Dedicated removal of immunoglobulin (Ig)A, IgM, and Factor (F)XI/activated FXI from human plasma IgG

Transfusion

Volumn 54, Issue 1, 2014, Pages 169-178

  Wu, Yu Wen ^b   Champagne, Jérôme ^b,c,d   Toueille, Magali ^b   Gantier, René ^b   Burnouf, Thierry ^a,b  

^a TAIPEI MEDICAL UNIVERSITY   (Taiwan)

^b Research and Development Chromatography Applications   (France)

^c Pall Life Sciences   (United States)

^d HUMAN PROTEIN PROCESS SCIENCES   (France)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING FACTOR 11; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; OCTANOIC ACID;

ACID PRECIPITATION; ANION EXCHANGE CHROMATOGRAPHY; APHERESIS; ARTICLE; CONTROLLED STUDY; CRYOPRECIPITATE; ELUTION; ENZYME LINKED IMMUNOSORBENT ASSAY; EXPERIMENTAL DESIGN; FRACTIONATION; GAS CHROMATOGRAPHY; HIGH THROUGHPUT SCREENING; HUMAN; HUMAN EXPERIMENT; IMMUNOGLOBULIN BLOOD LEVEL; ION EXCHANGE CHROMATOGRAPHY; NORMAL HUMAN; PH; PROCESS OPTIMIZATION; PURIFICATION; SCALE UP; WASTE COMPONENT REMOVAL;

ANION EXCHANGE RESINS; CAPRYLATES; CATION EXCHANGE RESINS; CHEMICAL FRACTIONATION; ENZYME-LINKED IMMUNOSORBENT ASSAY; FACTOR XI; FACTOR XIA; HUMANS; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; PLASMA; PROTEIN BINDING;

EID: 84891855800     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/trf.12243     Document Type: Article

References (44)

