and pasteurization during the manufacturing of albumin and immunoglobulins from human plasma
Kim, I. S.;H. G. Eo;C. W. Park;C. E. Chang;S. Lee
J. Microbiol
v.38
Solvent/detergent inactivation and chromatographic removal of human immunodeficiency virus during the manufacturing of a high purity antihemophilic factor Ⅷ concentrate
Kim, I. S.;Y. W. Choi;H. S. Woo;C. E. Chang;S. Lee
J. Microbiol. Biotechnol
v.11
Improvement of virus safety of a human intravenous immunoglobulin by low pH incubation
Kim, I. S.;Y. W. Choi;S. R. Lee;H. B. Cho;H. G. Eo;H. S. Woo;C. E. Chang;S. Lee
J. Microbiol. Biotechnol
v.11
Removal and inactivation of viruses during manufacture of a high purity antihemophilic factor Ⅷ concentrated from human plasma
Kim, I. S.;Y. W. Choi;S. R. Lee;H. S. Woo;S. Lee
J. Microbiol
v.39
Removal and inactivation of hepatitis A virus during manufacture of a high purity antihemophilic factor Ⅷ concentrate from human plasma
Kim, I. S.;Y. W. Choi;S. R. Lee;M. S. Lee;K. H. Huh;S. Lee
Dev. Biol. Stand
v.102
Residual risk of transfusion transmitted viral infections among seronegative donors: application of the incidence/window period model
Kleinman, S.
Virology(3rd ed.)
Levy, J. A.;H. Fraenkel-Conrat;R. A. Owens
Biologicals
v.22
Inactivation of hepatitis C Virus in low pH intravenous immunoglobulin
Louie, R. E.;C. J. Galloway;M. L. Dumas;M. F. Wong;G. Mitra
Transfusion
v.38
Safety of human albumin as a constituent of biologic therapeutic products
McClelland, D. B. L.
Prog. Clin. Biol. Res.
v.182
Measures to inactivate viral contaminants of pooled plasma products
Menache, D.;D. L. Aronson
Dev. Biol. Stand
v.81
Criteria for the choice of viruses in validation studies
Minor, P. D.
Beitr. Infusionsther
v.24
Inactivation of viruses and safety of stable plasma products
Morgenthaler, J. J.
Transfusion
v.39
Foundling viruses and transfusion medicine
Mosley, J. W.;J. Rakela
Dev. Biol. Stand
v.81
Inactivation of HIV, HBV, HCV related viruses and other viruses in human plasma derivatives by pasteurization
Nowak, T.;M. Niedrig;D. Bernhardt;J. Hilfenhaus
Transfusion
v.36
Virus inactivation by pepsin treatment at pH 4 of IgG solutions: tactors affecting the rate of virus inactivation
Omar, A.;C. Kempf;A. Immelmann;M. Rentsch;J. J. Morgenthaler
Biologicals
v.24
The use of a microporous polyvinylidene fluoride(PVDF) membrane filter to separate contaminating viral particles from biologically important proteins
Oshima, K. H.;T. T. Evans-strickfaden;A. K. Highsmith;E. W. Ades
Dev. Biol. Stand
v.88
Safety of biopharmaceuticals: a current perspective
Parkman, P. D.
Lancet
v.1
Sterilization of hepatitis and HTLV Ⅲ viruses by exposure to Tri-n-Butyl phosphate and sodium cholate
Prince, A. M.;B. Horowitz;B. Brotman
Vox Sang.
v.72
Human parvovirus B19 and blood products
Prowse, C.;C. A. Ludlam;P. L. Yap
Rev. Med. Virol.
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Virus safety of plasma products
Roberts, P.
Curr. Stud. Hematol. Blood Transf.
v.56
Overview of viruses relevant to blood transfusion
Schilt, U.
Dev. Biol. Stand
v.81
The significance of the blood-borne viruses: blood banking and transfusion medicine
Sherwood, W. C.
Intervirology
v.23
Characteristics and taxonomy of Parvoviridae
Siegl, G.;R. C. Bates;K. I. Berns;B. J. Carter;D. C. Kelly;E. Kurstak;P. Tattersall
Transfusion
v.39
The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1
Tabor, E.
Transfusion
v.35
Hepatitis C virus infection in hypogammaglobulinemic patients receiving long-term replacement therapy with intravenous immunoglobulin
Taliani, G.;E. Guerra;R. Rosso;M. C. Badolato;G. Luzi;G. Sacco;R. Lecce;C. De Bac;F. Aiuti
Note for guidance on virus validation studies: the disign, contribution and interpretation of studies validating the inactivation and removal of viruses(CPMP/BWP/268/95)
The European Agency for the Evaluation of Medicinal Products: Human Medicines Evaluation Unit.;Committee for Proprietary Medicinal Products(CPMP)
Note for guidance on plasma derived medicinal products(CPMP/BWP/269/95 rev2)
The European Agency for the Evaluation of Medicinal Products: Human Medicines Evaluation Unit.;Committee for Proprietary Medicinal Products(CPMP)
Note for guidance on quality of biotechnology products: viral safety evaluation of biotechnology products derived from cell Lines of human or animal origin(CPMP/ICH/295/95)
The European Agency for the Evaluation of Medicinal Products: Human Medicines Evaluation Unit.;Committee for Proprietary Medicinal Products(CPMP)
Dev. Biol. Stand
v.88
Process scale considerations in evaluation studies and scale-up
Walter, J. K.;W. Werz;W. Berthold
Dev. Biol. Stand
v.81
Theoretical considerations on viral inactivation or elimination
Willkommen, H.;J. Lower