Table 1.
Type of plasma | Source and quality | Pool size | Inactivation time and temperature | Removal of abnormal prion binding protein (PrPSc) | Final product |
---|---|---|---|---|---|
Octaplas (Austria) | high-quality apheresis or recovered plasma* | 380 l (630 apheresis units or 1,520 recovered units) | 4 h at 30 °C (1% TNBP + 1% Triton X-100) | 2.5 log reduction of PrPSc as a result of the SD manufacturing process | 200 ml frozen in plastic bags |
OctaplasLG (Austria) | high-quality apheresis or recovered plasma* | 380 l (630 apheresis units or 1,520 recovered units) | 1–1.5 h at 30 °C (1% TNBP + 1% Triton X-100) | > 5 log reduction of PrPSc after additional affinity chromatography with PrPSc binding ligand | 200 ml frozen in plastic bags |
Plasmasafe (Italy) | high-quality apheresis or recovered plasma* | 380 l (630 apheresis units or 1,520 recovered units) | 4 h at 30 °C (1% TNBP + 1% Triton X-100) | not documented, but probably similar to Octaplas | 200 ml frozen in plastic bags |
Plasma viro-atténué Solvant détergent (France) | high-quality apheresis plasma | 60 l (100 apheresis units) | 4 h at 30 °C (1% TNBP + 1% Triton X-100) | not documented, but probably similar to Octaplas | 200 ml frozen in plastic bags |
Bioplasma FDP (South Africa) | high-quality recovered plasma | 200 l | 4 h at 30 °C (1% TNBP + 1% Triton X-100) | not documented, but probably similar to Octaplas | 50 and 200 ml lyophilized in glass bottles |
PLAS+SD (USA) | recovered plasma frozen next day | 650 l (2,500 recovered units) | 4 h at 30 °C (1% TNBP + 1% Triton X-100) | not documented, but probably similar to Octaplas | 200 ml frozen in plastic bags (produced from 1998 to 2002) |
‘Mini-pool’ (for blood bank application in resource limited countries) | recovered plasma | 5–10 l | 4 h at 31 °C (1% TNBP + 1% Triton X-45) | unknown | depending upon local practice |
or | |||||
4 h at 37 °C (2% TNBP) |
Except Octaplas specially produced for Ireland where recovered US plasma of similar quality as that for PLAS+SD was used.