ABSTRACT
The transmittance of pathogenic viruses by the widespread administration of protein fractions such as F VIII prepared on a large scale from pooled human plasma has been of growing concern. We have now demonstrated that significant amounts of pathogenic viruses including LAV/HTLVIII may be removed by a new large scale fractionation process for the preparation of human F VIII (Monoclate) which employs immunoaffinity chromatography. Model viruses representative of different virus families and the LAV strain of HIV were added to cryoprecipitate and then the mixture was processed as for Monoclate manufacturing. Virus titers were determined at each step of the fractionation procedures. An overall reduction of at least 6 logs was obtained for the model viruses and the HIV due to the purification process. An added heating step further increased the safety margin for the product resulting in at least an overall reduction of 7-9 logs for HIV. Clinical experience with Monoclate in virgin hemophiliacs has confirmed its viral safety. Our laboratories are exploiting a similar strategy of immunoaffinity chromatography to ensure the viral safety of FIX and protein C preparations derived from plasma.