Prion removal effect of a specific affinity ligand introduced into the manufacturing process of the pharmaceutical quality solvent/detergent (S/D)-treated plasma OctaplasLG®

Vox Sanguinis

Volumn 97, Issue 3, 2009, Pages 226-233

  Neisser Svae, A ^a   Bailey, A ^b   Gregori, L ^c   Heger, A ^a   Jordan, S ^d   Behizad, M ^d   Reichl, H ^e   Romisch J ^a   Svae, T E ^a  

^a Octapharma Pharmazeutika Produktions GmbH   (Austria)

^b ViruSure GmbH   (Austria)

^c VETERANS AFFAIRS MEDICAL CENTER   (United States)

^d ProMetic Life Sciences Inc   (Canada)

^e Hämosan LS GmbH   (Austria)

Author keywords

Affinity ligand chromatography; OctaplasLG ; Prion safety; PrPSc; VCJD

Indexed keywords

DETERGENT; LIGAND; OCTOPLAS; PRION PROTEIN; SOLVENT; UNCLASSIFIED DRUG;

ARTICLE; CALCULATION; CELL SEPARATION; CONTROLLED STUDY; CREUTZFELDT JAKOB DISEASE; DISEASE TRANSMISSION; DRUG BINDING; DRUG EFFECT; DRUG MANUFACTURE; DRUG SAFETY; PRIORITY JOURNAL; PROTEIN ANALYSIS; RATING SCALE; RISK ASSESSMENT; VALIDATION PROCESS; WESTERN BLOTTING;

ANIMALS; BLOOD-BORNE PATHOGENS; BLOTTING, WESTERN; CHROMATOGRAPHY, AFFINITY; CREUTZFELDT-JAKOB SYNDROME; CRICETINAE; DETERGENTS; FEASIBILITY STUDIES; GERSTMANN-STRAUSSLER-SCHEINKER DISEASE; HUMANS; MESOCRICETUS; MICE; PILOT PROJECTS; PLASMA; PROTEIN BINDING; PRPSC PROTEINS; REPRODUCIBILITY OF RESULTS; RESINS, SYNTHETIC; SCRAPIE; SOLVENTS; SORPTION DETOXIFICATION; TIME FACTORS;

EID: 70349559216     PISSN: 00429007     EISSN: 14230410     Source Type: Journal    
DOI: 10.1111/j.1423-0410.2009.01206.x     Document Type: Article

References (16)

1. Llewelyn CA, Hewitt PE, Knight RS, Amar K, Cousens S, Mackenzie J, Will RG : Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet 2004 363 : 417 421
2. Wroe SJ, Pal S, Siddique D, Hyare H, Macfarlane R, Joiner S, Linehan JM, Brandner S, Wadsworth JD, Hewitt P, Collinge J : Clinical presentation and pre-mortem diagnosis of variant Creutzfeldt-Jakob disease associated with blood transfusion: a case report. Lancet 2006 368 : 2061 2067
3. Health Protection Agency : Fourth case of transfusion-associated variant-CJD infection. Health Protection Report 2007 1 - 26 Jan. 2007
4. Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW : Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004 264 : 527 529
5. Health Protection Agency : vCJD abnormal prion protein found in a patient with haemophilia at post mortem, press release, 17 February 2009, available at http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb-C/1234859690542?p= 1231252394302
6. Flan B, Arrabal S : Manufacture of plasma-derived products in France and measures to prevent the risk of vCJD transmission: Precautionary measures and efficacy of manufacturing processes in prion removal. Transfus Clin Biol 2007 14 : 51 62
7. Gregori L, Gurgel PV, Lathrop JT, Edwardson P, Lambert BC, Carbonell RG, Burton SJ, Hammond DJ, Rohwer RG : Reduction of infectivity of endogenous transmissible spongiform encephalopathies present in blood by adsorption to selective affinity resins. Lancet 2006 368 : 2226 2230
8. Gregori L, Lambert BC, Gurgel PV, Gheorghiu L, Edwardson P, Lathrop JT, MacAuley C, Carbonell RG, Burton SJ, Hammond D, Rohwer RG : Reduction of transmissible spongiform encephalopathy infectivity from human red blood cells with prion affinity ligands. Transfusion 2006 46 : 1152 1161
9. Sowemimo-Coker SO, Pesci S, Andrade F, Kim A, Kascsak RB, Kascsak RJ, Meeker C, Carp R : Pall leukotrap affinity prion-reduction filter removes exogenous infectious prions and endogenous infectivity from red cell concentrates. Vox Sang 2006 90 : 265 275
10. Svae TE, Neisser-Svae A, Bailey A, Reichl H, Biesert L, Schmidt T, Heger A, Römisch J : Prion safety of transfusion plasma and plasma-derivatives typically used for prophylactic treatment. Transfus Apher Sci 2008 39 : 59 67
11. Millson GC, Hunter GD, Kimberlin RH : An experimental examination of the scrapie agent in cell membran mixtures. J Com Path 1971 81 : 255 265
12. Hammond D, Lathrop J, Cervenakova L, Carbonell R, inventors : Prion protein ligands and methods of use U.S. patent WO 2004/050851A2. 2003 Dec 3
13. Sc) removal technology and reduction of the solvent/detergent (S/D) process time. Vox Sanguinis 2009 DOI
14. Cervenakova L, Yakovleva O, McKenzie C, Kolchinsky S, McShane L, Drohan WN, Brown P : Similar levels of infectivity in the blood of mice infected with human-derived vCJD and GSS strains of transmissible spongiform encephalopathy. Transfusion 2003 43 : 1687 1694
15. Volkel D, Zimmermann K, Zerr I, Bodemer M, Lindner T, Turecek PL, Poser S, Schwarz HP : Immunochemical determination of cellular prion protein in plasma from healthy subjects and patients with sporadic CJD or other neurologic diseases. Transfusion 2001 41 : 441 448
16. Gregori L, Gray BN, Rose E, Spinner DS, Kascsak RJ, Rohwer RG : A sensitive and quantitative assay for normal PrP in plasma. J Virol Methods 2008 149 : 251 259