메뉴 건너뛰기




Volumn 38, Issue 6, 2010, Pages 670-674

Capacity of the manufacturing process of Flebogamma® DIF, a new human high purity intravenous immunoglobulin, to remove a TSE model-agent

Author keywords

Flebogamma; Intravenous immunoglobulin; TSE clearance

Indexed keywords

FLEBOGAMMA DIF; IMMUNOGLOBULIN; MACROGOL; PRION PROTEIN; UNCLASSIFIED DRUG;

EID: 78650248293     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.08.003     Document Type: Article
Times cited : (15)

References (39)
  • 1
    • 0003661592 scopus 로고    scopus 로고
    • Cold Spring Harbor Laboratory Press, Cold Spring Harbor, New York
    • Prusiner S.B. Prion Biology and Diseases 2003, Cold Spring Harbor Laboratory Press, Cold Spring Harbor, New York.
    • (2003) Prion Biology and Diseases
    • Prusiner, S.B.1
  • 2
    • 33748369869 scopus 로고    scopus 로고
    • Creutzfeldt-Jacob disease and blood transfusion: results of the UK transfusion medicine epidemiological review study
    • Hewitt P.E., Llewelyn C.A., Mackenzie J., Will R.G. Creutzfeldt-Jacob disease and blood transfusion: results of the UK transfusion medicine epidemiological review study. Vox Sang 2006, 91:221-230.
    • (2006) Vox Sang , vol.91 , pp. 221-230
    • Hewitt, P.E.1    Llewelyn, C.A.2    Mackenzie, J.3    Will, R.G.4
  • 3
    • 65349173916 scopus 로고    scopus 로고
    • Lack of evidence of transfusion transmission of Creutzfeldt-Jacob disease in a US surveillance study
    • Dorsey K., Zou S., Schonberger L.B., Sullivan M., Kessler D., Notari E., et al. Lack of evidence of transfusion transmission of Creutzfeldt-Jacob disease in a US surveillance study. Transfusion 2009, 49:977-984.
    • (2009) Transfusion , vol.49 , pp. 977-984
    • Dorsey, K.1    Zou, S.2    Schonberger, L.B.3    Sullivan, M.4    Kessler, D.5    Notari, E.6
  • 7
    • 0141737854 scopus 로고    scopus 로고
    • Bovine spongiform encephalopathy (BSE) and its epidemiology
    • Smith P.G., Bradley R. Bovine spongiform encephalopathy (BSE) and its epidemiology. Br Med Bull 2003, 66:185-198.
    • (2003) Br Med Bull , vol.66 , pp. 185-198
    • Smith, P.G.1    Bradley, R.2
  • 8
    • 0035108777 scopus 로고    scopus 로고
    • Bovine spongiform encephalopathy and variant Creutzfeldt-Jakob Disease: background, evolution and current concern
    • Brown P., Will R.G., Bradley R., Asher M.D., Detwiler L. Bovine spongiform encephalopathy and variant Creutzfeldt-Jakob Disease: background, evolution and current concern. Emerg Infect Dis 2001, 7:6-16.
    • (2001) Emerg Infect Dis , vol.7 , pp. 6-16
    • Brown, P.1    Will, R.G.2    Bradley, R.3    Asher, M.D.4    Detwiler, L.5
  • 9
    • 78650239986 scopus 로고    scopus 로고
    • [accessed 03.11.09], The National Creutzfeldt-Jacob Disease Surveillance Unit (NCJDSU)
    • The National Creutzfeldt-Jacob Disease Surveillance Unit (NCJDSU) [accessed 03.11.09]. http://www.cjd.ed.ac.uk/figures.htm.
  • 10
    • 78650253292 scopus 로고    scopus 로고
    • [accessed 03.11.09], The National Creutzfeldt-Jacob Disease Surveillance Unit (NCJDSU)
    • The National Creutzfeldt-Jacob Disease Surveillance Unit (NCJDSU) [accessed 03.11.09]. http://www.cjd.ed.ac.uk/vcjdworld.htm.
  • 11
    • 1142273431 scopus 로고    scopus 로고
    • Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion
    • Llewelyn C.A., Hewitt P.E., Knights R.S., Amar K., Cousens S., Mackenzie J., et al. Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet 2004, 363:417-421.
    • (2004) Lancet , vol.363 , pp. 417-421
    • Llewelyn, C.A.1    Hewitt, P.E.2    Knights, R.S.3    Amar, K.4    Cousens, S.5    Mackenzie, J.6
  • 12
    • 4043157677 scopus 로고    scopus 로고
    • Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient
    • Peden A.H., Head M.W., Ritchie D.L., Bell J.E., Ironside J.W. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004, 364:527-529.