1. Toubi E, Etzioni A,. Intravenous immunoglobulin in immunodeficiency states: state of the art. Clin Rev Allergy Immunol 2005; 29: 167-172. (Pubitemid 43041667)
2. World Health Organization. WHO model list of essential medicines. 14th ed. Geneva: World Health Organization; 2011.
3. Kivity S, Katz U, Daniel N, Nussinovitch U, Papageorgiou N, Shoenfeld Y,. Evidence for the use of intravenous immunoglobulins-a review of the literature. Clin Rev Allergy Immunol 2010; 38: 201-269.
4. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV,. Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol 2007; 27: 233-245. (Pubitemid 46790823)
5. Radosevich M, Burnouf T,. Intravenous immunoglobulin G: trends in production methods, quality control and quality assurance. Vox Sang 2010; 98: 12-28.
6. Orbach H, Katz U, Sherer Y, Shoenfeld Y,. Intravenous immunoglobulin: adverse effects and safe administration. Clin Rev Allergy Immunol 2005; 29: 173-184. (Pubitemid 43041668)
7. Carbone J,. Adverse reactions and pathogen safety of intravenous immunoglobulin. Curr Drug Saf 2007; 2: 9-18. (Pubitemid 46723165)
8. Cunningham-Rundles C, Zhou Z, Mankarious S, Courter S,. Long-term use of IgA-depleted intravenous immunoglobulin in immunodeficient subjects with anti-IgA antibodies. J Clin Immunol 1993; 13: 272-278. (Pubitemid 23224364)
9. Mollnes TE, Hogasen K, De Carolis C, Vaquero E, Nielsen EW, Fontana L, Perricone R,. High-dose intravenous immunoglobulin treatment activates complement in vivo. Scand J Immunol 1998; 48: 312-317. (Pubitemid 28416976)
10. Bleeker WK, Agterberg J, Rigter G, de Vries-van Rossen A, Bakker JC,. An animal model for the detection of hypotensive side effects of immunoglobulin preparations. Vox Sang 1987; 52: 281-290. (Pubitemid 17084007)
11. Alving BM, Tankersley DL, Mason BL, Rossi F, Aronson DL, Finlayson JS,. Contact-activated factors: contaminants of immunoglobulins preparations with coagulant and vasoactive properties. J Lab Clin Med 1980; 96: 334-346. (Pubitemid 10034120)
12. Pierce LR, Jain N,. Risks associated with the use of intravenous immunoglobulin. Transfus Med Rev 2003; 17: 241-251. (Pubitemid 37310931)
13. Dalakas MC,. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994; 44: 223-226. (Pubitemid 24070955)
14. Wolberg AS, Kon RH, Monroe DM, Hoffman M,. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000; 65: 30-34.
15. Etscheid M, Breitner-Ruddock S, Gross S, Hunfeld A, Seitz R, Dodt J,. Identification of kallikrein and FXIa as impurities in therapeutic immunoglobulins: implications for the safety and control of intravenous blood products. Vox Sang 2012; 102: 40-46.
16. Drelich DA, Bray PF, Herman JH,. Immunoglobulin therapy and thrombosis: coincidence or causation? Transfusion 2012; 52: 2075-2077.
17. Daniel GW, Menis M, Sridhar G, Scott D, Wallace AE, Ovanesov MV, Golding B, Anderson SA, Epstein J, Martin D, Ball R, Izurieta HS,. Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010. Transfusion 2012; 52: 2113-2121.
18. Roemisch JR, Kaar W, Zoechling A, Kannicht C, Putz M, Kohla G,. Identification of activated FXI as the major biochemical root cause in IVIG batches associated with thromboembolic events. Analytical and experimental approaches resulting in corrective and preventive measures implemented into the Octagam® manufacturing process. WebmedCentral Immunother 2011; 2: WMC002002.
19. US Food and Drug Administration. Octagam (immune globulin intravenous (human)) 5% liquid preparation: market withdrawal-risk of thromboembolic events. Bethesda: US Food and Drug Administration; 2010 [cited 2013 Mar 12]. Available from: URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm223968.htm
20. European Medicines Agency. European Medicines Agency recommends suspension of Octagam in all EU member states. CHMP recommendation based on risk of thromboembolic reactions. EMA/CHMP/591722/2010. 24 September 2010. London. London: European Medicines Agency; 2010. [cited 2013 Mar 12]. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/ Safetywarningsandmessagesformedicines/CON094141
21. Caress JB, Hobson-Webb L, Passmore LV, Finkbiner AP, Cartwright MS,. Case-control study of thromboembolic events associated with IV immunoglobulin. J Neurol 2009; 256: 339-342.
22. Hefer D, Jaloudi M,. Thromboembolic events as an emerging adverse effect during high-dose intravenous immunoglobulin therapy in elderly patients: a case report and discussion of the relevant literature. Ann Hematol 2004; 83: 661-665. (Pubitemid 39317492)
