Effect of terminal (dry) heat treatment on non-enveloped viruses in coagulation factor concentrates.
Terminal dry heat treatment effectively inactivated hepatitis A virus (HAV) and canine parvovirus added to high-purity factor VIII. After 24 h at 80 degrees C, HAV infectivity was reduced by > or = 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 degrees 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 degrees C or 10 h at 90 degrees 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.
Hart
H F
HF
Protein Fractionation Centre, Scottish Blood Transfusion Service, Edinburgh, UK.
Hart
W G
WG
Crossley
J
J
Perrie
A M
AM
Wood
D J
DJ
John
A
A
McOmish
F
F
D000818:Animals; D001483:Base Sequence; D001769:Blood / Q000821:virology*; D001779:Blood Coagulation Factors / Q000302:isolation & purification*; D002460:Cell Line; D002522:Chlorocebus aethiops; D004797:Enzyme-Linked Immunosorbent Assay; D005164:Factor IX / Q000302:isolation & purification; D005612:Freeze Drying; D006507:Hepatovirus / Q000254:growth & development / Q000502:physiology; D006358:Hot Temperature; D006801:Humans; D008969:Molecular Sequence Data; D017993:Parvovirus, Canine / Q000502:physiology; D016133:Polymerase Chain Reaction; D014776:Virus Cultivation; D018406:Virus Physiological Phenomena; D014779:Virus Replication; D014780:Viruses
D001779:Blood Coagulation Factors; D005164:Factor IX