BACKGROUND: Data are lacking on the impact that the intensity of serial donor plasmapheresis has on the quality of source plasma. A study was conducted to examine the quality of source plasma produced by intensive plasmapheresis and slow deep-freezing and to compare it to source plasma manufactured by moderate plasmapheresis and rapid freezing. STUDY DESIGN AND METHODS: Seventy-five plasma samples from intensive plasmapheresis programs (Group 1) and 75 plasma units from moderate plasmapheresis programs (Group 2) were examined. The plasma had been deep-frozen either slowly at -30 degrees C in walk-in freezers (Group 1) or rapidly within 1 hour to a core temperature below -30 degrees C (Group 2). Determinations were made of the plasma levels of citrate; total protein; albumin; IgG; fibrinogen; factors II, V, VII, VIII, and IX; vWF; antithrombin; protein C; D-dimers; and prothrombin fragments 1+ 2. RESULTS: Plasma units of Group 2 contained substantially greater levels of citrate, IgG, FVIII, and FV than samples of Group 1 (p<0.0001). Plasma levels of total protein, albumin, and fibrinogen also were higher in Group 2 (p<0.0001, p = 0.007, and p = 0.006, respectively). Neither plasmapheresis intensity nor freezing procedure had any influence on the levels of factors II, VII, and IX, antithrombin, or protein C. There was no evidence of substantial coagulation activation in the plasma units of either group. However, higher FVIII clotting activity/chromogenic substrate activity ratios in rapidly frozen plasmas and a significant correlation between these ratios and prothrombin fragment 1+ 2 levels suggest that rapid freezing yields both more native FVIII and greater partial activation of FVIII. CONCLUSION: Source plasma collected from donors undergoing intensified plasmapheresis contains markedly lower levels of IgG than plasma units produced by moderate serial plasmapheresis. The combination of intensified plasmapheresis and slower freezing of source plasma results in substantially lower levels of FV and FVIII than does moderate plasmapheresis with rapid freezing. Prospective studies should establish the optimum conditions required for the safe and economic production of source plasma for fractionation.
BACKGROUND: Data are lacking on the impact that the intensity of serial donor plasmapheresis has on the quality of source plasma. A study was conducted to examine the quality of source plasma produced by intensive plasmapheresis and slow deep-freezing and to compare it to source plasma manufactured by moderate plasmapheresis and rapid freezing. STUDY DESIGN AND METHODS: Seventy-five plasma samples from intensive plasmapheresis programs (Group 1) and 75 plasma units from moderate plasmapheresis programs (Group 2) were examined. The plasma had been deep-frozen either slowly at -30 degrees C in walk-in freezers (Group 1) or rapidly within 1 hour to a core temperature below -30 degrees C (Group 2). Determinations were made of the plasma levels of citrate; total protein; albumin; IgG; fibrinogen; factors II, V, VII, VIII, and IX; vWF; antithrombin; protein C; D-dimers; and prothrombin fragments 1+ 2. RESULTS: Plasma units of Group 2 contained substantially greater levels of citrate, IgG, FVIII, and FV than samples of Group 1 (p<0.0001). Plasma levels of total protein, albumin, and fibrinogen also were higher in Group 2 (p<0.0001, p = 0.007, and p = 0.006, respectively). Neither plasmapheresis intensity nor freezing procedure had any influence on the levels of factors II, VII, and IX, antithrombin, or protein C. There was no evidence of substantial coagulation activation in the plasma units of either group. However, higher FVIII clotting activity/chromogenic substrate activity ratios in rapidly frozen plasmas and a significant correlation between these ratios and prothrombin fragment 1+ 2 levels suggest that rapid freezing yields both more native FVIII and greater partial activation of FVIII. CONCLUSION: Source plasma collected from donors undergoing intensified plasmapheresis contains markedly lower levels of IgG than plasma units produced by moderate serial plasmapheresis. The combination of intensified plasmapheresis and slower freezing of source plasma results in substantially lower levels of FV and FVIII than does moderate plasmapheresis with rapid freezing. Prospective studies should establish the optimum conditions required for the safe and economic production of source plasma for fractionation.