Inactivation of the Hutchinson strain of hepatitis non‐A, non‐B virus in intravenous immunoglobulin by β‐propiolactone

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Abstract
β‐propiolactone (β‐PL) treatment has been evaluated for its ability to inactivate 103.5 chimpanzee infectious doses (CID50) of the Hutchinson strain of hepatitis non‐A, non‐B virus (HNANBV). Two chimpanzees were inoculated with a β‐PL‐treated immunoglobulin solution to which this dose of the titrated virus had been added prior to β‐PL treatment. β‐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 β‐PL treated, both animals developed clear‐cut hepatitis non‐A, non‐B. The results of this experiment demonstrate that β‐PL treatment is effective for the inactivation of hepatitis non‐A, non‐B virus in intravenous immunoglobulin.