TSE Agent Clearance Issues. TSE Advisory Committee February 20, 2003 Dorothy Scott, M.D. DH/OBRR/CBER/FDA. Paradigm: Validation of Virus Removal/inactivation Includes:. Scaling down process steps Spiking appropriate steps with high titer of infectious agent (actual or model)
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TSE Advisory Committee
February 20, 2003
Dorothy Scott, M.D.
TSE Spike Plasma
Cryopoor Plasma Supernatant
1PI, ATIII, etc.
Cai, K. et. al. Biochem Biophys Acta 1597(1): 28-35, 2002
Starting MaterialDepth FilterReduction Factor (log10)
Fr V (albumin) Seitz KS80 > 4.9
Fr V (albumin) CUNO Delipid 1 2.3
S I + III (IGIV) Millipore AP20 < 1
Fr II (IGIV) Seitz K200 > 2.8
Foster et. al., Vox Sang 78: 86-95, 2000
Fr I supernatant (IGIV, albumin) Supra P80 < 1
Fr V supernatant (albumin) Supra P80 > 1.1
Fr V supernatant (albumin) –
Prp-sc spike Supra P80 > 2.4
Vey et al, Biologicals 30:187-96, 2002