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.