    • (2004) Lancet , vol.364 , pp. 527-529
    • Peden, A.H.1    Head, M.W.2    Ritchie, D.L.3    Bell, J.E.4    Ironside, J.W.5
  • 13
    • 33845227845 scopus 로고    scopus 로고
    • Clinical presentation and pre-mortem diagnosis of variant Creutzfeldt-Jakob disease associated with blood transfusion: a case report
    • Wroe S.J., Pal S., Siddique D., Hyare H., Macfarlane R., Joiner S., et al. Clinical presentation and pre-mortem diagnosis of variant Creutzfeldt-Jakob disease associated with blood transfusion: a case report. Lancet 2006, 368:2061-2067.
    • (2006) Lancet , vol.368 , pp. 2061-2067
    • Wroe, S.J.1    Pal, S.2    Siddique, D.3    Hyare, H.4    Macfarlane, R.5    Joiner, S.6
  • 14
    • 78650254085 scopus 로고    scopus 로고
    • HPA Press Statement, [accessed 28.04.09]J , Health Protection Agency
    • Health Protection Agency 4th Case Variant CJD Infection Associated Blood Transfusion January 2007, vol. 19. HPA Press Statement, [accessed 28.04.09]. http://www.hpa.org.uk/webw/HPAweb%26HPAwebStandard/HPAweb_C/1195733711457%3Fp%3D1171991026241.
    • (2007) 4th Case Variant CJD Infection Associated Blood Transfusion , vol.19
  • 15
    • 34547962876 scopus 로고    scopus 로고
    • Mortality rates, life expectancy, and causes of death in people with hemophilia A or B in the United Kingdom who were not infected with HIV
    • Darby S.C., Kan S.W., Spooner R.J., Giangrande P.L., Hill F.G., Hay C.R., et al. Mortality rates, life expectancy, and causes of death in people with hemophilia A or B in the United Kingdom who were not infected with HIV. Blood 2007, 110:815-825.
    • (2007) Blood , vol.110 , pp. 815-825
    • Darby, S.C.1    Kan, S.W.2    Spooner, R.J.3    Giangrande, P.L.4    Hill, F.G.5    Hay, C.R.6
  • 16
    • 78650253588 scopus 로고    scopus 로고
    • Signs of variant Creutzfeldt-Jakob disease in a patient with hemophilia: FVIII concentrates most likely cause
    • [accessed 23.04.09], World Federation of Hemophilia
    • World Federation of Hemophilia Signs of variant Creutzfeldt-Jakob disease in a patient with hemophilia: FVIII concentrates most likely cause. WFH Saf & Supply News 2009, 8. [accessed 23.04.09]. http://www.wfh.org/index.asp%3Flang%3DEN.
    • (2009) WFH Saf & Supply News , vol.8
  • 17
    • 77749322732 scopus 로고    scopus 로고
    • Variant CJD infection in the spleen of a neurologically asymptomatic UK adult patient with haemophilia
    • Peden A., McCardle L., Head M.W., Love S., Ward H.J., Cousens S.N., et al. Variant CJD infection in the spleen of a neurologically asymptomatic UK adult patient with haemophilia. Haemophilia 2010, 16:296-304.
    • (2010) Haemophilia , vol.16 , pp. 296-304
    • Peden, A.1    McCardle, L.2    Head, M.W.3    Love, S.4    Ward, H.J.5    Cousens, S.N.6
  • 18
  • 19
    • 62349138169 scopus 로고    scopus 로고
    • A recipient of immunoglobulin from a donor who developed vCJD
    • El-Shanawany T., Jolles S., Unsworth D.J., Williams P. A recipient of immunoglobulin from a donor who developed vCJD. Vox Sang 2009, 96:270.
    • (2009) Vox Sang , vol.96 , pp. 270
    • El-Shanawany, T.1    Jolles, S.2    Unsworth, D.J.3    Williams, P.4
  • 20
    • 37149043763 scopus 로고    scopus 로고
    • Creutfeldt-Jakob disease: reflections on the risk from blood product therapy
    • Brown P. Creutfeldt-Jakob disease: reflections on the risk from blood product therapy. Haemophilia 2007, 13(Suppl. 5):33-40.
    • (2007) Haemophilia , vol.13 , Issue.SUPPL. 5 , pp. 33-40
    • Brown, P.1
  • 21
    • 0032757723 scopus 로고    scopus 로고
    • Further studies of blood infectivity in an experimental model of transmissible spongiform encephalopathy, with an explanation of why blood components do not transmit Creutzfeldt-Jakob disease in humans
