Hyper-Tet Description

Hyper-Tet treated with solvent/detergent is a sterile solution of tetanus hyperimmune immune globulin for IM administration; it contains no preservative. Hyper-Tet is prepared by cold ethanol fractionation from the plasma of donors immunized with tetanus toxoid. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hrs. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally, ultrafiltration and diafiltration. Hyper-Tet is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. It is then incubated in the final container for 21-28 days at 20-27°C. Hyper-Tet is standardized against the U.S. Standard Antitoxin and the U.S. Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per container.
The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for Hyper-Tet has been validated in laboratory studies. Human immunodeficiency virus, type 1 (HIV-1), was chosen as the relevant virus for blood products; bovine viral diarrhea virus (BVDV) was chosen to model hepatitis C virus; pseudorabies virus (PRV) was chosen to model hepatitis B virus and the herpes viruses; and reovirus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at 2 steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: The precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.