Partitioning and inactivation of viruses by the caprylic acid precipitation followed by a terminal pasteurization in the manufacturing process of horse immunoglobulins

Biologicals

Volumn 35, Issue 4, 2007, Pages 335-341

  Mpandi, M ^a   Schmutz, P ^a   Legrand, E ^a   Duc, R ^a   Geinoz, J ^a   Henzelin Nkubana, C ^a   Giorgia, S ^a   Clerc, O ^a   Genoud, D ^a   Weber, T ^a  

^a R and D   (Switzerland)

Author keywords

Caprylic acid; Horse; Immunoglobulines; Manufacturing process; Pasteurization; Virus inactivation; Virus removal

Indexed keywords

HUMAN ALBUMIN; IMMUNOGLOBULIN; OCTANOIC ACID; SEROCYTOL; STABILIZING AGENT; UNCLASSIFIED DRUG;

ANIMAL CELL; ARTICLE; BOVINE VIRAL DIARRHOEA VIRUS; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG SAFETY; ENCEPHALOMYOCARDITIS VIRUS; FLAVIVIRUS; HORSE; NONHUMAN; PARTITION COEFFICIENT; PARVOVIRUS; PASTEURIZATION; PRECIPITATION; PRIORITY JOURNAL; PSEUDORABIES HERPETOVIRUS; SURVIVAL; VALIDATION PROCESS; VIRUS ENVELOPE; VIRUS INACTIVATION; VIRUS INFECTIVITY; VIRUS NEUTRALIZATION; VIRUS SPIKE;

ANIMALS; DIARRHEA VIRUS 1, BOVINE VIRAL; DISINFECTION; DRUG CONTAMINATION; ENCEPHALOMYOCARDITIS VIRUS; HEAT; HERPESVIRUS 1, SUID; HORSES; IMMUNOGLOBULINS; MINUTE VIRUS OF MICE; OCTANOIC ACIDS; PRECIPITATION; SAFETY; VIRUS INACTIVATION;

BOVINAE; BOVINE VIRAL DIARRHEA VIRUS 1; ENCEPHALOMYOCARDITIS VIRUS; EQUIDAE; MAMMALIA; MINUTE VIRUS OF MICE; SUID HERPESVIRUS 1;

EID: 35248891618     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2007.02.004     Document Type: Article

References (29)