23. Rojas G, Jimenez JM, Gutierrez JM,. Caprylic acid fractionation of hyperimmune horse plasma: description of a simple procedure for antivenom production. Toxicon 1994; 32: 351-363. (Pubitemid 24104444)
24. Pezzini J, Joucla G, Gantier R, Toueille M, Lomenech AM, Le Senechal C, Garbay B, Santarelli X, Cabanne C,. Antibody capture by mixed-mode chromatography: a comprehensive study from determination of optimal purification conditions to identification of contaminating host cell proteins. J Chromatogr A 2011; 1218: 8197-8208.
25. Burnouf-Radosevich M, Appourchaux P, Huart JJ, Burnouf T,. Nanofiltration, a new specific virus elimination method applied to high-purity factor IX and factor XI concentrates. Vox Sang 1994; 67: 132-138. (Pubitemid 24247527)
26. Burnouf-Radosevich M, Burnouf T,. A therapeutic, highly purified factor XI concentrate from human plasma. Transfusion 1992; 32: 861-867. (Pubitemid 23001636)
27. Su CY, Kuo YP, Lin YC, Huang CT, Tseng YH, Burnouf T,. A virally inactivated functional growth factor preparation from human platelet concentrates. Vox Sang 2009; 97: 119-128.
28. Su CY, Kuo YP, Nieh HL, Tseng YH, Burnouf T,. Quantitative assessment of the kinetics of growth factors release from platelet gel. Transfusion 2008; 48: 2414-2420.
29. Burnouf T,. Modern plasma fractionation. Transfus Med Rev 2007; 21: 101-117. (Pubitemid 46482990)
30. Hooper JA,. Intravenous immunoglobulins: evolution of commercial IVIG preparations. Immunol Allergy Clin North Am 2008; 28: 765-778.
31. Poelsler G, Berting A, Kindermann J, Spruth M, Hammerle T, Teschner W, Schwarz HP, Kreil TR,. A new liquid intravenous immunoglobulin with three dedicated virus reduction steps: virus and prion reduction capacity. Vox Sang 2008; 94: 184-192. (Pubitemid 351379655)
32. Parkkinen J, Rahola A, von Bonsdorff L, Tolo H, Torma E,. A modified caprylic acid method for manufacturing immunoglobulin G from human plasma with high yield and efficient virus clearance. Vox Sang 2006; 90: 97-104. (Pubitemid 43381497)
33. Lebing W, Remington KM, Schreiner C, Paul HI,. Properties of a new intravenous immunoglobulin (IGIV-C, 10%) produced by virus inactivation with caprylate and column chromatography. Vox Sang 2003; 84: 193-201. (Pubitemid 36514176)
34. Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J,. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol 2000; 20: 94-100. (Pubitemid 30314313)
35. Lihme A, Hansen MB, Andersen IV, Burnouf T,. A novel core fractionation process of human plasma by expanded bed adsorption chromatography. Anal Biochem 2010; 399: 102-109.
36. Vargas M, Segura A, Herrera M, Villalta M, Angulo Y, Gutierrez JM, Leon G, Burnouf T,. Purification of IgG and albumin from human plasma by aqueous two phase system fractionation. Biotechnol Prog 2012; 28: 1005-1011.
37. Lemm G,. Composition and properties of IVIg preparations that affect tolerability and therapeutic efficacy. Neurology 2002; 59: S28-32. (Pubitemid 36076546)
38. de Albuquerque Campos R, Sato MN, da Silva Duarte AJ,. IgG anti-IgA subclasses in common variable immunodeficiency and association with severe adverse reactions to intravenous immunoglobulin therapy. J Clin Immunol 2000; 20: 77-82. (Pubitemid 30210110)
39. Dichtelmuller H, Rudnick D, Kloft M,. Inactivation of lipid enveloped viruses by octanoic acid treatment of immunoglobulin solution. Biologicals 2002; 30: 135-142. (Pubitemid 36268641)
40. Burnouf T, Sayed M, Radosevich M, Goubran H, Gorgy G, El-Ekiaby M,. Small-pool caprylic acid fractionation of immunoglobulin G in disposable equipment (4D-S27-05). Vox Sang 2010; 99 (Suppl 1): 48.
41. Teschner W, Butterweck HA, Auer W, Muchitsch EM, Weber A, Liu SL, Wah PS, Schwarz HP,. A new liquid, intravenous immunoglobulin product (IGIV 10%) highly purified by a state-of-the-art process. Vox Sang 2007; 92: 42-55. (Pubitemid 44950349)
42. Hibbert DB,. Experimental design in chromatography: a tutorial review. J Chromatogr B Analyt Technol Biomed Life Sci 2012; 910: 2-13.
43. Burnouf T, Radosevich M,. Reducing the risk of infection from plasma products: specific preventative strategies. Blood Rev 2000; 14: 94-110. (Pubitemid 30616183)
44. Fujikawa K, Chung DW, Hendrickson LE, Davie EW,. Amino acid sequence of human factor XI, a blood coagulation factor with four tandem repeats that are highly homologous with plasma prekallikrein. Biochemistry 1986; 25: 2417-2424.