A novel core fractionation process of human plasma by expanded bed adsorption chromatography

Analytical Biochemistry - Tập 399 - Trang 102-109 - 2010
Allan Lihme1, Marie Bendix Hansen1, Inga Vaarst Andersen1, Thierry Burnouf2
1Upfront Chromatography, 2100 Copenhagen, Denmark
2Human Protein Process Sciences (HPPS), 59800 Lille, France

Tài liệu tham khảo

Cohn, 1946, Preparation and properties of serum and plasma proteins: IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids, J. Am. Chem. Soc., 68, 459, 10.1021/ja01207a034 Kistler, 1962, Large-scale production of human plasma fractions: eight years experience with the alcohol fractionation procedure of Nitschmann, Kistler, and Lergier, Vox Sang., 7, 414, 10.1111/j.1423-0410.1962.tb03274.x Burnouf, 2007, Modern plasma fractionation, Transfus. Med. Rev., 21, 101, 10.1016/j.tmrv.2006.11.001 Pool, 1964, High-potency antihaemophilic factor concentrate prepared from cryoglobulin precipitate, Nature, 203, 312, 10.1038/203312a0 Burnouf, 2001, Affinity chromatography in the industrial purification of plasma proteins for therapeutic use, J. Biochem. Biophys. Methods, 49, 575, 10.1016/S0165-022X(01)00221-4 Burnouf, 1991, Integration of chromatography with traditional plasma protein fractionation methods, Bioseparation, 1, 383 Bos, 1998, Virus validation of pH 4-treated human immunoglobulin products produced by the Cohn fractionation process, Biologicals, 26, 267, 10.1006/biol.1998.0148 Chandra, 1999, Virus reduction in the preparation of intravenous immune globulin: in vitro experiments, Transfusion, 39, 249, 10.1046/j.1537-2995.1999.39399219280.x Dichtelmuller, 1993, Validation of virus inactivation and removal for the manufacturing procedure of two immunoglobulins and a 5% serum protein solution treated with β-propiolactone, Biologicals, 21, 259, 10.1006/biol.1993.1083 Wells, 1986, Inactivation and partition of human T-cell lymphotrophic virus, type III, during ethanol fractionation of plasma, Transfusion, 26, 210, 10.1046/j.1537-2995.1986.26286152919.x Uemura, 1994, Inactivation and elimination of viruses during preparation of human intravenous immunoglobulin, Vox Sang., 67, 246, 10.1111/j.1423-0410.1994.tb01246.x Gregori, 2004, Partitioning of TSE infectivity during ethanol fractionation of human plasma, Biologicals, 32, 1, 10.1016/j.biologicals.2003.08.004 Foster, 2000, Studies on the removal of abnormal prion protein by processes used in the manufacture of human plasma products, Vox Sang., 78, 86, 10.1046/j.1423-0410.2000.7820086.x Flan, 2007, 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., 14, 51, 10.1016/j.tracli.2007.04.008 Burnouf, 2006, Current strategies to prevent transmission of prions by human plasma derivatives, Transfus. Clin. Biol., 13, 320, 10.1016/j.tracli.2006.11.001 Buchacher, 2006, Purification of intravenous immunoglobulin G from human plasma: aspects of yield and virus safety, Biotechnol. J., 1, 148, 10.1002/biot.200500037 Bayry, 2007, Shortage of human intravenous immunoglobulin: reasons and possible solutions, Nat. Clin. Pract. Neurol., 3, 120, 10.1038/ncpneuro0429 Morrow, 2004, new treatments abound for AAT deficiency, Manag. Care, 13, 48 Kasper, 2005, Products for clotting factor replacement in developing countries, Semin. Thromb. Hemost., 31, 507, 10.1055/s-2005-922221 Evatt, 2004, Comprehensive care for haemophilia around the world, Haemophilia, 10, 9, 10.1111/j.1365-2516.2004.01010.x Burnouf, 1995, Chromatography in plasma fractionation: benefits and future trends, J. Chromatogr. B, 664, 3, 10.1016/0378-4347(94)00532-A Berglof, 1983, Chromatographic preparation and in vitro properties of albumin from human plasma, J. Appl. Biochem., 5, 282 Lihme, 1999, Simplified and more robust EBA processes by elution in expanded bed mode, Bioseparation, 8, 93, 10.1023/A:1008076415540 Noel, 2007, Chromatography: industrial processing and biotherapeutics, Filtr. Sep., 44, 26, 10.1016/S0015-1882(07)70080-0 Noel, 2007, Industrial processing of immunoglobulins, Bioprocess Int., 5, 58 A. Lihme, Isolation of plasma or serum proteins, International patent application. Bradford, 1976, A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein–dye binding, Anal. Biochem., 72, 248, 10.1016/0003-2697(76)90527-3 Ingild, 1983, Single radial immunodiffusion, Scand. J. Immunol., 