    • Brown P., Cervenakova L., McShane L.M., Barber P., Rubenstein R., Drohan W.N. Further studies of blood infectivity in an experimental model of transmissible spongiform encephalopathy, with an explanation of why blood components do not transmit Creutzfeldt-Jakob disease in humans. Transfusion 1999, 39:1169-1178.
    • (1999) Transfusion , vol.39 , pp. 1169-1178
    • Brown, P.1    Cervenakova, L.2    McShane, L.M.3    Barber, P.4    Rubenstein, R.5    Drohan, W.N.6
  • 22
    • 3543092761 scopus 로고    scopus 로고
    • The distribution of infectivity in blood components and plasma derivatives in experimental models of transmissible spongiform encephalopathy
    • Brown P., Rohwer R.G., Dunstan B.C., MacAuley C., Gajdusek D.C., Drohan W.N. The distribution of infectivity in blood components and plasma derivatives in experimental models of transmissible spongiform encephalopathy. Transfusion 1998, 38:810-816.
    • (1998) Transfusion , vol.38 , pp. 810-816
    • Brown, P.1    Rohwer, R.G.2    Dunstan, B.C.3    MacAuley, C.4    Gajdusek, D.C.5    Drohan, W.N.6
  • 23
    • 23844471279 scopus 로고    scopus 로고
    • Blood infectivity, processing and screening tests in transmissible spongiform encephalopathy
    • Brown P. Blood infectivity, processing and screening tests in transmissible spongiform encephalopathy. Vox Sang 2005, 89:63-70.
    • (2005) Vox Sang , vol.89 , pp. 63-70
    • Brown, P.1
  • 24
    • 0036831212 scopus 로고    scopus 로고
    • Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma
    • Stenland C.J., Lee D.C., Brown P., Petteway S.R., Rubenstein R. Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. Transfusion 2002, 42:1497-1500.
    • (2002) Transfusion , vol.42 , pp. 1497-1500
    • Stenland, C.J.1    Lee, D.C.2    Brown, P.3    Petteway, S.R.4    Rubenstein, R.5
  • 26
    • 34250971354 scopus 로고
    • Beitrag zur kollectiven Behandlung Pharmacologisher Reihenversuche
    • Kärber G. Beitrag zur kollectiven Behandlung Pharmacologisher Reihenversuche. Archive Exp Pathologie Pharmakologie 1931, 162:480-483.
    • (1931) Archive Exp Pathologie Pharmakologie , vol.162 , pp. 480-483
    • Kärber, G.1
  • 27
    • 33745158157 scopus 로고
    • A simple method of estimating fifty per cent endpoints
    • Reed L.J., Muench H. A simple method of estimating fifty per cent endpoints. Am J Hyg 1938, 27:493-497.
    • (1938) Am J Hyg , vol.27 , pp. 493-497
    • Reed, L.J.1    Muench, H.2
  • 28
    • 33845612714 scopus 로고    scopus 로고
    • Reduction infectivity of endogenous transmissible spongiform encepahlopathies present in blood by adsorption to selective affinity resins
    • Gregori L., Gurgel P.V., Lathrop J.T., Eduwardson P., Lambert B.C., Carbonell R.G., et al. Reduction infectivity of endogenous transmissible spongiform encepahlopathies present in blood by adsorption to selective affinity resins. Lancet 2006, 368:2232-2236.
    • (2006) Lancet , vol.368 , pp. 2232-2236
    • Gregori, L.1    Gurgel, P.V.2    Lathrop, J.T.3    Eduwardson, P.4    Lambert, B.C.5    Carbonell, R.G.6
  • 29
    • 0035037753 scopus 로고    scopus 로고
    • A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins
    • Lee D.C., Stenland C.J., Miller J.L., Cai K., Ford E.K., Gilligan K.J., et al. A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion 2001, 41:449-455.
    • (2001) Transfusion , vol.41 , pp. 449-455
    • Lee, D.C.1    Stenland, C.J.2    Miller, J.L.3    Cai, K.4    Ford, E.K.5    Gilligan, K.J.6
  • 31
    • 78650238362 scopus 로고    scopus 로고
    • Efficacy of Flebogammadif® manufacturing process to eliminate an experimental TSE agent. XIIITh Meeting Eur Soc for Immunodeficiences ; Abstract P209
    • Diez JM, Caballero S, Domingo N, Belda FJ, Otegui M, Gajardo R et al. Efficacy of Flebogammadif® manufacturing process to eliminate an experimental TSE agent. XIIITh Meeting Eur Soc for Immunodeficiences 2008; Abstract P209.
