Assessment of the impact of solvent/detergent treatment on the quality and potency of a whole IgG equine antivenom

Biologicals

Volumn 37, Issue 5, 2009, Pages 306-312

  Segura, Álvaro ^a   León, Guillermo ^a   Su, Chen Yao ^b   Gutiérrez, José María ^a   Burnouf, Thierry ^c,d  

^a UNIVERSIDAD DE COSTA RICA   (Costa Rica)

^b NATIONAL YANG MING UNIVERSITY   (Taiwan)

^c TAIPEI MEDICAL UNIVERSITY   (Taiwan)

^d HUMAN PROTEIN PROCESS SCIENCES   (France)

Author keywords

Antivenom; Neutralization; Snake bite envenoming; Solvent detergent; Viral inactivation

Indexed keywords

IMMUNOGLOBULIN G ANTIBODY; OCTANOIC ACID; SNAKE VENOM ANTISERUM;

ANTIBODY TITER; ARTICLE; CENTRAL AMERICA; CONTROLLED STUDY; DRUG POTENCY; DRUG PURIFICATION; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; PHYSICAL CHEMISTRY; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRIORITY JOURNAL; QUALITY CONTROL; SNAKEBITE; TURBIDITY; VACCINE PRODUCTION;

ALGORITHMS; ANIMALS; ANTIVENINS; BOTHROPS; CROTALID VENOMS; DETERGENTS; HORSES; IMMUNOGLOBULIN G; NEUTRALIZATION TESTS; OCTOXYNOL; PHOSPHORIC ACID ESTERS; QUALITY CONTROL; SNAKE BITES; SOLVENTS;

ANIMALIA; BOTHROPS ASPER; EQUIDAE; VIPERIDAE;

EID: 69649102234     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2009.05.003     Document Type: Article

References (38)

