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

Abstract
We have evaluated for the first time the impact of a solvent/detergent (S/D) treatment on the quality and in vivo neutralization potency of horse-derived whole IgG antivenom used in the treatment of viperid snake bite envenoming in Central America. The S/D treatment by 1% tri (n-butyl) phosphate (TnBP) - 1% Triton X-45 at 22-25 degrees C was applied either on starting plasma or on purified immunoglobulins. The S/D agents were removed from both fractions by extractions with oil. S/D-treated plasma was subjected to caprylic acid precipitation to purify the immunoglobulins. Products were formulated, sterile-filtered, and filled into 10-mL vials, stored at 5+/-3 degrees C, and subjected to routine quality controls, SDS-PAGE, determination of anti-Bothrops asper venom antibody titre by ELISA, in vivo B. asper venom-neutralization potency tests, and safety test, comparatively with an antivenom manufactured by caprylic acid fractionation without S/D treatment. Results indicate that these conditions of S/D treatment on purified immunoglobulin yielded an antivenom of high turbidity that induced weight loss in animals. In contrast, antivenom fractionated from the S/D-treated plasma had physico-chemical and biological characteristics indistinguishable from those of the non-S/D-treated antivenom. S/D treatment of horse plasma may be considered to increase the viral safety of antivenoms.
AuthorsAlvaro Segura, Guillermo León, Chen-Yao Su, José-María Gutiérrez, Thierry Burnouf
JournalBiologicals : journal of the International Association of Biological Standardization (Biologicals) Vol. 37 Issue 5 Pg. 306-12 (Oct 2009) ISSN: 1095-8320 [Electronic] England
PMID19540775 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antivenins
  • Crotalid Venoms
  • Detergents
  • Immunoglobulin G
  • Organophosphates
  • Solvents
  • Octoxynol
  • tributyl phosphate
Topics
  • Algorithms
  • Animals
  • Antivenins (adverse effects, drug effects, immunology, therapeutic use)
  • Bothrops (immunology)
  • Crotalid Venoms (immunology)
  • Detergents (pharmacology)
  • Horses (blood, immunology)
  • Immunoglobulin G (chemistry, drug effects)
  • Neutralization Tests (methods, standards)
  • Octoxynol (pharmacology)
  • Organophosphates (pharmacology)
  • Quality Control
  • Snake Bites (drug therapy)
  • Solvents (pharmacology)

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