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

Biologicals. 2009 Oct;37(5):306-12. doi: 10.1016/j.biologicals.2009.05.003. Epub 2009 Jun 21.

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.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Algorithms
  • Animals
  • Antivenins / adverse effects
  • Antivenins / drug effects*
  • Antivenins / immunology
  • Antivenins / therapeutic use
  • Bothrops / immunology
  • Crotalid Venoms / immunology
  • Detergents / pharmacology*
  • Horses / blood
  • Horses / immunology
  • Immunoglobulin G / chemistry
  • Immunoglobulin G / drug effects*
  • Neutralization Tests / methods*
  • Neutralization Tests / standards
  • Octoxynol / pharmacology
  • Organophosphates / pharmacology
  • Quality Control
  • Snake Bites / drug therapy
  • Solvents / pharmacology*

Substances

  • Antivenins
  • Crotalid Venoms
  • Detergents
  • Immunoglobulin G
  • Organophosphates
  • Solvents
  • Octoxynol
  • tributyl phosphate