1. Theakston R.D., Warrell D.A., and Griffiths E. Report of a WHO workshop on the standardization and control of antivenoms. Toxicon 41 (2003) 541-557
2. Chippaux J.P., and Goyffon M. Venoms, antivenoms and immunotherapy. Toxicon 36 (1998) 823-846
3. Gutierrez J.M., Theakston R.D., and Warrell D.A. Confronting the neglected problem of snake bite envenoming: the need for a global partnership. PLoS Med 3 (2006) e150
4. Kasturiratne A., Wickremasinghe A.R., de Silva N., Gunawardena N.K., Pathmeswaran A., Premaratna R., et al. The global burden of snakebite: a literature analysis and modelling based on regional estimates of envenoming and deaths. PLoS Med 5 (2008) e218
5. CPMP. Note for guidance on production and quality control of animal immunoglobulins and immunsera for human (2002), European Agency for the Evaluation of Medicinal Products (EMEA), London. http://www.emea.eu.intuse
6. Grandgeorge M., Véron J.L., Lutsch C., Makula M.F., Riffard P., Pépin S., et al. Preparation of improved F(ab′)2 antivenoms. An example: new polyvalent European viper antivenom (equine). In: Bon C., and Goyffon M. (Eds). Envenomings and their treatments (1996), Fondation Marcel Mérieux, Lyon 161-172
7. Denton A: Practical experience with the use of Planova 15N in the manufacture of FDA approved products. In: Seventh Planova Workshop 2004 in Europe. Lisbon, Portugal, Asahi kasei; 2004.
8. Burnouf T., Radosevich M., Goubran H.A., and Willkommen H. Place of nanofiltration for assuring viral safety of biologicals. Curr Nanosci 1 (2005) 189-201
9. Burnouf T., Terpstra F., Habib G., and Seddik S. Assessment of viral inactivation during pH 3.3 pepsin digestion and caprylic acid treatment of antivenoms. Biologicals 35 (2007) 329-334
10. Mpandi M., Schmutz P., Legrand E., Duc R., Geinoz J., Henzelin-Nkubana C., et al. Partitioning and inactivation of viruses by the caprylic acid precipitation followed by a terminal pasteurization in the manufacturing process of horse immunoglobulins. Biologicals 35 (2007) 335-341
11. 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 (2004) 115-128
12. Horowitz B., Wiebe M.E., Lippin A., and Stryker M.H. Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri(n-butyl)phosphate detergent combinations. Transfusion 25 (1985) 516-522
13. Burnouf T., and Radosevich M. Reducing the risk of infection from plasma products: specific preventative strategies. Blood Rev 14 (2000) 94-110
14. WHO. Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products (2003), WHO, Geneva. www.WHO.int
15. 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
16. Angulo Y., Estrada R., and Gutierrez J.M. Clinical and laboratory alterations in horses during immunization with snake venoms for the production of polyvalent (Crotalinae) antivenom. Toxicon 35 (1997) 81-90
17. Burnouf T., Goubran H.A., Radosevich M., Sayed M.A., Gorgy G., and El-Ekiaby M. A process for solvent/detergent treatment of plasma for transfusion at blood centers that use a disposable-bag system. Transfusion 46 (2006) 2100-2108
18. Piet M.P., Chin S., Prince A.M., Brotman B., Cundell A.M., and Horowitz B. The use of tri(n-butyl)phosphate detergent mixtures to inactivate hepatitis viruses and human immunodeficiency virus in plasma and plasma's subsequent fractionation. Transfusion 30 (1990) 591-598
19. Horowitz B., Bonomo R., Prince A.M., Chin S.N., Brotman B., and Shulman R.W. Solvent/detergent-treated plasma: a virus-inactivated substitute for fresh frozen plasma. Blood 79 (1992) 826-831
20. Lacoste R.J., Venable S.H., and Stone J.C. Modified 4-aminoantipyrine colorimetric method for phenols. Application to an acrylic monomer. Anal Chem 31 (1959) 1246-1249
21. Su C.Y., Kuo Y.P., Nieh H.L., Tseng Y.H., and Burnouf T. Quantitative assessment of the kinetics of growth factors release from platelet gel. Transfusion 48 (2008) 2414-2420
22. Lomonte B., Gutierrez J.M., Rojas G., and Calderon L. Quantitation by enzyme-immunoassay of antibodies against Bothrops myotoxins in four commercially-available antivenoms. Toxicon 29 (1991) 695-702
23. Rojas E., Quesada L., Arce V., Lomonte B., Rojas G., and Gutierrez J.M. Neutralization of four Peruvian Bothrops sp. snake venoms by polyvalent antivenoms produced in Peru and Costa Rica: preclinical assessment. Acta Trop 93 (2005) 85-95
24. Gutiérrez J.M., Rojas G., Lomonte B., Gene J.A., Chaves F., Alvarado J., et al. Standardization of assays for testing the neutralizing ability of antivenoms. Toxicon 28 (1990) 1127-1129 [author reply 9-32]
25. Finney D.J. Probit analysis. 3rd ed (1971), Cambridge University Press, Cambridge, UK
26. Michalski C., Bal F., Burnouf T., and Goudemand M. Large-scale production and properties of a solvent-detergent-treated factor IX concentrate from human plasma. Vox Sang 55 (1988) 202-210
27. Nellaiappan K., Nicklas G., Yao S., and Malliaros D.P. Validation of a simple and sensitive gas chromatographic method for the analysis of tri-n-butyl phosphate from virally inactivated human immunoglobulin. J Chromatogr B Biomed Sci Appl 757 (2001) 181-189
28. Eriksson R.K., Fenge C., Lindner-Olsson E., Ljungqvist C., Rosenquist J., Smeds A.L., et al. The manufacturing process for B-domain deleted recombinant factor VIII. Semin Hematol 38 (2001) 24-31
29. Gutiérrez J.M. Clinical toxicology of snakebite in Central America. In: Meier J., and White J. (Eds). Handbook of toxicology of animal venoms and poisons (1995), CRC Press, Boca Raton, Florida 645-665
30. Tabor E. The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1. Transfusion 39 (1999) 1160-1168
31. Burnouf T. Modern plasma fractionation. Transfus Med Rev 21 (2007) 101-117
32. Solheim B.G., Rollag H., Svennevig J.L., Arafa O., Fosse E., and Bergerud U. Viral safety of solvent/detergent-treated plasma. Transfusion 40 (2000) 84-90
33. Remington K.M., Trejo S.R., Buczynski G., Li H., Osheroff W.P., Brown J.P., et al. Inactivation of west Nile virus, vaccinia virus and viral surrogates for relevant and emergent viral pathogens in plasma-derived products. Vox Sang 87 (2004) 10-18
34. Kreil T.R. West Nile virus: recent experience with the model virus approach. Dev Biol (Basel) 118 (2004) 101-105
35. CPMP. EEC regulatory document. Note for guidance. Validation of virus removal and inactivation procedures. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines. Biologicals 19 (1991) 247-251. http://www.emea.eu.int
36. CPMP. Note for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses (revised). CPMP/BWP/CPMP/5136/03 (1996), European Agency for the Evaluation of Medicinal Products (EMEA), London. http://www.emea.eu.int
37. CPMP. Note for guidance on plasma -derived medicinal products. CPMP/BWP/269/95 rev.3. (2001), The European Agency for the Evaluation of Medicinal Products. http://www.emea.eu.int
38. Hellstern P., Sachse H., Schwinn H., and Oberfrank K. Manufacture and in vitro characterization of a solvent/detergent-treated human plasma. Vox Sang 63 (1992) 178-185