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Tri(n‐Butyl) Phosphate/Detergent Treatment of Licensed Therapeutic and Experimental Blood Derivatives 1

Abstract. Incubation of an AHF concentrate with 0.3% tri(n‐butyl)phosphate (TNBP) and 0.2% sodium cholate was shown to inactivate at least 10,000 infectious doses of lipid‐enveloped viruses, including hepatitis B and non‐A, non‐B viruses and HTLV‐III [Prince et al., Lancet i, pp. 706–710, 1986]. The use of TNBP/detergent combinations for virus sterilization was evaluated further to determine its effect on the structure and function of a wide variety of blood proteins. Vesicular stormatitis and Sindbis viruses were used as markers of virus inactivation. TNBP/detergent treatment did not significantly alter the function of AHF, factor VII, factor IX, factor X, fibrinogen, factor XIII, fibronectin, anti‐HBsAg and anti‐HA in normal immune serum globulin, haptoglobin, tumor necrosis factor, α‐interferon, and both native and chemically polymerized stroma‐free hemoglobin. As compared with partially purified derivatives, the extent of virus sterilization of plasma and component cryoprecipitate with 0.3% TNBP and 0.2% sodium cholate at ambient temperature could be improved by raising the TNBP concentration and temperature. Virus sterilization by TNBP/detergent mixtures appears to be generally applicable to blood protein derivatives.