Inactivation of the Hutchinson strain of hepatitis non-A, non-B virus in intravenous immunoglobulin by beta-propiolactone.
beta-propiolactone (beta-PL) treatment has been evaluated for its ability to inactivate 10(3.5) chimpanzee infectious doses (CID50) of the Hutchinson strain of hepatitis non-A, non-B virus (HNANBV). Two chimpanzees were inoculated with a beta-PL-treated immunoglobulin solution to which this dose of the titrated virus had been added prior to beta-PL treatment. beta-PL treatment was performed in accordance with the production procedure used for a licensed intravenous immunoglobulin preparation. Neither animal developed hepatitis. When subsequently challenged with the same spiked immunoglobulin solution that had not been beta-PL treated, both animals developed clear-cut hepatitis non-A, non-B. The results of this experiment demonstrate that beta-PL treatment is effective for the inactivation of hepatitis non-A, non-B virus in intravenous immunoglobulin.
Stephan
W
W
Biotest Pharma GmbH, Res. Dept. Frankfurt/M, Federal Republic of Germany.
Dichtelmüller
H
H
Prince
A M
AM
Brotman
B
B
Huima
T
T
D000818:Animals; D000998:Antiviral Agents; D004340:Drug Contamination; D004353:Drug Evaluation, Preclinical; D005260:Female; D006526:Hepatitis C / Q000517:prevention & control* / Q000635:transmission; D006518:Hepatitis Viruses / Q000187:drug effects*; D006525:Hepatitis, Viral, Human / Q000517:prevention & control*; D007136:Immunoglobulins / Q000008:administration & dosage / Q000009:adverse effects*; D007275:Injections, Intravenous; D007783:Lactones / Q000494:pharmacology*; D002679:Pan troglodytes; D011420:Propiolactone / Q000494:pharmacology*
D000998:Antiviral Agents; D007136:Immunoglobulins; D007783:Lactones; D011420:Propiolactone