Biochemical quality of the pharmaceutically licensed plasma OctaplasLG ® after implementation of a novel prion protein (PrP Sc) removal technology and reduction of the solvent/detergent (S/D) process time

Vox Sanguinis

Volumn 97, Issue 3, 2009, Pages 219-225

  Heger, A ^a   Svae, T E ^a   Neisser Svae, A ^c   Jordan, S ^b   Behizad, M ^b   Romisch J ^a  

^a Octapharma Pharmazeutika Produktions GmbH   (Austria)

^b ProMetic Life Sciences Inc   (Canada)

^c Octapharma Pharmazeutika ProduktiongesmbH ^*

Author keywords

Affinity ligand chromatography; Biochemical characterization; Octaplas ; OctaplasLG ; Plasma quality; PrPSc

Indexed keywords

BLOOD CLOTTING FACTOR; DETERGENT; FIBRINOGEN; OCTAPLAS; OCTAPLASLG; PLASMA SUBSTITUTE; PLASMIN INHIBITOR; PRION PROTEIN; SOLVENT; UNCLASSIFIED DRUG; VON WILLEBRAND FACTOR CLEAVING PROTEINASE;

ARTICLE; BLOOD CLOTTING; CHROMATOGRAPHY; CONTROLLED STUDY; DRUG QUALITY; DRUG STABILITY; FIBRINOLYSIS; PARTIAL THROMBOPLASTIN TIME; PRIORITY JOURNAL; THROMBIN TIME;

ADAM PROTEINS; BLOOD COAGULATION TESTS; BLOOD PRESERVATION; BLOOD-BORNE PATHOGENS; CHROMATOGRAPHY, AFFINITY; DETERGENTS; FEASIBILITY STUDIES; FIBRINOGEN; HUMANS; PILOT PROJECTS; PLASMA; PROTEIN BINDING; PRPSC PROTEINS; RESINS, SYNTHETIC; SOLVENTS; SORPTION DETOXIFICATION; THROMBELASTOGRAPHY; THROMBIN; TIME FACTORS; VON WILLEBRAND FACTOR;

EID: 70349527966     PISSN: 00429007     EISSN: 14230410     Source Type: Journal    
DOI: 10.1111/j.1423-0410.2009.01190.x     Document Type: Article

References (18)

1. Will RG, Ironside JW, Zeidler M, Cousens SN, Estibeiro K, Alperovitch A, Poser S, Pocchiari M, Hofman A, Smith PG : A new variant of Creutzfeldt-Jakob disease in the UK. Lancet 1996 347 : 921 925
2. Wadsworth JDF, Jonier F, Hill AF, Campbell TA, Desbruslais M, Luthert PJ, Collinge J : Tissue distribution of protease resistant prion protein in variant Creutzfeldt-Jakob disease using a highly sensitive immunoblotting assay. Lancet 2001 358 : 171 180
3. Bruce ME, McConnell Will RG, Ironside JW : Detection of variant Creutzfeldt-Jakob disease infectivity in extraneural tissues. Lancet 2001 358 : 208 209
4. EMEA/CPMB/BWP/2879/02/rev 1. CHMP Position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products. June 2004
5. Hellstern P, Sachse H, Schwinn H, Oberfrank K : Manufacture and in vitro characterization of solvent/detergent-treated human plasma. Vox Sang 1992 63 : 178 185
6. Beeck H, Hellstern P : In vitro characterization of solvent/detergent- treated human plasma and of quarantine fresh frozen plasma. Vox Sang 1998 74 : 219 223
7. Heger A, Römisch J, Svae TE : A biochemical comparison of a pharmaceutically licensed coagulation active plasma (Octaplas) with a universally applicable development product (Uniplas) and single-donor FFPs subjected to methylene-blue dye and white-light treatment. Transfusion Apher Sci 2006 35 : 223 233
8. Heger A, Kannicht C, Römisch J, Svae TE : Normal levels of ADAMTS13 and factor H are present in the pharmaceutically licensed plasma for transfusion (Octaplas) and in the universally applicable plasma (Uniplas) in development. Vox Sang 2007 92 : 206 212
9. 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. Transfusion Apher Sci 2008 39 : 59 67
10. Metzner HJ, Hermentin P, Cuesta-Linker T, Langner S, Müller HG, Friedebold J. Characterization of factor VIII/von Willebrand factor concentrates using a modified method von Willebrand multimer analysis. Haemophilia 1998 4 : 25 32
11. Brown P, Rohwer RG, Dunstan BC, MacAuley C, Gajdusek DC, Drohan WN : The distribution of infectivity in blood components and plasma derivatives in experimental models of transmissible spongioform encephalopathies. Transfusion 1998 38 : 810 816
12. Williamson LM : New-variant Creutzfeldt-Jakob disease and leukocyte depletion of blood components. Infusionsther Transfusionsmed 1999 26 : 24 30
13. Gregori L, McCombie N, Palmer D, Birch P, Sowemimo-Coker SO, Giulivi A, Rohwer RG : Effectiveness of leucoreduction for removal of infectivity of transmissible spongiform encephalopathies from blood. Lancet 2004 364 : 529 531
14. Barz D : Detection of antigen structures in blood cells in differently prepared plasma presentations. Anaesthesiol Reanim 1994 19 : 155 158. German
15. Rutala WA, Weber DJ : Creutzfeldt-Jakob disease: recommendations for disinfection and sterilisation. Clin Infect Dis 2001 32 : 1348 1356
16. Foster PR : Removal of TSE agents from blood products. Vox Sang 2004 87 : 7 10
17. Hammond D, Lathrop J, Cervenakova L, Carbonell R (inventors): Prion protein ligands and methods of use. US patent WO 2004 /050851A2; 3 December 2003
18. Biesert L, Suhartono H : Solvent/detergent treatment of human plasma - a very robust method for virus inactivation. Validated virus safety of Octaplas. Vox Sang 1998 74 : 207 212