Preparation of lyophilized and liquid intravenous immunoglobulin G: Development and scale-up

Vox Sanguinis

Volumn 80, Issue 4, 2001, Pages 216-224

  Sisti, A M ^a   Vitali, M S ^a   Manfredi, M J ^a   Zarzur, J A ^a  

^a UNIVERSIDAD NACIONAL DE CÓRDOBA   (Argentina)

Author keywords

Liquid IVIG; Lyophilized IVIG; Molecular distribution

Indexed keywords

IMMUNOGLOBULIN G; PEPSIN A;

ARTICLE; AUTOIMMUNE DISEASE; DIAFILTRATION; DRUG MANUFACTURE; FREEZE DRYING; IMMUNE DEFICIENCY; INFECTION; INFLAMMATORY DISEASE; MEDICAL LITERATURE; PRIORITY JOURNAL; VIRUS INACTIVATION; WORLD HEALTH ORGANIZATION;

FREEZE DRYING; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULINS, INTRAVENOUS;

EID: 0035353336     PISSN: 00429007     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1423-0410.2001.00041.x     Document Type: Article

References (29)

1. WHO Expert Committee on Biological Standardization: Requirements for the collection, processing, quality control of blood, blood components and plasma derivatives. WHO Technical Reports Series 1994; 840:31-99
2. Human normal immunoglobulin for intravenous administration; in: European Pharmacopoeia. Strasbourg, The European Department for the Quality of Medicines - Council of Europe, 1997:963-965
3. Römer J, Späth PJ, Skvaril F, Nydegger UE: Characterization of various immunoglobulin preparations for intravenous application. Vox Sang 1982; 42:62-80
4. Van Furth R, Braat AGP, Leijh PCJ, Gardi A: Opsonic and physicochemical characteristics of intravenous immunoglobulin preparations. Vox Sang 1987; 53:70-75
5. Hämäläinen E, Suomela H, Ukhomen P: Virus inactivation during intravenous immunoglobulin production. Vox Sang 1992; 63:6-11
6. Bridonneau P, Marcilly H, Vernois-Martin M, Goigoux P, Bourdel V, Laulan A, Deramoudt FX, Desmadril M, Sitbon M, Basuyaux B, Steinbuch M, Schmitthaeusler R: Liquid pasteurization of an immunoglobulin preparation without stabilizer: Effects on its biological and biochemical properties. Vox Sang 1996; 70:203-209
7. Reid KG, Cuthbertson AD, Jones ADL, McIntosh RV: Potential contribution of mild pepsin treatment at pH4 to the viral safety of human immunoglobulin products. Vox Sang 1988; 55:75-80
8. Barandun S, Isliker H: Development of immunoglobulin preparations for intravenous use. Vox Sang 1986; 51:157-160
9. Cohn EJ, Strong LE, Hughes W, Mulford D, Ashworth J, Melin N, Taylor H: Preparation and properties of serum and plasma proteins. J Am Chem Soc 1946; 68:459-475
10. Oncley JL, Melin M, Richert DA, Cameron J: The separation of antibodies, issoagglutinins, prothrombin, plasminogen, and beta 1 lipoprotein into fractions of human plasma. J Am Chem Soc 1949; 71:541-550
11. Vitali MS: Thermal Viral Inactivation of IgG. Validation of Procedure. Master Thesis. Cordoba, Argentina, Laboratorio de Hemoderivados. University National of Cordoba, 1994
12. Uemura Y, Uriyu K, Hirao Y, Takechi K, Ishikawa H, Kakajima T, Kagitani Y, Yokoyama K, Funakoshi S, Nishida M, Yabushita S, Furuta K, Hamamoto Y, Tochikura S, Yamamoto N: Inactivation and elimination of viruses during the fractionation of an intravenous immunoglobulin preparation. Liquid heat treatment and polyethylene glycol fractionation. Vox Sang 1989; 56:155-161
13. Kabat EA, Mayer MM: Complement and complement fixation; in Kabat EA, Mayer MM (ed.): Experimental Immunochemistry, 2nd Edn. Springfield, IL, Thomas CC, 1961:135-154
14. Joy Yang YH, Ngo C, Ng Yeh I, Uemura Y: Antibody Fc functional activity of intravenous immunoglobulin preparations treated with solvent-detergent for virus inactivation. Vox Sang 1994; 67:337-344
15. Friderger P: Chromogenic peptide substrates, their use for the assay of factors in the fibrinolytic and plasma kallikrein-kinin systems. Scand J Clin Lab Invest 1982; 42:2-98
16. Alving BM, Tankersley DL, Mason BL, Rossi F, Aronson DL, Finlayson JS: Contact-activated factors: Contaminants of immunoglobulin preparations with coagulant and vasoactive properties. J Lab Cli Med 1980; 96:334-346
17. Committee for proprietary medicinal products, Ad hoc working party on biotechnology/pharmacy and working party on safety medicines: EEC regulatory document, note for guidance. Validation of virus removal and inactivation procedures. Biologicals 1991; 19:247-251
18. Sisti AM: Development of Methods to Obtain Preparations of Intravenous Immunoglobulin G. Master Thesis, Cordoba, Argentina, Laboratorio de Hemoderivados, University National of Cordoba, 1994
19. Memorandum from an IUIS/WHO meeting: Appropriate uses of human immunoglobulin in clinical practice. Bull WHO 1982; 60:43-47
20. Barandun S, Kistler P, Jeunet F, Isliker H: Intravenous administration of human γ-globulin. Vox Sang 1962; 7:157-174
21. Cuthbertson K, Reid G, Foster PR: Viral contamination of human plasma and procedures for preventing virus transmission by plasma products; in Harris JR (ed.): Blood Separation and Plasma Fractionation. New York, NY, John Wiley and Sons Inc., 1991:385-435
22. Hamamoto Y, Harada S, Yamamoto N, Huemura Y, Goto T, Suyama T: Elimination of viruses (human immunodeficiency, hepatitis B, vesicular stomatosis and sindbis viruses) from an intravenous immunoglobulin preparation. Vox Sang 1987; 53:56-69
23. Rosenquist E, Jossang T, Feder J: Thermal properties of human IgG. Mol Immunol 1960; 85:163-171
24. Meireles M, Aimar P, Sánchez V: Albumin denaturation during utrafiltration: Effects of operating conditions and consequences on membrane fouling. Biotechnol Bioeng 1991; 38:528-534
25. Dong A, Prestrelski SJ, Allison DS, Carpenter JF: Infrared spectroscopic studies of lyophilization- and temperature-induced protein aggregation. J Pharm Sci 1995; 84:415-424
26. Creighton TE: Physical and chemical properties of soluble proteins; in Creighton TE (ed.): Structures and Molecular Properties, 2nd Edn. New York, NY, W H Freeman and Company, 1993:261-276
27. Human plasma for fractionation; in: European Pharmacopoeia, Suppl. Strasbourg, The European Department for the Quality of Medicines - Council of Europe, 1998:339-341
28. Morgenthaler JJ: Effect of ethanol on viruses; in Morgenthaler JJ (ed.): Curr Stud Hematol Blood Transfus. Basel, Karger, 1989; 56:109-121
29. Morgenthaler JJ, Lerch PG.: Virus-safety of immunoglobulin preparations; in Stoltz JF, Rivat C (eds): Biotechnology of Plasma Proteins. Colloque INSERM, vol. 175. London, John Libbey Eurotext Ltd, INSERM, 1989:439-446