1. Buchacher A, Iberer G. Biotechnol J. Purification of intravenous immunoglobulin G from human plasma-aspects of yield and virus safety 2006 Feb;1(2):148-163.
2. Pharmacopée Européenne, IV ème édition, DEQM. Conseil de l'Europe, 67075 (2002), Strasbourg Cedex, France
3. Lundblad J.L., and Seng R.L. Inactivation of lipid-enveloped viruses in labile blood derivates by unsaturated fatty acids. Vox Sang 60 (1991) 75-81
4. Traul K.A., Driedger A., Ingle D.L., and Nakhasi D. Review of the toxicologic properties of medium-chain triglycerides. Food Chem Toxicol 38 (2000) 79-98
5. Steinbuch M., and Audran R. The isolation of IgG from mammalian sera with the aid of caprylic acid. Arch Biochem Biophys 134 (1969) 279-284
6. Rojas G., Jimenez J.M., and Gutierrez J.M. Caprylic acid fractionation of hyperimmune horse plasma: description of a simple procedure for antivenom production. Toxicon 32 (1994) 351-363
7. Gellis S.S., Neefe J.R., Stokes J., Strong L.E., Janeway C.A., and Scatchard G. Chemical clinical and immunological studies on the products of human plasma fractionation. XXXVI. Inactivation of the virus of homologous serum hepatitis in solutions of normal human serum albumin by means of heat. J Clin Invest 27 (1948) 239-244
8. ® "Muqueuse urinaire" and "S.R.E." in patients with urological disorders. Int Urol Nephrol 17 (1985) 29-33
9. Bridonneau P., Marcilly H., Vernois-Martin M., Goigoux P., Bourdel V., Laulan A., et al. Liquid pasteurization of an immunoglobulin preparation without stabilizer: effects on its biological and biochemical properties. Vox Sang 70 4 (1996) 203-209
10. Laemmli U.K. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature 227 (1970) 680-685
11. Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, Q5A, FDA; 1998.
12. Virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses. CPMP/BWP/268/95; 1996.
13. Galeone M., Moise G., Cacioli D., Megevand J., Bignamini A.A., and Beretta M.G. The use of antisera ('Serocytol') in the management of gastritis: a double-blind clinical assessment versus placebo. Curr Med Res Opin 9 (1985) 642-649
14. Ginsberg F., Mingard P., and Weber T. Double-blind study on antitissue immunoglobulin injections versus placebo in the treatment of acute lumbar pain with muscular spasms. Int J Clin Pharmacol Res 7 (1987) 401-405
15. Piccione F., Grecomoro G., Pinto B., and Sanfilippo A. Immune therapy of osteoarthritis: an open assessment of clinical results with heterologous antibodies to articular tissue ('Serocytol'). Pharmatherapeutica 4 (1986) 577-584
16. Ginsberg F. Comparative clinical evaluation of the activity of Ser-316 suppository in the treatment of lumbar osteoarthrosis. Curr Med Res Opin 12 (1991) 413-422
17. Kempenaers C., Simenon G., Vander E., Fransolet L., Mingard P., de Maertelaer V., et al. Effect of an antidiencephalon immune serum on pain and sleep in primary fibromyalgia. Neuropsychobiology 30 (1994) 66-72
18. Clot J., and Andary M. Anticorps de cheval anti-système réticulo-endothélial (SRE). Spécificité et propriétés vis à vis des cellules du SRE humain. Méd Hyg 41 (1983) 2838-2844
19. Burnouf T., Griffiths E., Padilla A., Seddik S., Stephano M.A., and Gutierrez J.M. Assessment of the viral safety of antivenoms fractionated from equine plasma. Biologicals 32 3 (2004 Sep) 115-128
20. ®) in age-related macular degeneration. Geneva Foundation for Medical Education and Research (11 Aug 2006). http://www.gfmer.ch/presentations_en/serocytol_age_related-macular_degeneration Available from: http://www.gfmer.ch/presentations_en/serocytol_age_related-macular_degeneration
21. McLaren R.D., Prosser C.G., Grieve R.C., and Borissenko M. The use of caprylic acid for the extraction of the immunoglobulin fraction from egg yolk of chickens immunised with ovine alpha-lactalbumin. J Immunol Methods 177 (1994) 175-184
22. Note for guidance on production and quality control of immunoglobulins and immunosera for human use. CPMP/BWP/3354/99; 2002.
23. Nowak T., Niedrig M., Bernhardt D., and Hilfenhaus J. Inactivation of HIV, HBV, HCV related viruses and other viruses in human plasma derivatives by pasteurisation. Dev Biol Stand 81 (1993) 169-176
24. Sisti M., Vitali M.S., Manfredi M.J., and Zarzur J.A. Preparation of lyophilized and liquid intravenous immunoglobulin G: development and scale-up. Vox Sang 80 (2001) 216-224
25. Horowitz B., and Ben-Hur E. Strategies for viral inactivation. Curr Opin Hematol 2 (1995) 484-492
26. Johnston A., Uren E., Johnstone D., Wu J., and Low p.H. caprylate incubation as a second viral inactivation step in the manufacture of albumin. Parametric and validation studies. Biologicals 31 (2003) 213-221
27. Korneyeva M., Hotta J., Lebing W., Rosenthal R.S., Franks L., and Petteway Jr. S.R. Enveloped virus inactivation by caprylate: a robust alternative to solvent-detergent treatment in plasma derived intermediates. Biologicals 30 (2002) 153-162
28. Lebing W., Remington K.M., Schreiner C., and Paul H.I. Properties of a new intravenous immunoglobulin (IGIV-C, 10%) produced by virus inactivation with caprylate and. Vox Sang 84 (2003) 193-201
29. Trejo S.R., Hotta J.A., Lebing W., Stenland C., Storms R.E., Lee D.C., et al. Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process. Vox Sang 84 (2003) 176-187