A strategy for testing established human plasma protein manufacturing procedures for their ability to inactivate or...

The manufacturing procedures used for the preparation of human plasma proteins that were established before AIDS was first described may reasonably be expected to provide AIDS safe products. Such manufacturing procedures are heat treatment at 60 degrees C in solution for ten hours, described as pasteurization, preparation of human immunoglobulins by ethanol precipitation, pepsin treatment, and sulfonation. To test whether these methods effectively inactivated and/or eliminated the AIDS causing human immunodeficiency virus (HIV), nine volumes or more of plasma or a plasma fraction taken from a production lot were spiked with HIV using one volume of a HIV concentrate and were then subjected to exactly the same procedure as that specified for the manufacturing process. HIV infectivity titres of the initial HIV/plasma protein mixtures and of the resulting products after treatment were determined by the H9 cell assay. In all cases studied complete inactivation/elimination of the added HIV was achieved. We therefore conclude that pasteurization of human plasma proteins or the manufacturing procedure used for the isolation of immunoglobulins from plasma pools result in final products which do not contain any infectious HIV and which are thus safe in that they cannot be vehicles for the transmission of AIDS.