Elimination of infectious retroviruses during preparation of immunoglobulins

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Abstract
Safety concerns for immunoglobulin preparations have led us to study partition/inactivation of two prototype retroviruses, mouse xenotropic type C and lymphadenopathy-associated virus (LAV) of the acquired immunodeficiency syndrome (AIDS), during manufacture and storage of immunoglobulins. Reduction of infectious retrovirus titers were 105 to 108-fold through Cohn-Oncley cold ethanol fractionation from plasma to fraction II, 103 to 105-fold through incubation at pH 4.0 and another 104-fold through incubation of the purified liquid immunoglobulin preparations at 27°C or 45°C. The results support the clinical and epidemiological evidence that therapeutic immunoglobulin preparations do not transmit AIDS virus.