    • (2008)
    • Diez, J.M.1    Caballero, S.2    Domingo, N.3    Belda F.J.Otegui, M.4    Gajardo, R.5
  • 32
    • 0036771299 scopus 로고    scopus 로고
    • Purity of spiking agent affects partitioning of prions in plasma protein purification
    • Vey M., Baron H., Weimer T., Gröner A. Purity of spiking agent affects partitioning of prions in plasma protein purification. Biologicals 2002, 30:187-196.
    • (2002) Biologicals , vol.30 , pp. 187-196
    • Vey, M.1    Baron, H.2    Weimer, T.3    Gröner, A.4
  • 33
    • 0033991241 scopus 로고    scopus 로고
    • Monitoring plasma processing with a sensitive western blot assay for the detection of the prion protein
    • Lee D.C., Stenland C.J., Hartwell R.C., Ford E.K., Cai K., Miller J.L., et al. Monitoring plasma processing with a sensitive western blot assay for the detection of the prion protein. J Virol Methods 2000, 84:77-89.
    • (2000) J Virol Methods , vol.84 , pp. 77-89
    • Lee, D.C.1    Stenland, C.J.2    Hartwell, R.C.3    Ford, E.K.4    Cai, K.5    Miller, J.L.6
  • 34
    • 0034068711 scopus 로고    scopus 로고
    • Studies on the removal of abnormal prion protein by processes used in the manufacture of human plasma products
    • Foster P.R., Welch A.G., McLean C., Griffin B.D., Hardy J.C., Bartley A., et al. Studies on the removal of abnormal prion protein by processes used in the manufacture of human plasma products. Vox Sang 2000, 78:86-95.
    • (2000) Vox Sang , vol.78 , pp. 86-95
    • Foster, P.R.1    Welch, A.G.2    McLean, C.3    Griffin, B.D.4    Hardy, J.C.5    Bartley, A.6
  • 35
    • 4444277653 scopus 로고    scopus 로고
    • Removal of TSE agents from blood products
    • Foster P.R. Removal of TSE agents from blood products. Vox Sang 2004, 87(Suppl. 2):S7-10.
    • (2004) Vox Sang , vol.87 , Issue.SUPPL. 2
    • Foster, P.R.1
  • 36
    • 0012954118 scopus 로고    scopus 로고
    • Studies on the removal of a bovine spongiform encephalopathy-derived agent by processes used in the manufacture of human immunoglobulin
    • Reichl H.E., Foster P.R., Welch A.G., Li Q., MacGregor I.R., Somerville R.A., et al. Studies on the removal of a bovine spongiform encephalopathy-derived agent by processes used in the manufacture of human immunoglobulin. Vox Sang 2002, 83:137-145.
    • (2002) Vox Sang , vol.83 , pp. 137-145
    • Reichl, H.E.1    Foster, P.R.2    Welch, A.G.3    Li, Q.4    MacGregor, I.R.5    Somerville, R.A.6
  • 37
    • 0242669192 scopus 로고    scopus 로고
    • Properties of a new intravenous immunoglobulin (IGIV-C, 10%) produced by virus inactivation with caprylate and column chromatography
    • Lebing W., Remington K.M., Paul H.L. Properties of a new intravenous immunoglobulin (IGIV-C, 10%) produced by virus inactivation with caprylate and column chromatography. Vox Sang 2003, 84:193-201.
    • (2003) Vox Sang , vol.84 , pp. 193-201
    • Lebing, W.1    Remington, K.M.2    Paul, H.L.3
  • 38
    • 0037396942 scopus 로고    scopus 로고
    • Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process
    • Trejo S.R., Hotta J.A., Lebing W., Stenland C., Storms R.E., Lee D.C., et al. Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process. Vox Sang 2003, 84:176-187.
    • (2003) Vox Sang , vol.84 , pp. 176-187
    • Trejo, S.R.1    Hotta, J.A.2    Lebing, W.3    Stenland, C.4    Storms, R.E.5    Lee, D.C.6
  • 39
    • 0037674975 scopus 로고    scopus 로고
    • Evaluation of depth filtration to remove prion challenge from an immune globulin preparation
    • Van Holten R.W., Autenrieth S.M. Evaluation of depth filtration to remove prion challenge from an immune globulin preparation. Vox Sang 2003, 85:20-24.
    • (2003) Vox Sang , vol.85 , pp. 20-24
    • Van Holten, R.W.1    Autenrieth, S.M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.