Inactivation and Clearance of Viruses During the Manufacture of High Purity Factor IX

The Use of Chromatography to Manufacture Purer and Safer Plasma Products

“…(1993) showed 2-3 log of enveloped viruses. Both Johnston et al (2000a) and Herring et al (1993) obtained a consistent log reduction of 1.6-1.9 for non-enveloped viruses.…”

“…Other conflicting examples are illustrated by Bees et al (1989) and Burnouf (1993). On the other hand, several studies showed comparable results between sindbis virus and HIV (Jernberg etal., 1996: Schreiber etal., 1989 between EMCV and HAV (Johnston et al, 2000a) and between BVDV and HCV (Johnston et al, 2000b).…”

“…Results of Jemberg et al (1996) show that combining two ion exchange steps and an affinity step gave overall log reductions of 3.7 for HIV, 4.5 for VSV, 5.2 for sindbis virus and 3.1 for CPV. In a similar process with two ion exchange steps and an affinity step, Johnston et al (2000a) showed an overall reduction of 3.6 for HIV. In the two steps studied by Michalski et a/.…”

“…The final affinity step (heparin Sepharose CL-6B) was added to remove Factors II and X. A similar process used by CSL Limited (Melbourne, Australia) has been described by Johnston et al (2000a).…”

“…These products are included in Table 2.7. Briefly, Burnouf (1993), Biescas et al (1998), andJohnston et a/. (2000a) demonstrated some reduction of a range of viruses (HIV, SV-40, VSV, PRV, BVDV and HAV) over a heparin affinity step in the manufacturing of antithrombin III.…”