Effect of Terminal (Dry) Heat Treatment on Non‐Enveloped Viruses in Coagulation Factor Concentrates

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Abstract
Terminal dry heat treatment effectively inactivated hepatitis A virus (HAV) and canine parvovirus added to high‐purity factor VIII. After 24 h at 80°C, HAV infectivity was reduced by ≥4.3 log10 TCID50, as measured in a newly developed infectivity assay. The same reduction in virus titer was achieved after 2 h and before 6 h at 90°C. Inactivation of hepatitis A virus was also seen in the freeze‐drying step prior to heat treatment with an approximately 2.0 log10 reduction in titer. Similar results were obtained with a high‐purity factor IX concentrate. Canine parvovirus was also inactivated at both temperatures, with residual infectivity being undetected after 48 h at 80°C or 10 h at 90°C. Canine parvovirus was not affected by lyophilisation. Canine parvovirus measurements by PCR did not reflect the levels of infectivity measured by the tissue‐culture‐based method. The addition of the terminal dry heat treatment to solvent/detergent could effectively eliminate the potential contamination of solvent/detergent‐treated coagulation factor concentrates by non‐lipid‐enveloped viruses. However, careful evaluation for any increased induction of non‐antigens for factor VIII, as a consequence of such treatment, is needed before use in patients can be recommended.