17, 41, 10.1111/j.1365-3083.1983.tb03999.x Pejaudier, 1987, Appraisal of the protein composition of prothrombin complex concentrates of different origins, Vox Sang., 52, 1, 10.1111/j.1423-0410.1987.tb02979.x Michalski, 1988, Large-scale production and properties of a solvent–detergent-treated factor IX concentrate from human plasma, Vox Sang., 55, 202, 10.1111/j.1423-0410.1988.tb04698.x Dike, 1980, A factor VII concentrate for therapeutic use, Br. J. Haematol., 45, 107, 10.1111/j.1365-2141.1980.tb03816.x Dike, 1972, The preparation and clinical use of a new concentrate containing factor IX, prothrombin, and factor X and of a separate concentrate containing factor VII, Br. J. Haematol., 22, 469, 10.1111/j.1365-2141.1972.tb05693.x Boudart, 1979, Preparation of factor VIII concentrates by cryoprecipitate sedimentation, Transfusion, 19, 594, 10.1046/j.1537-2995.1979.19580059817.x Foster, 1982, Control of large-scale plasma thawing for recovery of cryoprecipitate factor VIII, Vox Sang., 42, 180, 10.1111/j.1423-0410.1982.tb01093.x Allersma, 1991, Preparation of lyophilized heat-treated cryoprecipitates from a small pool of plasma obtained by apheresis, Pharm. Weekbl. Sci., 13, 18 The, 1993, Preparation of intermediate-purity factor VIII concentrate by direct gel filtration of cryoprecipitate, Vox Sang., 65, 251, 10.1111/j.1423-0410.1993.tb02164.x Burnouf, 1991, A highly purified factor VIII:C concentrate prepared from cryoprecipitate by ion-exchange chromatography, Vox Sang., 60, 8, 10.1111/j.1423-0410.1991.tb00864.x Rotblat, 1985, Purification of human factor VIII:C and its characterization by Western blotting using monoclonal antibodies, Biochemistry, 24, 4294, 10.1021/bi00337a007 Liu, 1989, Colloque INSERM, Biotechnology of Plasma Proteins, 175, 263 Mori, 2008, Progress in large-scale purification of factor VIII/von Willebrand factor concentrates using ion-exchange chromatography, Vox Sang., 95, 298, 10.1111/j.1423-0410.2008.01096.x Goudemand, 2006, Influence of the type of factor VIII concentrate on the incidence of factor VIII inhibitors in previously untreated patients with severe hemophilia A, Blood, 107, 46, 10.1182/blood-2005-04-1371 Kallas, 2001, Von Willebrand factor in factor VIII concentrates protects against neutralization by factor VIII antibodies of haemophilia A patients, Haemophilia, 7, 375, 10.1046/j.1365-2516.2001.00530.x Kaersgaard, 1998, Isolation of the factor VIII–von Willebrand factor complex directly from plasma by gel filtration, J. Chromatogr. B, 715, 357, 10.1016/S0378-4347(98)00250-3 te Booy, 1990, Large-scale purification of factor VIII by affinity chromatography: optimization of process parameters, J. Chromatogr., 503, 103, 10.1016/S0021-9673(01)81494-1 Teh, 1994, Direct capture of plasma factor VIII:C by ion exchange chromatography, Vox Sang., 67, 8, 10.1111/j.1423-0410.1994.tb05029.x Radosevich, 2010, Intravenous immunoglobulin G: trends in production methods, quality control, and quality assurance, Vox Sang., 98, 12, 10.1111/j.1423-0410.2009.01226.x Coan, 1985, Preparation and properties of α1-proteinase inhibitor concentrate from human plasma, Vox Sang., 48, 333, 10.1111/j.1423-0410.1985.tb00193.x Burnouf, 1987, Large scale chromatographic purification of α1-antitrypsin from human plasma supernatant II+III, Dev. Biol. Stand., 67, 31 Chen, 1998, Chromatographic purification of human α1 proteinase inhibitor from dissolved Cohn fraction IV-1 paste, J. Chromatogr. A, 800, 207, 10.1016/S0021-9673(97)01119-9 Johnston, 2003, Low pH, caprylate incubation as a second viral inactivation step in the manufacture of albumin: parametric and validation studies, Biologicals, 31, 213, 10.1016/S1045-1056(03)00062-9 Burnouf, 2000, Reducing the risk of infection from plasma products: specific preventative strategies, Blood Rev., 14, 94, 10.1054/blre.2000.0129 Committee for Proprietary Medicinal Products, Note for guidance on plasma-derived medicinal products, CPMP/BWP/269/95 rev. 3, 2001. Available from: http://www.emea.europa.eu/pdfs/human/bwp/026995en.pdf (European Agency for the Evaluation of Medicinal Products). World Health Organization, WHO guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products, Technical Report Series No. 924, Annex 4, 2003. Available from: http://www.who.int/bloodproducts.